Spazmizan^® (Capsules) Instructions for Use

Marketing Authorization Holder

Evalar, CJSC (Russia)

ATC Code

A03AX58 (Alverine in combination with other drugs)

Active Substances

Simeticone (Rec.INN registered by WHO)

Alverine (Rec.INN registered by WHO)

Dosage Form

Spazmizan®

Capsules 60 mg+300 mg

Dosage Form, Packaging, and Composition

Capsules

10 pcs. – blister packs – cardboard packs (10 pcs.) – Over-the-Counter
10 pcs. – blister packs (2 pcs.) – cardboard packs (20 pcs.) – Over-the-Counter
10 pcs. – blister packs (3 pcs.) – cardboard packs (30 pcs.) – Over-the-Counter
10 pcs. – blister packs (4 pcs.) – cardboard packs (40 pcs.) – Over-the-Counter
10 pcs. – blister packs (5 pcs.) – cardboard packs (50 pcs.) – Over-the-Counter
10 pcs. – blister packs (6 pcs.) – cardboard packs (60 pcs.) – Over-the-Counter
10 pcs. – blister packs (7 pcs.) – cardboard packs (70 pcs.) – Over-the-Counter
10 pcs. – blister packs (8 pcs.) – cardboard packs (80 pcs.) – Over-the-Counter
15 pcs. – blister packs – cardboard packs (15 pcs.) – Over-the-Counter
15 pcs. – blister packs (2 pcs.) – cardboard packs (30 pcs.) – Over-the-Counter
15 pcs. – blister packs (3 pcs.) – cardboard packs (45 pcs.) – Over-the-Counter
15 pcs. – blister packs (4 pcs.) – cardboard packs (60 pcs.) – Over-the-Counter
15 pcs. – blister packs (5 pcs.) – cardboard packs (75 pcs.) – Over-the-Counter
15 pcs. – blister packs (6 pcs.) – cardboard packs (90 pcs.) – Over-the-Counter
15 pcs. – blister packs (7 pcs.) – cardboard packs (105 pcs.) – Over-the-Counter
15 pcs. – blister packs (8 pcs.) – cardboard packs (120 pcs.) – Over-the-Counter

Pharmacotherapeutic Group

Drugs for the treatment of functional gastrointestinal disorders; other drugs for the treatment of functional gastrointestinal disorders

Pharmacological Action

Combined drug. It has an antispasmodic effect and reduces gas formation in the intestine.

Alverine is a myotropic antispasmodic, the action of which is not accompanied by an atropine-like effect or ganglioblocking activity. It reduces the increased tone of the intestinal smooth muscles.

Simeticone is a hydrophobic polymeric substance with low surface tension that reduces gas formation in the intestine and covers the walls of the gastrointestinal tract with a protective film.

Indications

Functional disorders of the gastrointestinal tract, manifested by abdominal pain, increased gas formation, belching, nausea, constipation, diarrhea or their alternation; preparation for X-ray, ultrasound or instrumental examination of the abdominal organs.

ICD codes

Dosage Regimen

Take the capsules orally with a sufficient amount of water.

For the relief of symptoms in functional gastrointestinal disorders, take one capsule containing the fixed combination of Alverine 60 mg and Simeticone 300 mg.

Administer this dose two to three times daily as needed.

For preparation for diagnostic procedures such as X-ray, ultrasound, or endoscopic examination, follow the specific regimen prescribed by the physician.

Do not exceed the recommended daily dosage.

The duration of use for self-treatment should not exceed a few days; consult a physician if symptoms persist.

This medication is contraindicated in children under 14 years of age.

Do not use during pregnancy or lactation unless explicitly directed by a doctor.

Discontinue use immediately and seek medical attention if signs of an allergic reaction occur.

Adverse Reactions

Allergic reactions rarely – urticaria (disappears upon discontinuation of treatment), laryngeal edema, shock.

From the digestive system rarely – impaired liver function (disappear upon discontinuation of treatment).

Contraindications

Hypersensitivity to alverine and simeticone; children under 14 years of age.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is not recommended.

Pediatric Use

Contraindicated for use in children under 14 years of age.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

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.