Name Phenibut-LF, tablets 250 mg. Composition One tablet contains: Active ingredient: Phenibut – 250 mg; Excipients: Calcium stearate, potato starch, sodium starch glycolate (type A), microcrystalline cellulose. Dosage form Tablets for oral administration. Round tablets of white or white color with a yellowish tint, flat-cylindrical shape, with a chamfer, with a risk on one side. Marbling is allowed on the surface of the tablet. The break line (risk) is intended solely to facilitate the separation of the tablet and its swallowing, and not division into equal doses. Indications for use The drug Phenibut-LF is used for increased nervous excitability (neurasthenia) and sleep disorders. In children – for the treatment of stuttering, tics. Dosage regimen and method of application Dosage regimen With increased nervous excitability (neurasthenia) and sleep disorders 250-500 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 – appoint 100 mg 2-3 times a day. To ensure this dosing regimen, it is recommended to use the drug Phenibut-LF, powder for oral solution. Children from 8 to 14 years old – 250 mg 3 times a day. Children over 14 years of age are prescribed doses for adults. Patients with impaired liver function In patients with impaired liver function, high doses of the drug 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. How to use Phenibut-LF is taken orally after meals with water. 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. Contraindications Hypersensitivity to the active substance or auxiliary components of the medicinal product. Acute renal failure. During pregnancy and breastfeeding. Special instructions and precautions for use 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. Interaction with other medicinal products and other types of interaction Combining a medicinal product with other psychotropic drugs requires prior consultation with a doctor and supervision of a doctor during treatment. The simultaneous administration of the drug with carbamazepine, oxcarbazepine or monoamine oxidase inhibitors is not recommended. Fertility, 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. In experimental studies on animals, no mutagenic, teratogenic and embryotoxic effects of the drug have been established. Influence on the ability to drive vehicles and work with mechanisms In connection with possible disorders of the central nervous system (drowsiness, dizziness), while taking the drug, you should not drive vehicles or work with mechanisms. Adverse reactions The following adverse reactions are classified according to the organ system groups and the frequency of occurrence of MedDRA: very often (≥1/10), often (≥1/100 to <1/10), infrequently (≥1/1000 to <1/100) , rare (≥1/10000 to <1/1000), very rare (<1/10000), frequency unknown (cannot be estimated from the available data). Immune system disorders: frequency unknown - hypersensitivity reactions (including urticaria, pruritus, erythema, rashes, angioedema, swelling of the face, swelling of the tongue). Nervous system disorders: frequency unknown - drowsiness (at the beginning of treatment), increased irritability, agitation, anxiety, headache, dizziness (when taking phenibut in doses of more than 2000 mg (8 tablets of the drug Phenibut-LF 250 mg) per day , with a decrease in the dose, the severity of side effects decreases). Gastrointestinal disorders: the frequency is unknown - nausea (at the beginning of treatment). Skin and subcutaneous tissue disorders: rarely - allergic reactions (skin rash, itching). Liver and biliary tract disorders: frequency unknown - 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 is no dependence on the drug, Phenibut-LF does not cause a "withdrawal syndrome". In the literature, there are data on individual cases of addiction caused by the use of the drug. In case of adverse reactions, including those not listed in the instructions for use, you should consult a doctor. Reporting Suspected Adverse Reactions It is important to report suspected adverse reactions after registration of a medicinal product in order to ensure continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are encouraged to report any suspected adverse drug reactions through the national system for reporting adverse reactions (UE Center for Expertise and Testing in Healthcare, http://www.rceth.by). Overdose There have been no reports of overdose with phenibut. 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. Pharmacodynamic properties Pharmacotherapeutic group: Other psychostimulants and nootropics. ATX code: N06BX22. The active substance of the drug Phenibut-LF (γ-amino-β-phenylbutyric acid hydrochloride) can be considered as a derivative of γ-aminobutyric acid (GABA) or as a derivative of β-phenylethylamine. Phenibut-LF has nootropic activity, and as a GABA derivative it has an anxiolytic (tranquilizing) effect. Does not affect cholinergic and adrenergic receptors. Does not have anticonvulsant activity. The drug lengthens the latent period of nystagmus and shortens its duration and severity. Pharmacokinetic properties The drug is well absorbed after oral administration and penetrates into all tissues of the body, penetrates 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. 80-95% of the dose is metabolized in the liver to pharmacologically inactive metabolites. About 5% is excreted by the kidneys unchanged. With the repeated introduction of cumulation is not observed. Incompatibility Not applicable. Shelf life 2 years. Do not use after the expiration date. Special precautions for storage Store below 25°C. The nature and content of the primary packaging 10 tablets in a blisters made of a three-layer PVC / PVDC / PVC film and lacquered aluminum foil. Two or three blister packs, together with instructions for medical use, are placed in a cardboard pack. Special precautions for disposal No special disposal requirements. Residues of the medicinal product and waste should be disposed of in the prescribed manner. Conditions of leave By doctor's prescription. Buy Phenibut-LF tablets 250mg No. 10x2 Price for Phenibut-LF tablets 250mg No. 10x2
INN | GAMMA-AMINO-BETA-PHENYLBUY ACID HYDROCHLORIDE |
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The code | 149 858 |
Barcode | 4 812 608 012 905 |
Active substance | Phenibut |
Manufacturer | Lekpharm SOOO, Belarus |
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