Each dragée contains: Active ingredient: 40mg otilonium bromide.
Excipients with known effects: lactose (see Precautions).
Excipients/Inactive Ingredients: Each dragée contains: Core: lactose monohydrate, rice starch, sodium starch glycolate A, magnesium stearate.
Film coating: hypromellose, titanium dioxide, macrogols, talc.
Pharmacotherapeutic group: synthetic anticholinergics, quaternary ammonium compounds. ATC code: A03AB06.
Pharmacology: Pharmacodynamics: Otilonium bromide has an intense spasmolytic action on the smooth muscles of the digestive tract.
Mechanism of action: SPASMOMEN mechanism of action is complex: otilonium bromide modifies Ca2+ fluxes from intracellular and extracellular sites and binds to the calcium channels Ca2+ and to the muscarinic receptors and tachykinin receptors. The combination of the blockage of calcium channels Ca2+ and the mild anti-muscarinic effects can explain the activity of otilonium bromide.
Pharmacokinetics: Pharmacokinetic studies have shown low systemic absorption of otilonium bromide by oral route (3%), and therefore plasma concentrations are very low.
A high distribution of the drug in the gastrointestinal smooth muscle has been described. Most fraction of the absorbed drug is excreted by the bile (95-97%).
Toxicology: Preclinical safety data: Acute toxicity: following oral administration, no mortality has been observed with up to 1500mg/kg in rats and up to 1000mg/kg in dogs.
Chronic toxicity: in experimental animals, oral otilonium bromide at a dose of 80mg/kg administered for 180 days did not cause any alterations in the haematochemical or histological tests.
Teratology: no embryotoxic or teratogenic effects have been observed in rats or rabbits, even up to doses of 60mg/kg.
Mutagenesis: no mutagenetic effects have been observed in the numerous tests performed.
Irritable Bowel Syndrome (IBS) and painful spastic conditions of the distal enteric tract.
Posology: Adults and elderly patients: The usual dosage is 1 dragée, 2-3 times a day, depending on the prescriber's judgment. Drageés should be swallowed whole with a glass of water, preferably 20 minutes before meals.
Paediatric population: There are no available data referring to the use of SPASMOMEN in paediatric populations, and as such the use of this medicinal product is not recommended in children.
Duration of the treatment: According to the prescriber's instructions.
Method of administration: For oral use.
Otilonium bromide has shown to be virtually devoid of toxicity in animals and therefore no particular problems should arise in humans in relation to overdosing. In case of overdosing, appropriate symptomatic and support therapy is recommended.
Hypersensitivity to the active ingredient or any of the excipients listed in Description.
To be used with caution in subjects with glaucoma, prostatic hypertrophy, pyloric stenosis.
This medicinal product contains lactose and is therefore not suitable for subjects with lactase deficiency, galactosemia, or glucose/galactose malabsorption syndrome.
Effects on ability to drive vehicles and use machinery: SPASMOMEN does not alter the capacity to drive vehicles or use machinery.
Although no embryo-toxic, teratogenic or mutagenic effects on animals have been reported, as with all medicinal products its use during pregnancy and lactation should be limited to cases of specific need and under direct medical supervision.
SPASMOMEN, in therapeutic doses, does not cause undesirable effects, namely atropine-like side effects.
There have been spontaneous post-marketing reports of the following adverse reactions. It is not possible to obtain a realistic estimate of the frequency of these reactions which therefore remains unknown.
Skin and subcutaneous tissue disorders:
No interaction studies have been conducted.
Special precautions for disposal and handling: Any unused product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: Not applicable.
A03AB06 - otilonium bromide ; Belongs to the class of synthetic anticholinergics, quaternary ammonium compounds. Used in the treatment of functional bowel disorders.