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

Source: Υπουργείο Υγείας (CY)  Revision Year: 2023  Publisher: CRESCENT PHARMA INTERNATIONAL LIMITED, 260, Triq San Albert, Gzira GZR 1150, Malta, Tel: (01256) 772730, Fax: (01256) 772740

5.1. Pharmacodynamic properties

Paracetamol is an effective analgesic possessing a remarkably low level of side effects. Its broad clinical utility has been extensively reported, and it now largely replaces aspirin for routine use. Paracetamol is well tolerated; having a bland effect on gastric mucosa, unlike aspirin, it neither exacerbates symptoms of peptic ulcer nor precipitates bleeding. Dihydrocodeine tartrate has been widely used for a number of years as a powerful analgesic.

In addition, the compound exhibits well-defined anti-tussive activity.

Fortifying paracetamol with dihydrocodeine tartrate provides an effective combination of drugs for the treatment of severe pain.

5.2. Pharmacokinetic properties

Pharmacotherapeutic group: analgesics
ATC code: N02AA58

Dihydrocodeine is well absorbed from the gastrointestinal tract. Like other phenanthrene derivatives, dihydrocodeine is mainly metabolized in the liver with the resultant metabolites being excreted mainly in the urine.

Metabolism of dihydrocodeine includes 0-demethylation, N-demethylation and 6-keto reduction.

Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring 30 minutes to 2 hours after ingestion. It is metabolized in the liver and excreted in the urine as the glucuronide and sulphate conjugates.

5.3. Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

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