TRANDATE Film-coated tablet Ref.[7719] Active ingredients: Labetalol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: RPH Pharmaceuticals AB, Lagervägen 7, 136 50 Haninge, Sweden

Product name and form

Trandate 50 mg film-coated tablets.

Pharmaceutical Form

Orange coloured, circular, biconvex film-coated tablets engraved Trandate 50 on one face.

Qualitative and quantitative composition

Each tablet contains 50 mg Labetalol hydrochloride.

Active Ingredient Description
Labetalol

Labetalol lowers the blood pressure by blocking peripheral arteriolar alphaadrenoceptors thus reducing peripheral resistance, and by concurrent betablockade, protects the heart from reflex sympathetic drive that would otherwise occur.
List of Excipients

Tablet core:

Lactose
Magnesium stearate
Starch maize special
Starch maize pregelatinised

Film coating suspension:

Hydroxypropylmethylcellulose
Sodium benzoate
Titanium dioxide
Sunset yellow
Methyl hydroxybenzoate
Propyl hydroxybenzoate
IMS 740P
Purified water

Pack sizes and marketing

Calendar blister pack containing 56 tablets; composed of hard tempered aluminium foil and opaque PVC blister.

Marketing authorization holder

RPH Pharmaceuticals AB, Lagervägen 7, 136 50 Haninge, Sweden

Marketing authorization dates and numbers

PL 36301/0013

01/11/1996

Drugs

Drug Countries
TRANDATE Austria, Australia, Canada, Cyprus, Estonia, Spain, France, Hong Kong, Ireland, Israel, Japan, Malta, Netherlands, New Zealand, Singapore, United Kingdom, South Africa
 
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