AZATHIOPRINE / SANDOZ Film-coated tablets

Active ingredients: Azathioprine

Product name and form

Azathioprine 25 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White to yellowish-white film-coated tablet, biconvex, no score-line.

Qualitative and quantitative composition

One film-coated tablet contains 25 mg azathioprine.

Excipient(s) with known effect: Lactose

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Azathioprine is a pro-drug of 6-mercaptopurine (6-MP). 6-MP is inactive but acts as a purine antagonist and requires cellular uptake and intracellular anabolism to thioguanine nucleotides (TGNs) for immunosuppression. The TGNs and other metabolites (e.g. 6-methyl-mecaptopurine ribonucleotides) inhibit de novo purine synthesis and purine nucleotide interconversions.

List of Excipients

Core:

Lactose monohydrate
Maize starch
Povidone
Colloidal silicon dioxide
Magnesium stearate

Coating:

Hypromellose
Microcrystalline cellulose
Polyoxyl 8 stearate
Talc

Colouring agent:

titanium dioxide (E171)

Pack sizes and marketing

The film-coated tablets are packed in either polypropylene-aluminium blister or PVC/PVDC-aluminium blister in a carton box.

The pack contains 20, 28, 30, 50, 90 or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

Marketing authorization dates and numbers

PL 04416/1247

25/10/2002