Methionine tablets 250 mg

Instructions for use for Methionine tablets 250 mg

Marketing Authorization Number: LS-001209

Brand Name: Methionine

International Nonproprietary Name: Methionine

Dosage Form:

Film-coated tablets

Composition per one tablet:

Active ingredient: Methionine - 250.0 mg

Inactive ingredients: Potato starch - 44.0 mg, Methylcellulose - 3.0 mg, Stearic acid - 3.0 mg

Coating ingredients to obtain a coated tablet weighing 400.0 mg: Sucrose (sugar) - 62.486 mg, Wheat flour - 18.556 mg, Magnesium carbonate (light) - 18.264 mg, Talc - 0.496 mg, Refined sunflower oil - 0.097 mg, Beeswax - 0.097 mg, Azorubine color - 0.004 mg.

Description

Round, biconvex, pink-coated tablets with slight speckling. A cross-section shows two distinct layers with a visible boundary between them.

Pharmacotherapeutic group: Metabolic agent.

ATC Code: A05BA

Pharmacological properties

An essential amino acid that serves as a donor of mobile methyl groups for the synthesis of choline and phospholipids, realizing a lipotropic effect. It is involved in the synthesis of adrenaline, proteins, and in transmethylation, deamination, and decarboxylation reactions. It participates in the metabolism of sulfur-containing amino acids, adrenaline, creatinine, cyanocobalamin, ascorbic and folic acids, hormones, and enzymes. It has a detoxifying effect and exerts metabolic and hepatoprotective actions. It is readily absorbed in the intestine and is excreted in the urine in small amounts.

Indications for use

Liver diseases (hepatitis, hepatosis, cirrhosis) accompanied by fatty infiltration of hepatocytes; prevention of toxic liver damage caused by arsenic, chloroform, benzene, and alcohol; protein deficiency of various origins, as part of combination therapy.

Contraindications

Viral hepatitis, severe hepatic insufficiency, hepatic encephalopathy, hypersensitivity to the components of the drug. The drug is contraindicated in children under 6 years of age.

Precautions

• Renal insufficiency (risk of increased hyperazotemia)
• Methionine is not recommended for viral hepatitis.

Use in pregnancy and lactation

Adequate data is not available.

Effect on ability to drive and operate machinery

Adequate data is not available.

Dosage and administration

Orally. Adults: 0.5-1.5 g, children over 6 years: 0.25 g - 0.5 g 3-4 times a day, 30-60 minutes before meals. The course of treatment is 10-30 days or in 10-day courses with 10-day intervals.

Adverse reactions

Allergic reactions, nausea, vomiting (due to unpleasant odor and taste) are possible.

Overdose

Symptoms: decreased blood pressure, tachycardia, disorientation. Treatment: symptomatic.

Special instructions

The drug should be prescribed in a balanced ratio with other amino acids. Unbalanced use of methionine in high doses may have a damaging effect on liver cells and other organs. The drug does not affect the ability to drive vehicles or engage in other potentially hazardous activities requiring increased concentration and rapid psychomotor reactions.

Pharmaceutical form

Film-coated tablets, 250 mg.

10 or 25 tablets in a blister pack made of polyvinyl chloride film and printed lacquered aluminum foil.

1, 2, or 5 blister packs together with the package insert are placed in a cardboard carton.

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf life

5 years. Do not use after the expiration date printed on the packaging.

Regulatory status

Over-the-counter.

Marketing Authorization Holder / Organization for claims:

JSC "AVVA RUS", Russia, 121614, Moscow, Krylatskie Kholmy St., 30, building 9.

Tel/Fax: +7 (495) 956-75-54.

avva.com.ru

Manufacturing address:

JSC "AVVA RUS", Russia, 610044, Kirov Region, Kirov, Luganskaya St., 53a.

Tel: +7 (8332) 25-12-29; +7 (495) 956-75-54.