Milgamma

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT MИЛЬГАМА® (MILGAMMA®)

Composition:

Active substances: 1 tablet contains benfotiamine 100 mg, pyridoxine hydrochloride 100 mg;

Excipients: colloidal anhydrous silicon dioxide, microcrystalline cellulose, sodium croscarmellose, povidone, talc, partially hydrogenated long-chain glycerides; coating: shellac, sucrose, calcium carbonate (E 170), talc, acacia, corn starch, titanium dioxide (E 171), colloidal anhydrous silicon dioxide, povidone, polyethylene glycols, glycerol 85%, polysorbates, glycol montan wax.

Pharmaceutical form. Film-coated tablets.

Main physicochemical characteristics: white film-coated tablets with a smooth surface.

Pharmacotherapeutic group.
Vitamin B1 preparations, simple and in combination with vitamins B6 and B12. ATC code A11D B.

Pharmacological properties.

Pharmacodynamics.

Neurotropic vitamins of group B exert a beneficial effect on the course of inflammatory and degenerative diseases of nerves and the musculoskeletal system. They should be used to eliminate deficiency conditions; in high doses, these vitamins have analgesic properties, improve blood circulation, and normalize the function of the nervous system and the process of hematopoiesis.

Pharmacokinetics.

Vitamin B6 and its derivatives are mostly rapidly absorbed in the upper part of the gastrointestinal tract by passive diffusion and are excreted within 2–5 hours.

Clinical characteristics.

Indications.

In neurological disorders caused by proven deficiency of vitamins B1 and B6.

Contraindications.

Hypersensitivity to the components of the drug.

Vitamin B1 is contraindicated in allergic reactions.

Vitamin B6 is contraindicated in peptic ulcer of the stomach and duodenum in the stage of exacerbation (since it may increase gastric juice acidity).

Pregnancy or breastfeeding period.

Interaction with other medicinal products and other types of interactions.

Thiamine is inactivated by 5-fluorouracil, as the latter competitively inhibits phosphorylation of thiamine to thiamine pyrophosphate. Antacids reduce thiamine absorption.

Loop diuretics (e.g., furosemide), which inhibit tubular reabsorption, may during long-term therapy cause increased excretion of thiamine and thus reduce thiamine levels.

Concomitant administration of vitamin B6 with levodopa may reduce the effect of levodopa.

Simultaneous use of pyridoxine antagonists (e.g., isoniazid, hydralazine, D-penicillamine, or cycloserine), alcohol, as well as prolonged use of oral contraceptives containing estrogens, may lead to vitamin B6 deficiency.

Consumption of alcohol and black tea reduces thiamine absorption.

Benfotiamine is incompatible with oxidizing and reducing compounds: mercury chloride, iodides, carbonates, acetates, tannic acid, iron-ammonium citrate, as it becomes inactivated in their presence. Copper accelerates the degradation of benfotiamine; in addition, thiamine loses its activity at increased pH values (above 3).

Beverages containing sulfites (e.g., wine) enhance thiamine degradation.

Pyridoxine may reduce the efficacy of altretamine.

Special precautions for use.

The decision to use Milgamma® in patients with severe or acute forms of decompensated heart failure should be made individually by a physician, taking into account the patient's condition.

When vitamin B12 is administered, the clinical picture as well as laboratory findings in funicular myelosis or pernicious anemia may lose their specificity.

Since the preparation contains vitamin B6, it should be prescribed with caution to patients with a history of peptic ulcer of the stomach and duodenum, or severe liver and kidney insufficiency.

Milgamma® should not be used in patients with neoplastic diseases, except in cases associated with megaloblastic anemia and vitamin B12 deficiency. The drug is contraindicated in severe or acute forms of decompensated cardiac dysfunction and angina pectoris.

If signs of peripheral sensory neuropathy (paresthesia) occur, the dosage should be reassessed and administration of Milgamma® should be discontinued if necessary. Peripheral neuropathies have been observed with prolonged use (more than 6–12 months) of daily doses exceeding 50 mg of vitamin B6, as well as with short-term use (more than 2 months) of more than 1 g of vitamin B6 per day. Therefore, ongoing monitoring is recommended during long-term treatment.

The preparation contains sucrose. Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency should not use this medicinal product.

Use during pregnancy or breastfeeding.

The daily requirement for vitamin B6 during pregnancy and lactation is up to 2.5 mg.

During pregnancy or breastfeeding, the recommended daily intake is 1.4–1.6 mg of vitamin B1 and 2.4–2.6 mg of vitamin B6.

There is no evidence supporting the use of higher doses than the recommended daily amounts.

Vitamins B1 and B6 are excreted into breast milk.

High doses of vitamin B6 may interfere with milk production. The preparation contains 100 mg of vitamin B6; therefore, it should not be used during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

Since the drug may cause adverse effects such as dizziness, headache, and tachycardia in some patients, caution should be exercised when driving or operating machinery.

Method of Administration and Dosage

Take orally, swallowing with sufficient amount of liquid.

The recommended dose is 1 tablet per day. In individual cases, the dose may be increased to 1 tablet three times daily.

Tablets should be swallowed whole with liquid, after meals.

The duration of treatment is determined individually by a physician. After the maximum treatment period (4 weeks), a decision is made regarding dose adjustment and reduction.

Children

The efficacy and safety of the drug in children have not been established; therefore, it should not be prescribed to this age group.

Overdose

Chronic use in high doses may lead to impaired hepatic enzyme activity, cardiac pain, and hypercoagulation. High doses of vitamin B1 may produce curare-like effects.

Vitamin B1

Thiamine has a wide therapeutic range. Very high doses (more than 10 g) may produce ganglion-blocking effects similar to curare, and may inhibit nerve impulse conduction.

Vitamin B6

Vitamin B6 is considered to have very low toxicity. However, prolonged use (more than 6–12 months) of vitamin B6 in doses exceeding 50 mg per day may cause peripheral sensory neuropathy.

Continuous use of vitamin B6 in doses exceeding 1 g per day for longer than 2 months may lead to neurotoxic effects.

Long-term use of vitamin B1 in doses exceeding 2 g per day has been associated with neuropathies with ataxia and sensory disturbances, cerebral seizures with EEG changes, and in isolated cases, hypochromic anemia and seborrheic dermatitis.

In case of overdose, symptoms of the drug's adverse effects are intensified.

Treatment: gastric lavage, administration of activated charcoal. Symptomatic therapy.

Adverse reactions.

Gastrointestinal disorders: nausea, vomiting, diarrhea, abdominal pain, increased gastric juice acidity.

Cardiovascular disorders: tachycardia.

Immune system disorders: hypersensitivity reactions, including anaphylactic shock; anaphylaxis; urticaria.

Skin disorders: skin rashes, pruritus.

In extremely rare cases – shock.

Nervous system disorders: prolonged use (more than 6–12 months) at doses exceeding 50 mg of vitamin B6 daily may lead to peripheral sensory neuropathy, nervous overexcitement, dizziness, headache.

Endocrine system disorders: inhibition of prolactin secretion.

Shelf life. 5 years.

Storage conditions.

Keep out of reach of children at a temperature not exceeding +25 °C.

Do not use after the expiry date stated on the packaging.

Packaging.

15 film-coated tablets in a blister; 2 or 4 blisters per cardboard box.

Supply category.

Over-the-counter (without prescription).

Manufacturer.

Mauermann-Arzneimittel KG, Germany.

Manufacturer's address and place of business.

Heinrich-Knote-Strasse 2, 82343 Poecking, Germany.