Spasmomen® (Spasmomen®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceOtilonium bromideOtilonium bromide
Dosage form: & nbspfilm coated tablets
Composition:

Composition per one tablet

Core:

Active substance:

Otilonium bromide 40.0 mg Excipients: lactose monohydrate 28.0 mg, rice starch 29.0 mg, sodium carboxymethyl starch 2.0 mg, magnesium stearate 1.0 mg;
Sheath: hypromellose 1.25 mg, titanium dioxide 0.50 mg, macrogol 0.50 mg, talc 0.25 mg.
Description:round biconvex tablets, film-coated, white or almost white.
Pharmacotherapeutic group: myotropic antispasmodic
ATX: & nbsp

A.03.A.B.06   Otilonium bromide

Pharmacodynamics:

Otiloniya bromide - the active substance of the drug Spasmomen® - is a myotropic antispasmodic that exerts a selective effect on the smooth muscles of the gastrointestinal tract (GIT), without affecting normal peristalsis.

The antispasmodic effect of bromide otilonium is based on a combination of its properties as a blocker of Ca2+channels and its ability to exert a moderately pronounced local antimuscarinic action.


Pharmacokinetics:

After oral administration otilonium bromide binds to membranes of smooth muscle cells of the intestine, predominantly thick.

In experimental studies, a low systemic absorption of otilonium bromide (about 3% of the systemic blood flow) was demonstrated, and therefore its concentration in the blood plasma after ingestion is insignificant.


After release from the intestinal wall otilonium bromide transported to its lumen and excreted by the intestine.

Indications:
  • Symptomatic treatment of pain and functional disorders in diseases of the digestive tract, accompanied by a spasm of smooth muscles of the intestine.
  • Symptomatic treatment of pain, spasms and functional disorders that occur in irritable bowel syndrome.
Contraindications:

hypersensitivity to otilonium bromide or other components of the drug; hereditary intolerance to galactose, lactase deficiency and malabsorption of glucose and galactose; age to 18 years.

Carefully:

  • glaucoma;
  • stenosis of the pylorus;
  • hypertrophy of the prostate.

Pregnancy and lactation:

Pre-clinical studies show no embryotoxic, teratogenic and mutagenic effects of the drug, however,the use of the drug during pregnancy and during breastfeeding is possible only under the supervision of a doctor and if the intended benefit to the mother exceeds the possible risk to the fetus or the baby.

Dosing and Administration:

Inside. The tablets are taken whole, without chewing, with a glass of water, preferably 20 minutes before meals.


If not prescribed otherwise, the drug Spasmomen® should be taken 1 tablet 2-3 times a day. The duration of the use of the drug Spasmomen® is from 5-7 days to 4 weeks, depending on the severity of the symptoms. If you need to continue using the drug, you should consult your doctor.

Data on the effectiveness and safety of the use of the drug Spasmomen ® in children are absent.

Side effects:

When using the drug, it is possible to develop allergic reactions in the form of urticaria. In case of occurrence of possible undesirable phenomena it is necessary to address to the doctorthe.

Overdose:

Cases of overdose are not described.

In case of an overdose, treatment should be symptomatic and supportive.

Interaction:

It is not known.

Effect on the ability to drive transp. cf. and fur:

The negative effect of the drug on the ability to drive vehicles and manage the mechanisms of communications was not.

Form release / dosage:

Film coated tablets 40 mg.

Packaging:

For 10 tablets in a planar cell package (blister) [PVC / PVDC / aluminum foil].

For 3 blisters together with instructions for use in a cardboard bundle.

Storage conditions:

At a temperature of no higher than 30 ° C.

Keep the medicine out of the reach of children!

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe
Registration number:LSR-007995/10
Date of registration:12.08.2010
The owner of the registration certificate:A.Menarini Industry Pharmaceuticals Riunite S.L.A.Menarini Industry Pharmaceuticals Riunite S.L. Italy
Manufacturer: & nbsp
Representation: & nbspBERLIN-CHEMI / MENARINI PHARMA GmbH BERLIN-CHEMI / MENARINI PHARMA GmbH Germany
Information update date: & nbsp19.08.2014
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