OLMETEC Film-coated tablet Ref.[51039] Active ingredients: Olmesartan medoxomil

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Daiichi Sankyo UK Limited, 1<sup>st</sup> Floor, Building 4, Uxbridge Business Park, Sanderson Road, Uxbridge, UB8 1DH

Product name and form

Olmetec 10 mg film-coated tablets.

Olmetec 20 mg film-coated tablets.

Olmetec 40 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Olmetec 10 and 20 mg tablets: White, circular, film-coated tablets with C13 and C14 respectively debossed on one side.

Olmetec 40 mg tablets: White, oval, film-coated tablets with C15 debossed on one side.

Qualitative and quantitative composition

Olmesartan medoxomil

Each film-coated tablet contains 10 mg olmesartan medoxomil.

Each film-coated tablet contains 20 mg olmesartan medoxomil.

Each film-coated tablet contains 40 mg olmesartan medoxomil.

Excipient with known effect:

Olmetec 10 mg film-coated tablets: each film-coated tablet contains 61.6 mg lactose monohydrate.

Olmetec 20 mg film-coated tablets: each film-coated tablet contains 123.2 mg lactose monohydrate.

Olmetec 40 mg film-coated tablets: each film-coated tablet contains 246.4 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

Daiichi Sankyo UK Limited, 1st Floor, Building 4, Uxbridge Business Park, Sanderson Road, Uxbridge, UB8 1DH

Marketing authorization dates and numbers

Olmetec 10 mg: PL 08265/0015

Olmetec 20 mg: PL 08265/0016

Olmetec 40 mg: PL 08265/0017

22 May 2003/12 August 2007

Drugs

Drug Countries
OLMETEC Albania, Australia, Brazil, Canada, Germany, Ecuador, Spain, Finland, France, Hong Kong, Italy, Japan, Netherlands, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa

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