FASIGYN Film-coated tablet Ref.[8084] Active ingredients: Tinidazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ

Product name and form

FASIGYN 500mg film-coated tablets.

Pharmaceutical Form

Film-coated tablets.

White, round, biconvex film-coated tablet embossed on one side with “FAS 500”.

Qualitative and quantitative composition

Tinidazole 500mg.

Active Ingredient Description
Tinidazole

Tinidazole is active against both protozoa and obligate anaerobic bacteria. The activity against protozoa involves Trichomonas vaginalis, Entamoeba histolytica and Giardia lamblia. The mode of action of tinidazole against anaerobic bacteria and protozoa involves penetration of the drug into the cell of the micro-organism and subsequent damage of DNA strands or inhibition of their synthesis.

List of Excipients

Tablet Core:

Microcrystalline cellulose (Avicel PH 101)
Alginic acid
Maize starch
Magnesium stearate
Sodium lauryl sulfate

Film Coating:

Hydroxypropyl methyl cellulose
Propylene glycol
Titanium dioxide (E171)

Pack sizes and marketing

Aluminium foil backed blister packs of 16 500mg tablets consisting of:

a) 250 micron PVC blister coated with 40gsm of PVdC

b) 20 micron aluminium foil backing coated with 20gsm PVdC

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ

Marketing authorization dates and numbers

PL 00057/0150

08/02/2006

Drugs

Drug Countries
FASIGYN Mexico, Singapore

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