Spasmomen

Active ingredient: Each dragée contains 40 mg otilonium bromide.
Excipients with known effects: Each dragée contains 28 mg of lactose monohydrate.
Excipients/Inactive Ingredients: Core: lactose monohydrate, rice starch, sodium starch glycolate A, magnesium stearate.
Film coating: hypromellose, titanium dioxide, macrogols (polyethylene glycol 4000, polyethylene glycol 6000), talc.

Pharmacotherapeutic group: synthetic anticholinergic agents, quaternary ammonium compounds. ATC code: A03AB06.
Pharmacology: Pharmacodynamics: Otilonium bromide belongs to a class of 2-aminoethyl-N-benzoylamino-benzoate quaternary salts.
Mechanism of action: Otilonium bromide acts mainly by modifying Ca(2+) ion fluxes from cellular and extracellular locations, reducing contractile activity probably through the inhibition of L-type and T-type calcium channels into intestinal smooth muscle cells, and peripheral sensory neurons.
Moreover, it interacts with NK1 and NK2 tachykinin receptors.
Pharmacodynamic effects: Otilonium bromide exerts an antispasmodic action on the smooth muscles of the distal enteric tract (colon and rectum). It has this effect at doses that do not affect gastric secretion.
In a study conducted in patients with irritable bowel syndrome, otilonium bromide, administrated at the maximum recommended dose of 40 mg 3 times daily for 4 weeks, did not increase the intestinal transit time.
Clinical efficacy and safety: An extended analysis of a double-blind, placebo-controlled, 15-week study with otilonium bromide, conducted in 378 IBS patients (SpC1M study) showed that the rate of response to treatment within 2-4 months was significantly higher in the otilonium bromide group (36.9%) than in the placebo group (22.5%; P=0.007). In each month of treatment, the rate of monthly response was higher in the otilonium bromide group compared to the placebo group (P < 0.05).
The efficacy of otilonium bromide was confirmed in a recent double-blind, placebo-controlled clinical trial (OBIS study, n=356 patients with irritable bowel syndrome) confirming its superiority over placebo in reducing the frequency of abdominal pain, the severity of abdominal bloating and in preventing the recurrence of symptoms.
Pharmacokinetics: Absorption: Otilonium bromide probably reaches the site of pharmacological effect directly through the intestinal wall, because systemic absorption of the drug after oral administration is very low (3%). The plasma concentration is therefore low.
Distribution: After oral administration, high distribution of the drug has been described in the smooth muscles of the colon and rectum.
Renal and hepatic impairment: Otilonium has not been studied in patients with renal and hepatic impairment.
Toxicology: Preclinical safety data: Acute toxicity: The minimal lethal oral doses in rats and mice are 900 and 1250 mg/kg, respectively; no mortality was observed in dogs up to 1000 mg/kg.
Chronic toxicity: No signs of severe toxicity were observed in rats and dogs after oral doses up to 80 mg/kg/day for 26 weeks.
Genotoxicity: Standard in vitro and in vivo tests have shown no mutagenic or clastogenic effects of otilonium bromide.
Carcinogenicity: No histopathological changes have been observed in long-term studies carried out in mice (87 weeks) and rats (104 weeks) with doses equal to 300 mg/kg/day.
Reproductive and developmental toxicity: No embryotoxic, fetotoxic, teratogenic effects were observed in rats up to 60 mg/kg/day. At the same dose, a reduction in maternal food intake was observed in rabbits, with weight reduction in the offspring.

Irritable Bowel Syndrome (IBS) and spastic-painful manifestations of the distal enteric tract.

Posology: 1 dragée 2-3 times a day, as advised by the physician. During treatment: as prescribed by the physician.
Patients with hepatic or renal impairment: No data are available (see Pharmacology: Pharmacokinetics under Actions).
The elderly: No data are available.
Paediatric population: The safety and efficacy of otilonium bromide in patients below 18 years have not been established, therefore this medicinal product is not recommended for use in this population.
Method of administration: Oral use.
The dragée must be swallowed whole, with a glass of water, preferably before meals.

In animals, otilonium bromide has been shown to be non-toxic. Consequently, no particular problems should arise in humans due to overdose. In this specific case, possible symptomatic and supportive therapy is recommended.

Hypersensitivity to the active substance or to any of the excipients listed in Description.

Caution is needed when used in patients with glaucoma, prostatic hypertrophy and pyloric stenosis.
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per dragée, that is to say essentially 'sodium-free'.
Effects on ability to drive and use machines: SPASMOMEN has no or negligible effects on the ability to drive and use machines.

Otilonium bromide must only be recommended to pregnant women and nursing mothers (with maternal milk) only if absolutely necessary and under close medical supervision.
Pregnancy: There are no clinical data about the use of otilonium bromide in pregnant women. Animal studies did not show embryotoxic, teratogenic or mutagenic effects (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Breastfeeding: There are no clinical data about the use of otilonium bromide in breastfeeding women.

Tabulated list of adverse reactions collected during clinical trials: The frequency of adverse reactions occurring in patients treated with otilonium bromide is classified as follows: Common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000). (See table.)

Click on icon to see table/diagram/image

During post-marketing surveillance, cases of skin hypersensitivity, including urticaria and angioedema, have been reported. Because these reactions are reported from a population of undefined size, their frequency cannot be defined based on the available data, therefore it is not known.
Reporting suspected adverse drug reactions: Reporting suspected adverse drug reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions according to the guidelines issued by the local health authority.

No interaction studies have been performed.

Incompatibilities: Not applicable.
Special precautions for disposal and handling: Any unused product or waste material should be disposed of in accordance with local requirements.

Antispasmodics

A03AB06 - otilonium bromide ; Belongs to the class of synthetic anticholinergics, quaternary ammonium compounds. Used in the treatment of functional bowel disorders.

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