DIAMOX SR Capsule

Active ingredients: Acetazolamide

Product name and form

Diamox SR 250mg Prolonged-release Capsules.

Pharmaceutical Form

Prolonged-release capsule.

Orange spherical pellets contained in a size ‘1’ capsule with clear body and opaque orange cap. ‘GS 250’ is printed on the orange cap in black text.

Qualitative and quantitative composition

Each capsule contains 250 mg acetazolamide.

Excipient(s): For a full list of excipients, see section 6.1.

Active Ingredient
Description

Acetazolamide is an enzyme inhibitor which acts specifically on carbonic anhydrase. By inhibiting the reaction catalysed by this enzyme in the renal tubules, acetazolamide increases the excretion of bicarbonate and of cations, chiefly sodium and potassium, and so promotes alkaline diuresis. By inhibiting carbonic anhydrase in the eye acetazolamide decreases intra-ocular pressure and is therefore useful in the treatment of glaucoma.

List of Excipients

Film coated Pellets:

Microcrystalline Cellulose, sodium Lauryl sulphate, purified water, ethylcellulose, Hydroxypropylmethyl cellulose (E464), mineral oil light and Pigment Blend PB-230005 Orange [hydroxyl propyl cellulose, titanium dioxide and FD&C Yellow #6/Sunset yellow FCF aluminium lake (15–18% grade), Talc and FD&C Yellow #6/Sunset yellow FCF aluminium lake (38–42% grade)].

Capsules shells:

Gelatine, titanium dioxide (E171), yellow iron oxide (E172) erythrosine (E127).

Pack sizes and marketing

Blister Packs: 28 and 30 Capsules/ Pack

Opaque UPVC/PVDC blister Pack heat sealed with aluminium foil backing in an outer carton

Not all pack sizes may be marketed.

Marketing authorization holder

Mercury Pharmaceuticals Ltd., Capital House, 85 King William Street, London EC4N 7BL, UK

Marketing authorization dates and numbers

PL 12762/0145

22 June 2004

Drugs

Drug
Countries
Austria, Australia, Brazil, France, Ireland, Netherlands, New Zealand, Tunisia, United Kingdom