Legalon^®

Legalon^® 140 mg Capsule (milk thistle fruit extract)

Abbreviated Prescribing Information¹

Active ingredient: Milk thistle fruit extract.

Composition: One capsule contains 173.0–186.7 mg of dry extract from the fruits of Silybum marianum (36–44:1) equivalent to 75–80.9% of silymarin, calculated as silibinin (extractant: ethyl acetate). Other ingredients: Gelatin, microcrystalline cellulose, sodium starch glycolate, maize starch, magnesium stearate, sodium lauryl sulphate, titanium dioxide E171, ferric oxides E172.

A medicine acting on the liver: This is a traditional medicine.

Use: Traditionally used for liver tonic.

Contraindications: No restrictions. There have been no adequate investigations of the use of this medicine in children. It should, therefore, not be used in children under 12 years of age. No experience is available with regard to the use of Legalon^® 140 mg Capsule during pregnancy and lactation.

Dosage guidance, mode and duration of use: Treatment should be commenced with one capsule three times daily (milk thistle fruit extract equivalent to 420 mg of silymarin). As a maintenance dose, one capsule two times daily (milk thistle fruit extract equivalent to 280 mg of silymarin) is sufficient. The capsules should be taken whole with some liquid before meals.

Incorrect use and overdosage: In the event of an overdose, the described side effects may occur to a greater extent. In this case, you should ask your doctor for symptomatic measures.

Side effect: A mild laxative effect has occasionally been observed.

API-LEGALON-1212

Reference: 1. Malaysia Legalon^® 140 mg Capsule Approved Prescribing Information December 2012.