RENICARD Film-coated tablet Ref.[115263] Active ingredients: Losartan

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2024  Publisher: Unichem SA (Pty) Ltd, San Domenico, Ground Floor, Unit G4, 10 Church Street, Durbanville, 7551 Cape Town, Tel: +27 21 531 0436

Product name and form

RENICARD 50 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablets.

Light pink, biconvex, oblong, film-coated tablet with score mark on one side.

Qualitative and quantitative composition

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

Excipient with known effect:

Contains sugar: 25,5 mg lactose monohydrate per tablet.

For the full list of excipients, see section 6.1.

Active Ingredient

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

Microcrystalline cellulose (E460)
Lactose monohydrate
Pregelatinised starch
Purified talc (E553)
Magnesium stearate (E572)
Opadry Pink (consisting of hypromellose [E464], titanium dioxide [E171], macrogol [E1521], talc [E553], iron oxide red [E172])

Pack sizes and marketing

Aluminium/PVC blister strips of 10 tablets. Three strips will be packed in an outer carton.

Marketing authorization holder

Unichem SA (Pty) Ltd, San Domenico, Ground Floor, Unit G4, 10 Church Street, Durbanville, 7551 Cape Town, Tel: +27 21 531 0436

Marketing authorization dates and numbers

A39/7.1.3/0580

12 June 2009

Drugs

Drug Countries
RENICARD South Africa

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