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Actol M (Paracetamol & DL-Methionine)

Composition:

Actol M Tablet: Each film coated tablet contains Paracetamol BP 500 mg and DL- Methionine BP 100 mg.

Pharmacology:

Actol M is a combination of Paracetamol (an analgesic and antipyretic) and DL- Methionine (its antidote); this mixture is called co-methiamol. Paracetamol is used in the treatment of mild to moderate pain. It is also useful for reducing fever. Paracetamol is broken down to toxic compounds which are normally neutralised by a substance in the liver called glutathione. Glutathione is only produced in limited amounts, so the body cannot neutralise the excessive toxins resulting from a Paracetamol overdose. This leads to liver damage. DL-Methionine is a substance obtained from the diet and used by the body to produce glutathione. Methionine is added to this preparation as it may prevent liver damage occurring if a paracetamol overdose is taken.

Indication:

Actol M is indicated for the treatment of pain and fever in patients with the risk of liver toxicity.

Dosage and administration:

Adult: 2 tablets every 4 hours; max 8 tablets daily

Use in pregnancy and Lactation:

Actol M has shown no ill effects in human pregnancy due to Paracetamol used in the recommended dosage and Methionine is an essential amino acid. Paracetamol is excreted in breast milk but not in a clinically significant amount. Available data on Paracetamol do not contraindicate breast-feeding. However, the tablet should be used with caution during pregnancy and lactation.

Side Effects:

Side effects of Paracetamol are rare but hypersensitivity, including skin rash may occur. There have been a few reports of blood dyscrasias, including thrombocytopenia and agranulocytosis, but these were not necessarily related to Paracetamol.

Contraindication:

Hypersensitivity to Paracetamol, Methionine or any other ingredients of this preparation. It should not be used in patients taking monoamine-oxidase inhibitors (MAOIs) or in the presence of hepatic disease, as there is an increased risk of psychosis or encephalopathy

Precaution:

Care is advised in the administration of Paracetamol to patients with severe renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic hepatic disease. Patients should be advised not to exceed the recommended dose and not to take other Paracetamol-containing products concurrently.

Drug Interaction:

This tablet should not be used with monoamine-oxidase inhibitors (MAOI) and antidepressants (e.g. phenelzine). Prolonged use of Paracetamol may enhance the effects of anti-clotting/blood thinning drug such as warfarin, leading to an increased risk of bleeding. Methionine may reduce the effect of levodopa. Metoclopramide and Domperidone increase the rate of absorption of Paracetamol from the gut. The absorption of Paracetamol is decreased if cholestyramine is taken at the same time.

Storage:

· Store in cool & dry place, protect from light.  

· Keep out of reach of children.

Packaging:

Actol M Tablet: Each box contain 5x10’s, 6x10’s, 10x10’s, 15x10’s, 20x 10’s tablets in blister pack.

 

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