SURMONTIL Film-coated tablet Ref.[49836] Active ingredients:

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: Sanofi-Aventis Ireland Limited T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Surmontil 25mg film-coated Tablets.

Pharmaceutical Form

Film-coated tablet.

White to pale yellow, circular, biconvex, film-coated tablet, one face impressed “SURMONTIL” just inside the perimeter around a centrally impressed ‘25’, reverse face plain.

Qualitative and quantitative composition

Each tablet contains Trimipramine Maleate equivalent to 25 mg of Trimipramine.

Excipients: each tablet contains 4.32 mg lactose monohydrate.

For a full list of excipients, see section 6.1.

List of Excipients

Starch potato
Calcium hydrogen phosphate
Talc
Magnesium stearate
Lactose monohydrate
Hypromellose
Titanium dioxide E171
Macrogol 400

Pack sizes and marketing

Surmontil 25 mg tablets are marketed in Grey 50 ml High density polyethylene (h.d.p.e.) bottles. Each bottle contains 50 tablets.

Marketing authorization holder

Sanofi-Aventis Ireland Limited T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PA0540/128/005

Date of first authorisation: 01 April 1978
Date of last renewal 05 October 2010

Drugs

Drug Countries
SURMONTIL Spain, Finland, France, Hong Kong, Ireland, Japan, Tunisia

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