Co-Codamol 8/500 Tablets Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Co-codamol 8/500 Tablets BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Codeine Phosphate 8mg Paracetamol 500mg
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Tablet for oral use
White, circular tablets marked CDM with a breakline on one face and CP on the reverse.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of pain such as muscular and rheumatic pain, headache, migraine, neuralgia, toothache, sore throat and period pains. Co-codamol Tablets BP may be effective in relieving symptoms associated with influenza and feverish colds.
4.2 Posology and method of administration
Adults
One or two tablets every four to six hours, with a maximum doe of eight tablets in any 24 hour period.
Elderly
The dosage should be reduced.
Hepatic impairment
The dosage should be reduced.
Children (6-12 years)
Half to one tablet, with a maximum of four tablets in any 24 hour period.
4.3 Contraindications
Known hypersensitivity to paracetamol and/or other constituents. Respiratory depression.
Obstructive airways disease.
Acute alcoholism.
Head injury or raised intracranial pressure.
Coma.
4.4 Special warnings and precautions for use
Co-codamol Tablets BP may cause drowsiness. Co-codamol Tablets BP should be given in reduced doses or with caution to patients with hypothyroidism, asthma, adrenocortical insufficiency, prostatic hypertrophy, hypotension, shock, inflammatory or obstructive bowel disorders, myasthenia gravis, hepatic or renal impairment and in those with a history of drug abuse.
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 (noncirrhotic) alcoholic liver disease.
Co-codamol Tablets BP enhance the effects of alcohol. Their concurrent use should be avoided.
The carton label and patient information leaflet will carry the following warning:
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.
4.5 Interaction with other medicinal products and other forms of interaction
In high doses or with regular treatment, paracetamol may potentiate the effects of warfarin. The absorption of paracetamol is reduced by cholestyramine and accelerated by domperidone and metoclopramide.
Codeine antagonises the effect of metoclopramide on gastrointestinal activity. It delays the absorption of flecainide and mexiletine and potentiates the effect of hypnotics and anxiolytics. Codeine may produce CNS excitation and hypertension in conjunction with MAOI drugs.
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
As with all medication, caution should be exercised during pregnancy, especially in the first trimester. Administration of codeine during labour may depress respiration in the neonate.
Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage. Available published data do not contraindicate breast feeding, but patients should follow the advice of their doctor regarding its use.
Paracetamol and codeine are excreted in breast milk but not in clinically significant quantities.
4.7 Effects on ability to drive and use machines
Co-codamol Tablets BP may cause drowsiness. If affected patients should not drive or operate machinery.
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. Renal damage may occur rarely with long term use.
The codeine phosphate component of Co-codamol Tablets BP may give rise to nausea, vomiting, constipation, confusion, drowsiness, dizziness, sedation, vertigo, excitement, difficulty with micturition, dry mouth, sweating, facial flushing, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, mood changes, hallucinations, miosis or raised intracranial pressure. Dependence may develop.
4.9 Overdose
a) Symptoms
Codeine:
The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.
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 pinpoint in size; nausea and vomiting are common. Hypotension and tachycardia are possible but unlikely. Other symptoms include somnolence, rash, miosis, vomiting, itching, ataxia and swelling of the skin.
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 of paracetamol overdose 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.
b) Management
Codeine:
Management should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated.
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 4 hours after ingestion, or 8 hours if a sustained release preparation has been taken.
Paracetamol:
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 has analgesic and antipyretic properties.
Codeine phosphate is an opioid analgesic but much less potent than morphine.
5.2 Pharmacokinetic properties
Both paracetamol and codeine phosphate are readily absorbed from the gastrointestinal tract giving peak plasma levels within one hour of administration.
Paracetamol is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half-life varies from about one to four hours. At usual therapeutic concentrations plasma-protein binding is negligible.
Codeine is metabolised in the liver to morphine and norcodeine, which are both excreted in the urine partly as conjugates with glucuronic acid. Most of the excretion products appear in the urine within six hours and up to 80% of the dose is excreted in 24 hours. About 70% of the dose is excreted as free codeine, 10% as free and conjugated morphine and a further 10% as free or conjugated norcodeine. Only traces are found in the faeces. The plasma half-life is approximately three to four hours.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber, which are additional to those included in other sections.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Pregelatinised Maize Starch Magnesium Stearate Povidone K30 *Purified Water
*Removed during the granulation procedure.
6.2 Incompatibilities
Not applicable
6.3 Shelf life
24 months Blister packs
36 months Polypropylene/polyethylene containers
6.4 Special precautions for storage
Do not store above 25°C
Store in original container
6.5 Nature and contents of container
500 or 1000 tablets in polypropylene/polyethylene containers, with polypropylene/polyethylene tamper evident closures or 100 tablets in blister strips of aluminium foil and PVC film in cartons.
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
Aspar Pharmaceuticals Limited 29-30 Capitol Way
Capitol Way Industrial Park, Colindale
London
NW9 0EQ
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 08977/0039
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
25/06/2002 / 10/06/2011
10 DATE OF REVISION OF THE TEXT
14/09/2006