INDERAL Film-coated tablet Ref.[50771] Active ingredients: Propranolol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Atnahs Pharma UK Limited, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, United Kingdom

Product name and form

Inderal 10 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Pink, round, biconvex, intagliated with “10” on one face and bisected on the reverse face. Diameter of each film-coated tablet is approximately 6.5 mm. The score line is not intended for breaking the tablet.

Qualitative and quantitative composition

ach tablet contains 10 mg propranolol hydrochloride.

Excipient(s) with known effect: Lactose – 79 mg of lactose per tablet.

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:

Lactose
Calcium Carboxymethyl Cellulose
Gelatin (E441)
Magnesium Stearate

Coating:

Carmine (E120)
Glycerol (E422)
Hypromellose (E464)
Titanium Dioxide (E171)

Pack sizes and marketing

PVC-PVDC/Al blisters available in pack size of 50 tablets (5 × 10 tablets).

Marketing authorization holder

Atnahs Pharma UK Limited, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, United Kingdom

Marketing authorization dates and numbers

PL 43252/0036

Date of first authorisation: 27th May 1975
Date of latest renewal: 4th June 2003

Drugs

Drug Countries
INDERAL Austria, Australia, Canada, Germany, Japan, Malta, United States, South Africa

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