Storage:
active substances: ethyl ether of a-bromosovaleric acid, phenobarbital, mint oil, hop oil;
1 ml of solution (26 drops) contains: ethyl ether of a-bromosovaleric acid in a 100% substance – 20 mg, phenobarbital – 18 mg, peppermint oil – 1.4 mg, hop oil – 0.2 mg;
auxiliary substances: stabilizer, ethanol 96%, purified water.
Medicinal form. Oral drops.
Main physicochemical properties: transparent colorless liquid with a specific smell.
Pharmacotherapeutic group.
Sleeping pills and sedatives. Barbiturates in combination with other components.
Clinical characteristics.
Indication.
– Neuroses with increased irritability;
– insomnia;
– in complex therapy of hypertensive disease and vegetative-vascular dystonia;
– mild spasms of coronary vessels, tachycardia;
– intestinal spasms caused by neurovegetative disorders (as an antispasmodic drug).
Contraindication.
Hypersensitivity to active substances or to any other component of the drug, bromine; acute hepatic porphyria; severe liver and kidney function disorders; diabetes, myasthenia. Medicinal products containing phenobarbital are contraindicated in case of alcoholism, drug and drug addiction (including in the anamnesis); with respiratory diseases with shortness of breath, obstructive syndrome, pronounced arterial hypotension, with acute myocardial infarction; in depression and depressive disorders with the patient’s tendency to suicidal behavior.
Method of application and dosage.
Take 15-30 drops orally before meals with a small amount (30-50 ml) of liquid 2-3 times a day. If necessary, a single dose can be increased to 40-50 drops.
The duration of drug use is determined by the doctor depending on the clinical effect and tolerability of the drug.
Children.
There is no experience of use for the treatment of children, so the drug should not be used in pediatric practice.
Adverse reactions.
On the part of the nervous system: asthenia, weakness, impaired coordination of movements, nystagmus, ataxia, hallucinations, paradoxical excitement, insomnia (in elderly patients), decreased concentration of attention, fatigue, slowness of reactions, headache, cognitive impairment. In some cases, drowsiness and slight dizziness, confusion of consciousness may be observed.
On the part of the musculoskeletal system: with long-term use of products containing phenobarbital, there is a risk of osteogenesis disorders. There have been reports of decreased bone mineral density, osteopenia, osteoporosis, and fractures in patients receiving long-term phenobarbital therapy. The mechanism by which phenobarbital affects bone metabolism has not been identified.
From the side of the digestive tract: nausea, vomiting, constipation, heaviness in the epigastric area, with long-term use – impaired liver function.
From the hematopoietic organs: agranulocytosis, megaloblastic anemia, thrombocytopenia, anemia.
From the side of the cardiovascular system: a decrease in blood pressure, bradycardia.
From the skin and mucous membranes: Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic reactions, including rash, itching, urticaria.
From the side of the immune system: hypersensitivity reactions, including angioedema, difficulty breathing, facial swelling.
Long-term use of bromine-containing drugs can lead to bromine poisoning characterized by the following symptoms: central nervous system depression, depression, confusion, ataxia, apathy, conjunctivitis, rhinitis, lacrimation, acne, or purpura.
Expiration date.
3 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions.
Store in the original packaging at a temperature not higher than 25 °C. Keep out of the reach of children.
Packaging. 25 ml in a bottle. 1 bottle in a pack.
Leave category. Without a prescription.
Producer. “Farmak” JSC.
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