OMESAR Film-coated tablet Ref.[50287] Active ingredients: Olmesartan medoxomil

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, 1611 Luxembourg, Luxembourg

Product name and form

Omesar 10 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablets.

White, circular, film-coated tablets with C13 debossed on one side.

Qualitative and quantitative composition

Olmesartan medoxomil.

Each film-coated tablet contains 10 mg olmesartan medoxomil.

Excipient with known effect: Each film-coated tablet contains 61.6 mg lactose monohydrate.

For the full list of excipients, see section 6.1

Active Ingredient Description
Olmesartan medoxomil

Olmesartan medoxomil is a potent, orally active, selective angiotensin II receptor (type AT1) antagonist. It is expected to block all actions of angiotensin II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin II. The selective antagonism of the angiotensin II (AT1) receptors results in increases in plasma renin levels and angiotensin I and II concentrations, and some decrease in plasma aldosterone concentrations.

List of Excipients

Tablet core:

Cellulose, microcrystalline
Lactose monohydrate
Hydroxypropylcellulose
Low substituted hydroxypropylcellulose
Magnesium stearate

Tablet coat:

Titanium dioxide (E171)
Talc
Hypromellose

Pack sizes and marketing

Laminated polyamide / aluminium/polyvinyl chloride // aluminium blister pack.

Packs of 14, 28, 30, 56, 84, 90, 98 and 10 × 28 film-coated tablets.

Packs with perforated unit dose blisters of 10, 50 and 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, 1611 Luxembourg, Luxembourg

Marketing authorization dates and numbers

PA0865/011/001

Date of first authorisation: 19th September 2003
Date of last renewal: 25th April 2008

Drugs

Drug Countries
OMESAR Ireland, Malta, South Africa

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