STEMETIL Tablet Ref.[27712] Active ingredients: Prochlorperazine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Product name and form

Stemetil 5 mg tablets.

Pharmaceutical Form

Tablet.

Off-white to pale cream coloured circular tablets for oral use. The tablets are marked on one face ‘STEMETIL’ around a centrally impressed ‘5’, reverse face plain.

Qualitative and quantitative composition

The active component of the Stemetil tablets is prochlorperazine maleate BP 5 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Prochlorperazine

Prochlorperazine belongs to the phenothiazine group. Prochlorperazine has a wide range of activity arising from its depressant actions on the CNS and its alpha-adrenergic blocking and weaker anti-muscarinic properties. It inhibits dopamine and prolactin-release-inhibitory factor, thus stimulating the release of prolactin.

List of Excipients

Lactose
Maize starch
Aerosil (E551)
Magnesium stearate

Pack sizes and marketing

Stemetil tablets 5mg are available in โ€œsecuritainersโ€ or HDPE bottles in packs of 25, 250 and 1000 tablets and PVDC coated UPVC/aluminium foil blisters containing 28 or 84 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Trading as

Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Marketing authorization dates and numbers

PL 04425/0593

Date of first authorisation: 2 October 2006

Drugs

Drug Countries
STEMETIL Australia, Cyprus, Estonia, Finland, Hong Kong, Ireland, Malta, New Zealand, Singapore, United Kingdom

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