DIFLUCAN Hard capsule Ref.[6841] Active ingredients: Fluconazole

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

Product name and form

Diflucan 150 mg hard capsules.

Pharmaceutical Form

Hard capsule.

The 150 mg hard gelatin capsule has a turquoise blue body and turquoise blue cap overprinted with “Pfizer” and the code “FLU-150” with black ink. The capsule size is no. 1.

Qualitative and quantitative composition

Each hard capsule contains fluconazole 150 mg

Excipient(s) with known effects: each hard capsule also contains 149.12 mg lactose monohydrate

For the full list of excipients, see section 6.1.

Active Ingredient Description
Fluconazole

Fluconazole is a triazole antifungal agent. Its primary mode of action is the inhibition of fungal cytochrome P-450-mediated 14 alpha-lanosterol demethylation, an essential step in fungal ergosterol biosynthesis.

List of Excipients

Capsule content:

Lactose monohydrate
Maize starch
Colloidal silica anhydrous
Magnesium stearate
Sodium laurilsulfate

Capsule shell composition:

150 mg capsules:

Gelatin (E441)
Titanium dioxide (E171)
Patent blue V (E131)

Printing ink:

Shellac (glaze), black iron oxide (E172), N-Butyl alcohol, dehydrated alcohol, purified water, propylene glycol (E1520), industrial methylated spirit, isopropyl alcohol, strong ammonia solution, potassium hydroxide (E525).

Pack sizes and marketing

150 mg capsules: clear PVC blister packs or white opaque PVC/PVDC blister packs with aluminium foil backing.

Each pack contains 1, 2, 3, 4, 6, 7, 10, 12, 14, 20, 28, 30, 42, 50, 60, 100 or 500 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 00057/0290

Date of first authorisation: 07 June 1988
Date of latest renewal: 02 December 2008

Drugs

Drug Countries
DIFLUCAN Austria, Australia, Canada, Germany, Ecuador, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, United Kingdom, United States, South Africa

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