Neuromed Forte capsules №10х3

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Neuromed Forte caps. in a box No. 10х3
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Capsules hard gelatinous cylindrical shape with hemispherical ends with a white body and a dark red cap. The main active substance Pyridoxine + thiamine + cyanocobalamin Release form Capsules Pharmacological action Pharmacodynamics Neuromed forte contains a combination of neurotropic substances – a complex of vitamins. The vitamins contained in the preparation – thiamine (B1), pyridoxine (B6) and cyanocobalamin (B12) are coenzymes in metabolic reactions occurring in the central and peripheral nervous system. They are essential nutrients that cannot be synthesized by the body itself. The use of therapeutic doses of vitamins B1, B6 and B12 provides the necessary need for vitamins in case of their insufficient intake with food. Therapeutic use of B vitamins in diseases of the nervous system is possible in order to compensate for the deficiency (caused by an increase in demand) and stimulate natural recovery mechanisms. PharmacokineticsThiamin After oral administration, thiamine undergoes dose-dependent transport, the mechanism of which is dual in nature: active absorption at concentrations up to 2 μmol / l and passive diffusion at concentrations above 2 μmol / l. Thiamine is phosphorylated in the liver. The half-life is about 4 hours. The human body contains about 30 mg of thiamine. Given the rapid metabolism, it is excreted in 4-10 days. Pyridoxine Pyridoxine is absorbed very quickly, mainly in the upper intestine, and is excreted in a maximum of 2-5 hours. The function of the coenzyme requires the phosphorylation of pyridoxine. Pyridoxine in its phosphorylated form (pyridoxal phosphate) is almost 80% bound to plasma proteins. The human body contains about 40-150 mg of pyridoxine. The kidneys excrete 1.7-3.6 mg per day. Cyanocobalamin Cyanocobalamin is absorbed from the gastrointestinal tract through 2 mechanisms: – release under the action of gastric juice and rapid binding to intrinsic factor; – passive diffusion through the intestinal epithelium, regardless of the internal factor. At doses above 1.5 µg, the latter mechanism plays a significant role. In patients with B12 deficiency anemia, reabsorption after oral administration is approximately 1% of 100 micrograms or more. Excess cyanocobalamin mainly accumulates in the liver. From the liver, it is excreted in the bile to the intestine and is largely reabsorbed in the enterohepatic circulation. The metabolic rate of cyanocobalamin per day is 2.5 mcg. Indications for use Neurological disorders of various origins caused by a lack of vitamins B1, B6 and B12, which cannot be eliminated by nutritional correction. Dosage and administration Dosage The usual dose is 1 capsule 1 time per day. In some cases, the dose may be increased: 1 capsule 3 times a day. Children The safety of using Neuromed forte in children and adolescents under 18 years of age has not been established. The use of the drug is not recommended. Dosing and Administration Capsules should be swallowed without chewing with a small amount of liquid after meals. Duration of treatment The duration of treatment is determined by the doctor. After use for 4 weeks, in order to reduce the risk of developing neuropathy, it is necessary to evaluate the possibility of reducing the dosage to 1 capsule per day (see section “Precautions”). Use during pregnancy and lactation Use during pregnancy and lactation During pregnancy and lactation, the use of Neuromed forte is not recommended due to the high content of vitamins. Vitamins B1, B6 and B12 are excreted in breast milk, however, the risk of overdose in a newborn has not been established. In some cases, taking high doses of vitamin B6 (more than 600 mg per day) can suppress the secretion of breast milk. If necessary, taking the drug during lactation, breastfeeding should be discontinued. Precautions With prolonged use (more than 6-12 months) of vitamin B6 in a daily dose of 50 mg, peripheral sensory neuropathy may occur. Therefore, during long-term therapy, it is recommended to regularly monitor the patient’s condition. If signs of peripheral sensory neuropathy (paresthesia) appear, it is necessary to adjust the dose and, if necessary, stop taking the drug. When taking vitamin B12, the clinical picture, as well as laboratory parameters for funicular myelosis or pernicious anemia, may lose their specificity. Neuromed forte contains lactose as an excipient. The drug is not recommended for patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose / galactose malabsorption syndrome. If symptoms persist or worsen while taking the drug, you should consult a doctor. Interaction with other drugs With prolonged use (more than 6-12 months) of vitamin B6 in a daily dose of 50 mg, peripheral sensory neuropathy may occur. Therefore, during long-term therapy, it is recommended to regularly monitor the patient’s condition. If signs of peripheral sensory neuropathy (paresthesia) appear, it is necessary to adjust the dose and, if necessary, stop taking the drug. When taking vitamin B12, the clinical picture, as well as laboratory parameters for funicular myelosis or pernicious anemia, may lose their specificity. Neuromed forte contains lactose as an excipient. The drug is not recommended for patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose / galactose malabsorption syndrome. If symptoms persist or worsen while taking the drug, you should consult a doctor. Contraindications – Hypersensitivity to the components of the drug. – Children’s age up to 18 years due to the high content of active ingredients. Composition 1 capsule contains: active substances: thiamine mononitrate – 100.0 mg, pyridoxine hydrochloride – 200.0 mg, cyanocobalamin in the form of vitamin B12 1% SD – 0.2 mg. excipients: potato starch, magnesium stearate, talc, povidone K30, lactose monohydrate. composition of gelatin capsule No. 0: gelatin, purified water, titanium dioxide E-171, Ponceau 4R E-124. OverdoseVitamin B1 No overdose symptoms have been reported following oral administration. Vitamin B6 After oral ingestion of more than 2 g per day, neuropathies with ataxia and sensory disturbance, cerebral convulsions with EEG changes and, in very rare cases, hypochromic anemia and seborrheic dermatitis were noted. Vitamin B12 After high doses with parenteral use (in rare cases after oral use) – allergic reactions, skin eczema and mild acne. Treatment: should be supportive and symptomatic. Side effect Very common: ≥1/10, Often: ≥ 1/100, <1/10, Uncommon: ≥1/1000, <1/100, Rare: ≥1/10,000, <1/1000, Very rare: < 1/10,000, Not known: The frequency cannot be estimated from the available data. On the part of the immune system Very rarely: hypersensitivity reactions, manifested by sweating, tachycardia, skin reactions, itching of the skin and rash. From the nervous system Unknown: long-term use of the drug (within 6-12 months) can cause the development of sensory neuropathy. From the digestive tract Rarely: nausea, vomiting, diarrhea, abdominal discomfort. Other Rarely: headache, dizziness. In the event of adverse reactions, including those not listed in this leaflet, you must stop taking the drug and 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! 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