CODANOL Tablet Ref.[108859] Active ingredients: Dihydrocodeine Paracetamol

CODANOL tablets should be given with caution in patients with allergic disorders and should not be given during an attack of asthma. Caution should also be observed if there is marked impairment of liver function, advanced kidney disease and in chronic alcoholics.

Do not exceed the recommended dose.

Patients should be advised not to take other paracetamol-containing products concurrently.

Dosage should be reduced in the elderly, in hypothyroidism and in chronic hepatic disease. An overdose can cause hepatic necrosis.

Dihydrocodeine should be used with caution in patients taking monoamine oxidase inhibitors and should be avoided in those patients with raised intracranial pressure or head injury.

Use with caution in patients with prostatic hypertrophy since dihydrocodeine may cause urinary retention.

In patients already habituated to a drug such as pethidine, the substitution of dihydrocodeine in equi-analgesic doses has led to the appearance of abstinence symptoms. This suggests that dihydrocodeine, despite its effectiveness as an analgesic, has a low addiction potential. Nevertheless, when dihydrocodeine is prescribed for chronic use the physician should take care to avoid any unnecessary increase in dosage especially when there is a previous history of drug dependence or abuse.

Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as those using maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5-oxoproline, is recommended.

Effects of withdrawal – abrupt withdrawal precipitates a withdrawal syndrome. Symptoms may include tremor, insomnia, nausea, vomiting, sweating and increase in heart rate, respiratory rate and blood pressure. NOTE – tolerance diminishes rapidly after withdrawal so a previously tolerated dose may prove fatal.

Regularly prolonged use of dihydrocodeine is known to lead to addiction and tolerance. Symptoms of restlessness and irritability may result when treatment is then stopped.

Prolonged use of a painkiller for headaches can make them worse.

Additive CNS depression may occur with alcohol, and other CNS depressants such as anxiolytics, anti-depressants, hypnotics and anti-psychotics. The rate of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption of paracetamol may be reduced by cholestyramine.

The anti-coagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding.

Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis, especially in patients with risks factors (see section 4.4).

Epidemiological studies in human pregnancy have shown no effects due to paracetamol or dihydrocodeine. However, both drugs should be avoided during pregnancy unless considered essential by the physician.

Paracetamol is excreted in breast milk but not in a clinically significant amount.

Available published data do not contraindicate breast-feeding.

Dihydrocodeine may cause drowsiness and, if affected, patients should not drive or operate machinery.

Constipation, if it occurs, is readily treated with a mild laxative.

Other side-effects of dihydrocodeine which may occur in a few patients, are nausea, vomiting, headache, vertigo, giddiness, urinary retention, pruritus, sedation, dysphoria, hallucinations, allergic reactions including skin rashes and abdominal pain.

Adverse effects of paracetamol are rare but hypersensitivity reactions including skin rash, blood dyscrasias and acute pancreatitis have been reported.

None known.