ALMIRAL Gastro-resistant tablet Ref.[28117] Active ingredients: Diclofenac

Source: Υπουργείο Υγείας (CY) Revision Year: 2019 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Almiral 25 mg gastro-resistant tablets.

Almiral 50 mg gastro-resistant tablets.

Pharmaceutical Form
Gastro-resistant tablets. Almiral tablets are orange, round, convex, for oral administration.

Qualitative and quantitative composition

Almiral tablets contain either 25 mg or 50 mg of diclofenac sodium.

Excipients with known effect: lactose, propylene glycol, sunset yellow (FCF) aluminium lake (E110), tartrazine aluminium lake (E102).

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Diclofenac	Diclofenac is a non-steroidal anti-inflammatory drug. The mechanism of action of diclofenac in AK may be related to the inhibition of the cycloxygenase pathway leading to reduced prostaglandin E₂ (PGE₂) synthesis. In addition, immunohistochemistry (IHC) from skin biopsies ac revealed that the clinical effects of diclofenac in AK are primarily due to anti-inflammatory, anti-angiogenic and possibly anti-proliferative effects and apoptosis-inducing mechanisms.

List of Excipients
Almiral tablets 25 mg: Microcrystalline cellulose Lactose monohydrate Croscarmellose sodium Silica colloidal anhydrous Magnesium stearate Propylene glycol Talc Methacrylic acid copolymer (1:1) Simeticone Opandry orange OY-3538, (hydroxypropylmethylcellulose, polyethylene glycol 8000, sunset yellow (FCF) aluminium lake (E110), talc and tartrazine aluminium lake (E102)) Almiral tablets 50 mg: Microcrystalline cellulose 101 Lactose monohydrate Croscarmellose sodium Colloidal silicon dioxide Magnesium stearate Methacrylic acid copolymer Propylene glycol Talc Simeticone Opandry orange OY-3538 (hydroxypropylmethylcellulose, polyethylene glycol 8000, sunset yellow aluminium lake (E110), talc and tartrazine aluminium lake (E102))

Pack sizes and marketing

Almiral tablets 25 mg are presented in aluminium/polyvinylchloride blisters of ten tablets in packs of three or ten blisters.

Almiral tablets 50 mg are presented in aluminium/polyvinylchloride blisters of ten tablets in packs of two, three, ten or 100 blisters.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Almiral 25mg tablets: 9918
Almiral 50mg tablets: 9919

Almiral 25mg tablets: 06.03.1985/10.11.2011
Almiral 50mg tablets: 06.03.1985/15.07.2013

Drugs

Drug	Countries
ALMIRAL	Cyprus, Estonia, Hong Kong, Malta, Romania, Singapore

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