OLMESARTAN Film-coated tablet Ref.[7013] Active ingredients: Olmesartan medoxomil

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland

Product name and form

Olmesartan 10mg Film-coated Tablets.

Pharmaceutical Form

Film-coated tablet.

Olmesartan 10 mg film-coated tablets are white, round, biconvex and 6.5mm in diameter, with OL 10 debossed on one side.

Qualitative and quantitative composition

Olmesartan medoxomil.

Each 10 mg tablet contains 10 mg of olmesartan medoxomil.

Excipients with known effect: Each 10 mg tablet contains 75.53mg of 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

Film-coating:

Opadry II White 33G28435 containing:

Titanium dioxide (E171)
Hypromellose 6cP
Lactose monohydrate
Macrogol 3350
Triacetin

Pack sizes and marketing

Aluminium/aluminium blister pack.

Packs of 7, 10, 14, 28, 30, 56, 60, 84, 90, 98 and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland

Marketing authorization dates and numbers

PL 30306/0701

18/08/2016 / 16/05/2018

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