EMFORAL Film-coated tablet Ref.[28187] Active ingredients: Propranolol

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Emforal 10 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Pink, round, film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 10 mg propranolol hydrochloride.

Excipient(s) with known effect:

This product contains 60.9 mg lactose and 0.093 mg carmoisine E122.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Propranolol

Propranolol is a competitive antagonist at both beta, and beta2-adrenoceptor, but has membrane stabilising activity at concentrations exceeding 1-3mg/litre, though such concentrations are rarely achieved during oral therapy. Competitive beta-blockade has been demonstrated in man by a parallel shift to the right in the dose-heart rate response curve to beta-agonists such as isoprenaline.

List of Excipients

Core:

Cellulose, microcrystalline
Sodium starch glycolate (type A)
Lactose monohydrate
Maize starch
Povidone
Silica, colloidal anhydrous
Magnesium stearate
Talc

Coating:

Hypromellose
Polyethylene glycol 400
Titanium dioxide E171
Talc
Carmoisine azorubine aluminium lake E122
Brilliant blue FCF aluminium lake E133
Ferric oxide red E172

Pack sizes and marketing

PVC/Aluminium blisters. Pack-size of 50 film-coated tablets.

PP containers with PE closure. Pack-sizes of 500 and 1000 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

19733

Date of first authorisation: 08 November 2005
Date of latest renewal: 15 March 2011

Drugs

Drug Countries
EMFORAL Cyprus, Malta, Singapore

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