LOSAR Film-coated tablet Ref.[49796] Active ingredients: Losartan

Source: Υπουργείο Υγείας (CY)  Revision Year: 2017  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Losar 50 mg film-coated tablets.

Losar 100 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Losar 50 mg film-coated tablets:

White, round, biconvex, film-coated tablets, scored on one side.

The tablet can be divided into equal doses.

Losar 100 mg film-coated tablets:

White, round, biconvex, film-coated tablets, scored on one side.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each Losar 50 mg film-coated tablet contains losartan potassium 50 mg.

Each Losar 100 mg film-coated tablet contains losartan potassium 100 mg.

Excipient(s) with known effect:

Each Losar 50 mg film-coated tablet contains 23.4 mg lactose.

Each Losar 100 mg film-coated tablet contains 46.8 mg lactose.

For the full list excipients, see section 6.1.

Active Ingredient Description
Losartan

Losartan is a synthetic oral angiotensin-II receptor (type AT1) antagonist. Antihypertensive activity and suppression of plasma aldosterone concentration are maintained, indicating effective angiotensin II receptor blockade.

List of Excipients

Core:

Cellulose, microcrystalline
Lactose monohydrate
Starch, pregelatinised
Sodium starch glycolate (Type A)
Magnesium stearate

Coating:

Hydroxypropylcellulose (E463)
Hypromellose
Titanium dioxide

Pack sizes and marketing

Losar 50 mg film-coated tablets: Aluminium-PVC/PE/PVDC blisters. Pack-sizes of 30 and 100 film-coated tablets.

Losar 100 mg film-coated tablets: Aluminium-PVC/PE/PVDC blisters. Pack-sizes of 30 and 100 film-coated 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

Losar 50 mg film-coated tablets: 20786
Losar 100 mg film-coated tablets: 20787

Date of first authorization: 04 October 2010
Date of latest renewal: 16 September 2015

Drugs

Drug Countries
LOSAR Cyprus, Germany, Hong Kong

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