International generic name
Drug form and composition
Coated tablets. One coated tablet contains: 0.1 mg Belladonna Alkaloids; 0.3
mg Ergotamine tartrate; 20 mg Phenobarbital.
Neuroses; insomnia; climacteric symptom complex; cardiovascular diseases with
neuro-vegetative symptoms; Meniere syndrome; vertigo; kinesias; migraine; neurodermitis
and pruritus; ulcer; gastrointestinal diseases accompanies with hypermotility and
Dosage and administration
The recommended dose is 1 tablet, 3-4 times daily. In lack of satisfactory therapeutic
effect, the daily dose may be increased.
Hypersensitivity to some components of the preparation; arterial hypertension;
stenocardia; myocardial infarction; atrial fibrillation; peripheral vascular spastic
diseases; pregnancy and lactation; liver porphyria and other severe liver and renal
diseases; narrow angle glaucoma; high degree hypertrophy of prostate; sepsis.
Special warnings and precautions
The obstructive uropathy with various etiology requires a special attention in
the use of preparation. In case of mechanical obstacles along gastrointestinal tract
of various etiology, pyloro-duodenal stenosis, in megacolon, the administration
of Bellergamin may lead to retention of gastrointestinal content, meteorism, intoxication.
In a long-term treatment the preparation may lead to visual disturbances (mydriasis
and cycloplegia). There are no data on the therapeutic efficacy and safety of the
preparation in pediatric practice. The long-term therapy with high doses requires
an exact precision of daily doses of phenobarbital administration due to a danger
of development of tolerance and drug interaction. Its administration by drivers
and persons working with machines is not desirable due to failing of active attention
The phenothiazine preparations, the antiparkinsonics, and the tricyclic antidepressants
potentiate atropine effects. Ergotamine toxicity is increased at the simultaneous
administration with macrolide antibiotics and non-selective beta-blockers. Phenobarbital
decreases the activity of dicumarol and increases toxicity of phenytoin and halothan.
Alcohol and narcotic analgesics increase the sedative effect of phenobarbital.
Xerostomia; sense of fatigue; drowsiness; visual disturbances (mydriasis and
cycloplegia); glaucoma attack at higher doses; reduced gastrointestinal motility
and constipation; gastrointestinal discomfort (nausea, vomiting, colics); tachycardia;
Bellergamin possesses cholinolytic ganglioplegic and sedative action and has
a regulation effect on the functions of vegetative nervous system. Alkaloids of
Atropa belladonna, exerting a manifested peripheral and a certain central M-cholinolytic
action, suppress the spasms of smooth muscles of gastrointestinal and urogenital
tract, inhibit the secretion of exocrine glands, at therapeutic doses manifest a
sedative effect. Ergotamine exerts adrenolytic effect, weakly inhibits metabolism,
exerts a manifested antiserotonine action, has a manifested uterotonic and vasospastic
effect. Phenobarbital exerts a central sedative effect, suppresses insomnia, has
a manifested anticonvulsive action.
20 or 800 coated tablets.