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

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

Not recommended.

Method of administration

Oral.

Elderly

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.

CODANOL tablets should, if possible, be taken during or after meals.

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, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias have been reported.

Liver damage is likely in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to lever tissue.

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 and any patient who has ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N–acetylcysteine which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.

Severe respiratory depression due to dihydrocodeine can be treated with naloxone hydrochloride 0.8 to 2mg intravenously, repeated as required at 2 or 3-minute intervals.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to: Pharmaceutical Services, Ministry of Health, CY-1471 Nicosia, Tel: +357 22608607, Fax: +357 22608669, Website: www.moh.gov.cy/phs.

Three years.

Store at or below 25°C.

CODANOL tablets are disposed in PVdC/PVC blister pack 20μm hard tempered aluminium backing foil (10 tablets) in a printed carton. Each printed carton contains 20 tablets (2 blisters of 10).

None.