Co-Dydramol Tablets Bp
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Co-Dydramol Tablets BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Dihydrocodeine Tartrate BP 10 mg & Paracetamol BP 500 mg.
3 PHARMACEUTICAL FORM
White, flat bevel edged tablet engraved with company logo on one face and A476 and a bar on the other face.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For oral administration as an analgesic and an antitussive.
4.2 Posology and method of administration
Co-Dydramol Tablets should, if possible, be taken during or after meals.
Dose for Adults and Children Over 12 years
As an analgesic 1 tablet every 4-6 hours, as required. This may, if necessary, be increased to a maximum of 2 tablets four times daily.
As an antitussive 1 tablet every 4-6 hours, as required. This may, if necessary, be increased to a maximum of 2 tablets four times daily.
Not recommended for children under 12 years. Dosage should be reduced in the elderly.
4.3 Contraindications
Hypersensitivity to dihydrocodeine tartrate or paracetamol and/or any other constituents. Respiratory depression, obstructive airways disease, liver disease. Allergic disorders during an attack of asthma.
4.4 Special warnings and precautions for use
Dihydrocodeine may bring about histamine release, therefore it should not be given during an asthma attack and it should be administered with due care to persons liable to such attack.
The dosage should be reduced in hypothyroidism, renal insufficiency and chronic hepatic disease.
Alcohol should be avoided. When dihydrocodeine is prescribed for chronic use, care should be taken to avoid unnecessary increase in dosage.
Use with caution in the administration of this medicine to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. If symptoms persist, consult your doctor. Keep out of the reach of children.
Patients should be advised not to exceed the recommended dose and not to take other paracetamol-containing products concurrently.
The risk-benefit of continued use should be assessed regularly by the prescriber.
The label will have the following warnings:
• Immediate medical advice should be sought in the event of an overdose, even if you feel well.
• Do not take with any other paracetamol containing product.
• Contains paracetamol.
• Do not exceed the stated dose.
• If symptoms persist consult your doctor.
The label will also state (to be displayed prominently on outer pack - not boxed):
• Do not take for longer than directed by your prescriber as taking dihydrocodeine regularly for a long time can lead to addiction.
The leaflet will state in a prominent position in the “before taking” section:
• Do not take for longer than directed by your prescriber
• By taking dihydrocodeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets.
• By taking a painkiller for headaches too often or for too long can make them worse
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.
4.5 Interaction with other medicinal products and other forms of interaction
Additive CNS depression may occur with alcohol.
Dihydrocodeine should be used with caution in patients taking monoamine oxidase inhibitors, CNS depressants or metoclopramide. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption 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
Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended therapeutic dosage but patients should follow the advice of their doctor regarding its use. Dihydrocodeine has been used for many years without apparent ill effects. It should be used with caution in late pregnancy as it may cause respiratory depression in the neonate. As with all medicines, use should be avoided during the first trimester. Dihydrocodeine and Paracetamol are excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast-feeding.
4.7 Effects on ability to drive and use machines
Dihydrocodeine may cause vertigo which may affect the ability to drive or use machines.
4.8 Undesirable effects
Regular prolonged use of dihydrocodeine is known to lead to addiction and tolerance. Symptoms of restlessness and irritability may result when treatment is then stopped. Dihydrocodeine tartrate may cause constipation, nausea, vomiting, headache, vertigo and giddiness in some patients and these are relatively common if the dose is increased above 30mg. If constipation occurs it can be treated with a gentle laxative.
Tolerance and dependence may occur with dihydrocodeine especially with prolonged dosage.
There have been very rare occurrences of pancreatitis.
Prolonged use of a painkiller for headaches can make them worse.
Adverse effects of paracetamol are rare but hypersensitivity including skin rash and other allergic reactions may occur occasionally. There have been isolated reports of blood dyscrasias including thrombocytopenia, purpura and agranulocytosis, but these were not necessarily causally related to paracetamol.
4.9 Overdose
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
• Is on long term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.
• Regularly consumes ethanol in excess of recommended amounts.
• 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, coma and death. Acute renal failure with 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.
Managament
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 24 hours from ingestion should be discussed with the NPIS or a liver unit.
Dihydrocodeine
Symptoms
Acute overdosage with dihydrocodeine can be manifested by somnolence progressing to stupor or coma, miotic pupils, rhabdomyolysis, non-cardiac pulmonary oedema, bradycardia, hypotension and respiratory depression or apnoea.
Management
Primary attention should be given to the establishment of a patent airway and institution of assisted or controlled ventilation.
In the case of massive overdosage, administer naloxone intravenously (0.4 to 2 mg for an adult and 0.01 mg/kg body weight for children) if the patient is in a coma or respiratory depression is present. Repeat the dose at 2 minute intervals if there is no response, or by an infusion. An infusion of 60% of the initial dose per hour is a useful starting point. A solution of 10 mg made up in 50 ml dextrose will produce 200 micrograms/ml for infusion using an IV pump (dose adjusted to the clinical response). Infusions are not a substitute for frequent review of the patient's clinical state. Intramuscular naloxone is an alternative in the event that IV access is not possible.
As the duration of action of naloxone is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably re-established. Naloxone is a competitive antagonist and large doses (4 mg) may be required in seriously poisoned patients. For less severe overdosage, administer naloxone 0.2 mg intravenously followed by increments of 0.1 mg every 2 minutes if required.
Naloxone should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to dihydrocodeine overdosage. Naloxone should be administered cautiously to persons who are known, or suspected, to be physically dependent on dihydrocodeine. In such cases, an abrupt or complete reversal of opioid effects may precipitate pain and an acute withdrawal syndrome.
Consider activated charcoal (50 g for adults, 10-15 g for children), if an adult presents within 1 hour of ingestion of more than 420mg or a child more than 3mg/kg.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Co-Dydramol contains paracetamol and dihydrocodeine tartrate in a ratio of 500 mg : 10 mg. Paracetamol has analgesic and antipyretic properties. Dihydrocodeine is an opioid (narcotic analgesic) which, together with paracetamol, lends additive analgesic characteristic to the product. Paracetamol and dihydrocodeine act by inhibiting prostaglandin synthesis in the central nervous system (CNS) and through a peripheral action by blocking pain-impulse generation. The peripheral action may also be due to inhibition of the synthesis of prostaglandins or to inhibition of the synthesis of actions of
other substances which sensitise pain receptors to mechanical or chemical stimulation.
Paracetamol probably produces antipyresis by acting centrally on the hypothalmic heat-regulating centre to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus. Dihydrocodeine also has an antidiarrhoeal action. It acts locally and probably centrally to alter the intestinal motility. It has anti-tussive action due to suppression of the cough reflex by a direct action probably in the medulla or pons.
5.2 Pharmacokinetic properties
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract following oral administration. Peak plasma concentrations are attained within 30-60 minutes and the half-life in plasma is about 2 hours following therapeutic doses. The duration of action is 3-4 hours.
Protein binding of paracetamol is variable; 20-50% may be bound at concentrations encountered during acute intoxication. It is relatively uniformly distributed throughout the body fluids. Approximately 90-95% of the drug is metabolised in the liver primarily by conjugation with glucuronic acid, sulphuric acid and cysteine. When high doses are ingested, paracetamol undergoes N-hydroxylation to form N-acetyl benzo-quinoneimine, a highly reactive intermediate. This metabolite reacts with sulphydryl groups in proteins and glutathione. When hepatic glutathione is depleted (following overdosage) reaction with hepatic proteins is increased and hepatic necrosis results.
Dihydrocodeine is well absorbed from the gastro-intestinal tract following oral administration and a small quantity is bound to plasma proteins. Peak levels of plasma dihydrocodeine concentration are attained in an hour following ingestion. Plasma half-life has been reported to be between 3-4 hours after oral ingestion. Dihydrocodeine is metabolised in the liver by O- and N-demethylation.
Paracetamol, dihydrocodeine and their metabolites are excreted by the kidneys mainly as conjugates.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that covered in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Starch, Polyvinylpyrrolidone, Sodium Starch Glycollate, Stearic Acid, Colloidal Silicon Dioxide, Talc, Potable Water.
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months for opaque plastic containers. 24 months for blisters.
6.4 Special precautions for storage
Store below 25°C. Protect from light and moisture. Keep out of the reach of children.
6.5 Nature and contents of container
Co-Dydramol tablets are packed in the following containers and closures and pack sizes.
Opaque plastic containers composed of polypropylene tubes fitted with polyethylene made tamper-evident closures in pack sizes of 10, 12, 20, 24, 25, 30, 50, 100, 250, 500 and 1,000 tablets.
Opaque plastic containers composed of either, high density polypropylene or high density polyethylene with a tamper evident or child resistant tamper evident closure composed of high density polyethylene in pack sizes of 10, 12, 20, 24, 25, 30, 50, 100, 250, 500 and 1,000 tablets.
Blister packs of 20pm hard aluminium foil laminated to 15 pm rigid PVC film, and 250pm white opaque PVC film, containing 30 and 100 tablets.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
AUDEN MCKENZIE LIMITED
Mckenzie house
Bury Street
Ruislip
Middlesex
Ha4 7TL
8 MARKETING AUTHORISATION NUMBER(S)
PL 17507/0195
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
28 July 2004
10 DATE OF REVISION OF THE TEXT
18/01/2011