PEROFEN Coated / Film-coated tablet Ref.[28046] Active ingredients: Ibuprofen

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Perofen 400 mg coated tablets.

Perofen 400 mg film-coated tablets.

Pharmaceutical Form

Perofen 400 mg coated tablets: Coated tablet.
Perofen 400 mg film-coated tablets: Film-coated tablet.

Perofen 400 mg coated tablets: Pink, round, sugar-coated tablets.
Perofen 400 mg film-coated tablets: Pink, round, film-coated tablets.

Qualitative and quantitative composition

Perofen 400 mg coated tablets: Each tablet contains 400 mg ibuprofen.

Perofen 400 mg film-coated tablets: Each tablet contains 400 mg ibuprofen.

Excipient(s) with known effect:

Perofen 400 mg coated tablets: This product contains 203.82 mg sucrose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ibuprofen

Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation.

List of Excipients

Core:

Perofen 400 mg coated tablets and Perofen 400 mg film-coated tablets:

Cellulose, microcrystalline
Sodium starch glycolate (type A)
Starch, pregelatinised
Silica, colloidal anhydrous
Talc

Coating:

Perofen 400 mg coated tablets:

Gelatin
Macrogol 6000
Povidone
Sucrose
Calcium carbonate
Erythrosine E127
Talc

Perofen 400 mg film-coated tablets:

Hypromellose
Macrogol 400
Titanium dioxide
Erythrosine aluminium lake E127
Talc

Pack sizes and marketing

Perofen 400 mg coated tablets:

PVC/Aluminium blisters. Pack-sizes of 20, 100 and 1000 tablets.

PP containers with PE closure. Pack-size of 1000 tablets.

Perofen 400 mg film-coated tablets:

PVC/Aluminium blisters. Pack-sizes of 20, 30, 100 and 1000 tablets.

PP containers with PE closure. Pack-size of 1000 tablets.

Not all pack-sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

Perofen 400 mg coated tablets: 8595
Perofen 400 mg film-coated tablets: 8597

Perofen 400 mg coated tablets:

Date of first authorization: 11 January 1983
Date of latest renewal: 02 November 2009

Perofen 400 mg film-coated tablets:

Date of first authorization: 11 January 1983
Date of latest renewal: 17 December 2012

Drugs

Drug Countries
PEROFEN Cyprus, Hong Kong, Malta, Singapore

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