Bellalgin (Tablets) Instructions for Use

ATC Code

A03DB (Belladonna and its derivatives in combination with analgesics)

Clinical-Pharmacological Group

Drug with m-cholinolytic, antacid and analgesic action

Pharmacotherapeutic Group

Drugs for the treatment of functional gastrointestinal disorders. Spasmolytics in combination with analgesics. Belladonna and its derivatives in combination with analgesics

Pharmacological Action

A combined drug with spasmolytic, antacid, local anesthetic, and analgesic action.

Belladonna leaf extract contains the alkaloids atropine, hyoscyamine, and scopolamine, which possess m-cholinolytic activity. It blocks m-cholinergic receptors and prevents their interaction with acetylcholine, the neurotransmitter 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, primarily 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.

Metamizole sodium is a pyrazolone derivative with analgesic, antipyretic, and weak anti-inflammatory action, the mechanism of which is associated with the inhibition of prostaglandin synthesis.

Sodium bicarbonate is an antacid. When taken orally, it quickly neutralizes hydrochloric acid of gastric juice and provides a rapid but short-lived antacid effect.

Indications

As a symptomatic agent for the relief of pain syndrome in gastrointestinal diseases accompanied by increased gastric juice secretion and smooth muscle spasms: hyperacid gastritis; gastric and duodenal ulcer; heartburn, belching; gastralgia; spastic colitis; spasm of the smooth muscles of the gastrointestinal tract organs.

ICD codes

Dosage Regimen

Take the tablets orally, before meals, with a sufficient amount of water.

The standard adult dosage is 1 tablet taken 2-3 times per day.

Do not exceed the maximum single dose of 3 tablets.

Do not exceed the maximum daily dose of 10 tablets.

The duration of therapy is determined by the physician based on the indication and clinical response.

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

Discontinue use and consult a physician if symptoms persist or worsen.

For elderly patients or those with renal or hepatic impairment, use with caution and potentially at a reduced dosage.

Avoid concomitant use with alcohol and other sedative drugs due to risk of enhanced adverse effects.

Do not use to relieve acute abdominal pain until the cause has been diagnosed by a physician.

Adverse Reactions

From the urinary system impaired renal function, oliguria, anuria, proteinuria, interstitial nephritis, red discoloration of urine.

Allergic reactions urticaria (including on the conjunctiva and mucous membranes of the nasopharynx), angioedema, in rare cases – malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), bronchospastic syndrome, anaphylactic shock.

From the hematopoietic organs agranulocytosis, leukopenia, thrombocytopenia.

Other decreased blood pressure, dry mouth, thirst, constipation, mydriasis, accommodation paresis, temporary visual impairment, dysuria, urinary retention, palpitations, drowsiness, dizziness, psychomotor agitation, convulsions.

Contraindications

Hypersensitivity to the drug components; angle-closure glaucoma; prostatic hyperplasia; bone marrow depression (granulocytopenia, leukopenia, agranulocytosis, cytostatic or infectious neutropenia); severe hepatic and/or renal failure; hereditary hemolytic anemia associated with glucose-6-phosphate dehydrogenase deficiency; aspirin-induced asthma; pregnancy (especially in the first trimester and the last 6 weeks); lactation (breastfeeding) period.

With caution kidney diseases (pyelonephritis, glomerulonephritis, including in history), chronic alcoholism.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy (especially in the first trimester and the last 6 weeks) and during lactation (breastfeeding).

Use in Hepatic Impairment

Contraindication — severe hepatic insufficiency.

Use in Renal Impairment

Contraindication — severe renal insufficiency.

With caution kidney diseases (pyelonephritis, glomerulonephritis, including in history).

Special Precautions

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

When treating patients receiving cytostatics, the intake of metamizole sodium should be carried out only under medical supervision.

Patients with atopic bronchial asthma and hay fever have an increased risk of developing allergic reactions.

During the intake of metamizole sodium, agranulocytosis may develop, therefore, if an unmotivated rise in temperature, chills, sore throat, difficulty swallowing, stomatitis are detected, as well as if symptoms of vaginitis or proctitis develop, immediate withdrawal of the drug is necessary.

With prolonged use, it is necessary to monitor the peripheral blood picture.

It is unacceptable to use for the relief of acute abdominal pain (until the cause is clarified).

During treatment, red discoloration of urine is possible due to the excretion of a metabolite (of no significance).

Drug Interactions

Enhances the effects of ethanol.

Concomitant use with chlorpromazine or other phenothiazine derivatives may lead to the development of severe hyperthermia.

Radiocontrast agents, colloidal blood substitutes, and penicillin should not be used during treatment with metamizole sodium.

With simultaneous use of cyclosporine, its concentration in the blood decreases.

Metamizole, displacing from protein binding oral hypoglycemic agents, indirect anticoagulants, corticosteroids, and indomethacin, increases their activity.

Phenylbutazone, barbiturates, and other inducers of liver microsomal enzymes reduce the effectiveness of metamizole when taken simultaneously.

Concomitant administration with other non-narcotic analgesics, tricyclic antidepressants, hormonal contraceptives, and allopurinol may lead to increased toxicity.

Sedative and anxiolytic drugs (tranquilizers) enhance the analgesic effect of metamizole sodium.

Thiamazole and cytostatics increase the risk of developing leukopenia.

The effect is enhanced by codeine, histamine H₂-receptor blockers, and propranolol (slows down inactivation).

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.