Source: Medicines Authority (MT) Revision Year: 2021 Publisher: A. Menarini Industrie Farmaceutiche Riunite Srl, Via Sette Santi 3, 50131 Florence, Italy
Irritable Bowel Syndrome (IBS); relief of abdominal pain, distension and motility disorders characterised by smooth muscle spasm.
Spasmomen is indicated in adults.
1 Tablet 2-3 times a day, according to the physician’s judgement.
Dose adjustment is not necessary (see section 5.2).
Dose adjustment is not necessary.
Clinical data on the use of otilonium bromide 40 mg coated tablets in paediatric patients below 18 years is limited, therefore this medicinal product is not recommended for use in this population.
Oral administration.
Tablets should be swallowed whole, with a glass of water, preferably 20 minutes before meal.
In the animal, otilonium bromide was proven practically devoid of toxicity, used in doses that exceeded many times the usual pharmacological dose (please see section 5.3). Consequently also in the human, no particular overdosage-related problems should appear. In case of overdose a possible symptomatic and support therapy is recommended.
36 months.
This medicinal product does not require any special storage conditions.
PVC/PVDC//Al blister packs with 30 film-coated tablets.
No special requirements.
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