PROZAC Hard capsules / Oral solution Ref.[6849] Active ingredients: Fluoxetine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Eli Lilly and Company Limited, Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom

Product name and form

PROZAC 20mg hard capsules.

PROZAC 20mg per 5ml oral solution.

Pharmaceutical Form

Hard capsules.

The capsules are green and yellow, printed ‘Lilly 3105’.

Oral solution.

The solution is clear, colourless, mint odoured.

Qualitative and quantitative composition

Each capsule contains 20 mg of fluoxetine (as fluoxetine hydrochloride).

Each 5 ml of oral solution contains 20 mg of fluoxetine (as fluoxetine hydrochloride).

Excipients with known effect: contains 3 g of sucrose per 5 ml dose. Also contains small amounts of ethanol (alcohol), less than 100 mg per 5 ml dose.

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

The oral solution contains:

Benzoic acid
Sucrose
Glycerine
Mint flavour (containing 0.23% ethanol (alcohol))
Purified water

The capsules contain:

Maize starch flowable
Dimeticone

Capsule components:

Patent blue V (E131)
Yellow iron oxide (E172)
Titanium dioxide (E171)
Gelatin

Pharmaceutical grade edible printing ink, containing shellac, hydrated ferric oxide (black) E172, propylene glycol and may contain ammonium hydroxide and potassium hydroxide.

Pack sizes and marketing

Capsules: PVC/aluminium blister packs of 2, 7, 12, 14, 20, 28, 30, 50, 56, 70, 98, 100 and 500 capsules.

Oral solution: Brown glass bottles containing 60 ml, 70 ml or 140 ml oral solution. The pack may include one of the following measuring and dosing devices:

  • a measuring cup, with a 5 ml graduation,
  • a 5 ml capacity syringe with graduations to measure 1.25, 2.5, 3.75 and 5 ml,
  • a 5 ml capacity syringe with graduations to measure 5, 10, 15 and 20 mg,
  • a double-ended spoon with the smaller spoon marked with a fill level equivalent to 2.5 ml and the larger spoon marked with a fill level equivalent to 5 ml.

Not all pack/bottle sizes may be marketed.

Marketing authorization holder

Eli Lilly and Company Limited, Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom

Marketing authorization dates and numbers

Capsules: PL 00006/0195
Oral solution: PL 00006/0272

Capsules:

Date of first authorisation: 25 November 1988
Date of latest renewal: 01 April 2013

Oral solution:

Date of first authorisation: 28 October 1992
Date of latest renewal: 01 April 2013

Drugs

Drug Countries
PROZAC Australia, Brazil, Canada, Ecuador, Estonia, Spain, France, Hong Kong, Ireland, Israel, Italy, Malta, Mexico, Netherlands, New Zealand, Romania, Singapore, Turkey, United Kingdom, United States, South Africa
 
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