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Papazol (Tablets) Instructions for Use

ATC Code

A03AD (Papaverine and its derivatives)

Active Substances

Papaverine (BAN)

Bendazol (Rec.INN)

Clinical-Pharmacological Group

Myotropic antispasmodic

Pharmacotherapeutic Group

Peripheral vasodilators; other peripheral vasodilators

Pharmacological Action

A combined drug with antispasmodic, hypotensive, and vasodilating effects.

Bendazole is a myotropic antispasmodic; it has hypotensive and vasodilating effects, stimulates spinal cord function, and possesses moderate immunostimulating activity.

Papaverine is an antispasmodic agent with a hypotensive effect. It inhibits phosphodiesterase, leading to the accumulation of cAMP in the cell and a decrease in calcium content, reducing the tone and relaxing the smooth muscles of internal organs (gastrointestinal tract, respiratory and genitourinary systems) and blood vessels. In large doses, it reduces the excitability of the heart muscle and slows intracardiac conduction. The effect on the central nervous system is weak (in large doses, it has a sedative effect).

Indications

Arterial hypertension (labile); spasm of peripheral arteries and cerebral vessels; spasm of smooth muscles of internal organs (including gastric and duodenal ulcers, pylorospasm, intestinal colic, cholecystitis, spastic colitis); poliomyelitis (residual effects); peripheral facial nerve paralysis.

ICD codes

ICD-10 code Indication
B91 Sequelae of poliomyelitis
G45 Transient cerebral ischemic attacks [TIAs] and related syndromes
G51 Disorders of facial nerve
I10 Essential [primary] hypertension
I73.9 Peripheral vascular disease, unspecified (including intermittent claudication, arterial spasm)
K25 Gastric ulcer
K26 Duodenal ulcer
K31.3 Pylorospasm, not elsewhere classified
K52.9 Noninfective gastroenteritis and colitis, unspecified
K81.0 Acute cholecystitis
K81.1 Chronic cholecystitis
R10.4 Other and unspecified abdominal pain (colic)
R51 Headache
ICD-11 code Indication
1G83 Sequelae of poliomyelitis
8A8Z Headache disorders, unspecified
8B10.Z Transient ischemic attack, unspecified
8B88.Z Lesions of facial nerve, unspecified
BA00.Z Essential hypertension, unspecified
BD4Z Chronic obliterative arterial diseases, unspecified
DA41.Y Other specified disorders of gastroduodenal motility and secretion
DA60.Z Gastric ulcer, unspecified
DA63.Z Duodenal ulcer, unspecified
DA90.0 Syndromic diarrhea
DC12.0Z Acute cholecystitis, unspecified
DC12.1 Chronic cholecystitis
DD93.1 Infantile colic
DE2Z Diseases of the digestive system, unspecified
MD81.4 Other and unspecified abdominal pain

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.

Administer orally with a sufficient amount of water.

For adults, the standard dose is 1-2 tablets, taken 2-3 times daily.

Adjust the dosage and frequency based on the therapeutic indication and individual patient response.

The maximum single dose is 2 tablets; do not exceed this amount.

The maximum daily dose is 6 tablets; do not exceed this total.

For arterial hypertension, initiate therapy with the lower end of the dosage range.

For smooth muscle spasm relief (gastrointestinal, biliary, genitourinary), administer at the onset of symptoms.

The duration of treatment is determined by the treating physician based on clinical efficacy.

Discontinue use and consult a physician if adverse reactions occur or if there is no improvement in condition.

Do not use in children under 1 year of age.

Use with caution in elderly patients and those with hepatic or renal impairment.

Avoid concomitant use with alcohol due to a potential additive hypotensive effect.

Adverse Reactions

From the digestive system: nausea, constipation.

From the central nervous system: dizziness.

From the cardiovascular system: AV block, arrhythmias, decreased myocardial contractility.

Other: allergic reactions, increased sweating.

Contraindications

Impaired AV conduction; epileptic syndrome; bronchial obstruction syndrome; children under 1 year of age; hypersensitivity to the drug components.

Use with caution in reduced intestinal peristalsis, traumatic brain injury, hepatic and/or renal failure, hypothyroidism, adrenal insufficiency, prostatic hyperplasia, during pregnancy and lactation.

Use in Pregnancy and Lactation

Use with caution during pregnancy and lactation.

Use in Hepatic Impairment

Contraindicated in hepatic failure.

Use in Renal Impairment

Contraindicated in renal failure.

Pediatric Use

Contraindicated in children under 1 year of age.

Special Precautions

The safety of the drug during pregnancy and lactation has not been established.

Drug Interactions

Concomitant use of the drug with antispasmodics, sedatives, diuretics, tricyclic antidepressants, procainamide, reserpine, quinidine may enhance the hypotensive effect.

Papazol weakens the effect of anticholinesterase drugs on smooth muscle (galantamine, proserin, physostigmine).

Adsorbents, astringents, and coating agents reduce the absorption of the drug in the gastrointestinal tract.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°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

Dalkhimpharm, JSC (Russia)

Dosage Form

Bottle OTC Icon Papazol 30 mg+30 mg tablets: 10, 20 or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a grayish tint, round, flat-cylindrical in shape, with a bevel; the presence of inclusions is allowed.

1 tab.
Bendazole hydrochloride 30 mg
Papaverine hydrochloride 30 mg

Excipients: potato starch – 56.5 mg, talc – 2.3 mg, calcium stearate – 1.2 mg.

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

Marketing Authorization Holder

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Manufactured By

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle OTC Icon Papazol 30 mg+30 mg tablets: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a grayish tint, round, flat-cylindrical, with a double-sided bevel; the presence of barely noticeable inclusions is allowed.

1 tab.
Bendazole 30 mg
Papaverine hydrochloride 30 mg

Excipients: potato starch – 57 mg, calcium stearate – 1 mg, talc – 2 mg.

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

Marketing Authorization Holder

Medisorb, JSC (Russia)

Dosage Form

Bottle OTC Icon Papazol Tablets 30 mg+30 mg: 10, 20, 30, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Bendazol 30 mg
Papaverine hydrochloride 30 mg

Excipients: povidone, potato starch, lactose monohydrate, calcium stearate.

10 pcs. – non-cell contour packs.
10 pcs. – contour packs (1) – packs.
10 pcs. – contour packs (2) – packs.
10 pcs. – contour cell packs.
10 pcs. – contour packs (3) – packs.
10 pcs. – contour packs (5) – packs.
10 pcs. – contour packs (10) – packs.

Marketing Authorization Holder

N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)

Dosage Form

Bottle OTC Icon Papazol 30 mg+30 mg tablets: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a grayish tint, flat-cylindrical in shape, with a bevel; the presence of barely noticeable inclusions is allowed.

1 tab.
Bendazole 30 mg
Papaverine hydrochloride 30 mg

Excipients: potato starch – 56.49 mg, talc – 2.34 mg, calcium stearate – 1.17 mg.

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

Marketing Authorization Holder

Pharmstandard-Tomskkhimpharm OJSC (Russia)

Manufactured By

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Bottle OTC Icon Papazol 30 mg+30 mg tablets: 10, 20 or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a grayish tint, flat-cylindrical, with a bevel; the presence of barely noticeable inclusions is allowed.

1 tab.
Bendazole hydrochloride 30 mg
Papaverine hydrochloride 30 mg

Excipients: potato starch – 56 mg, talc – 3 mg, stearic acid – 1 mg.

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

Marketing Authorization Holder

Pharmstandard-Tomskkhimpharm OJSC (Russia)

Dosage Form

Bottle OTC Icon Papazol Tablets 30 mg+30 mg: 10 or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a grayish tint, flat-cylindrical, with a bevel; the presence of barely noticeable inclusions is allowed.

1 tab.
Bendazole hydrochloride 30 mg
Papaverine hydrochloride 30 mg

Excipients: potato starch – 56 mg, talc – 3 mg, stearic acid – 1 mg.

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

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle OTC Icon Papazol Renewal 30 mg+30 mg tablets: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a bevel.

1 tab.
Bendazole 30 mg
Papaverine hydrochloride 30 mg

Excipients: potato starch – 56 mg, talc – 3 mg, stearic acid – 1 mg.

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

Marketing Authorization Holder

Uralbiopharm, JSC (Russia)

Dosage Form

Bottle OTC Icon Papazol-UBF 30 mg+30 mg tablets: 10, 20, 25, 30, 40, 50 or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a grayish tint, round, flat-cylindrical in shape, with a bevel; the presence of barely noticeable inclusions is allowed.

1 tab.
Bendazole hydrochloride 30 mg
Papaverine hydrochloride 30 mg

Excipients: lactose (milk sugar) – 51.2 mg, povidone (polyvinylpyrrolidone) – 4 mg, potato starch – 2.4 mg, talc – 1.2 mg, calcium stearate – 1.2 mg.

10 pcs. – non-cell contour packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – polymer jars (1) – polyethylene bags or cardboard boxes.
20 pcs. – polymer jars (1) – polyethylene bags or cardboard boxes
25 pcs. – polymer jars (1) – polyethylene bags or cardboard boxes.
30 pcs. – polymer jars (1) – polyethylene bags or cardboard boxes.
40 pcs. – polymer jars (1) – polyethylene bags or cardboard boxes.
50 pcs. – polymer jars (1) – polyethylene bags or cardboard boxes.
60 pcs. – polymer jars (1) – polyethylene bags or cardboard boxes.

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