MIANSERIN Film-coated tablet Ref.[9798] Active ingredients: Mianserin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Generics [UK] Limited, t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL

Product name and form

Mianserin 10 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Round, white film-coated convex tablet marked “MI 10” on one side and “G” on reverse.

Qualitative and quantitative composition

Each film-coated tablet contains 10 mg mianserin hydrochloride.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Mianserin

Mianserin is a tetracyclic antidepressant. It does not appear to have significant anti-cholinergic properties, but has a marked sedative action. Unlike amitriptyline, it does not prevent the peripheral re-uptake of noradrenaline; it blocks presynaptic alpha-adrenoceptors and increases the turnover of brain noradrenaline.

List of Excipients

The tablet contains:

Maize starch, pregelatinised
Silica, colloidal anhydrous
Cellulose, microcrystalline
Calcium hydrogen phosphate
Magnesium stearate

The film coat contains:

Talc
Titanium dioxide (E171)
Hypromellose
Macrogol 400

Pack sizes and marketing

Mianserin film-coated tablets are available in polypropylene containers with polyethylene caps (with optional polyethylene ullage filler) and PVC/foil blister packs of 28, 30, 56, 60, 84, 90, 100, 112, 250, 500 or 1000 tablets.

Marketing authorization holder

Generics [UK] Limited, t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL

Marketing authorization dates and numbers

PL 04569/0170

Date of first authorisation: 2 November 1987
Date of last renewal: 13 May 2003

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