CIMETIDINE Film-coated tablet

Active ingredients: Cimetidine

Product name and form

Cimetidine 200mg Tablets BP.

Pharmaceutical Form

Film-coated tablet.

Plane green coloured, round, biconvex, film coated tablets debossed “CC” on one side and plain on the other side.

Qualitative and quantitative composition

Cimetidine 200 mg Tablets.

Each film coated tablet contains 200 mg cimetidine.

Excipient: each tablet contains 9.25 mg of Lactose monohydrate, 0.19 mg of sodium.

For a full list of excipients, see section 6.1.

Active Ingredient
Description

Cimetidine is a histamine H2-receptor antagonist which rapidly inhibits both basal and stimulated gastric secretion of acid and reduces pepsin output. It is a reversible, competitive antagonist, and is used as an anti-ulcer drug.

List of Excipients

Core:

Lactose monohydrate
Maize starch
Magnesium stearate (E572)
Povidone (K30)
Sodium starch glycollate
Colloidal anhydrous silica

Tablet Coating:

Hypromellose (E464)
Titanium dioxide (E171)
Quinoline yellow (E104)
Iron oxide yellow (E172)
Indigo carmine (E132)
Polyethylene glycol 400

Pack sizes and marketing

Tablet containers (opaque polypropylene containers with polypropylene cap): 100,250,500 and 1000 tablets.

Blister (PVC/aluminium foil blister strips in a carton): 60 and 120 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Marketing authorization dates and numbers

PL 20075/0045

27/02/2009