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Andipal (Tablets) Instructions for Use

ATC Code

N02BB72 (Metamizole sodium in combination with psycholeptics)

Clinical-Pharmacological Group

Spasm analgesic

Pharmacotherapeutic Group

Analgesics; other analgesics and antipyretics; pyrazolones

Pharmacological Action

A combination drug that exerts vasodilating, analgesic, spasmolytic, and sedative effects.

Sodium metamizole has analgesic, antipyretic, and weak anti-inflammatory effects. The combination of spasmolytics (Bendazole and papaverine hydrochloride) with sodium metamizole enhances the analgesic effect of the latter for headache and migraine. The presence of phenobarbital in the preparation contributes to the manifestation of a sedative effect and enhances the action of the other components.

By reducing total peripheral vascular resistance and acting on arterioles, it lowers blood pressure, improves collateral circulation, and increases oxygen delivery to the heart.

Indications

Pain syndrome associated with spasm of peripheral arteries, smooth muscles of the gastrointestinal tract, and cerebral vessels.

Arterial hypertension.

ICD codes

ICD-10 code Indication
I10 Essential [primary] hypertension
R10.4 Other and unspecified abdominal pain (colic)
R51 Headache
R52.0 Acute pain
R52.2 Other chronic pain
ICD-11 code Indication
8A8Z Headache disorders, unspecified
BA00.Z Essential hypertension, unspecified
DD93.1 Infantile colic
MD81.4 Other and unspecified abdominal pain
MG30.Z Chronic pain syndrome, unspecified
MG31.Z Acute pain, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Take tablets orally with a sufficient amount of water.

For adults and children over 14 years of age, the typical single dose is one tablet.

Take the dose two to three times per day as needed for pain relief.

The maximum single dose is one tablet.

The maximum daily dose is three tablets.

Do not exceed the recommended maximum daily dose.

The duration of treatment should not exceed 5-7 days without medical supervision.

For children aged 8 to 14 years, use only under strict medical supervision with individual dosing.

Use the lowest effective dose for the shortest duration necessary to control symptoms.

Discontinue use and consult a physician if pain persists beyond 5 days or if a high fever continues.

Adverse Reactions

Possible allergic reactions, drowsiness, decreased speed of psychomotor reactions, nausea, constipation, decreased blood pressure, leukopenia, agranulocytosis, impaired liver/kidney function.

Contraindications

Severe renal failure; severe hepatic failure; glucose-6-phosphate dehydrogenase deficiency; blood diseases; tachyarrhythmia; severe angina pectoris; arterial hypotension; decompensated chronic heart failure; glaucoma; prostatic hyperplasia; intestinal obstruction; megacolon; pregnancy; lactation period; children under 8 years of age; hypersensitivity to these active substances.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated in severe hepatic insufficiency.

Use in Renal Impairment

Contraindicated in severe renal insufficiency.

Pediatric Use

Contraindicated in children under 8 years of age.

Special Precautions

With long-term use (more than 7 days), monitoring of the peripheral blood picture and functional state of the liver is necessary.

Effect on the ability to drive vehicles and operate machinery

During the treatment period, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Nitrates, calcium channel blockers, beta-blockers, ganglion blockers, diuretics (including furosemide, hypothiazide), myotropic spasmolytics – enhanced hypotensive effect.

Opioid analgesics – mutual increase in the risk of side effects.

Adsorbents, astringents, coating medicinal products – reduce the absorption of the combination’s active substances from the gastrointestinal tract.

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

As-Pharm OJSC (Russia)

Dosage Form

Bottle OTC Icon Andipal Tablets: 10 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Bendazol 20 mg
Metamizole sodium 250 mg
Papaverine hydrochloride 20 mg
Phenobarbital 20 mg

10 pcs. – non-cell contour packaging.

Marketing Authorization Holder

AsPharma LLC (Russia)

Dosage Form

Bottle OTC Icon Andipal Tablets: 10 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Bendazol 20 mg
Metamizole sodium 250 mg
Papaverine hydrochloride 20 mg
Phenobarbital 20 mg

10 pcs. – non-cell contour packaging.

Marketing Authorization Holder

Barnaul Plant of Medical Preparations, LLC (Russia)

Dosage Form

Bottle OTC Icon Andipal Tablets: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Bendazole 20 mg
Metamizole sodium 250 mg
Papaverine hydrochloride 20 mg
Phenobarbital 20 mg

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

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Bottle OTC Icon Andipal Tablets: 10 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Bendazole 20 mg
Metamizole sodium 250 mg
Papaverine hydrochloride 20 mg
Phenobarbital 20 mg

10 pcs. – non-cell contour packaging.
10 pcs. – blister contour packaging.

Marketing Authorization Holder

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle OTC Icon Andipal Tablets: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Bendazole 20 mg
Metamizole sodium 250 mg
Papaverine hydrochloride 20 mg
Phenobarbital 20 mg

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

Marketing Authorization Holder

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle OTC Icon Andipal Tablets: 10 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Bendazol 20 mg
Metamizole sodium 250 mg
Papaverine hydrochloride 20 mg
Phenobarbital 20 mg

10 pcs. – non-cell contour packaging.

Marketing Authorization Holder

Moscow Endocrine Plant FSUE (Russia)

Dosage Form

Bottle OTC Icon Andipal Tablets: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Bendazole 20 mg
Metamizole sodium 250 mg
Papaverine hydrochloride 20 mg
Phenobarbital 20 mg

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

Marketing Authorization Holder

Moscow Endocrine Plant FSUE (Russia)

Dosage Form

Bottle OTC Icon Andipal Tablets: 10 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Bendazol 20 mg
Metamizole sodium 250 mg
Papaverine hydrochloride 20 mg
Phenobarbital 20 mg

10 pcs. – non-cell contour packaging.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle OTC Icon Andipal Tablets: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

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

1 tab.
Metamizole sodium monohydrate 264 mg,
   Equivalent to sodium metamizole content 250 mg
Phenobarbital 20 mg
Bendazole 20 mg
Papaverine hydrochloride 20 mg

Excipients: potato starch – 33 mg, talc – 10 mg, calcium stearate – 3 mg.

10 pcs. – blister contour packaging (1) – cardboard packs.
10 pcs. – blister contour packaging (2) – cardboard packs.

Marketing Authorization Holder

Uralbiopharm, JSC (Russia)

Dosage Form

Bottle OTC Icon Andipal Tablets: 10 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Bendazole 20 mg
Metamizole sodium 250 mg
Papaverine hydrochloride 20 mg
Phenobarbital 20 mg

10 pcs. – non-cell contour packaging.

Marketing Authorization Holder

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle OTC Icon Andipal Tablets: 10, 20, 30, or 50 pcs.

Dosage Form, Packaging, and Composition

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

1 tab.
Metamizole sodium 250 mg
Phenobarbital 20 mg
Bendazole 20 mg
Papaverine hydrochloride 20 mg

Excipients: potato starch – 47 mg, talc – 10 mg, calcium stearate – 3 mg.

10 pcs. – non-cell contour packaging (1) – cardboard packs.
10 pcs. – non-cell contour packaging (2) – cardboard packs.
10 pcs. – non-cell contour packaging (3) – cardboard packs.
10 pcs. – non-cell contour packaging (5) – cardboard packs.
10 pcs. – blister contour packaging (1) – cardboard packs.
10 pcs. – blister contour packaging (2) – cardboard packs.
10 pcs. – blister contour packaging (3) – cardboard packs.
10 pcs. – blister contour packaging (5) – cardboard packs.
10 pcs. – non-cell contour packaging (200) – cardboard boxes (for hospitals).
10 pcs. – non-cell contour packaging (400) – cardboard boxes (for hospitals).
10 pcs. – non-cell contour packaging (500) – cardboard boxes (for hospitals).
10 pcs. – non-cell contour packaging (600) – cardboard boxes (for hospitals).
10 pcs. – non-cell contour packaging (1000) – cardboard boxes (for hospitals).

Marketing Authorization Holder

Usolye-Sibirskiy Chemical and Pharmaceutical Combine, JSC (Russia)

Dosage Form

Bottle OTC Icon Andipal Tablets: 10 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Bendazole 20 mg
Metamizole sodium 250 mg
Papaverine hydrochloride 20 mg
Phenobarbital 20 mg

10 pcs. – non-cell contour packaging.

Marketing Authorization Holder

Usolye-Sibirskiy Chemical and Pharmaceutical Combine, JSC (Russia)

Dosage Form

Bottle OTC Icon Andipal Tablets: 10 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Bendazol 20 mg
Metamizole sodium 250 mg
Papaverine hydrochloride 20 mg
Phenobarbital 20 mg

10 pcs. – non-cell contour packaging.

Marketing Authorization Holder

PharmaDon, LLC (Russia)

Dosage Form

Bottle OTC Icon Andipal Tablets: 10 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Bendazol 20 mg
Metamizole sodium 250 mg
Papaverine hydrochloride 20 mg
Phenobarbital 20 mg

10 pcs. – non-cell contour packaging.

Marketing Authorization Holder

Pharmstandard-Tomskkhimpharm OJSC (Russia)

Dosage Form

Bottle OTC Icon Andipal Tablets: 10, 20, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Bendazole 20 mg
Metamizole sodium 250 mg
Papaverine hydrochloride 20 mg
Phenobarbital 20 mg

10 pcs. – cell contour packaging (1) – cardboard packs.
10 pcs. – cell contour packaging (2) – cardboard packs.
10 pcs. – cell contour packaging (5) – cardboard packs.
10 pcs. – non-cell contour packaging (1) – cardboard packs.
10 pcs. – non-cell contour packaging (2) – cardboard packs.
10 pcs. – non-cell contour packaging (5) – cardboard packs.

Marketing Authorization Holder

Pharmstandard-Tomskkhimpharm OJSC (Russia)

Dosage Form

Bottle OTC Icon Andipal Tablets: 10 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Bendazol 20 mg
Metamizole sodium 250 mg
Papaverine hydrochloride 20 mg
Phenobarbital 20 mg

10 pcs. – non-cell contour packaging.

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle OTC Icon Andipal Tablets: 10 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Bendazol 20 mg
Metamizole sodium 250 mg
Papaverine hydrochloride 20 mg
Phenobarbital 20 mg

10 pcs. – non-cell contour packaging.

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TABLE OF CONTENTS