Iveegam EN

Generic Name: immune globulin (Intramuscular route, Intravenous route, Subcutaneous route)

i-MUNE GLOB-ue-lin

Intravenous route(Powder for Solution;Solution)

Immune globulin intravenous (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Use caution in patients predisposed to acute renal failure and administer at the minimum concentration available and the minimum rate of infusion practicable in such patients. Higher rates of renal failure were associated with IGIV products containing sucrose . Flebogamma(R) 5%, Flebogamma(R) 5% DIF, Flebogamma(R) 10% DIF, Gammagard (R), Gamunex(R)-C, and Previgen(R) do not contain sucrose . Glycine is used as a stabilizer in Gamunex(R)-C .

Subcutaneous route(Solution)

Immune globulin intravenous (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Use caution in patients predisposed to acute renal failure and administer at the minimum concentration available and the minimum rate of infusion practicable in such patients. Higher rates of renal failure were associated with IGIV products containing sucrose. Gammagard(R) does not contain sucrose .

Commonly used brand name(s)

In the U.S.

• Baygam


• Carimune


• Gamimune N


• Gammagard


• Gammar-P


• Hizentra


• Iveegam EN


• Octagam


• Panglobulin NF


• Polygam S/D


• Sandoglobulin


• Vivaglobin

Available Dosage Forms:

• Solution


• Powder for Solution

Therapeutic Class: Immune Serum

Uses For Iveegam EN

Immune globulin injection belongs to a group of medicines known as immunizing agents. It is used to prevent or treat diseases that occur when your body has a weak immune system. Immune globulin contains antibodies that make your immune system stronger. It is used for patients who have primary humoral immunodeficiency (PI), idiopathic thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP).

This medicine is to be administered only by or under the supervision of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, immune globulin is used in certain patients with the following medical conditions:

• Chronic parvovirus B19 infection (treatment).


• Dermatomyositis (treatment).


• Guillain-Barré syndrome (treatment).


• Hyperimmunoglobulinemia E syndrome (treatment).


• Infections in low-birth-weight preterm high-risk neonates (prophylaxis and treatment adjunct).


• Lambert-Eaton myasthenic syndrome (treatment).


• Multifocal motor neuropathy (treatment).


• Relapsing-remitting multiple sclerosis (treatment).

Before Using Iveegam EN

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of immune globulin injection in children. However, safety and efficacy have not been established in children with CIDP, safety and efficacy have not been established for Flebogamma® and subcutaneous injection of Gamunex®-C in children with PI, and safety and efficacy have not been established for Gammagard Liquid and Vivaglobin® in children younger than 2 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of immune globulin injection in the elderly. However, elderly patients are more likely to have age-related blood clotting problems, kidney disease, or heart disease, which may require caution for patients receiving immune globulin injection.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia, history of or


• Bleeding problems, history of or


• Hyponatremia (low sodium in the blood) or


• Kidney problems—Use with caution. May make these conditions worse.

• Atherosclerosis (hardening of the arteries), history of or


• Blood clotting problems, history of or


• Diabetes or


• Heart attack or stroke, recent or


• Heart or blood vessel disease or


• Hyperproteinemia (high protein in the blood) or


• Hyperviscosity (thick blood), known or suspected or


• Hypovolemia (low blood volume or major loss of body fluids) or


• IgA (immunoglobulin A) deficiency with antibodies against IgA or


• Paraproteinemia (paraproteins in the blood) or


• Sepsis (serious infection in the body)—Use with caution. May cause side effects to become worse.

Proper Use of immune globulin

This section provides information on the proper use of a number of products that contain immune globulin. It may not be specific to Iveegam EN. Please read with care.

A doctor or other trained health professional will give you or your child this medicine. This medicine is given through a needle placed in one of your veins, as a shot into one of your muscles, or as a shot under your skin.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

While you or your child are being treated with immune globulin injection, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given for 3 months after receiving immune globulin.

The Gammagard Liquid, Gamunex®-C, Hizentra®, and Vivaglobin® products may sometimes be given at home to patients who do not need to be in the hospital or clinic. They are given as an infusion under your skin once every week. If you or your child are using this medicine at home, your doctor will teach you how to prepare and infuse the medicine. Be sure you understand how to use the medicine.

Do not change the brand or type of your immune globulin unless your doctor tells you to. If you or your child must change the brand or type of medicine, talk to your doctor before giving yourself an injection.

If you or your child are using Gammagard Liquid, Gamunex®-C, Hizentra®, or Vivaglobin® at home, you will be shown the body areas where the medicine can be given. Use a different body area each time you give yourself an infusion. Keep track of where you give each infusion to make sure you rotate body areas. This will help prevent skin problems.

Allow the Gammagard Liquid, Gamunex®-C, or Vivaglobin® brand to reach room temperature before using it.

To use Gammagard Liquid, Gamunex®-C, Hizentra®, or Vivaglobin®:

• First, gather the items you will need on a clean, flat surface using a cloth or towel in a well-lighted area.


• Wash your hands with soap and water before and after using this medicine.


• If you have been told to wear gloves when preparing your infusion, put the gloves on.


• Check the liquid in the vial (glass container). It should be clear and slightly yellow to light brown in color. If it is cloudy, discolored, or contains large flecks (particles), do not use the vial. Select another vial.


• If the liquid is clear, place it on the clean, flat surface. Do not heat up or shake the medicine.


• Follow your doctor's instructions on how to prepare the correct amount of medicine.


• Choose an injection site on your body (e.g., abdomen or stomach area, thigh, upper arm, upper leg, or hip). Clean the injection site with a fresh alcohol wipe, and let it dry.


• With two fingers, pinch together the skin at the injection site. Insert the needle with the tube under the skin.


• Put sterile gauze and tape over the injection site to keep the needle from coming out.


• Before starting the infusion, make sure no blood is flowing into the infusion tube. If blood is present, remove and throw away the used needle and tube.


• Follow your doctor's instructions on how to use the infusion pump.


• Remove the peel-off portion of the label from the used vial. Place this label in your treatment diary or log book. Write down the amount of medicine you used, the date, and the time of your treatment.


• It usually takes about 60 minutes for each infusion.


• When all of the medicine has been infused, turn off the pump.


• Take the gauze off and remove the needle and tube from your skin.


• Clean and store the infusion pump.


• Throw away used needles and tubes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the Hizentra® product at room temperature, away from heat and moisture. Keep from freezing.

Protect the Hizentra® product from direct light. Keep the medicine in the original package until you are ready to use it.

Store the Gamunex®-C and Vivaglobin® products in the refrigerator, but do not freeze the medicine. Store it in the original container.

You may store the Gammagard Liquid product in the refrigerator for 36 months, or at room temperature for up to 12 months (if within the first 24 months of the date of manufacture). Check the box for the date of manufacture. Store it in the original container. Do not freeze. Talk with your pharmacist if you have questions about storage of this product.

Precautions While Using Iveegam EN

It is very important that your doctor check the progress of you or your child at regular visits for any problems that may be caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.

Patients with idiopathic thrombocytopenic purpura (ITP) should not be treated with Gamunex®-C that is injected under the skin (subcutaneously). Doing so may increase the risk of having a hematoma (buildup of blood under the skin).

This medicine may cause fever, chills, flushing, headaches, nausea, and vomiting, especially if you are receiving it for the first time or if you have not received it for more than 8 weeks. Check with your doctor or nurse right away if you have any of these symptoms.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and required testing of the medicine when it is made. Although the risk is low, talk with your doctor if you have concerns.

This medicine may cause a serious type of allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, hives, chest pain, dizziness or lightheadedness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine. Certain people, including those with IgA (an immunoglobulin) deficiency and antibodies against IgA and a history of hypersensitivity to human immunoglobulin products should not use this medicine.

Check with your doctor right away if you or your child start to have a stiff neck, drowsiness, fever, severe headache, nausea or vomiting, painful eye movements, or eye sensitivity to light. These could be symptoms of a serious condition called aseptic meningitis syndrome (AMS).

This medicine may cause bleeding (hemolysis) or hemolytic anemia. Tell your doctor right away if you or your child have stomach or back pain, dark urine, decreased urination, difficulty with breathing, an increased heart rate, tiredness, or yellow eyes or skin after you receive the medicine.

Check with your doctor right away if you or your child start having chest pain; difficult, fast, or noisy breathing, sometimes with wheezing; blue lips and fingernails; fever; pale skin; increased sweating; coughing that sometimes produces a pink frothy sputum; shortness of breath; or swelling of the legs and ankles, after receiving this medicine. These may be symptoms of a serious lung problem.

This medicine may cause blood clots. This is more likely to occur if you have a history of blood clotting problems, heart disease, or atherosclerosis (hardening of the arteries), or if you are obese, take medicines containing estrogen, or must stay in bed for a long time because of surgery or illness. Check with your doctor right away if you or your child suddenly have chest pain, shortness of breath, a severe headache, leg pain, or problems with vision, speech, or walking. .

Check with your doctor right away if you or your child start having red or dark brown urine; lower back or side pain; a sudden weight gain; a swollen face, arms, or legs; decreased urine output; or any problems with urination after you receive this medicine. These may be symptoms of a serious kidney problem.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Iveegam EN Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Chills


• cough


• difficulty with breathing


• fast, pounding, or irregular heartbeat or pulse


• fever


• noisy breathing


• shortness of breath


• tightness in the chest


• troubled breathing


• unusual tiredness or weakness

Less common

• Bluish coloring of the lips or nailbeds


• burning sensation in the head


• faintness or lightheadedness

Rare

• Difficulty with swallowing


• hives or welts


• itching, especially of the feet or hands


• reddening of the skin, especially around the ears


• swelling of the eyes, face, or inside of the nose

Incidence not known

• Back, leg, or stomach pains


• bleeding gums


• blistering, peeling, or loosening of the skin


• bloody, black, or tarry stools


• blurred vision


• change in consciousness


• chest pain or discomfort


• cold, clammy, or pale skin


• confusion


• convulsions


• coughing that sometimes produces a pink frothy sputum


• dark urine


• decrease in urine amount


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• fever with or without chills


• headache that is severe and occurs suddenly


• increased sweating


• light-colored stools


• loss of appetite


• loss of bladder control


• loss of consciousness


• low blood pressure or pulse


• muscle spasm or jerking of all extremities


• nausea or vomiting


• nosebleeds


• painful or difficult urination


• pains in the chest, groin, or legs, especially calves of the legs


• red skin lesions, often with a purple center


• red, irritated eyes


• shakiness in the legs, arms, hands, or feet


• shivering


• skin blisters


• slurred speech that occurs suddenly


• slow breathing


• sores, ulcers, or white spots in the mouth or on the lips


• sudden loss of consciousness


• sudden loss of coordination


• sudden vision changes


• sudden, severe weakness or numbness in the arm or leg


• sweating


• swelling in the legs and ankles


• tightness in the chest


• trembling or shaking of the hands or feet


• unusual bleeding or bruising


• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea


• dizziness


• headache


• joint pain


• muscle pain


• redness, swelling, itching, or pain at the injection site


• skin rash

Less common

• Hip pain


• leg cramps

Incidence not known

• Feeling of warmth


• redness of the face, neck, arms, and occasionally, upper chest


• stomach pain


• swollen glands


• tiredness


• weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Iveegam EN side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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More Iveegam EN resources

• Iveegam EN Side Effects (in more detail)
• Iveegam EN Use in Pregnancy & Breastfeeding
• Iveegam EN Drug Interactions
• Iveegam EN Support Group
• 0 Reviews for Iveegam EN - Add your own review/rating

• Carimune Prescribing Information (FDA)


• Flebogamma MedFacts Consumer Leaflet (Wolters Kluwer)


• Flebogamma Prescribing Information (FDA)


• Gammaplex Prescribing Information (FDA)


• Gammar-P I.V. Consumer Overview


• Gammar-P I.V.


• Gamunex MedFacts Consumer Leaflet (Wolters Kluwer)


• Gamunex Consumer Overview


• Octagam Prescribing Information (FDA)


• Octagam Consumer Overview


• Privigen Prescribing Information (FDA)


• Privigen Consumer Overview

Compare Iveegam EN with other medications

• Autoimmune Neutropenia
• Bone Marrow Transplantation
• Chronic Lymphocytic Leukemia
• Evan's Syndrome
• HIV Infection
• Idiopathic Thrombocytopenic Purpura
• Kawasaki Disease
• Polymyositis/Dermatomyositis
• Primary Immunodeficiency Syndrome

Theraflu Multi-Symptom Severe Cold

Generic Name: acetaminophen, dextromethorphan, and phenylephrine (a SEET a MIN of fen, DEX troe me THOR fan, and FEN il EFF rin)

Brand Names: Comtrex Cold & Cough, Daytime, Flu & Severe Cold & Cough Daytime Powder, Mapap Cold Formula, Theraflu Daytime Severe Cold & Cough, Theraflu Multi-Symptom Severe Cold, Theraflu Nighttime Severe Cold & Cough, Theraflu Warming Relief Daytime Multi-Symptom Cold, Theraflu Warming Severe Cold Daytime, Tylenol Children's Plus Cold & Cough, Tylenol Cold Multi-Symptom Daytime

What is Theraflu Multi-Symptom Severe Cold (acetaminophen, dextromethorphan, and phenylephrine)?

Acetaminophen is a pain reliever and fever reducer.

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of acetaminophen, dextromethorphan, and phenylephrine is used to treat headache, fever, body aches, cough, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.

Acetaminophen, dextromethorphan, and phenylephrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about this medicine?

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

What should I discuss with my healthcare provider before taking this medicine?

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take acetaminophen, dextromethorphan, and phenylephrine if you have:

• 
  

  liver disease, cirrhosis, or a history of alcoholism;

  
  


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  diabetes;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  enlarged prostate or urination problems;

  
  


• 
  

  pheochromocytoma (an adrenal gland tumor); or

  
  


• 
  

  cough with mucus, or cough caused by emphysema or chronic bronchitis.

  
  

It is not known whether acetaminophen, dextromethorphan, and phenylephrine will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant. Acetaminophen, dextromethorphan, and phenylephrine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Artificially sweetened cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take this medicine?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

Measure liquid medicine with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one.

Dissolve one packet of the powder in at least 4 ounces of water. Stir this mixture and drink all of it right away.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days. Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

What happens if I miss a dose?

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking this medicine?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen.

This medicine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. chest pain, fast, slow, or uneven heart rate; Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  chest pain, fast, slow, or uneven heart rate;

  
  


• 
  

  severe dizziness, feeling like you might pass out;

  
  


• 
  

  mood changes, confusion, hallucinations;

  
  


• 
  

  tremor, seizure (convulsions);

  
  


• 
  

  fever;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or

  
  


• 
  

  nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, uneven heartbeats, seizure).

  
  

Less serious side effects may include:

• 
  

  dizziness, weakness;

  
  


• 
  

  mild headache;

  
  


• 
  

  mild nausea, diarrhea, upset stomach;

  
  


• 
  

  dry mouth, nose, or throat;

  
  


• 
  

  feeling nervous, restless, irritable, or anxious; or

  
  


• 
  

  sleep problems (insomnia).

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect this medicine?

Ask a doctor or pharmacist if it is safe for you to take this medicine if you are also using any of the following drugs:

• 
  

  leflunomide (Arava);

  
  


• 
  

  tapentadol (Nucynta);

  
  


• 
  

  an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

  
  


• 
  

  an antidepressant;

  
  


• 
  

  birth control pills or hormone replacement therapy;

  
  


• 
  

  blood pressure medication;

  
  


• 
  

  cancer medicine;

  
  


• 
  

  cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

  
  


• 
  

  gout or arthritis medications (including gold injections);

  
  


• 
  

  HIV/AIDS medication;

  
  


• 
  

  medicines to treat psychiatric disorders;

  
  


• 
  

  migraine headache medicine;

  
  


• 
  

  an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

  
  


• 
  

  seizure medication.

  
  

This list is not complete and other drugs may interact with acetaminophen, dextromethorphan, and phenylephrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Theraflu Multi-Symptom Severe Cold resources

• Theraflu Multi-Symptom Severe Cold Use in Pregnancy & Breastfeeding
• Theraflu Multi-Symptom Severe Cold Drug Interactions
• 0 Reviews for Theraflu Multi-Symptom Severe Cold - Add your own review/rating

• Tylenol Cold Multi-Symptom Daytime Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Theraflu Multi-Symptom Severe Cold with other medications

• Cold Symptoms
• Cough
• Cough and Nasal Congestion
• Nasal Congestion
• Pain/Fever
• Sinus Symptoms
• Tonsillitis/Pharyngitis

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen, dextromethorphan, and phenylephrine.

Broflex Syrup 5mg / 5ml

1. Name Of The Medicinal Product

Broflex syrup (5mg/5mL).

2. Qualitative And Quantitative Composition

Trihexyphenidyl hydrochloride BP 5mg/5mL.

3. Pharmaceutical Form

A blackcurrant scented and flavoured clear pink syrup.

4. Clinical Particulars

4.1 Therapeutic Indications

Parkinsonism and drug induced extrapyramidal syndrome.

4.2 Posology And Method Of Administration

Adults and Elderly:

Initial dose 2mg. Subsequent doses up to 20mg as recommended by a physician.

Children:

Not recommended.

4.3 Contraindications

Hypersensitivity to trihexyphenidyl or any of the other ingredients.

Incipient glaucoma may be precipitated. The following are not absolute contra-indications, nevertheless caution must be observed in patients with: hypertension, cardiac, liver or kidney dysfunction, glaucoma, obstructive disease of the gastro-intestinal or genito-urinary tracts and in males with a prostatic hypertrophy.

4.4 Special Warnings And Precautions For Use

Anticholinergic medications, including trihexyphenidyl, should not be withdrawn abruptly in patients on long-term therapy, to avoid recurrence of the original symptoms and possible anticholinergic rebound. Prescribers should be aware that trihexyphenidyl may be the subject of abuse due to its euphoric or hallucinogenic properties.

Since atropine-like drugs may cause psychiatric symptoms such as confusion, delusion and hallucinations, trihexyphenidyl should be used with extreme caution in elderly patients.

As trihexyphenidyl may provoke or exacerbate tardive dyskinesia, it is not recommended for use in patients with this condition.

Since trihexyphenidyl has been associated with clinical worsening of myasthenia gravis, the drug should be avoided or used with great caution in patients with myasthenia gravis.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsoprtion or sucrase-maltase insufficiency should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Monoamine oxidase inhibitors (MAOI's), antihistamines, disopyramide, phenothiazines and tricyclic antidepressants increase the side effects of blurred vision and dry mouth, constipation, urinary retention. MAOI's, amantidine and some tricyclic antidepressents may also cause excitation, confusion and hallucination.

4.6 Pregnancy And Lactation

Pregnancy

There is inadequate information regarding the use of trihexyphenidyl in pregnancy. Animal studies are insufficient with regard to effects on pregnancy, embryonal/foetal development, parturition and postnatal development. The potential risk for humans is unknown. Trihexyphenidyl should not be used during pregnancy unless clearly necessary.

Lactation

It is unknown whether trihexyphenidyl is excreted in human breast milk. The excretion of trihexyphenidyl in milk has not been studied in animals. Infants may be very sensitive to the effects of antimuscarinic medications. Trihexyphenidyl should not be used during breast feeding.

4.7 Effects On Ability To Drive And Use Machines

Patients should be warned of the potential hazards of driving or operating machinery if they experience blurred vision or a reduction in alertness.

4.8 Undesirable Effects

Dry mouth, constipation and blurred vision may occur. This is more frequent in the elderly but reduces with tolerance. Psychiatric symptoms such as agitation, confusion, hallucinations, euphoria, insomnia, restlessness and very occasionally paranoid delusions have been reported. These are more likely to occur in patients receiving higher than recommended doses. There have been reports of abuse of trihexyphenidyl due to its euphoric and hallucinogenic properties.

Impairment of immediate and short-term memory functions has also been reported.

4.9 Overdose

Symptoms

Symptoms of overdose with antimuscarinic agents include flushing and dryness of the skin, dilated pupils, dry mouth and tongue, tachycardia, rapid respiration, hyperpyrexia, hypertension, nausea, vomiting. A rash may appear on the face or upper trunk. Symptoms of CNS stimulation include restlessness, confusion, hallucinations, paranoid and psychotic reactions, incoordination, delirium and occasionally convulsions. In severe overdose, CNS depression may occur with coma, circulatory and respiratory failure and death.

Treatment

Treatment should always be supportive. An adequate airway should be maintained. Diazepam may be administered to control excitement and convulsions but the risk of central nervous system depression should be considered. Hypoxia and acidosis should be corrected. Antiarrhythmic drugs are not recommended if dysrhythmias occur.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Trihexyphenidyl is a tertiary amine antimuscarinic. It also has a direct antispasmodic action on smooth muscle.

5.2 Pharmacokinetic Properties

Trihexyphenidyl is well absorbed from the gastro-intestinal tract.

5.3 Preclinical Safety Data

No formal preclinical studies have been undertaken with Broflex, as its active ingredient is a well established pharmaceutical.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Anhydrous citric acid, benzoic acid, propylene glycol, amaranth E123, glycerol, chloroform spirit, blackcurrant flavour A402, syrup, purified water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

200 mL pack size in amber glass bottle with polycone lined enclosure.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Alliance Pharmaceuticals Ltd

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

8. Marketing Authorisation Number(S)

PL16853/0023

9. Date Of First Authorisation/Renewal Of The Authorisation

30 June 1999

10. Date Of Revision Of The Text

25^th July 2007.

Alliance, Alliance Pharmaceuticals and associated devices are registered Trademarks of Alliance Pharmaceuticals Ltd.

Insulin Isophane Pens

Pronunciation: IN-su-lin EYE-soe-fane
Generic Name: Insulin Isophane
Brand Name: Examples include Humulin N and Novolin N

Insulin Isophane Pens are used for:

Treating diabetes mellitus.

Insulin Isophane Pens are an intermediate-acting form of the hormone insulin. It works by helping your body to use sugar properly. This lowers the amount of glucose in the blood, which helps to treat diabetes.

Do NOT use Insulin Isophane Pens if:

• you are allergic to any ingredient in Insulin Isophane Pens


• you are having an episode of low blood sugar

Contact your doctor or health care provider right away if any of these apply to you.

Before using Insulin Isophane Pens:

Some medical conditions may interact with Insulin Isophane Pens. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you drink alcoholic beverages or smoke


• if you have kidney or liver problems; nerve problems; adrenal, pituitary, or thyroid problems; or diabetic ketoacidosis


• if you use 3 or more insulin injections per day


• if you are fasting, have high blood sodium levels, or are on a low-salt (sodium) diet

Some MEDICINES MAY INTERACT with Insulin Isophane Pens. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), clonidine, guanethidine, lithium, or reserpine because they may increase the risk of high or low blood sugar, or may hide the signs and symptoms of low blood sugar, if it occurs


• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), disopyramide, fenfluramine, fibrates (eg, clofibrate, gemfibrozil), fluoxetine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), oral medicines for diabetes (eg, glipizide, metformin, nateglinide), pentamidine, propoxyphene, salicylates (eg, aspirin), somatostatin analogs (eg, octreotide), or sulfonamide antibiotics (eg, sulfamethoxazole) because the risk of low blood sugar may be increased


• Corticosteroids (eg, prednisone), danazol, diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives (eg, birth control pills), isoniazid, niacin, phenothiazines (eg, chlorpromazine), progesterones (eg, medroxyprogesterone), somatropin, sympathomimetics (eg, albuterol, epinephrine, terbutaline), or thyroid hormones (eg, levothyroxine) because they may decrease Insulin Isophane Pens's effectiveness, resulting in high blood sugar

This may not be a complete list of all interactions that may occur. Ask your health care provider if Insulin Isophane Pens may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Insulin Isophane Pens:

Use Insulin Isophane Pens as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Insulin Isophane Pens. Talk to your pharmacist if you have questions about this information.


• Check with your doctor about how you should use Insulin Isophane Pens with regard to meals.


• If you will be using Insulin Isophane Pens at home, a health care provider will teach you how to use it. Be sure you understand how to use Insulin Isophane Pens. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Carefully rotate the vial or container as directed before each injection. This will ensure that the contents are evenly mixed. This insulin should look uniformly cloudy or milky.


• Do not use Insulin Isophane Pens if it contains particles or clumps, is discolored, or if the vial or container is cracked or damaged.


• If you are mixing Insulin Isophane Pens with another insulin, draw the other insulin into the syringe first. Inject the dose immediately after mixing, as directed by your doctor.


• Do NOT use Insulin Isophane Pens in an insulin pump.


• Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into a vein or muscle.


• Injection sites within an injection area (abdomen, thigh, upper arm) must be rotated from one injection to the next.


• Be sure you have purchased the correct insulin. Insulin comes in a variety of containers, including vials, cartridges, and pens. Make sure that you understand how to properly measure and prepare your dose. If you have any questions about measuring and preparing your dose, contact your doctor or pharmacist for information.


• Insulin Isophane Pens begins lowering blood sugar within 30 to 90 minutes after an injection. The peak effect occurs within 4 to 12 hours after a dose. The effect may last for up to 24 hours.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• It is very important to follow your insulin regimen exactly. Do NOT miss any doses. Ask your doctor for specific instructions to follow in case you ever miss a dose of insulin.

Ask your health care provider any questions you may have about how to use Insulin Isophane Pens.

Important safety information:

• Drowsiness, dizziness, lightheadedness, or blurred vision may occur while you use Insulin Isophane Pens. These effects may be worse if you take it with alcohol or certain medicines. Use Insulin Isophane Pens with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol without discussing it with your doctor. Drinking alcohol may increase the risk of developing high or low blood sugar.


• Do NOT take more than the recommended dose, use Insulin Isophane Pens more often than prescribed, or change the type or dose of insulin you are using without checking with your doctor.


• Any change of insulin should be made cautiously and only under medical supervision. Changes in purity, strength, brand (manufacturer), type (regular, NPH, lente), species (beef, pork, beef-pork, human), and/or method of manufacture may require a change in dose.


• Illness, especially with nausea and vomiting, may cause your insulin requirements to change. Even if you are not eating, you still require insulin. You and your doctor should establish a sick day plan to use in case of illness. When you are sick, test your blood/urine frequently and call your doctor as instructed.


• Tell your doctor or dentist that you take Insulin Isophane Pens before you receive any medical or dental care, emergency care, or surgery.


• If you will be traveling across time zones, consult your doctor concerning adjustments in your insulin schedule.


• Carry an ID card at all times that says you have diabetes.


• An insulin reaction resulting from low blood sugar levels (hypoglycemia) may occur if you take too much insulin, skip a meal, or exercise too much. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.


• Developing a fever or infection, eating significantly more than prescribed, or missing your dose of insulin may cause high blood sugar (hyperglycemia). High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell you doctor right away.


• Check with your doctor if you notice a depression in the skin or skin thickening at the injection site. You may need to change your injection technique.


• Proper diet, regular exercise, and regular testing of blood sugar are important for best results when using Insulin Isophane Pens.


• Lab tests, including fasting blood glucose and hemoglobin A_1c levels, may be performed while you use Insulin Isophane Pens. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Insulin Isophane Pens with caution in the ELDERLY; if low blood sugar occurs, it may be more difficult to recognize in these patients.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Insulin Isophane Pens while you are pregnant. It is not known if Insulin Isophane Pens are found in breast milk. If you are or will be breast-feeding while you use Insulin Isophane Pens, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Insulin Isophane Pens:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Redness, swelling, itching, or mild pain at the injection site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing; muscle pain); changes in vision; chills; confusion; dizziness; drowsiness; fainting; fast or irregular heartbeat; headache; loss of consciousness; mood changes; seizures; slurred speech; swelling; tremor; trouble breathing; trouble concentrating; unusual hunger; unusual sweating; weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Insulin Isophane side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center or emergency room immediately. Symptoms may include chills; dizziness; drowsiness; fainting; fast or irregular heartbeat; headache; loss of consciousness; nervousness; seizures; shakiness; sweating; tremor; vision changes; weakness.

Proper storage of Insulin Isophane Pens:

VIALS: Store new (unopened) vials in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Certain brands of the medicine may be stored at room temperature, below 77 degrees F (25 degrees C) for up to 6 weeks (42 days), if refrigeration is not possible. Check with your pharmacist to see if your brand can be stored at room temperature. Keep Insulin Isophane Pens in the carton to protect from light.

Store used (open) vials as directed in the extra patient leaflet or by your health care provider. Check with your pharmacist to see how long unrefrigerated or opened vials may be used. Store away from heat and light. If Insulin Isophane Pens has been frozen or overheated, throw it away.

INNOLETS, PENS, and PENFILL CARTRIDGES: Store new (unopened) InnoLets, pens, or PenFill cartridges in a refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store used (open) InnoLets, pens, or PenFill cartridges at room temperature, below 86 degrees F (30 degrees C). Do NOT store used (open) InnoLets, pens, or PenFill cartridges in the refrigerator. Store away from heat and light. If Insulin Isophane Pens has been frozen or overheated, throw it away. Throw away unrefrigerated or used InnoLets, pens, or PenFill cartridges after 14 days, even if they still contain medicine.

Do not leave Insulin Isophane Pens in a car on a warm or sunny day. Do not use Insulin Isophane Pens after the expiration date stamped on the label. Keep Insulin Isophane Pens, as well as syringes and needles, out of the reach of children and away from pets. If Insulin Isophane Pens has been mixed with other medicines, you may need to store it differently. Ask your doctor, pharmacist, or other health care provider how to store Insulin Isophane Pens.

General information:

• If you have any questions about Insulin Isophane Pens, please talk with your doctor, pharmacist, or other health care provider.


• Insulin Isophane Pens are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Insulin Isophane Pens. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Insulin Isophane resources

• Insulin Isophane Side Effects (in more detail)
• Insulin Isophane Use in Pregnancy & Breastfeeding
• Insulin Isophane Drug Interactions
• Insulin Isophane Support Group
• 2 Reviews for Insulin Isophane - Add your own review/rating

Compare Insulin Isophane with other medications

• Diabetes, Type 1
• Diabetes, Type 2
• Gestational Diabetes

Konsyl-D

Generic Name: psyllium (SIL ee um)

Brand Names: Fiberall, Hydrocil, Konsyl, Konsyl Orange Sugar-free, Konsyl-D, Konsyl-Orange, Laxmar, Laxmar Orange, Laxmar Sugar Free, Metamucil, Metamucil Berry Burst Smooth Texture Sugar Free, Metamucil Orange Coarse Milled Original Texture, Metamucil Orange Smooth Texture, Metamucil Orange Smooth Texture Sugar Free, Metamucil Original Texture Regular, Metamucil Pink Lemonade Smooth Texture Sugar-Free, Metamucil Unflavored Coarse Milled Original Texture, Metamucil Unflavored Smooth Texture Sugar Free, Natural Fiber Therapy, Perdiem Fiber Powder, Reguloid

What is Konsyl-D (psyllium)?

Psyllium is a bulk-forming fiber laxative. Psyllium works by absorbing liquid in the intestines and swelling to create a softer, bulky stool that is easier to pass.

Psyllium is used to treat occasional constipation or bowel irregularity. Psyllium may also be used to treat diarrhea and may help lower cholesterol when used together with a diet low in cholesterol and saturated fat.

Psyllium may also be used for purposes not listed in this product guide.

What is the most important information I should know about Konsyl-D (psyllium)?

Laxatives may be habit-forming if they are used too often or for too long. This can lead to damage of intestinal nerves or muscle tissues. Do not take psyllium for longer than directed on the label or prescribed by your doctor. You should not take this product if you are allergic to psyllium, or if you have trouble swallowing, a sudden change in bowel habits that lasts longer than 2 weeks, severe nausea, vomiting, or stomach pain, or if you have ever had a skin rash while taking psyllium.

Also talk with your doctor before using psyllium if you have a colostomy or ileostomy, rectal bleeding, or a blockage in your intestines.

Stop using psyllium and call your doctor at once if you have choking or trouble swallowing, severe stomach pain or cramping, nausea or vomiting, constipation that lasts longer than 7 days, rectal bleeding, or itchy skin rash. Do not take psyllium for longer than 7 days in a row unless your doctor has told you to.

What should I discuss with my healthcare provider before taking Konsyl-D (psyllium)?

Laxatives may be habit-forming if they are used too often or for too long. This can lead to damage of intestinal nerves or muscle tissues. Do not take psyllium for longer than directed on the label or prescribed by your doctor. You should not take this product if you are allergic to psyllium, or if you have:

• 
  

  trouble swallowing;

  
  


• 
  

  a sudden change in bowel habits that lasts longer than 2 weeks;

  
  


• 
  

  severe nausea, vomiting, or stomach pain; or

  
  


• 
  

  if you have ever had a skin rash while taking psyllium.

  
  

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• 
  

  a colostomy or ileostomy;

  
  


• 
  

  rectal bleeding; or

  
  


• 
  

  a blockage in your intestines.

  
  

Psyllium products may contain sugar, sodium, or artificial sweeteners. This may be of concern to you if you have diabetes, high blood pressure, or phenylketonuria (PKU). Check the product label if you have any of these conditions.

Psyllium is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether psyllium passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Konsyl-D (psyllium)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Take psyllium with a full glass (at least 8 ounces) of water or another liquid. Taking psyllium without enough liquid may cause it to swell in your throat and cause choking. Drinking plenty of fluids each day while you are taking psyllium will also help improve bowel regularity.

The psyllium wafer must be chewed before you swallow it.

Do not swallow psyllium powder dry. It must be mixed with liquid. Place the psyllium powder into an empty glass and add at least 8 ounces of water or other liquid such as fruit juice. Stir this mixture and drink all of it right away.

If the powder and liquid mixture is too thick, add more liquid. After drinking the entire mixture, add a little more liquid to the same glass, swirl gently and drink right away to make sure you get the entire dose of psyllium.

Psyllium may be only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

It may take up to 3 days of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 2 or 3 days of treatment.

Do not take psyllium for longer than 7 days in a row unless your doctor has told you to. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since psyllium is used as needed, it does not have a daily dosing schedule. Call your doctor promptly if your symptoms do not improve after using psyllium.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, and stomach pain. Using a laxative too often or for too long may cause severe medical problems involving your intestines.

What should I avoid while taking Konsyl-D (psyllium)?

Avoid taking other oral (by mouth) medications within 2 hours before or after you take psyllium. Bulk-forming laxatives can make it harder for your body to absorb other medications, possibly making them less effective.

Avoid breathing in the dust from psyllium powder when mixing. Inhaling psyllium dust may cause an allergic reaction.

If you take psyllium as part of a cholesterol-lowering treatment plan, avoid eating foods that are high in fat or cholesterol. Your treatment will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Konsyl-D (psyllium) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using psyllium and call your doctor at once if you have a serious side effect such as:

• 
  

  choking or trouble swallowing;

  
  


• 
  

  severe stomach pain, cramping, nausea or vomiting;

  
  


• 
  

  constipation that lasts longer than 7 days;

  
  


• 
  

  rectal bleeding; or

  
  


• 
  

  itchy skin rash.

  
  

Less serious side effects may include:

• 
  

  bloating; or

  
  


• 
  

  minor change in your bowel habits.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Konsyl-D (psyllium)?

Tell your doctor about all other medications you use, especially:

• 
  

  a blood thinner such as warfarin (Coumadin, Jantoven); or

  
  


• 
  

  demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

  
  

This list is not complete and other drugs may interact with psyllium. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Konsyl-D resources

• Konsyl-D Side Effects (in more detail)
• Konsyl-D Use in Pregnancy & Breastfeeding
• Konsyl-D Drug Interactions
• Konsyl-D Support Group
• 0 Reviews for Konsyl-D - Add your own review/rating

• Konsyl Powder MedFacts Consumer Leaflet (Wolters Kluwer)


• Metamucil MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Konsyl-D with other medications

• Constipation
• Dietary Fiber Supplementation
• Irritable Bowel Syndrome

Where can I get more information?

• Your pharmacist can provide more information about psyllium.

See also: Konsyl-D side effects (in more detail)

Ultra Chloraseptic Anaesthetic Throat Spray 0.71%

1. Name Of The Medicinal Product

Ultra Chloraseptic Anaesthetic Throat Spray

2. Qualitative And Quantitative Composition

Benzocaine         0.71 % w/v

For full list of excipients, see 6.1

3. Pharmaceutical Form

Oromucosal Spray

Direct application to the throat by spraying

Clear, colourless to straw coloured liquid

4. Clinical Particulars

4.1 Therapeutic Indications

Symptomatic relief of sore throat pain.

4.2 Posology And Method Of Administration

Posology

Adults and children 13 years and over: Administer 3 sprays (3mg) to the back of the throat. Repeat every 2-3 hours up to a maximum of 8 doses per day.

Children 6-12 years: Use only under adult supervision. Administer 1 spray (1mg) to the back of the throat. Repeat every 2-3 hours up to a maximum of 8 doses per day

This product is contraindicated in children under 6 years.

Method of administration: oromucosal

Hold breath and spray to the back of the throat.

Do not use in a child who is unable to hold their breath whilst spraying.

Before first use, or after prolonged storage, activate the pump by spraying 3 times away from the face into the sink.

4.3 Contraindications

Children under 6 years.

Epiglottitis

Known hypersensitivity to benzocaine or any of the other ingredients.

Methaemoglobinaemia

4.4 Special Warnings And Precautions For Use

Do not administer to children under 6 years.

Do not use for more than 3 consecutive days.

Do not spray into eyes.

If sore throat is severe or persistent, or accompanied by fever, headache or nausea consult your doctor.

You should experience temporary numbness in your throat after using the spray. This indicates that the product is working. Avoid eating or drinking as long as the numbness lasts.

Labelling will include the following information:

Do not use if you have any difficulty in breathing, noisy breathing or severe difficulty in swallowing.

Do not use if you have been told that you have a rare blood condition called methaemoglobinaemia.

Contains propylene glycol which may cause skin irritation.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

Animal studies are insufficient with respect to effects on pregnancy and lactation. The potential risk for humans is unknown. Therefore Ultra Chloraseptic spray is not recommended during pregnancy or breast-feeding.

4.7 Effects On Ability To Drive And Use Machines

None expected

4.8 Undesirable Effects

Allergic reactions have been reported very occasionally with benzocaine. There have been occasional reports of temporary breathing difficulty, face or mouth swelling.

Methaemoglobinaemia has been reported with benzocaine use.

4.9 Overdose

Pronounced reversible anaesthesia would be observed. No systemic adverse effects are expected due to the poor systemic absorption and low administered dose of benzocaine.

Treatment of overdose

N/A

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC code: R02AD01

Benzocaine is a local anaesthetic of the ester type. The mode of action is a reversible inhibition of the flux of sodium and potassium ions through the axonal membranes of peripheral pain receptors. As a consequence, the depolarisation and propagation of nerve impulses are inhibited.

The onset of action of benzocaine on mucous membranes is rapid due to the spray delivery of the anaesthetic direct to the site of action, rapid absorption, and the surface analgesic effect. The local anaesthesia induced by benzocaine is temporary but Ultra Chloraseptic spray has not been tested for duration of action.

5.2 Pharmacokinetic Properties

Benzocaine is absorbed into the mucosal membranes. After systemic absorption, which is negligible, the drug is thought to be metabolised to ethanol and aminobenzoic acid by plasma esterases. Aminobenzoic acid is excreted unchanged or conjugated with glycerine to amoniohippuric acid in the liver, the metabolites and unchanged benzocaine are excreted in the urine.

5.3 Preclinical Safety Data

No animal data are available on Ultra Chloraseptic spray. Non-clinical studies on benzocaine showed local irritation and sensation, and methaemoglobinaemia at high doses in some species.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Ethanol

Macrogol 300

Propylene glycol

Glycerol

Cetylpyridinium chloride

Levomenthol

Saccharin sodium

Sodium dihydrogen phosphate dihydrate

Sodium hydroxide

Purified water

6.2 Incompatibilities

None known.

No data held.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

This medicinal product does not require any special storage conditions.

6.5 Nature And Contents Of Container

Uncoloured, clear or textured Type III glass bottle, containing 15ml of product with a polypropylene/low density polyethylene pump and polypropylene cap.

Or

Amber, clear Type III glass bottle, containing 15ml of product with a polypropylene/polyethylene pump.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Prestige Brands (UK) Limited

Beechwood, 3 Scotlands Drive, Farnham Common

Slough, Berkshire SL2 3ES

United Kingdom

8. Marketing Authorisation Number(S)

PL 18259/0001

9. Date Of First Authorisation/Renewal Of The Authorisation

07 July 2000

10. Date Of Revision Of The Text

24^th October 2010

11 DOSIMETRY (IF APPLICABLE)

Not applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Not applicable

Recent History:

24^th October 2010 – 0033 – User Test – Sections 4.4, 6.2

5^th May 2010 – 0046 - Type IB Az Group – Sections 2, 3, 4.2, 5.1, 6.4

30^th Dec 2009 – 0042 - Type IB 29a textured bottle – Section 6.5

Ala-Scalp HP

Generic Name: hydrocortisone topical (hye droe KOR ti sone)

Brand Names: Ala-Cort, Ala-Scalp HP, Aquanil HC, Beta HC, Caldecort, Cortaid, Cortaid Intensive Therapy, Cortaid Maximum Strength, Cortaid with Aloe, Cortalo with Aloe, Corticaine, Cortizone for Kids, Cortizone-10, Cortizone-10 Intensive Healing Formula, Cortizone-10 Plus, Cortizone-5, Dermarest Dricort, Dermarest Eczema Medicated, Dermarest Plus Anti-Itch, Dermtex HC, Genasone/Aloe, Gly-Cort, Gynecort Maximum Strength, Hycort, Hydrocortisone 1% In Absorbase, Hydrocortisone with Aloe, Hydrocortisone-Aloe, Hytone, Instacort, Itch-X Lotion, Locoid, Locoid Lipocream, Locoid Lotion, Massengill Medicated Soft Cloth, MD Hydrocortisone, Neutrogena T-Scalp, NuCort with Aloe, NuZon, Pandel, Recort Plus, Rederm, Sarnol-HC, Scalacort, Texacort, U-Cort, Westcort

What is Ala-Scalp HP (hydrocortisone topical)?

Hydrocortisone is a topical steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Hydrocortisone topical is used to treat inflammation of the skin caused by a number of conditions such as allergic reactions, eczema, or psoriasis.

Hydrocortisone topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Ala-Scalp HP (hydrocortisone topical)?

There are many brands and forms of hydrocortisone topical available and not all brands are listed on this leaflet.

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone topical.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

What should I discuss with my healthcare provider before using Ala-Scalp HP (hydrocortisone topical)?

Do not use this medication if you are allergic to hydrocortisone.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

FDA pregnancy category C. It is not known whether hydrocortisone topical is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether hydrocortisone topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone topical.

How should I use Ala-Scalp HP (hydrocortisone topical)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger or smaller amounts, or use it for longer than recommended.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Wash your hands before and after each application, unless you are using hydrocortisone topical to treat a hand condition.

Apply a small amount to the affected area and rub it gently into the skin.

Avoid using this medication on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days. It is important to use hydrocortisone topical regularly to get the most benefit. Store hydrocortisone topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it. An overdose of hydrocortisone topical applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while using Ala-Scalp HP (hydrocortisone topical)?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use hydrocortisone topical on sunburned, windburned, irritated, or broken skin. Also avoid using this medication in open wounds.

Avoid using skin products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Ala-Scalp HP (hydrocortisone topical) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using hydrocortisone topical and call your doctor at once if you have any of these serious side effects:

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  blurred vision, or seeing halos around lights;

  
  


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  uneven heartbeats;

  
  


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  sleep problems (insomnia);

  
  


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  weight gain, puffiness in your face; or

  
  


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  feeling tired.

  
  

Less serious side effects may include:

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  skin redness, burning, itching, or peeling;

  
  


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  thinning of your skin;

  
  


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  blistering skin; or

  
  


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  stretch marks.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Ala-Scalp HP (hydrocortisone topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied hydrocortisone. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Ala-Scalp HP resources

• Ala-Scalp HP Side Effects (in more detail)
• Ala-Scalp HP Use in Pregnancy & Breastfeeding
• Ala-Scalp HP Drug Interactions
• Ala-Scalp HP Support Group
• 0 Reviews for Ala-Scalp HP - Add your own review/rating

• Ala-Scalp HP Advanced Consumer (Micromedex) - Includes Dosage Information


• Anusol-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Carmol HC Prescribing Information (FDA)


• Carmol HC MedFacts Consumer Leaflet (Wolters Kluwer)


• Cortizone-10 Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Hydrocortisone Acetate Monograph (AHFS DI)


• Hydrocortisone with Aloe Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Hytone Prescribing Information (FDA)


• Instacort Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Locoid Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Locoid Lipocream Prescribing Information (FDA)


• Locoid Lotion Prescribing Information (FDA)


• Nutracort Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• Pandel Prescribing Information (FDA)


• Pediaderm HC Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• ProctoCream-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Proctocort Prescribing Information (FDA)


• Texacort Prescribing Information (FDA)


• U-cort Prescribing Information (FDA)


• Westcort Prescribing Information (FDA)

Compare Ala-Scalp HP with other medications

• Anal Itching
• Aphthous Stomatitis, Recurrent
• Atopic Dermatitis
• Dermatitis
• Eczema
• Gingivitis
• Proctitis
• Pruritus
• Psoriasis
• Seborrheic Dermatitis
• Skin Rash

Where can I get more information?

• Your pharmacist can provide more information about hydrocortisone topical.

See also: Ala-Scalp HP side effects (in more detail)