SPASMOMEN Film-coated tablet Ref.[51156] Active ingredients: Otilonium

Source: Medicines Authority (MT)  Revision Year: 2021  Publisher: A. Menarini Industrie Farmaceutiche Riunite Srl, Via Sette Santi 3, 50131 Florence, Italy

Product name and form

SPASMOMEN 40 mg – film-coated tablets.

Pharmaceutical Form

Film-coated tablets.

White to almost-white round shaped, biconvex film-coated tablets of 5.4 mm diameter.

Qualitative and quantitative composition

Each film-coated tablet contains 40 mg of otilonium bromide.

Excipient(s) with known effect: approximately 28 mg of lactose monohydrate per tablet.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Otilonium

Otilonium is endowed with a marked spasmolytic action on the smooth muscle of the digestive tract.
List of Excipients

Each tablet contains:

Tablet core:

Lactose
Rise starch
Sodium starch glycolate
Magnesium stearate

Tablet coat:

Hydroxypropylmethyl cellulose
Titanium dioxide
Polyethylene glycol
Talc

Pack sizes and marketing

PVC/PVDC//Al blister packs with 30 film-coated tablets.

Marketing authorization holder

A. Menarini Industrie Farmaceutiche Riunite Srl, Via Sette Santi 3, 50131 Florence, Italy

Marketing authorization dates and numbers

MA 205/00401

Date of first authorisation: 30 May 2006
Date of latest renewal: 30 September 2012

Drugs

Drug Countries
SPASMOMEN Ecuador, Hong Kong, Croatia, Lithuania, Malta, Romania, Tunisia, Turkey
 
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