Andipal Avexima (Tablets) Instructions for Use

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Avexima Siberia LLC (Russia)

ATC Code

N02BB72 (Metamizole sodium in combination with psycholeptics)

Dosage Form

Andipal Avexima

Tablets: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a slight yellowish tint, flat-cylindrical, with a bevel and a score line.

Excipients: potato starch – 46 mg, talc – 7 mg, stearic acid – 3 mg, calcium stearate – 4 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – non-cell contour packs (1) – group packaging.

Clinical-Pharmacological Group

Spasm analgesic

Pharmacotherapeutic Group

Analgesics; other analgesics and antipyretics; pyrazolones

Pharmacological Action

Combined drug. The combination of the drug’s components leads to a mutual enhancement of their pharmacological action.

Metamizole sodium – a pyrazolone derivative, has analgesic and antipyretic effects.

Bendazole – a vasodilating agent; has a vasodilating effect, stimulates spinal cord function. It has a direct antispasmodic effect on the smooth muscles of blood vessels and internal organs. Facilitates synaptic transmission in the spinal cord.

Papaverine hydrochloride – an antispasmodic agent, has a hypotensive effect, reduces tone and relaxes the smooth muscles of internal organs and blood vessels.

Phenobarbital, in small doses, has a sedative effect and enhances the action of other components.

Indications

• Pain syndrome (mild or moderate) with spasms of the smooth muscles of internal organs: renal colic, biliary colic, intestinal colic; biliary dyskinesia; postcholecystectomy syndrome; spasm of the ureters and bladder; dysmenorrhea;
• Spasm of cerebral vessels, migraine;
• As an auxiliary medicinal product: pain syndrome after surgical intervention and diagnostic procedures.

ICD codes

Dosage Regimen

Administer the tablets orally with a sufficient amount of water.

For adults and children over 8 years of age, the standard dose is one tablet taken two to three times per day.

Adjust the frequency of administration based on the intensity of the pain syndrome and the individual patient response.

The maximum single dose is one tablet.

The maximum daily dose is three tablets.

Do not exceed the recommended daily dose.

The duration of self-administered therapy without medical consultation should not exceed seven days.

Discontinue use if there is no therapeutic effect within three days and consult a physician.

For children and adolescents under 18 years of age, use only under medical supervision.

Avoid activities requiring increased concentration and rapid psychomotor reactions during treatment due to potential drowsiness.

With prolonged use exceeding seven days, monitoring of the peripheral blood picture and liver function is necessary.

Adverse Reactions

Allergic reactions.

From the central nervous system: drowsiness, decreased speed of psychomotor reactions.

From the gastrointestinal tract: nausea, constipation.

From the cardiovascular system: arterial hypotension.

With prolonged use: leukopenia, agranulocytosis, impaired liver and kidney function.

Contraindications

• Hypersensitivity (including to pyrazolone derivatives);
• Suppression of bone marrow hematopoiesis;
• Severe hepatic and/or renal impairment;
• Glucose-6-phosphate dehydrogenase deficiency;
• Children under 8 years of age;
• Pregnancy;
• Lactation period;
• Tachyarrhythmias;
• Severe angina pectoris;
• Collapse;
• Decompensated chronic heart failure;
• Closed-angle glaucoma;
• Prostatic hyperplasia;
• Intestinal obstruction;
• Megacolon.

Use in Hepatic Impairment

The use of the drug is prohibited in patients with severe hepatic impairment.

Use in Renal Impairment

The use of the drug is prohibited in patients with severe renal impairment.

Pediatric Use

The use of the drug is prohibited for children under 8 years of age. For children over 8 years of age, 1 tablet 2-3 times/day.

Special Precautions

With prolonged (more than 7 days) use, monitoring of the peripheral blood picture and functional state of the liver is necessary. If there is no effect within 3 days, you should stop taking the drug and consult a doctor.

During treatment, you should refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

The drug should be used in children and adolescents under 18 years of age only as prescribed by a doctor.

Drug Interactions

Combination with nitrates (nitroglycerin, nitrosorbide, sustak, etc.), calcium channel blockers (nifedipine, corinfar, etc.), beta-blockers (anaprilin, metoprolol, talinolol, etc.), ganglion blockers (pentamin, etc.), diuretics (furosemide, hypothiazide, etc.), myotropic antispasmodics (dipyridamole, euphyllin, etc.) enhances the hypotensive effect of these drugs.

Simultaneous use with other non-narcotic analgesics may lead to mutual enhancement of toxic effects.

Concomitant use with adsorbents, astringents and coating agents reduces the absorption of the drug in the gastrointestinal tract.

Storage Conditions

The drug should be stored in a dry place, protected from light and out of the reach of children.

Shelf Life

Shelf life – 2 years 6 months.

The drug should not be used after the expiration date.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.