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Bellasthesin (Tablets) Instructions for Use

ATC Code

A03DB (Belladonna and its derivatives in combination with analgesics)

Active Substances

Benzocaine (Rec.INN registered by WHO)

Belladonna (Ph.Eur. European Pharmacopoeia)

Clinical-Pharmacological Group

Drug with m-cholinolytic, antacid and analgesic action

Pharmacotherapeutic Group

Spasmolytic agent

Pharmacological Action

A combined drug that has a spasmolytic, local anesthetic, and analgesic effect; reduces the acidity of gastric juice and the tone of smooth muscle cells of the gastrointestinal tract organs.

Belladonna leaf extract contains the alkaloids atropine, hyoscyamine, and scopolamine, which have m-cholinolytic activity. It blocks m-cholinergic receptors and prevents their interaction with acetylcholine, the mediator of the parasympathetic division of the autonomic nervous system. It reduces the secretion of digestive, bronchial, lacrimal, and sweat glands. It relaxes smooth muscles and causes spasm of the intestinal sphincters, biliary and urinary tracts, and has a bronchodilatory effect, mainly on small bronchi and bronchioles. It reduces the cholinergic influence of the vagus nerve on the heart. As a result of the predominance of adrenergic (sympathetic) influence on the heart, tachycardia occurs and AV conduction improves. It has practically no effect on blood vessels and blood pressure level.

Benzocaine is a local anesthetic. It prevents the occurrence of pain sensations in the endings of sensory nerves and the conduction of pain impulses along nerve fibers.

Indications

Use for the symptomatic treatment of gastrointestinal spasms and associated pain.

  • Hyperacid gastritis.
  • Gastric colic.
  • Biliary colic.
  • Intestinal colic.

ICD codes

ICD-10 code Indication
K29 Gastritis and duodenitis
K80 Cholelithiasis [cholelithiasis] (including biliary colic)
R10.4 Other and unspecified abdominal pain (colic)
ICD-11 code Indication
DA42.Z Gastritis, unspecified
DA51.Z Duodenitis, unspecified
DA7Z Diseases of stomach or duodenum, unspecified
DC11.Z Cholelithiasis, unspecified
DD93.1 Infantile colic
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. The dosage is one tablet taken two to three times per day, depending on the severity of symptoms.

Adhere strictly to the recommended frequency. Do not exceed the maximum daily dose of three tablets.

Take with a sufficient amount of water. The duration of use is determined by the physician based on clinical response.

Adverse Reactions

Adverse reactions are primarily related to the anticholinergic effects of belladonna alkaloids.

Common effects include dry mouth, drowsiness, dizziness, and tachycardia. Ophthalmic effects such as mydriasis and accommodation paresis may occur.

Monitor for allergic reactions, including skin rash and urticaria. Discontinue use if severe adverse reactions develop.

Contraindications

Do not use in patients with known hypersensitivity to any component of the formulation.

  • Angle-closure glaucoma.
  • Prostatic hypertrophy with urinary retention.

Contraindicated in myasthenia gravis and severe ulcerative colitis. Avoid use in obstructive diseases of the gastrointestinal tract.

Drug Interactions

Concurrent use with other anticholinergic agents increases the risk of adverse effects.

Belladonna alkaloids may antagonize the effects of prokinetic agents like metoclopramide. Use with caution with drugs causing sedation due to additive CNS depression.

Absorption of other orally administered drugs may be altered. Monitor for interactions with amantadine, antihistamines, and tricyclic antidepressants.

Overdose

Symptoms of overdose are anticholinergic and include severe dry mouth, dilated pupils, tachycardia, hyperthermia, and CNS disturbances from restlessness to psychosis.

In severe cases, coma and circulatory collapse may occur. Immediately discontinue the drug and initiate symptomatic and supportive care.

Gastric lavage may be performed. Physostigmine may be considered as an antidote in severe, life-threatening cases under strict medical supervision.

Special Precautions

The drug should be avoided by persons whose activities require increased visual acuity.

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

Aspen Pharma, Pty. Ltd. (India)

Manufactured By

Vifitech, CJSC (Russia)

Dosage Form

Bottle OTC Icon Bellasthesin Tablets 15 mg+300 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Belladonna extract 15 mg
Benzocaine 300 mg

10 pcs. – glass tubes.
10 pcs. – contour cell blisters.
10 pcs. – contour non-cell blisters.

Marketing Authorization Holder

Vifitech, CJSC (Russia)

Dosage Form

Bottle OTC Icon Bellasthesin Tablets 15 mg+300 mg: 10, 500, 1000, or 2000 pcs.

Dosage Form, Packaging, and Composition

Tablets of flat-cylindrical shape with a score and a bevel, from light brown to brown in color with lighter and darker inclusions.

1 tab.
Belladonna extract thick 0.015 g
Benzocaine 0.3 g

Excipients: microcrystalline cellulose – 0.035417 g, hydroxypropylcellulose (hyprolose) – 0.00851 g, croscarmellose sodium – 0.003691 g, talc – 0.003691 g, calcium stearate – 0.003691 g.

10 pcs. – contour cell blisters.
10 pcs. – contour cell blisters (50) – cardboard boxes.
10 pcs. – contour cell blisters (100) – cardboard boxes.
10 pcs. – contour cell blisters (200) – cardboard boxes.

Marketing Authorization Holder

Tatkhimpharmpreparaty, JSC (Russia)

Dosage Form

Bottle OTC Icon Bellasthesin Tablets 0.015 g+0.3 g: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets of flat-cylindrical shape, with a score and a bevel, from light yellow to light brown in color with inclusions.

1 tab.
Belladonna extract 0.015 g
Benzocaine 0.3 g

Excipients: potato starch 0.0281 g, sodium carboxymethyl starch 0.0148 g, colloidal silicon dioxide 0.009 g, talc 0.0018 g, calcium stearate 0.0013 g.

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

Marketing Authorization Holder

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

Dosage Form

Bottle OTC Icon Bellasthesin Tablets 15 mg+300 mg: 6, 10, 12, 18, 20, 30, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets from light yellow to light brown in color with inclusions, flat-cylindrical in shape, with a bevel and a score.

1 tab.
Atropa belladonna leaf extract 15 mg
Benzocaine 300 mg

Excipients: potato starch – 28.1 mg, sodium carboxymethyl starch – 14.8 mg, colloidal silicon dioxide (aerosil) – 9 mg, talc – 1.8 mg, calcium stearate – 1.3 mg.

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

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