SOMINEX Tablet Ref.[7734] Active ingredients: Promethazine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Actavis Group PTC ehf, Reykjavíkurvegi 76-78, 220 Hafnarfjordur, Iceland

Product name and form

Sominex.

Pharmaceutical Form

Tablet.

Qualitative and quantitative composition

Promethazine hydrochloride EP 20mg/tab.

Excipient with known effect: Each 20mg tablet contains 276.00mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Promethazine

Promethazine is a potent, long acting, antihistamine with additional anti-emetic central sedative and anti-cholinergic properties.
List of Excipients

Lactose
Maize starch
Croscarmellose sodium
Magnesium stearate

Pack sizes and marketing

Opaque blister strip of polyvinylchloride/polyvinylidine chloride. Backed with aluminium foil. Each strip contains 8 tablets. One or two strips are packed into each cardboard carton.

Marketing authorization holder

Actavis Group PTC ehf, Reykjavíkurvegi 76-78, 220 Hafnarfjordur, Iceland

Marketing authorization dates and numbers

PL 30306/0080

Date of first authorisation: 6th September 2002

Drugs

Drug Countries
SOMINEX United Kingdom
 
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