DETRUNORM Film-coated tablet Ref.[9724] Active ingredients: Propiverine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Amdipharm UK Ltd., Capital House, 85 King William Street, London, EC4N 7BL, United Kingdom

Product name and form

Detrunorm 15 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White, round, biconvex film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 15 mg propiverine hydrochloride equivalent to 13.64 mg propiverine.

Excipients with known effect: Each film-coated tablet contains 100.7 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Propiverine

Propiverine inhibits calcium influx and modulates intracellular calcium in urinary bladder smooth muscle cells causing musculotropic spasmolysis. Also, it inhibits the efferent connection of the nervus pelvicus due to anticholinergic action.

List of Excipients

Tablet core:

Lactose monohydrate
Cellulose, powdered
Magnesium stearate

Tablet film coat:

Hypromellose
Cellulose, microcrystalline
Stearic acid
Talc
Titanium dioxide (E171)

Pack sizes and marketing

They are available in PVC/PVDC/aluminium blister packs of 14, 20, 28, 30, 49, 50, 56, 60, 84, 98, 100, 112, 168, 252, 300 or 500 tablets and multipacks containing 280 (10 packs of 28) film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Amdipharm UK Ltd., Capital House, 85 King William Street, London, EC4N 7BL, United Kingdom

Marketing authorization dates and numbers

PL 20072/0243

05/08/2016

Drugs

Drug Countries
DETRUNORM Croatia, Ireland, United Kingdom, South Africa

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