Noofen 100 powder for solution for oral administration 100mg in bags №15

Name:
Noofen por. 100mg No. 15 Main active ingredient Gamma-amino-beta-phenylbutyric acid hydrochloride Release form Powder Composition Active ingredient: ?-amino-?-phenylbutyric acid hydrochloride 100 mg. Excipients: mannitol (E 421), thaumatin (E 957), flavor “Orange Durarome” flavor composition: corn maltodextrin, sugar, flavoring components, starch sodium octenyl succinate (E1450), gum arabic (E414), esters of citric acid and mono- and fatty acid diglycerides (E472c), silicon dioxide (E551). The total weight of the powder is 1000 mg.
Description:
Powder of white or almost white color with a yellowish tinge. Yellow inclusions are allowed. Dosage 100 mg Pharmacological properties Pharmacodynamics The active substance of Noofen (?-amino-?-phenylbutyric acid hydrochloride) can be considered as a derivative of ?-aminobutyric acid (GABA) or as a derivative of ?-phenylethylamine. Noofen has nootropic activity, and as a GABA derivative it has an anxiolytic (tranquilizing) effect. Does not affect cholinergic and adrenergic receptors. Noofen is devoid of anticonvulsant activity. Noofen lengthens the latent period of nystagmus and shortens its duration and severity. Pharmacokinetics The drug is well absorbed after oral administration and penetrates into all tissues of the body, overcomes the blood-brain barrier. About 0.1% of the administered dose of the drug penetrates into the brain tissue, and in young and old people to a much greater extent. Metabolized in the liver – 80-95%, to pharmacologically inactive metabolites. About 5% is excreted by the kidneys unchanged. With repeated administration, cumulation is not observed. Indications for use Apply with increased nervous excitability (neurasthenia) and sleep disorders. In children – for the treatment of stuttering, tics. Contraindications Hypersensitivity to the active substance or excipients of the drug. Acute renal failure. During pregnancy and breastfeeding. Use during pregnancy and lactation Use during pregnancy and lactation is contraindicated, because. there are no adequate and well-controlled clinical studies on the safety of the drug during these periods. Influence on the ability to drive vehicles or maintain mechanisms Due to possible disorders of the central nervous system (drowsiness, dizziness), while taking the drug, you should not drive vehicles or maintain mechanisms. Dosage and administration The contents of the package are dissolved in half a glass of warm water and taken orally after a meal. The prepared medicinal product is not subject to storage, it should be taken immediately after preparation. The duration of the course of treatment is determined by the doctor, taking into account the disease, the tolerance of the drug and the effect achieved. With increased nervous excitability (neurasthenia) and sleep disorders 300-500 mg 3 times a day. The maximum single dose is 750 mg, for patients over 60 years of age – 500 mg. The course of treatment is 2-3 weeks. If necessary, the course can be extended up to 4-6 weeks. Use in children and adolescents (for the treatment of stuttering, tics) Children aged 3 to 8 years are prescribed 100 mg 2-3 times a day, from 8 to 14 years – 200 mg 3 times a day. Children over 14 years old – doses for adults. Maximum single doses for children: from 3 to 8 years – 100 mg, from 8 to 14 years – 200 mg. g Patients with impaired liver function In patients with impaired liver function, high doses of Noofen may cause a hepatotoxic effect. Patients in this group are prescribed smaller doses of the drug under the control of liver function. Patients with impaired renal function The use of the drug is contraindicated in patients with acute renal failure. With prolonged use in patients with impaired liver and / or kidney function, it is necessary to monitor indicators of kidney and liver function. If you miss a dose, take the medicine as soon as you remember, but skip if it is almost time for your next dose. Never take double doses to make up for a missed dose. Side effects Noofen, like all medicines, can cause side effects that may not affect everyone. Classification of unwanted side effects according to the frequency of development: very often (? 1/10); often (? 1/100 to < 1/10); infrequently (? 1/1000 to < 1/100); rare (? 1/10,000 to < 1/1000); very rarely (< 1/10,000); not known (cannot be determined from the available data). Nervous system disorders: not known - drowsiness (at the beginning of treatment), increased irritability, agitation, anxiety, headache, dizziness (when taken in doses of more than 2 g per day, with a decrease in dose, the severity of side effects decreases). Gastrointestinal disorders: not known - nausea (at the beginning of treatment). Skin and subcutaneous tissue disorders: rarely - allergic reactions (skin rash, itching). Liver and biliary tract disorders: not known - hepatotoxicity (with prolonged use of high doses). There have been reports of cases of development of emotional instability and sleep disturbances in children after taking the drug. There are data on cases of tolerance (addiction) to the drug. In case of adverse reactions, including those not listed in the instructions for use, you should consult a doctor. Overdose No cases of overdose have been reported. In case of an overdose, the following symptoms may develop: drowsiness, nausea, vomiting, dizziness. With prolonged use of high doses, eosinophilia, arterial hypotension, impaired renal activity, and fatty degeneration of the liver (more than 7 g) may develop. Treatment: gastric lavage, symptomatic treatment. There is no specific antidote. Interaction with other drugsCombining the drug Noofen with other psychotropic drugs requires prior consultation with a doctor and supervision of a doctor during treatment. The simultaneous administration of the drug Noofen with carbamazepine, oxcarbazepine or MAO inhibitors is not recommended. Precautions Caution should be exercised in patients with erosive and ulcerative diseases of the gastrointestinal tract due to the irritant effect of the drug. These patients are prescribed smaller doses of the drug. With prolonged use, it is necessary to monitor peripheral blood and liver function. If the symptoms of the disease persist or worsen while taking the drug, you should consult a doctor. Storage conditions In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Noofen 100 powder for oral solution 100mg in bags #15