Corvalol-Pharmstandard drops for oral administration in 25ml №1

NameCorvalol. Release form Drops for oral administration. Dosage 25 ml. Qty per package: 1 pc. Producer Farmak Kyiv. INN peppermint oil + phenobarbital + ethyl bromoisovalerianate. FTGS sedative. Basic physical and chemical propertiesTransparent colorless liquid with a specific odor. Ingredients: ethyl ester of α-bromoisovaleric acid, phenobarbital, mint oil; 1 ml of solution (26 drops) contains: ethyl ester of α-bromoisovaleric acid 20 mg, phenobarbital 18.26 mg, mint oil 1.42 mg; excipients: ethyl alcohol (ethanol 96%), stabilizer (sodium isovalerianate), purified water. The medicinal product contains at least 56% (v/v) ethyl alcohol. Classification code Hypnotics and sedatives. Barbiturates in combination with other drugs. ATC code N05C B02. Pharmacological propertiesIndications for use As part of complex therapy as a symptomatic remedy for functional disorders of the nervous system (neurasthenia, sleep disorders). The drug is intended for short-term use due to the risk of addiction and dependence. Method of application and dosage Doses and duration of administration are set by the doctor individually. Adults are prescribed inside before meals 2-3 times a day for 15-30 drops, previously dissolved in a small amount of water. The drug is intended for episodic short-term use due to the risk of addiction and dependence. Side effects From the nervous system: drowsiness, decreased concentration, slow reactions, impaired coordination of movements, dizziness, headache, nervousness, agitation, anxiety, confusion, increased motor activity, ataxia, depression of the central nervous system, sleep disturbance, insomnia, night nightmares, mental disorders, hallucinations. From the respiratory system: hypoventilation, apnea. On the part of the digestive system: nausea, vomiting, constipation with prolonged use – impaired liver function. On the part of the hematopoietic organs: megaloblastic anemia, thrombocytopenia, agranulocytosis. From the cardiovascular system: bradycardia, low blood pressure, fainting. On the part of the musculoskeletal system: with prolonged use of drugs containing phenobarbital, there is a risk of impaired osteogenesis. There have been reports of reduced bone mineral density, the development of osteopenia and osteoporosis, fractures in patients who have been taking phenobarbital for a long time. Other: blurred vision, allergic reactions (angioedema, skin rash, exfoliative dermatitis), fever, liver damage. With prolonged use – drug dependence. With prolonged use of large doses, chronic bromine poisoning may develop, the manifestations of which are: depressive mood, apathy, rhinitis, conjunctivitis, hemorrhagic diathesis, impaired coordination of movements. After prolonged use, megaloblastic anemia may develop. With the use of drugs containing phenobarbital, there have been reports of the development of life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis). In the event of adverse reactions, including those not listed in these instructions, you should stop taking the drug and consult a doctor. Contraindications – Hypersensitivity to bromine or any component of the drug; – renal and / or liver failure; – porphyria; – alcoholism, epilepsy, traumatic brain injury and other brain diseases with a decrease in the seizure threshold; – pregnancy, lactation; – children’s age up to 18 years. Overdose Symptoms of chronic overdose: depression of the central nervous system, nystagmus, ataxia, lowering blood pressure, blood count disorders, agitation, chronic bromine intoxication (depression, apathy, rhinitis, conjunctivitis, hemorrhagic diathesis, impaired coordination of movements). With the development of symptoms of an overdose, it is necessary to stop taking the drug and consult a doctor. Acute overdose of barbiturates is manifested in the depression of the functions of the central nervous system and the respiratory system: Cheyne-Stokes respiration, areflexia, oliguria, tachycardia, arterial hypotension, hypothermia and coma. Shock (apnea, circulatory collapse, respiratory arrest and death) may develop. With the development of symptoms of acute overdose, it is necessary to maintain the vital functions of the body and conduct detoxification therapy, resuscitation may be required. Precautions The drug contains at least 56% (v / v) ethyl alcohol, that is, 255-510 mg of ethanol per single dose (15-30 drops), respectively. The drug should not be taken by patients with alcohol dependence, pregnant and breastfeeding women, children under 18 years of age, high-risk patients such as patients with liver disease and epilepsy. Concomitant consumption of alcoholic beverages should be avoided. Simultaneous alcohol intake increases the toxicity of phenobarbital. It should be avoided prescribing the drug to patients with depressive disorders, suicidal tendencies, people with drug addiction. Elderly and debilitated patients may respond to phenobarbital by developing marked agitation, depression, and confusion. With prolonged use, the accumulation of bromine in the body and the development of intoxication are possible. Phenobarbital can cause the development of addiction, mental and physical dependence. When addiction (tolerance) to phenobarbital develops, the dose required to maintain the same level of effect increases. Abrupt discontinuation of phenobarbital after long-term use in a dependent individual may lead to withdrawal symptoms. In case of signs of intoxication, addiction (tolerance) or dependence, the patient should immediately consult a doctor. Signs of chronic intoxication include confusion, decreased criticism, irritability, insomnia, and somatic complaints. Caution should be exercised when prescribing phenobarbital to patients with acute or chronic pain because paradoxical arousal may develop and important clinical symptoms may be masked. There have been reports of the development of life-threatening skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis) with the use of drugs containing phenobarbital. The best results in the treatment of Stevens-Johnson syndrome or toxic epidermal necrolysis have been obtained with early diagnosis and immediate discontinuation of the suspected drug. These patients should no longer resume the use of Corvalol®. Children. The drug is contraindicated in children and adolescents under the age of 18 years. Use during pregnancy or lactation Taking phenobarbital during pregnancy may cause fetal abnormalities. After oral administration, phenobarbital crosses the placental barrier and is distributed to all tissues of the fetus, high concentrations are determined in the placenta, liver and brain. If phenobarbital was taken during pregnancy or if pregnancy occurred while taking phenobarbital, the patient should be informed of the potential hazard to the fetus. When taking phenobarbital to a nursing mother, small amounts of phenobarbital are excreted in breast milk. The drug Corvalol is contraindicated in pregnant women and women who are breastfeeding. The ability to influence the reaction rate when driving vehicles or working with other mechanisms The drug contains ethyl alcohol, phenobarbital and ethyl ester of α-bromisovaleric acid, therefore, patients taking Corvalol® are contraindicated in driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions. Interaction with other drugs It is not recommended to take drugs that depress the central nervous system and alcohol at the same time. Phenobarbital induces liver enzymes and therefore may accelerate the metabolism of certain drugs that are metabolized by these enzymes (for example, coumarin derivatives, antibacterials and sulfonamides). When taken simultaneously with coumarin derivatives, lamotrigine, thyroid hormones, doxycycline, chloramphenicol, antifungal drugs (azole type), griseofulvin, glucocorticoids or oral contraceptives with Corvalol®, adverse reactions and interactions may occur due to the phenobarbital contained in the preparation. Women taking phenobarbital should be offered non-hormonal methods of contraception. The toxicity of pharmaceutical preparations containing methotrexate is increasing. The effect of phenobarbital on the metabolism of phenytoin is unpredictable, the concentrations of phenytoin and phenobarbital in the blood should be monitored if these drugs are prescribed simultaneously. Sodium valproate and valproic acid inhibit the metabolism of phenobarbital. Interactions associated with the presence of ethyl alcohol in the composition: it is necessary to avoid co-administration of drugs that cause a disulfiram-like reaction (feeling of heat, redness of the skin, vomiting, tachycardia) when taken together with alcohol (disulfiram, cefamandol, cefoperazone, latamoxef, chloramphenicol, chlorpropamide, glibenclamide, glipizide, tolbutamide, griseofulvin, nitro-5-imidazole derivatives (metronidazole, ornidazole, tinidazole), ketoconazole, procarbazip). It is necessary to avoid the simultaneous use of other drugs containing ethyl alcohol. If you are taking other medicines at the same time, you should consult your doctor. Storage conditions and shelf life Store in a place protected from light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Best before date. 2 years and 6 months. Do not use the drug after the expiration date indicated on the package. Holiday conditions Without a prescription. Packing of 25 ml in vials sealed with stoppers-droppers and screw caps with control of the first opening. Buy Corvalol-Pharmstandard drops for oral administration in 25 ml No. 1 drops for oral administration in 25ml №1