Mastodon

Besalol (Tablets) Instructions for Use

ATC Code

A03ED (Spasmolytics in combination with other drugs)

Active Substances

Belladonna (Ph.Eur. European Pharmacopoeia)

Phenylsalicylate (Group Grouping name)

Clinical-Pharmacological Group

Drug with antispasmodic and anti-inflammatory action

Pharmacotherapeutic Group

Spasmolytic agent

Pharmacological Action

A combined medicinal product for oral administration. It has antispasmodic, antisecretory, and analgesic (due to the m-cholinoblocking activity of belladonna extract), as well as antiseptic and anti-inflammatory (due to phenylsalicylate, which breaks down in an alkaline environment into phenol and salicylic acid) effects.

Indications

Use for the management of gastrointestinal disorders characterized by smooth muscle spasm and microbial imbalance.

  • Gastrointestinal diseases accompanied by spasms of the smooth muscles of the abdominal organs and intestinal dysbiosis.

ICD codes

ICD-10 code Indication
K63.8 Other specified diseases of intestine
R10.4 Other and unspecified abdominal pain (colic)
ICD-11 code Indication
DA92.1 Pneumatosis intestinalis of the small intestine
DA98.Z Polyps of small intestine, unspecified
DB31.1 Pneumatosis of the colon
DB36.Z Certain infections of the colon, unspecified
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. The dosage is dependent on the patient’s age and the clinical presentation being treated.

For adults, the typical regimen is 1 tablet taken 2 to 3 times per day. Do not exceed the recommended daily dosage. The duration of therapy is determined by the physician based on symptom resolution.

Tablets

Adults take 1 tablet orally 2-3 times/day.

Adverse Reactions

Adverse reactions are primarily related to the anticholinergic properties of belladonna extract. Monitor for signs of intolerance.

From the nervous system: dizziness, accommodation paresis. From the eye: mydriasis, increased intraocular pressure. From the gastrointestinal tract: dry mouth, constipation. From the urinary system: urinary retention. Allergic reactions may also occur.

Drug Interactions

Concurrent use with other agents possessing anticholinergic activity may lead to an additive therapeutic effect and an increased risk of adverse reactions.

Avoid concomitant administration with other anticholinergics, tricyclic antidepressants, antihistamines, and antiarrhythmic drugs like quinidine. Exercise caution with drugs affecting gastrointestinal motility.

Contraindications

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

  • Angle-closure glaucoma.
  • Prostatic hypertrophy with impaired urine outflow.
  • Gastrointestinal bleeding.
  • Hypersensitivity to belladonna extract, phenylsalicylate, or any excipient.

Overdose

Symptoms of overdose are an extension of the drug’s anticholinergic effects and constitute a medical emergency requiring immediate attention.

Manifestations include severe dry mouth, dilated pupils, blurred vision, tachycardia, hyperthermia, urinary retention, CNS effects from restlessness to delirium, and respiratory depression. Treatment is symptomatic and supportive; gastric lavage and activated charcoal may be considered. Specific antidote: physostigmine.

Special Precautions

Effect on the ability to drive vehicles and mechanisms

During the treatment period, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration, speed of psychomotor reactions, and good vision.

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

Tatkhimpharmpreparaty, JSC (Russia)

Dosage Form

Bottle OTC Icon Besalol Tablets 10 mg+300 mg: 12, 18, or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Belladonna extract 10 mg
Salol (phenylsalicylate) 300 mg

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

Marketing Authorization Holder

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

Dosage Form

Bottle OTC Icon Besalol Tablets 10 mg+300 mg: 6, 10, 12, 18, 20, 24, 30, 40 or 50 pcs.

Dosage Form, Packaging, and Composition

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

1 tab.
Atropa belladonna leaf extract (thick belladonna extract) 10 mg
Phenyl salicylate 300 mg

Excipients: microcrystalline cellulose (MCC-101), povidone K25 (kollidon 25), sodium carboxymethyl starch (primogel), magnesium stearate.

6 pcs. – blister contour packs (1) – cardboard packs.
6 pcs. – blister contour packs (2) – cardboard packs.
6 pcs. – blister contour packs (3) – cardboard packs.
6 pcs. – blister contour packs (4) – cardboard packs.
6 pcs. – blister contour packs (5) – cardboard packs.
10 pcs. – blister contour packs (1) – cardboard packs.
10 pcs. – blister contour packs (2) – cardboard packs.
10 pcs. – blister contour packs (3) – cardboard packs.
10 pcs. – blister contour packs (4) – cardboard packs.
10 pcs. – blister contour packs (5) – cardboard packs.

Marketing Authorization Holder

Pharmaceutical Company Zdorovye, LLC (Ukraine)

Dosage Form

Bottle OTC Icon Besalol Tablets 10 mg+300 mg: 6, 10, 12, 18, 20, 24, 30, 40 or 50 pcs.

Dosage Form, Packaging, and Composition

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

1 tab.
Belladonna leaf extract 10 mg
Phenylsalicylate 300 mg

Excipients: microcrystalline cellulose (MCC-101), povidone K25, sodium carboxymethyl starch (primogel), magnesium stearate.

6 pcs. – blister contour packs (1) – cardboard packs.
6 pcs. – blister contour packs (2) – cardboard packs.
6 pcs. – blister contour packs (3) – cardboard packs.
6 pcs. – blister contour packs (4) – cardboard packs.
6 pcs. – blister contour packs (5) – cardboard packs.
10 pcs. – blister contour packs (1) – cardboard packs.
10 pcs. – blister contour packs (2) – cardboard packs.
10 pcs. – blister contour packs (3) – cardboard packs.
10 pcs. – blister contour packs (4) – cardboard packs.
10 pcs. – blister contour packs (5) – cardboard packs.
6 pcs. – blister contour packs (100) – cardboard boxes (for hospitals).
6 pcs. – blister contour packs (200) – cardboard boxes (for hospitals).
6 pcs. – blister contour packs (300) – cardboard boxes (for hospitals).
6 pcs. – blister contour packs (400) – cardboard boxes (for hospitals).
6 pcs. – blister contour packs (600) – cardboard boxes (for hospitals).
6 pcs. – blister contour packs (800) – cardboard boxes (for hospitals).
10 pcs. – blister contour packs (100) – cardboard boxes (for hospitals).
10 pcs. – blister contour packs (200) – cardboard boxes (for hospitals).
10 pcs. – blister contour packs (300) – cardboard boxes (for hospitals).
10 pcs. – blister contour packs (400) – cardboard boxes (for hospitals).
10 pcs. – blister contour packs (600) – cardboard boxes (for hospitals).
10 pcs. – blister contour packs (800) – cardboard boxes (for hospitals).

Table of Contents

→ TABLE OF CONTENTS