Metoprolol Succinate Extended-Release Tablets

Pronunciation: MET-oh-PROE-lol SUX-i-nate
Generic Name: Metoprolol Succinate
Brand Name: Toprol XL

Do not suddenly stop taking Metoprolol Succinate Extended-Release Tablets. Sharp chest pain, irregular heartbeat, and sometimes heart attack may occur if you suddenly stop Metoprolol Succinate Extended-Release Tablets. The risk may be greater if you have certain types of heart disease. Your doctor should slowly lower your dose over several weeks if you need to stop taking it. This should be done even if you only take Metoprolol Succinate Extended-Release Tablets for high blood pressure. Heart disease is common and you may not know you have it. Limit physical activity while you are lowering your dose. If new or worsened chest pain or other heart problems occur, contact your doctor right away. You may need to start taking Metoprolol Succinate Extended-Release Tablets again.

Tell your doctor or dentist that you take Metoprolol Succinate Extended-Release Tablets before you receive any medical or dental care, emergency care, or surgery.

Tell your doctor if you have a history of diabetes or if you take medicine to lower your blood sugar (eg, glyburide, insulin). Metoprolol Succinate Extended-Release Tablets may hide signs of low blood sugar, such as fast heartbeat. Be sure to watch for other signs of low blood sugar (eg, anxiety, chills, dizziness, drowsiness, fainting, headache, tremor, unusual sweating, vision changes, weakness). Tell your doctor right away if these effects occur.

Metoprolol Succinate Extended-Release Tablets should not usually be used by patients who have a history of certain lung or breathing problems (eg, asthma) or who have a certain type of adrenal gland tumor (pheochromocytoma). It may worsen these conditions. Tell your doctor if you have a history of breathing problems or adrenal gland tumors. If you have these conditions and must take Metoprolol Succinate Extended-Release Tablets, your doctor may need to adjust your dose or prescribe additional medicine to reduce the risk of side effects. Check with your doctor for more information.

Tell your doctor if you have a history of overactive thyroid. Metoprolol Succinate Extended-Release Tablets may hide symptoms of overactive thyroid (eg, fast heartbeat). Do not suddenly stop taking Metoprolol Succinate Extended-Release Tablets; suddenly stopping Metoprolol Succinate Extended-Release Tablets could worsen your condition. Your doctor should slowly lower your dose over several weeks if you need to stop taking it. Check with your doctor for more information.

Metoprolol Succinate Extended-Release Tablets are used for:

Treating high blood pressure, alone or with other medicines; long-term treatment of chest pain; and treating certain types of heart failure. It may also be used for other conditions as determined by your doctor.

Metoprolol Succinate Extended-Release Tablets are a beta-adrenergic blocking agent (beta-blocker). It works by reducing the amount of work the heart has to do (reduces chest pain) and the amount of blood the heart pumps out (lowers high blood pressure). It is also used to stabilize the heart rhythm in conditions in which the heart is beating too fast or in an irregular rhythm.

Do NOT use Metoprolol Succinate Extended-Release Tablets if:

• you are allergic to any ingredient in Metoprolol Succinate Extended-Release Tablets or to another beta-blocker (eg, propranolol)


• you have a very slow heart rate (eg, bradycardia), certain types of irregular heartbeat (eg, atrioventricular [AV] block, sick sinus syndrome), moderate to severe heart failure, very low systolic blood pressure (less than 100 mm Hg), or severe blood circulation problems


• you are taking mibefradil

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

Before using Metoprolol Succinate Extended-Release Tablets:

Some medical conditions may interact with Metoprolol Succinate Extended-Release Tablets. 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 have an adrenal gland tumor (pheochromocytoma), an overactive thyroid, or are scheduled to have surgery


• if you have low blood pressure or a history of heart attack, slow or irregular heartbeat, heart failure, or other heart problems; chest pain or angina; blood circulation problems; or liver problems


• if you have diabetes mellitus, chronic obstructive pulmonary disease (COPD), bronchitis, breathing problems, or a history of asthma

Some MEDICINES MAY INTERACT with Metoprolol Succinate Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Amiodarone, bupropion, cimetidine, digoxin, diltiazem, diphenhydramine, disopyramide, flecainide, certain HIV protease inhibitors (eg, ritonavir), hormonal contraceptives (eg, birth control pills), hydralazine, hydroxychloroquine, ketanserin, mefloquine, mibefradil, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), phenothiazines (eg, thioridazine), propafenone, propylthiouracil, quinazolines (eg, alfuzosin), quinidine, reserpine, certain selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine), terbinafine, or verapamil because serious side effects, such as very slow heart rate, very low blood pressure, fainting, severe dizziness, or lightheadedness when standing, may occur


• Clonidine because stopping either of these medicines suddenly can lead to a rapid increase in blood pressure


• Barbiturates (eg, phenobarbital), indomethacin, or phenylpropanolamine because they may decrease Metoprolol Succinate Extended-Release Tablets's effectiveness


• Bupivacaine, disopyramide, flecainide, hydralazine, ketanserin, or lidocaine because the risk of their side effects may be increased by Metoprolol Succinate Extended-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Metoprolol Succinate Extended-Release Tablets 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 Metoprolol Succinate Extended-Release Tablets:

Use Metoprolol Succinate Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Metoprolol Succinate Extended-Release Tablets by mouth either always with food or immediately following a meal, at the same time each day.


• Swallow Metoprolol Succinate Extended-Release Tablets whole. Do not break, crush, or chew before swallowing. Some brands of Metoprolol Succinate Extended-Release Tablets may be broken in half before taking. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.


• If you miss a dose of Metoprolol Succinate Extended-Release Tablets, take it if you remember the same day. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss more than one dose, check with your doctor or pharmacist.

Ask your health care provider any questions you may have about how to use Metoprolol Succinate Extended-Release Tablets.

Important safety information:

• Metoprolol Succinate Extended-Release Tablets may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Metoprolol Succinate Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Metoprolol Succinate Extended-Release Tablets may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• Do not suddenly stop taking Metoprolol Succinate Extended-Release Tablets without first consulting your doctor. If your doctor decides you should no longer use Metoprolol Succinate Extended-Release Tablets, you will need to stop Metoprolol Succinate Extended-Release Tablets gradually according to your doctor's instructions.


• If your doctor has instructed you to check your blood pressure and heart rate regularly, be sure to do so.


• Do not take any medicines used to treat colds or congestion without first consulting with your doctor or pharmacist.


• Diabetes patients - Metoprolol Succinate Extended-Release Tablets may hide signs of low blood sugar, such as rapid heartbeat. Be sure to watch for other signs or low blood sugar. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your vision change; give you a headache, chills, or tremors; or make you more hungry. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Tell your doctor or dentist that you take Metoprolol Succinate Extended-Release Tablets before you receive any medical or dental care, emergency care, or surgery.


• If you have a history of any severe allergic reaction, talk with your doctor. You may be at risk of an even more severe allergic reaction if you come into contact with the substance that caused your allergy. Some medicines used to treat severe allergies may also not work as well while you are using Metoprolol Succinate Extended-Release Tablets.


• Lab tests, including liver function and blood cholesterol levels, may be performed while you use Metoprolol Succinate Extended-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Metoprolol Succinate Extended-Release Tablets should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Metoprolol Succinate Extended-Release Tablets while you are pregnant. Metoprolol Succinate Extended-Release Tablets are found in breast milk. If you are or will be breast-feeding while you use Metoprolol Succinate Extended-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Metoprolol Succinate Extended-Release Tablets:

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:

Constipation; diarrhea; dizziness; dry mouth or eyes; gas; headache; heartburn; lightheadedness; mild drowsiness; muscle aches; nausea; stomach pain; trouble sleeping; unusual tiredness or weakness; vomiting.

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; unusual hoarseness); blue or unusually cold hands or feet; chest pain; chills, fever, or sore throat; fainting; hallucinations; mood or mental changes (eg, confusion, depression, foggy thinking, short-term memory loss); pounding in the chest; severe dizziness or lightheadedness; shortness of breath; slow or irregular heartbeat; swelling of the arms, hands, and feet; unusual bruising or bleeding; vision changes; wheezing; yellowing of the skin or eyes.

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: Metoprolol Succinate 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 ( http://www.aapcc.org), or emergency room immediately. Symptoms may include blue skin discoloration; difficult or slowed breathing; fainting; impaired consciousness; severe dizziness; very slow heart rate; vomiting; weakness.

Proper storage of Metoprolol Succinate Extended-Release Tablets:

Store Metoprolol Succinate Extended-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Metoprolol Succinate Extended-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Metoprolol Succinate Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Metoprolol Succinate Extended-Release Tablets 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 Metoprolol Succinate Extended-Release Tablets. 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 Metoprolol Succinate resources

• Metoprolol Succinate Side Effects (in more detail)
• Metoprolol Succinate Dosage
• Metoprolol Succinate Use in Pregnancy & Breastfeeding
• Drug Images
• Metoprolol Succinate Drug Interactions
• Metoprolol Succinate Support Group
• 102 Reviews for Metoprolol Succinate - Add your own review/rating

Compare Metoprolol Succinate with other medications

• Angina
• Angina Pectoris Prophylaxis
• Atrial Fibrillation
• Benign Essential Tremor
• Heart Attack
• Heart Failure
• High Blood Pressure
• Left Ventricular Dysfunction
• Mitral Valve Prolapse
• Premature Ventricular Depolarizations
• Supraventricular Tachycardia

Guaifenex DM

Generic Name: dextromethorphan and guaifenesin (DEX troe me THOR fan and gwye FEN e sin)

Brand Names: Allfen DM, Altarussin DM, Aquatab DM, Benylin Expectorant, Drituss DM, Extuss LA, Fenesin DM IR, Glycotuss-DM, Guaifen DM, Mucinex Children's Cough, Mucinex DM, MucusRelief DM, Naldecon DX Liquigel, Relacon LAX, Respa-DM, Robitussin Cough & Congestion, Tussi-Bid, Tussi-Organidin DM NR, Vicks 44E

What is Guaifenex DM (dextromethorphan and guaifenesin)?

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

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

The combination of dextromethorphan and guaifenesin is used to treat cough and chest congestion caused by the common cold, infections, or allergies.

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

Dextromethorphan and guaifenesin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Guaifenex DM (dextromethorphan and guaifenesin)?

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains dextromethorphan or guaifenesin. Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

What should I discuss with my healthcare provider before taking Guaifenex DM (dextromethorphan and guaifenesin)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have emphysema or chronic bronchitis.

FDA pregnancy category C. It is not known whether dextromethorphan and guaifenesin is harmful to an unborn baby. Before you take this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether this medication 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.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take Guaifenex DM (dextromethorphan and guaifenesin)?

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

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

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

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Dextromethorphan and guaifenesin granules should be sprinkled directly onto the tongue and swallowed right away.

Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

Since cough or cold medicine is usually taken only as 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. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take 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.

Overdose symptoms may include feeling restless or nervous.

What should I avoid while taking Guaifenex DM (dextromethorphan and guaifenesin)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with cough or cold medicine can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. Dextromethorphan and guaifenesin are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains dextromethorphan or guaifenesin.

Guaifenex DM (dextromethorphan and guaifenesin) 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 this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  confusion, hallucinations; or

  
  


• 
  

  slow, shallow breathing.

  
  

Less serious side effects may include:

• 
  

  dizziness;

  
  


• 
  

  headache;

  
  


• 
  

  skin rash or itching; or

  
  


• 
  

  nausea, vomiting, or stomach upset.

  
  

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 Guaifenex DM (dextromethorphan and guaifenesin)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

• 
  

  celecoxib (Celebrex);

  
  


• 
  

  cinacalcet (Sensipar);

  
  


• 
  

  darifenacin (Enablex);

  
  


• 
  

  imatinib (Gleevec);

  
  


• 
  

  quinidine (Quinaglute, Quinidex);

  
  


• 
  

  ranolazine (Ranexa);

  
  


• 
  

  ritonavir (Norvir);

  
  


• 
  

  sibutramine (Meridia);

  
  


• 
  

  terbinafine (Lamisil);

  
  


• 
  

  medicines to treat high blood pressure; or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Etrafon), bupropion (Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), paroxetine (Paxil), sertraline (Zoloft), and others.

  
  

This list is not complete and there may be other drugs that can interact with dextromethorphan and guaifenesin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Guaifenex DM resources

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

• Guaifenex DM Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Atuss-12 DX Extended-Release Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Duratuss DM 12 Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Guaifenesin DM Elixir MedFacts Consumer Leaflet (Wolters Kluwer)


• Humibid CS MedFacts Consumer Leaflet (Wolters Kluwer)


• Mucinex DM Prescribing Information (FDA)


• Mucinex DM Maximum Strength Prescribing Information (FDA)


• Robitussin DM infant drops


• Scot-Tussin DM Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Tussin DM Prescribing Information (FDA)

Compare Guaifenex DM with other medications

• Cough
• Expectoration

Where can I get more information?

• Your pharmacist can provide more information about dextromethorphan and guaifenesin.

See also: Guaifenex DM side effects (in more detail)

Irrigandum

Irrigandum may be available in the countries listed below.

Ingredient matches for Irrigandum

Nimodipine

Nimodipine is reported as an ingredient of Irrigandum in the following countries:

• Peru

International Drug Name Search

Caltrate 600 with D

Generic Name: calcium and vitamin D combination (KAL see um and VYE ta min D)

Brand Names: Calcarb with D, Calcet, Calcio Del Mar, Calcitrate with D, Calcium 600+D, Caltrate 600 with D, Caltrate 600 with D Plus Soy, Caltrate Colon Health, Citracal + D, Citracal 250 mg + D, Citracal Creamy Bites, Citracal Maximum + D, Citracal Petites, Citrus Calcium with Vitamin D, Dical-D, Os-Cal 250 with D, Os-Cal 500 + D, Os-Cal with D, Oysco 500 with D, Oysco D, Oyst-Cal-D, Oyster Shell Calcium with Vitamin D, Oyster-D, Oystercal-D, Posture-D H/P, Risacal-D

What is Caltrate 600 with D (calcium and vitamin D combination)?

Calcium is a mineral that is found naturally in foods. Calcium is necessary for many normal functions of your body, especially bone formation and maintenance.

Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.

Calcium and vitamin D combination is used to prevent or to treat a calcium deficiency.

Calcium and vitamin D combination may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Caltrate 600 with D (calcium and vitamin D combination)?

Before you take calcium and vitamin D combination, tell your doctor if you have kidney disease, past or present kidney stones, heart disease, circulation problems, a parathyroid disorder, or if you are pregnant or breast-feeding.

Avoid taking any other vitamin or mineral supplements that contain calcium or vitamin D without first talking to your doctor.

Before taking calcium and vitamin D combination, 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.

What should I tell my healthcare provider before taking Caltrate 600 with D (calcium and vitamin D combination)?

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take calcium and vitamin D combination, tell your doctor if you have:

• kidney disease;


• past or present kidney stones;


• 
  

  heart disease;

  
  


• 
  

  circulation problems; or

  
  


• 
  

  a parathyroid gland disorder.

  
  

Talk to your doctor before taking calcium and vitamin D combination if you are pregnant. Talk to your doctor before taking calcium and vitamin D combination if you are breast-feeding.

How should I take Caltrate 600 with D (calcium and vitamin D combination)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take the calcium and vitamin D regular tablet with a full glass of water.

The chewable tablet should be chewed before you swallow it.

Store calcium and vitamin D combination at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take 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.

Overdose symptoms may include irregular heartbeat, stomach pain, nausea, vomiting, dry mouth, a metallic taste in your mouth, confusion, loss of appetite, constipation, weakness, headache, confusion, or fainting.

What should I avoid while taking Caltrate 600 with D (calcium and vitamin D combination)?

Avoid taking any other vitamin or mineral supplements that contain calcium or vitamin D without first talking to your doctor.

Caltrate 600 with D (calcium and vitamin D combination) 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.

Less serious side effects may include:

• 
  

  an irregular heartbeat;

  
  


• 
  

  nausea, vomiting, or decreased appetite;

  
  


• 
  

  dry mouth;

  
  


• 
  

  constipation;

  
  


• 
  

  weakness;

  
  


• 
  

  headache;

  
  


• 
  

  a metallic taste;

  
  


• 
  

  muscle or bone pain; or

  
  


• 
  

  drowsiness.

  
  

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 Caltrate 600 with D (calcium and vitamin D combination)?

Before taking calcium and vitamin D combination, tell your doctor if you are taking:

• 
  

  digoxin (Lanoxin, Lanoxicaps);

  
  


• 
  

  antacids containing calcium, aluminum, or magnesium;

  
  


• 
  

  other calcium supplements;

  
  


• 
  

  calcitriol (Rocaltrol) or other vitamin D supplements; or

  
  


• 
  

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

  
  

This list is not complete and there may be other drugs that can interact with calcium and vitamin D combination. 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 Caltrate 600 with D resources

• Caltrate 600 with D Side Effects (in more detail)
• Caltrate 600 with D Use in Pregnancy & Breastfeeding
• Caltrate 600 with D Drug Interactions
• Caltrate 600 with D Support Group
• 0 Reviews for Caltrate 600 with D - Add your own review/rating

Compare Caltrate 600 with D with other medications

• Dietary Supplementation
• Osteoporosis

Where can I get more information?

• Your pharmacist can provide more information about calcium and vitamin D combination.

See also: Caltrate 600 with D side effects (in more detail)

Anbesol Extra Strength

Generic Name: benzocaine (Oral route, Oromucosal route)

BEN-zoe-kane

Commonly used brand name(s)

In the U.S.

• Anbesol


• Babee Teething


• Benzodent


• Benz-O-Sthetic


• Bi-Zets/Benzo-Troches


• Dentemp's


• Dent-O-Kain/20


• Detane


• Gumsol


• HAD


• Hurricaine


• Hurricane Spray Kit


• Kank-A Soft Brush


• Larynex


• Miradyne-3


• Mycinette


• Orabase-B


• Oracaine


• Ora film


• Orajel


• OraMagic Plus


• Orasol


• Red Cross Canker Sore


• Thorets


• Trocaine


• Zetts


• Zilactin


• Zilactin-B

In Canada

• Anbesol Extra Strength


• Anbesol Liquid


• Baby Anbesol


• Baby Orajel


• Baby Orajel Liquid


• Maximum Strength Orajel Pm


• Orajel Extra Strength

Available Dosage Forms:

• Liquid


• Gel/Jelly


• Solution


• Lozenge/Troche


• Film


• Lotion


• Ointment


• Powder for Suspension


• Cream


• Tablet, Disintegrating


• Swab


• Spray


• Gum


• Paste

Therapeutic Class: Anesthetic, Local

Chemical Class: Amino Ester

Uses For Anbesol Extra Strength

Benzocaine lozenges are used to relieve pain and irritation caused by sore throat, sore mouth, or canker sores.

This medicine is available without a prescription; however, your doctor may have special instructions on the proper use and dose for your medical problem.

Before Using Anbesol Extra Strength

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

No information is available on the relationship of age to the effects of benzocaine lozenges in the pediatric population. Safety and efficacy have not been established in children below 5 years of age.

Geriatric

No information is available on the relationship of age to the effects of benzocaine in geriatric patients.

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:

• Infection in or around your mouth or


• Large sores in or around your mouth—The chance of side effects may be increased.

Proper Use of benzocaine

This section provides information on the proper use of a number of products that contain benzocaine. It may not be specific to Anbesol Extra Strength. Please read with care.

Use this medicine exactly as directed by your doctor. Do not use more of this medicine, do not use it more often, and do not use it for a longer time than directed. To do so may increase the chance of absorption into the body and the risk of side effects.

This medicine should be used only for problems being treated by your doctor or conditions listed in the package directions. Check with your doctor before using it for other problems, especially if you think that an infection may be present.

Do not use this medicine for more than 2 days without checking first with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (lozenges):
  
  • For sore throat and mouth pain:
    
    • Adults, teenagers, and children 5 years of age and older—One lozenge, dissolved slowly in the mouth every 2 hours as needed.
    
    
    • Children younger than 5 years of age—Use is not recommended.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

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.

Precautions While Using Anbesol Extra Strength

If your condition does not improve within 7 days, or if it becomes worse, check with your doctor.

Call your doctor right away if you start to have a severe sore throat or sore throat that occurs with a high fever, headache, nausea, or vomiting. These maybe signs of an infection.

Anbesol Extra Strength 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 immediately if any of the following side effects occur:

Incidence not known

• Headache


• high fever


• nausea


• vomiting


• worsening of pain, redness, swelling, or irritation in or around the mouth

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: Anbesol Extra Strength 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.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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Paxil Suspension

Pronunciation: par-OX-e-teen
Generic Name: Paroxetine
Brand Name: Paxil

Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using Paxil Suspension outweigh the risks.

Families and caregivers must closely watch patients who take Paxil Suspension. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.

Paxil Suspension is used for:

Treating depression or obsessive-compulsive disorder (OCD). It may be used to treat panic disorder or posttraumatic stress disorder (PTSD). It may also be used to treat generalized anxiety disorder or social anxiety disorder. It may also be used for other conditions as determined by your doctor.

Paxil Suspension is a selective serotonin reuptake inhibitor (SSRI). It works by restoring the balance of serotonin, a natural substance in the brain, which helps to improve certain mood problems.

Do NOT use Paxil Suspension if:

• you are allergic to any ingredient in Paxil Suspension


• you are taking or have taken linezolid, methylene blue, a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), selegiline, or St. John's wort within the last 14 days


• you are taking a fenfluramine derivative (eg, dexfenfluramine), nefazodone, pimozide, a serotonin-norepinephrine reuptake inhibitor (SNRI) (eg, venlafaxine), another SSRI (eg, fluoxetine), sibutramine, thioridazine, or tryptophan

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

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Before using Paxil Suspension:

Some medical conditions may interact with Paxil Suspension. 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 or a family member has a history of bipolar disorder (manic-depression), other mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse


• if you have a history of seizures, heart problems, liver problems, severe kidney problems, stomach or bowel bleeding, narrow-angle glaucoma, diabetes, or metabolism problems


• if you are dehydrated, have low blood sodium levels, or drink alcohol


• if you will be having electroconvulsive therapy (ECT)

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

• Anorexiants (eg, phentermine), cimetidine, fenfluramine derivatives (eg, dexfenfluramine), fentanyl, linezolid, lithium, MAOIs (eg, phenelzine), methylene blue, metoclopramide, nefazodone, selegiline, serotonin 5-HT₁ receptor agonists (eg, sumatriptan), sibutramine, SNRIs (eg, venlafaxine), another SSRI (eg, fluoxetine), St. John's wort, tramadol, trazodone, or tryptophan because severe side effects, such as a reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, or coma, may occur


• Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of bleeding, including stomach bleeding, may be increased


• Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood sodium levels may be increased


• Antiarrhythmics (eg, flecainide, propafenone, quinidine), astemizole, phenothiazines (eg, chlorpromazine, thioridazine), or terfenadine because severe heart problems, including irregular heartbeat, may occur


• Cyproheptadine, HIV protease inhibitors (eg, ritonavir), phenobarbital, or phenytoin because they may decrease Paxil Suspension's effectiveness


• Aripiprazole, atomoxetine, clozapine, fluoxetine, pimozide, procyclidine, risperidone, theophylline, or tricyclic antidepressants (eg, amitriptyline) because the risk of their side effects may be increased by Paxil Suspension


• Digoxin or tamoxifen because their effectiveness may be decreased by Paxil Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Paxil Suspension 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 Paxil Suspension:

Use Paxil Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Paxil Suspension comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Paxil Suspension refilled.


• Take Paxil Suspension by mouth with or without food.


• Shake well before each use.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• Taking Paxil Suspension at the same time each day will help you remember to take it.


• Continue to take Paxil Suspension even if you feel well. Do not miss any doses.


• Do not suddenly stop taking Paxil Suspension without checking with your doctor. Side effects may occur. They may include mental or mood changes, numbness or tingling of the skin, dizziness, confusion, headache, trouble sleeping, or unusual tiredness. You will be closely monitored when you start Paxil Suspension and whenever a change in dose is made.


• If you miss a dose of Paxil Suspension, take it as soon as possible. If it almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Paxil Suspension.

Important safety information:

• Paxil Suspension may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Paxil Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Paxil Suspension; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not drink alcohol while you are taking Paxil Suspension.


• Several weeks may pass before your symptoms get better. Do NOT take more than the recommended dose, change your dose, or use Paxil Suspension for longer than prescribed without checking with your doctor.


• Children, teenagers, and young adults who take Paxil Suspension may be at increased risk of suicidal thoughts or actions. Closely watch all patients who take Paxil Suspension. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.


• If your doctor tells you to stop taking Paxil Suspension, you will need to wait for several weeks before beginning to take certain other medicines (eg, MAOIs, nefazodone). Ask your doctor when you should start to take your new medicines after you have stopped taking Paxil Suspension.


• Paxil Suspension may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.


• Serotonin syndrome is a possibly fatal syndrome that can be caused by Paxil Suspension. Your risk may be greater if you take Paxil Suspension with certain other medicines (eg, "triptans," MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.


• Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Paxil Suspension. Your risk may be greater if Paxil Suspension is used with certain other medicines called antipsychotics (eg, aripiprazole, risperidone). Symptoms may be similar to serotonin syndrome and may include fever, rigid muscles, blood pressure changes, and mental changes. Contact your doctor at once if you have any of these symptoms.


• Paxil Suspension may affect fertility in some men. Discuss any questions or concerns with your doctor.


• Use Paxil Suspension with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.


• Caution is advised when using Paxil Suspension in CHILDREN; they may be more sensitive to its effects, especially increased risk of suicidal thoughts or actions.


• Paxil Suspension should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• Paxil Suspension may cause weight changes. CHILDREN and teenagers may need regular weight and growth checks while they take Paxil Suspension.


• PREGNANCY and BREAST-FEEDING: Paxil Suspension may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Paxil Suspension while you are pregnant. Paxil Suspension is found in breast milk. If you are or will be breast-feeding while you take Paxil Suspension, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Paxil Suspension:

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:

Anxiety; blurred vision; constipation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; gas; increased sweating; increased urination; loss of appetite; nausea; nervousness; numbness or tingling of the skin; stomach upset; trouble sleeping; weakness; yawning.

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); bizarre behavior; black or bloody stools; chest pain; confusion; decreased concentration; decreased coordination; exaggerated reflexes; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; memory loss; new or worsening mental or mood changes (eg, agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still); persistent or severe ringing in the ears; persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe or persistent anxiety or trouble sleeping; severe or persistent headache or dizziness; significant weight loss; stomach pain; suicidal thoughts or attempts; tremor; unusual bone pain or unexplained swelling, tenderness, or bruising; unusual bruising or bleeding; unusual weakness; vision changes; worsening of depression.

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: Paxil 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 coma; confusion; dilated pupils; fainting; fast, slow, or irregular heartbeat; inability to urinate; seizures; severe muscle pain; severe or persistent dizziness, drowsiness, nausea, or vomiting; tremor; yellowing of the eyes or skin.

Proper storage of Paxil Suspension:

Store Paxil Suspension at or below 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Paxil Suspension out of the reach of children and away from pets.

General information:

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


• Paxil Suspension is 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 summary only. It does not contain all information about Paxil Suspension. 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.

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Creon 40000 Capsules

1. Name Of The Medicinal Product

Creon^® 40000 Capsules

2. Qualitative And Quantitative Composition

Each capsule contains pancreatin PhEur 400 mg equivalent to:

Lipase	40,000 PhEur units
Amylase	25,000 PhEur units
Protease	1,600 PhEur units

3. Pharmaceutical Form

Capsules.

Brown/clear size 00 capsules containing light brown, gastro-resistant granules.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of pancreatic exocrine insufficiency.

4.2 Posology And Method Of Administration

Adults (including the elderly) and children:

Creon 40000 should only be used if the patient requires equal to or more than 40,000 lipase units per meal or snack. Creon 40000 should only be used in patients in whom the minimum effective dose has already been determined using lower strength pancreatic enzyme products.

Initially one or two capsules with each meal. The capsules should be swallowed whole or for ease of administration they may be opened and the granules taken with acidic fluid or soft food, but without chewing. This could be apple sauce or yoghurt or any fruit juice with a pH less than 5.5, e.g. apple, orange or pineapple juice. If the granules are mixed with food it is important that they are taken immediately, otherwise dissolution of the enteric coating may result. In order to protect the enteric coating, it is important that the granules are not crushed or chewed.

Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology.

It is important to ensure adequate hydration of patients at all times whilst dosing Creon 40000.

Fibrosing colonopathy has been reported in patients with cystic fibrosis taking in excess of 10,000 units of lipase/kg/day (see section 4.4).

4.3 Contraindications

Hypersensitivity to pancreatin of porcine origin or to any of the excipients

4.4 Special Warnings And Precautions For Use

Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatin preparations. Case control studies did not reveal evidence for an association between Creon and the appearance of fibrosing colonopathy. As a precaution, unusual abdominal symptoms or changes in abdominal symptoms should be medically assessed to exclude the possibility of fibrosing colonopathy, especially if the patient is taking in excess of 10,000 units of lipase/kg/day.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interaction studies have been performed.

4.6 Pregnancy And Lactation

Pregnancy

For pancreatic enzymes no clinical data on exposed pregnancies are available.

Animal studies show no evidence for any absorption of porcine pancreatic enzymes. Therefore, no reproductive or developmental toxicity is to be expected.

Caution should be exercised when prescribing to pregnant women.

Lactation

No effects on the suckling child are anticipated since animal studies suggest no systemic exposure of the breast-feeding woman to pancreatic enzymes. Pancreatic enzymes can be used during breast-feeding.

If required during pregnancy or lactation Creon should be used in doses sufficient to provide adequate nutritional status.

4.7 Effects On Ability To Drive And Use Machines

Creon has no or negligible influence on the ability to drive or use machines.

4.8 Undesirable Effects

In clinical trials, more than 600 patients with pancreatic exocrine insufficiency, due to cystic fibrosis, chronic pancreatitis, and pancreatic surgery were exposed to Creon. The most commonly reported adverse reactions were gastrointestinal disorders and were primarily mild or moderate in severity.

The following adverse reactions have been observed during placebo-controlled clinical trials with the below indicated frequencies;

Gastrointestinal disorders

Common ( nausea, vomiting, constipation, diarrhoea and abdominal distension.

Gastrointestinal disorders are mainly associated with the underlying disease. Similar or lower incidences compared to placebo were reported for abdominal pain (very common

Skin and subcutaneous tissue disorders

Uncommon ( rash

Pruritus and urticaria have been additionally identified as adverse reactions during post-approval use. Because these reactions were reported spontaneously from a population of uncertain size, it is not possible to reliably estimate their frequency.

Multiple clinical trials were conducted in other patient populations: HIV, acute pancreatitis, diabetes mellitus. No additional adverse drug reactions were identified compared to the above three patient groups.

Paediatric population

No specific adverse reactions were identified in the paediatric population. Frequency, type and severity of adverse reactions were similar in children with cystic fibrosis as compared to adults.

4.9 Overdose

Extremely high doses of pancreatin have been reported to be associated with hyperuricosuria and hyperuricaemia.

Supportive measures including stopping enzyme therapy and ensuring adequate rehydration are recommended.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The ATC code is A09A A (Enzyme preparations).

Replacement therapy in pancreatic enzyme deficiency states. The enzymes have hydrolytic activity on fat, carbohydrates and proteins.

5.2 Pharmacokinetic Properties

Pharmacokinetic data are not available as the enzymes act locally in the gastro-intestinal tract. After exerting their action, the enzymes are digested themselves in the intestine.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Granules:

Macrogol 4000

Hypromellose phthalate

Dimeticone

Cetyl alcohol

Triethyl citrate

Capsules:

Gelatin

Anhydrous iron (III) oxide (E172)

Hydrated iron (III) oxide (E172)

Iron (II, III) oxide (E172)

Titanium dioxide E171

Sodium lauryl sulphate

6.2 Incompatibilities

None known.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 25°C. Keep container tightly closed.

6.5 Nature And Contents Of Container

HDPE container with tamper-evident PP cap. Each container contains 100 capsules.

6.6 Special Precautions For Disposal And Other Handling

No special instructions.

7. Marketing Authorisation Holder

Abbott Healthcare Products Limited

Mansbridge Road

West End

Southampton

SO18 3JD

United Kingdom

8. Marketing Authorisation Number(S)

PL 00512/0177

9. Date Of First Authorisation/Renewal Of The Authorisation

25/02/2009

10. Date Of Revision Of The Text

30/06/2011