Medinol Over 6 Paracetamol Oral Suspension.

Paracetamol BP 250mg/5ml.

Oral suspension.

For the relief of mild to moderate pain including headache, migraine, neuralgia, toothache and sore throat. Symptomatic relief of rheumatic aches and pains. Symptomatic relief of influenza, feverishness and colds.

Oral. To be taken four times daily. Do not repeat doses more frequently than every four hours.

Adults, the elderly and children over 12 years of age: two to four 5ml spoonfuls. Children 6 to 12 years: one to two 5ml spoonfuls. Not to be given to children under 6 years of age. Do not take more than 4 doses in 24 hours

Should be used with caution in patients with impaired kidney or liver function. Hypersensitivity to paracetamol and/or other constituents.

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment and in those with non-cirrhotic alcoholic liver disease. The hazards of overdose are greater in those with alcoholic liver disease. If pain or fever persists for more than 3 days, consult your doctor. Prolonged use without medical supervision may be harmful. Do not exceed the stated dose. Keep out of the reach of children.

The labels state: Do not give with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if the child seems well.

The leaflet states: Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed serious liver damage.

Alcohol, barbiturates, anticonvulsants and tricyclic antidepressants may increase hepatotoxicity of paracetamol, particularly after an overdose. Paracetamol may increase the half life of chloramphenicol. 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.

Epidemiological studies in human pregnancy have shown no effects due to paracetamol used in the recommended dosage. However, paracetamol should be avoided in 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.

None known.

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopaenia and agranulocytosis, and of acute pancreatitis.

Symptoms of 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, 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 gluthathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.

Treatment: Immediate treatment is essential in the management of a 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.

Paracetamol has analgesic and antipyretic properties.

Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring 30 minutes to 2 hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. The elimination half-life varies from 1 to 4 hours.

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

Sodium Methylhydroxybenzoate; Sodium Propylhydroxybenzoate; Sodium Saccharin; Sodium Cyclamate 1968; Tragacanth; Lycasin 80/55; Strawberry Flavour PFW 500253E; Purified Water.

None known.

36 months.

Store below 25^oC.

Amber glass sirop bottle with tamper evident cap fitted with polycone liner, containing 100 or 200ml of product.

Not applicable.

Cupal Ltd. Venus, 1 Old Park Lane, Trafford Park, Manchester, M41 7HA

PL 0338/0069.

10^th November 1989 / 16/05/96

July 2006