BETAC Film-coated tablet Ref.[28143] Active ingredients: Betaxolol

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: Medochemie Ltd., 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Betac, 10 mg, film-coated tablets.

Betac 20 mg, film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Betac 10mg film-coated tablets: White, round, convex, film-coated tablets.

Betac 20mg film-coated tablets: White, round, scored, biconvex, film-coated tablets.

Betac 20mg film-coated tablet can be divided into equal halves.

Qualitative and quantitative composition

Each film-coated tablet of Betac 10mg contains 10mg betaxolol hydrochloride.

Each film-coated tablet of Betac 20mg contains 20 mg betaxolol hydrochloride.

Excipient with known effect: lactose monohydrate

One film-coated tablet of Betac 10mg contains 50mg of lactose monohydrate.

One film-coated tablet of Betac 20mg contains 100mg of lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Betaxolol

Betaxolol is a cardioselective Beta1 receptor blocker which, when applied topically to the eye, lowers intraocular pressure. It is thought to produce this effect by reducing the rate of production of aqueous humour.

List of Excipients

Betac contains lactose monohydrate, cellulose microcrystalline, sodium starch glycolate, colloidal anhydrous silica, magnesium stearate, titanium oxide (E171), polyvinyl alcohol, talc, lecithin and xanthan gum.

Pack sizes and marketing

10 betaxolol tablets are folded into PVC-Al blister.

Boxes of 10, 20, 28 and 30 film-coated tablets are available.

Not all pack sizes may be marketed.

Marketing authorization holder

Medochemie Ltd., 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Betac 20mg f.c tablets: 17976
Betac 10mg f.c tablets: 21867

Betac 20mg f.c tablets: 22.10.1998
Betac 10mg f.c tablets: 12.07.2013 / 6/11/2019

Drugs

Drug Countries
BETAC Cyprus, Hong Kong, Lithuania, Romania, Singapore

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