1. Name Of The Medicinal Product
Co-codamol Disp./Co-codamol Eff.
2. Qualitative And Quantitative Composition
|
|
|
|
|
|
For a full list of excipients see section 6.1
3. Pharmaceutical Form
Soluble Tablet.
4. Clinical Particulars
4.1 Therapeutic Indications
For the treatment of pain, including muscular and rheumatic pains, headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains, discomfort associated with influenza, feverishness and feverish colds.
4.2 Posology And Method Of Administration
Posology:
Tablets are to be dissolved in water before oral administration.
Adults:
1 - 2 tablets, which may be repeated every four to six hours with a maximum of 8 tablets in 24 hours.
Elderly:
No current evidence for the 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
Persons hypersensitive to any of the ingredients should avoid taking this product.
4.4 Special Warnings And Precautions For Use
The tablet has a sodium content of 383 mg. Persons on a low sodium diet should be aware of this if they wish to take Co-Codamol Tablets.
Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.
In cases of renal insufficiency the rate of excretion of codeine and paracetamol metabolites may be reduced, and dosage schedules may need to be revised accordingly.
Do not exceed the stated dose.
If symptoms persist, consult your doctor.
Contains paracetamol. 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.
Keep out of the sight and reach of children.
The leaflet will state in a prominent position in the 'before taking' section:
• Do not take for longer than directed by your prescriber.
• Taking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets.
• Taking a painkiller for headaches too often or for too long 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 Co-Codamol Eff. 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.
The label will state (To be displayed prominently on outer pack – not boxed):
• Do not take for longer than directed by your prescriber as taking codeine regularly for a long time can lead to addiction.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Paracetamol should be given with care to patients taking other drugs which affect the liver. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and reduced by cholestyramine.
The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding. Occasional doses have no significant effect.
4.6 Pregnancy And Lactation
There is inadequate evidence of safety of the drug in human pregnancy, but it has been in wide use for many years without apparent ill-consequence.
Paracetamol:
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.
Codeine:
There is evidence that exposure to codeine during pregnancy may give a higher incidence of respiratory malformations. If drug therapy is needed in pregnancy, this drug can be used 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
No effects known at the recommended dose.
4.8 Undesirable Effects
Codeine may sometimes cause constipation and occasional skin rashes.
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 causality related to paracetamol.
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
Co-Codamol has analgesic and antipyretic actions. Codeine phosphate hemihydrate is a narcotic analgesic for relief of mild to moderate pain.
5.2 Pharmacokinetic Properties
Not applicable.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Povidone
Sodium hydrogen carbonate
Anhydrous sodium carbonate
Anhydrous citric acid
Mannitol
Saccharin sodium
Sodium docusate
Sodium benzoate
6.2 Incompatibilities
None known.
6.3 Shelf Life
24 months.
6.4 Special Precautions For Storage
Protect from moisture and heat. Do not store above 25 °C.
6.5 Nature And Contents Of Container
Aluminium foil/polyethylene laminate strip pack or Paper/polyethylene/aluminium foil/polyethylene laminate.
Pack sizes: 32 & 100
6.6 Special Precautions For Disposal And Other Handling
None.
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 00010/0320
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of first authorisation: 31/07/94
Date of last renewal: 18/05/04
10. Date Of Revision Of The Text
January 2011
No comments:
Post a Comment