Spasmomen^® (Tablets) Instructions for Use

Marketing Authorization Holder

A.Menarini Industrie Farmaceutiche Riunite, S.r.l. (Italy)

Manufactured By

Berlin-Chemie, AG (Germany)

ATC Code

A03AB06 (Otilonium bromide)

Active Substance

Otilonium bromide (Rec.INN registered by WHO)

Dosage Form

Spasmomen®

Film-coated tablets, 40 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex.

Excipients: lactose monohydrate – 28 mg, rice starch – 29 mg, sodium carboxymethyl starch – 2 mg, magnesium stearate – 1 mg.

Film coating composition: hypromellose – 1.25 mg, titanium dioxide – 0.5 mg, macrogol – 0.5 mg, talc – 0.25 mg.

10 pcs. – blister packs (3) – cardboard packs.

Clinical-Pharmacological Group

Myotropic antispasmodic

Pharmacotherapeutic Group

Spasmolytic agent

Pharmacological Action

Otilonium bromide – the active substance of the drug Spasmomen^® – is a myotropic antispasmodic: it reduces the tone of the smooth muscles of the gastrointestinal tract.

The mechanism of action is due to the ability of otilonium bromide to influence the transport of Ca²⁺ ions in the intra- and extracellular space, as well as to block Ca²⁺ channels, muscarinic and tachykinin receptors.

The combination of properties of a Ca²⁺ channel blocker and a moderately pronounced antimuscarinic action explains the pharmacological action of otilonium bromide.

Pharmacokinetics

Absorption

After oral administration, Otilonium bromide is absorbed from the gastrointestinal tract in a very small amount (3%), which is why the plasma concentration of the drug is very low.

Distribution

High degree of distribution in the smooth muscles of the rectum.

Elimination

Most of the absorbed drug is excreted through the bile ducts (95-97%).

Indications

• Spastic conditions, dyskinesias (hyperkinetic type) of the gastrointestinal tract (esophagitis, gastritis, duodenitis, enteritis, irritable bowel syndrome);
• Preparation of patients for endoscopic examination of the gastrointestinal tract.

ICD codes

Dosage Regimen

Administer Spasmomen^® orally.

Swallow the tablet whole with a sufficient amount of water.

The standard adult dosage is one tablet (40 mg) taken two to three times daily.

Adhere to the prescribed dosage and frequency as directed by a physician.

For preparation prior to gastrointestinal endoscopic procedures, follow the specific instructions provided by the healthcare professional.

Do not exceed the recommended daily dose.

The duration of therapy is determined by the treating physician based on the clinical indication and patient response.

Efficacy and safety data for the use of otilonium bromide in the pediatric population are not established.

The drug is contraindicated in children under 3 years of age.

Adverse Reactions

When taking the drug Spasmomen^® in therapeutic doses, no side effects were detected, in particular, the drug does not cause atropine-like reactions.

In rare cases, allergic reactions are possible.

Contraindications

• Hypersensitivity to otilonium bromide or other components of the drug;
• Children under 3 years of age.

With caution: glaucoma; pyloric stenosis; prostatic hyperplasia.

Use in Pregnancy and Lactation

Data from preclinical studies show the absence of teratogenic and mutagenic effects of the drug, but its use during pregnancy and lactation is possible only if the intended benefit to the mother outweighs the possible risk to the fetus or child.

Pediatric Use

Contraindicated in children under 3 years of age.

Data on the efficacy and safety of otilonium bromide in children are not available.

Special Precautions

Effect on the ability to drive vehicles and mechanisms

There have been no reports of a negative effect of the drug on the ability to drive vehicles and operate machinery.

Overdose

Since the drug is practically non-toxic, no cases of overdose have been reported. In case of overdose, treatment should be symptomatic and supportive.

Drug Interactions

Not known.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C (86°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

Over-the-counter.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.