METRONIDAZOLE Film-coated tablet Ref.[6986] Active ingredients: Methronidazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2024  Publisher: Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip, HA46QD, United Kingdom

Product name and form

Metronidazole 500 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablets.

White to off white, oblong shaped, coated tablets, debossed with ‘M’ and '500’on one face and a break line on the other face. The size is 16.6 mm x 7.3 mm.

Qualitative and quantitative composition

Each film-coated tablet contains 500 mg metronidazole.

Excipient(s) with known effect:

Each tablet contains 1.981mg of sodium.

For the full list of excipients, see Section 6.1.

Active Ingredient Description
Methronidazole

Metronidazole is an anti-infectious drug belonging to the pharmacotherapeutic group of nitroimidazole derivatives, which have effect mainly on strict anaerobes. This effect is probably caused by interaction with DNS and different metabolites.

List of Excipients

Tablet core:

Cellulose microcrystalline
Starch pregelatinised (maize starch)
Hydroxypropylcellulose
Silica colloidal anhydrous
Sodium starch glycolate
Stearic acid

Tablet coat:

Hypromellose 2910 (5cps)
Polyethylene glycol

Pack sizes and marketing

Metronidazole film-coated tablets are available in clear PVC/Aluminium foil containing 21 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip, HA46QD, United Kingdom

Marketing authorization dates and numbers

PL 16363/0574

22/11/2019

Drugs

Drug Countries
METRONIDAZOLE Nigeria

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