Irritable bowel syndrome and pain associated with spasm of the distal intestines.
active substance: otilonium bromide;
1 film-coated tablet contains otilonium bromide 40 mg;
Excipients: lactose monohydrate, rice starch, sodium starch glycolate (type A), magnesium stearate, hypromellose, titanium dioxide (E 171), polyethylene glycol 4000, polyethylene glycol 6000, talc.
Otilonium bromide is a typical representative of the class of drugs based on the Quaternary salt
Otilonium bromide has an antispasmodic effect on the smooth muscles of the distal intestine (colon and rectum). This effect is observed at doses that do not affect gastric secretion and do not show typical atropine-like side effects.
Symptomatic treatment of irritable bowel syndrome (IBS) and spasms of the distal intestine (colon and rectum) accompanied by pain, relief of abdominal pain, bloating and peristalsis due to spasm of the smooth muscles of the distal intestine in 18-year-old patients.
Treatment of IBS should begin with non-pharmacological measures (lifestyle changes, diet, emotional support, psychotherapy), pharmacotherapy is prescribed when such measures do not have the desired effect.
Presence in the anamnesis of hypersensitivity reactions to the active substance or to any of the excipients of the drug.
Use during pregnancy or breastfeeding
There are no clinical data on the use of Spasmomen® during pregnancy or breastfeeding. In animal studies, Spazmomen® did not have embryotoxic, teratogenic or mutagenic effects, nor did it show reproductive or ontogenetic toxicity. However, like all medicines, it should be used during pregnancy or breastfeeding only when absolutely necessary and under close medical supervision.
Ability to influence the speed of reaction when driving a car or working with other mechanisms
Spasmomen® has no or very little effect on the speed of reaction when driving or operating machinery.
Method of application and dosage
The tablets should be swallowed whole and washed down with a glass of water. The tablets should preferably be taken 20 minutes before meals.
The recommended single dose is 1 tablet of 40 mg; recommended daily dose –
80–120 mg (1 tablet 2–3 times a day). The dose depends on the clinical picture and response to therapy, prescribed in accordance with the therapeutic guidelines for the treatment of IBS.
Duration of treatment: depends on the course of the disease. Physicians should periodically evaluate the need for continued therapy.
Special groups of patients
Patients with impaired liver and kidney function.
No dose adjustment is required (see Pharmacokinetics for details).
No dose adjustment is required.
Clinical data on the use of the drug in patients under 18 years of age are limited, so it is not intended for use in children.
In animal studies, otilonium bromide had virtually no toxic effects at doses many times the usual pharmacological dose (see “Preclinical safety data” for details). Therefore, it is assumed that in case of drug overdose in humans, any serious disorders should not occur. In case of overdose, symptomatic maintenance therapy is recommended.
- From the gastrointestinal tract: dry mouth, nausea, upper abdominal pain;
- From the skin and subcutaneous tissue: itching, erythema;
- General disorders and administration site conditions: weakness, asthenia;
- From the nervous system: headache;
- From the organs of hearing and labyrinth: dizziness.
Do not use the drug after the expiration date indicated on the package.
No special storage conditions are required.