1. Name Of The Medicinal Product
Paracodol capsules
2. Qualitative And Quantitative Composition
Paracetamol | 500.0 mg |
Codeine Phosphate | 8.0 mg |
3. Pharmaceutical Form
Capsules
4. Clinical Particulars
4.1 Therapeutic Indications
For the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone.
Treatment of acute moderate pain including:- muscular and rheumatic pains, headache, migraine, neuralgia, toothache, period pains, aches and pains.
4.2 Posology And Method Of Administration
For oral administration.
Adults:
1 - 2 capsules. If necessary, the dose may be repeated every 4 - 6 hours with a maximum of 8 capsules in 24 hours.
Elderly
No current evidence for alteration of the adult dose except where there is impaired hepatic function when dosage reduction may be necessary.
Children
Children under 12 years, not recommended.
Do not take for more than 3 days continuously without medical review.
4.3 Contraindications
Hypersensitivity to paracetamol and/or other constituents of Paracodol capsules.
4.4 Special Warnings And Precautions For Use
Keep out of the reach of children.
Warning: Do not exceed the stated dose.
If symptoms persist, consult you doctor.
An overdose of paracetamol can cause hepatic necrosis. Preparations containing paracetamol should be given with care to patients with impaired renal and liver function. The hazards of overdose are greater in those with alcoholic liver disease.
Do not take with any other paracetamol - containing products. Immediate medical advice should be sought in the event of an overdose even if you feel well because of the risk of delayed, serious liver damage.
Codeine is partially metabolised by CYP2D6. If a patient has a deficiency or is completely lacking this enzyme they will not obtain adequate analgesic effects. Estimates indicate that up to 7% of the Caucasian population may have this deficiency. However, if the patient is an ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at low doses. General symptoms of opioid toxicity include nausea, vomiting, constipation, lack of appetite and somnolence. In severe cases this may include symptoms of circulatory and respiratory depression. Estimates indicate that up to 1 to 2% of the Caucasian population may be ultra-rapid metabolisers.
The label will state:
Front of Pack
• Can cause addiction
• For three days use only
Back of Pack
• This medicine can only be used for the short term treatment of acute moderate pain when other pain killers have not worked. If you have already taken another pain killer wait at least four hours before taking this medicine. For relief from muscular and rheumatic pains, headache, migraine, neuralgia, toothache, period pain, aches and pains.
• If you need to take this medicine continuously for more than three days you should see your doctor or pharmacist
• This medicine contains codeine which can cause addiction if you take it continuously for more than three days. If you take this medicine for headaches for more than three days it can make them worse
The leaflet will state:
Headlines section (to be prominently displayed)
• This medicine can only be used for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone.
• You should only take this product for a maximum of three days at a time. If you need to take it for longer than three days you should see your doctor or pharmacist for advice
• This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it
• If you take this medicine for headaches for more than three days it can make them worse
Section 1: What the medicine is for
• This medicine can only be used for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone. This includes muscular and rheumatic pains, headache, migraine, neuralgia, toothache, period pain, aches and pains.
Section 2: Before taking
• This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it
• If you take a painkiller for headaches for more than three days it can make them worse
The leaflet will state in the 'Pregnancy and breast-feeding' subsection of section 2 'Before taking your medicine':
Usually it is safe to take Paracodol Capsules while breast feeding as the levels of the active ingredients of this medicine in breast milk are too low to cause your baby any problems. However, some women who are at increased risk of developing side effects at any dose may have higher levels in their breast milk. If any of the following side effects develop in you or your baby, stop taking this medicine and seek immediate medical advice: feeling sick, vomiting, constipation, decreased or lack of appetite, feeling tired or sleeping for longer than normal, and shallow or slow breathing.
Section 3: Dosage
• Do not take for more than 3 days. If you need to use this medicine for more than three days you must speak to your doctor or pharmacist
• This medicine contains codeine and can cause addiction if you take it continuously for more than three days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.
Section 4: Side effects
• Some people may have side-effects when taking this medicine. If you have any unwanted side-effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.yellowcard.gov.uk; alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday – Friday) or fill in a paper form available from your local pharmacy.
How do I know if I am addicted?
If you take the medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:
• You need to take the medicine for longer periods of time
• You need to take more than the recommended dose
• When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Paracetamol should be given with care to patients taking other drugs that affect the liver.
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone. Concurrent use need not be avoided.
The absorption of paracetamol may possibly be reduced if cholestyramine is given at the same time, but the reduction in absorption is small if given an hour later.
The anticoagulatory effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding.
4.6 Pregnancy And Lactation
Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.
Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.
There is inadequate evidence of safety of codeine in pregnancy. Codeine has been used for many years without apparent ill-consequences, and animal studies have not shown any hazard.
The use of Paracodol Capsules in pregnancy is therefore acceptable if there is no safer alternative.
At normal therapeutic doses codeine and its active metabolites may be present in breast milk at very low doses and is unlikely to adversely affect the breast fed infant.
However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolites may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant.
If symptoms of opioid toxicity develop in either the mother or the infant, then all codeine containing medicines should be stopped and alternative non-opioid analgesics prescribed. In severe cases consideration should be given to prescribing naloxone to reverse these effects.
4.7 Effects On Ability To Drive And Use Machines
None stated.
4.8 Undesirable Effects
Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
Codeine may sometimes cause constipation.
Regular prolonged use of codeine is known to lead to addiction and symptoms of restlessness and irritability may result when treatment is then stopped.
Prolonged use of a painkiller for headaches can make them worse.
4.9 Overdose
Codeine
The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.
Symptoms
Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been co-ingested, including alcohol, or the overdose is very large. The pupils may be pin-point in size; nausea and vomiting are common. Hypotension and tachycardia are possible but unlikely.
Management
This should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350 mg or a child more than 5 mg/kg.
Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life so large and repeated doses may be required in a seriously poisoned patient. Observe for at least four hours after ingestion, or eight hours if a sustained release preparation has been taken.
Paracetamol
Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk factors
If the patient:
a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.
Or
b) Regularly consumes ethanol in excess of recommended amounts.
Or
c) Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Paracetamol is well known for its analgesic and antipyretic actions. Codeine phosphate is an analgesic with uses similar to those of morphine, but only with mild sedative effects, and is much less liable than morphine to produce dependence or toxic effects.
5.2 Pharmacokinetic Properties
Codeine phosphate is well absorbed after oral administration, producing peak plasma concentrations in about one hour. The plasma half-life is between 3 and 4 hours, excretion being mainly in the urine. Paracetamol is also readily absorbed after oral administration, with peak plasma concentrations occurring between 30 minutes and 2 hours after ingestion. The plasma half life varies between 1 and 4 hours. Excretion is mainly via the urine.
5.3 Preclinical Safety Data
None.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Capsules contents
Pregelatinised Maize Starch
Colloidal Silicon Dioxide
Magnesium Stearate (E 572)
Capsule shell
Titanium dioxide (E 171)
Gelatin
Printing ink
Shellac (E 904)
Red Iron Oxide (E 172)
6.2 Incompatibilities
None stated.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
Do not store above 25 C
6.5 Nature And Contents Of Container
Blisters of white 250 micron PVC/40 gsm PVDC base with 30 micron hard temper aluminium foil lidding.
Pack sizes: 2, 10, 20, 24, 30, 32.
6.6 Special Precautions For Disposal And Other Handling
None.
Administrative Data
7. Marketing Authorisation Holder
Bayer plc
Bayer House
Strawberry Hill
Newbury, Berkshire
RG14 1JA.
Trading as Bayer plc, Consumer Care Division
8. Marketing Authorisation Number(S)
PL 00010/0339
9. Date Of First Authorisation/Renewal Of The Authorisation
30/04/1994
10. Date Of Revision Of The Text
January 2011
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