CARBIMAZOLE Tablet

Active ingredients: Carbimazole

Product name and form

Carbimazole 20 mg Tablets.

Pharmaceutical Form

Pale pink, uncoated, round, biconvex tablets marked with LINK C20 on one side and a scoreline on the reverse.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each tablet contains 20 mg of carbimazole.

Excipients with known effect: Lactose Anhydrous (125.35 mg per tablet).

For a full list of excipients see section 6.1.

Active Ingredient
Description

Carbimazole, a thionamide, is a pro-drug which undergoes rapid and virtually complete metabolism to the active metabolite, thiamazole, also known as methimazole. The method of action is believed to be inhibition of the organification of iodide and the coupling of iodothyronine residues which in turn suppress the synthesis of thyroid hormones.

List of Excipients

Anhydrous lactose
Croscarmellose sodium
Iron oxide (red) (E172)
Magnesium stearate

Pack sizes and marketing

The tablets are supplied in white, opaque 250 micron thermoformed PVC blister packs sealed with 20 micron lacquered aluminium foil containing 28, 56, 100 or 112 tablets.

Not all pack sizes may be marketed.

The heatseal coating lacquer of the aluminium foil consists of a PVC/PVAC co-polymer and polymethacrylate, with the outer side being a heat resistant lacquer based on polyester.

Marketing authorization holder

Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK

Marketing authorization dates and numbers

PL 20072/0240

08/05/2008