Active ingredients: Azathioprine
Azathioprine 25 mg film-coated tablets.
Film-coated tablet.
White to yellowish-white film-coated tablet, biconvex, no score-line.
One film-coated tablet contains 25 mg azathioprine.
Excipient(s) with known effect: Lactose
For the full list of excipients, see section 6.1.
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.
Core:
Lactose monohydrate
Maize starch
Povidone
Colloidal silicon dioxide
Magnesium stearate
Coating:
Hypromellose
Microcrystalline cellulose
Polyoxyl 8 stearate
Talc
Colouring agent:
titanium dioxide (E171)
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.
Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom
PL 04416/1247
25/10/2002