FLUXIL Capsule Ref.[28203] Active ingredients: Fluoxetine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: Delorbis Pharmaceuticals Ltd., 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union

Product name and form

Fluxil 20 mg capsules.

Pharmaceutical Form

Capsules.

Fluxil 20 mg capsules are light green and buff, hard gelatine capsules, size 3, containing white odourless powder.

Qualitative and quantitative composition

Each capsule contains fluoxetine hydrochloride (22.4 mg) equivalent to 20 mg of fluoxetine.

Excipient(s) with known effect: each capsule contains 146.60 mg of lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Fluoxetine

Fluoxetine is a selective inhibitor of serotonin reuptake, and this probably accounts for the mechanism of action. Fluoxetine has practically no affinity to other receptors such as α1, α2, and β-adrenergic; serotonergic; dopaminergic; histaminergic1; muscarinic; and GABA receptors.

List of Excipients

Capsule content:

Microcrystalline cellulose
Colloidal silicon dioxide
Lactose monohydrate
Magnesium stearate

Hard gelatin capsule shell composition:

Titanium dioxide
Yellow iron oxide
Indigo carmine-FD&C Blue 2
Quinoline yellow E104
Gelatine

Pack sizes and marketing

Fluoxetine 20 mg capsules are supplied in Alu/PVC-PVDC blister packs of 1x10 or 3x10 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Delorbis Pharmaceuticals Ltd., 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union

Marketing authorization dates and numbers

Fluxil 20 mg capsules: 019991

Date of first authorisation: 29 December 2005

Drugs

Drug Countries
FLUXIL Cyprus, Hong Kong, Malta, Singapore

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