Instructions for use of Megamilbedoce

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Composition

One film-coated tablet Megamilbedoce contains Active ingredients
One film-coated tablet Megamilbedoce contains Active ingredients

One film-coated tablet Megamilbedoce contains: Active ingredients – benfotiamine 100 mg, pyridoxine hydrochloride 100 mg, excipients – microcrystalline cellulose, colloidal anhydrous silicon dioxide, croscarmellose sodium, povidone KZO, partially long-chain glycerides, Talc shell composition – shellac, sucrose, calcium carbonate (E170), talc, acacia powder, corn starch, titanium dioxide (E171), colloidal anhydrous silicon dioxide, povidone KZO, macrogol 6000, glycerin 85%, polysorbate 80, glycol wax.
Description
Round, biconvex, white film-coated tablets with a smooth surface; bumps, irregularities, and small spots are permitted.
Pharmacological Action
Thiamine and its phosphorylated derivatives are widely distributed in plants and animals. The adult human body contains about 30 mg of thiamine. Thiamine deficiency is common in alcohol abuse, in patients on hemodialysis, after gastrointestinal surgery, after prolonged malnutrition, malabsorption, or parenteral nutrition. To prevent vitamin B1 deficiency, daily intake should be 1.3-1.5 mg for men and 1.1-1.3 mg for women. During pregnancy, an additional 0.3 mg of vitamin B1 per day is needed, and during lactation, an additional 0.6 mg per day.
The vitamin B6 content in humans is 40-150 mg. Daily renal excretion is 1.7 to 2.6 mg. The required daily amount of vitamin B6 depends on the intensity of protein metabolism, its deficiency is prevented in men by a daily dose of 2.3 mg per day, in women – 2.0 mg. During pregnancy, an additional 1.0 mg of pyridoxine per day is required, during lactation – 0.6 mg of pyridoxine.
Vitamins B6 and B1 belong to the critical vitamins of the B-vitamin complex. Since there are no significant reserves of these vitamins in the human body, their intake should be daily. Pyridoxine, pyridoxal and pyridoxamine are widely available in plant and animal products. Deficiency of vitamins B1 and B6 can be detected by biochemical methods.
The biologically active thiamine derivatives thiamine pyrophosphate and thiamine triphosphate play key roles in carbohydrate metabolism as coenzymes of pyruvate decarboxylase, 2-oxoglutarate dehydrogenase, and transketolase. In the pentose phosphate cycle, thiamine pyrophosphate is involved in the transfer of aldehyde groups.
Pyridoxine in its phosphorylated form (pyridoxal-5-phosphate) is a
coenzyme of numerous enzymes, mainly involved in the metabolism of amino acids as well as carbohydrates and fats.
Analgesic effects have been demonstrated for both vitamins in animal studies.

Pharmacokinetics

One film-coated tablet Megamilbedoce contains Active ingredients
One film-coated tablet Megamilbedoce contains Active ingredients

Neurological disorders of different genesis caused by vitamin B1 and B6 deficiency.
Contraindications.
Hypersensitivity to the active ingredients and excipients of the drug.
Milgamma® is contraindicated in pregnancy and lactation.
Infancy due to lack of data.
Pregnancy and lactation
It is not recommended to use it during pregnancy.
Dosage and administration
The usual dose for adults is 1 tablet per day. If necessary, the dose may be increased to 3 tablets per day. The medication is washed down with enough liquid. After a maximum of 4 weeks, the doctor should decide on the appropriateness of taking 1 tablet 3 times a day. To reduce the risk of neuropathy from the vitamin B6 contained in Milgamma®, treatment may be continued at a dose of 1 tablet daily.
The efficacy and safety of Milgamma® in children has not been established.
Elderly patients
No dose adjustment is usually required in elderly patients.
Impaired renal function
No dose adjustment is required in patients with impaired renal function.
Impaired liver function.

Indikationen

Neurological disorders of different genesis caused by vitamin B1 and B6 deficiency.
Contraindications.
Hypersensitivity to the active ingredients and excipients of the drug.
Milgamma® is contraindicated in pregnancy and lactation.
Infancy due to lack of data.
Pregnancy and lactation
It is not recommended to use it during pregnancy.

Dosage and administration

The usual dose for adults is 1 tablet per day. If necessary, the dose may be increased to 3 tablets per day. The medication is washed down with enough liquid. After a maximum of 4 weeks, the doctor should decide on the appropriateness of taking 1 tablet 3 times a day. To reduce the risk of neuropathy from the vitamin B6 contained in Milgamma®, treatment may be continued at a dose of 1 tablet daily.
The efficacy and safety of Milgamma® in children has not been established.
Elderly patients
No dose adjustment is usually required in elderly patients.
Impaired renal function
No dose adjustment is required in patients with impaired renal function.

Impaired liver function

No dose adjustment is required in patients with impaired liver function.
Side effects
Immune system disorders: hypersensitivity reactions (skin reactions, urticaria, exanthema, anaphylactic shock).
Nervous system disorders: dizziness, confusion, prolonged use of the drug (over 6 months) may cause the development of sensory neuropathy.
Gastrointestinal disorders: Nausea

Overdose

With oral administration of benfotiamine, the phenomenon of overdose does not occur. High doses of vitamin Bb (more than 1000 mg per day) may have a neurotoxic effect. Prolonged use of pyridoxine at a dose of 100 mg per day (more than 6 months) may also lead to the development of neuropathy.
Overdose manifests as sensory neuropathy, and sometimes ataxia. Exceptionally high doses of pyridoxine may cause seizures. In neonates and infants, sedation, hypotension, and respiratory disturbances (dyspnea, apnea) may occur.
Therapeutic measures in case of overdose: In case of pyridoxine hydrochloride above 150 mg/kg body weight, it is necessary to induce vomiting and administer activated charcoal. Vomiting is most effective in the first 30 min after pyridoxine administration. Sometimes intensive therapy may be required.

Interaction with other drugs

One film-coated tablet Megamilbedoce contains Active ingredients
One film-coated tablet Megamilbedoce contains Active ingredients

Therapeutic doses of vitamin B6 may reduce the effect of levodopa. Use of pyridoxine antagonists (isoniazid, D-penicillinamine, cycloserine), alcohol, and long-term use of estrogen-containing oral contraceptives may lead to vitamin B6 deficiency. Thiamine is inactivated by 5-fluorouracil, which blocks phosphorylation of thiamine, is incompatible with oxidizing and reducing agents, as well as phenobarbital, riboflavin, benzylpenicillin, dextrose.
Features of use
Effect on ability to drive vehicles and operate machinery.
Milgamma® does not affect the ability to drive a vehicle and operate machinery requiring increased attention.

Precautions

Prolonged use of the drug (more than 6 months) may lead to the development of neuropathy. Milgamm® should not be used in patients with congenital fructose intolerance or glucose-galactose malabsorption or sucrose isomaltase deficiency.

Effect on driving ability and ability to operate machinery.
Milgamm® does not affect the ability to drive a car and perform work involving mechanisms requiring increased attention.

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