Updated: 21 May 2009
For the treatment of severe pain.
Paracetamol / opiates (opioids / compound analgesics).
REMEDEINE tablets contain Paracetamol 500 mg and Dihydrocodeine Tartrate BP 20 mg. REMEDEINE FORTE tablets contain Paracetamol 500 mg and Dihydrocodeine Tartrate BP 30 mg.
White to off-white, circular, flat faced tablets with a bevelled edge. REMEDEINE tablets are engraved PD/20 on one side. REMEDEINE FORTE tablets are engraved PD/30 on one side.
Napp Pharmaceuticals Limited
Route of Administration
REMEDEINEREMEDEINE FORTE tablets should, if possible, be taken during or after meals.
Adults and children over 12 years
1 or 2 tablets every four to six hours.
Do not exceed eight tablets in any 24-hour period.
Children under 12 years
One tablet every 4 - 6 hours increasing to two tablets every 4 - 6 hours if required and tolerated. Caution should be exercised when increasing the dose in the elderly.
REMEDEINEREMEDEINE FORTE 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.
The risk-benefit of continued use should be assessed regularly by the prescriber, and in particular the prescriber should take care to avoid any unnecessary increase in dosage especially where there is evidence of a previous history of drug dependence or abuse.
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 and allergic reactions including skin rashes.
Adverse effects of paracetamol are rare but hypersensitivity reactions including skin rash, blood dyscrasias, acute pancreatitis have been reported.
Dependence may occur. 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.
Prolonged use of a painkiller can make conditions such as headache worse.
Respiratory depression, obstructive airways disease, hypersensitivity to paracetamol, dihydrocodeine or other tablet constituents.
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