9 Months Vitamins-minerals complex (Tablets) Instructions for Use

Marketing Authorization Holder

Valenta Pharmaceuticals, PJSC (Russia)

ATC Code

A11AA04 (Multivitamins and trace elements)

Dosage Form

9 Months Vitamins-minerals complex

Film-coated tablets: 30 or 100 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.

Clinical-Pharmacological Group

Multivitamins with macro- and microelements

Pharmacotherapeutic Group

Multivitamin agent + multimineral

Pharmacological Action

The pharmacological properties are determined by the complex of vitamins and minerals included in the drug. Vitamins maintain a certain level of metabolism in the body, are necessary for the growth and renewal of tissues, regulation of the hormonal system, and normal growth and development of the embryo.

After childbirth, the complex of vitamins and minerals replenishes the reserves of trace elements in the woman’s body and meets the increased needs for vitamins and trace elements (contained in the drug) during breastfeeding.

Retinol (vitamin A) increases the body’s resistance to various infections, helps improve vision, growth and strengthening of bones, maintaining healthy skin, and is necessary for the formation of hair, teeth, gums, and the production of red blood cells.

The complex of B vitamins contributes to the normal functioning of the nervous and cardiovascular systems, reduces the frequency of nausea and vomiting attacks during toxicosis in pregnant women, affects protein, fat, and carbohydrate metabolism, is necessary for the growth of the unborn child, and prevents the development of vascular diseases, congenital malformations, and pregnancy complications (preeclampsia, fetal hypotrophy, fetal neural tube defects).

Ascorbic acid (vitamin C) is involved in redox processes, ensures normal blood clotting, and is necessary for the prevention of colds.

Colecalciferol (vitamin D) ensures the absorption of calcium and the preservation of bone structure.

Alpha-tocopherol acetate (vitamin E) contributes to the normal formation of muscle tissue and prevents pregnancy complications (miscarriage, toxicosis, placental insufficiency).

Trace elements are necessary for maintaining hormonal balance and tissue regeneration, and the normal formation of the fetal nervous, immune, skeletal, and reproductive systems.

Indications

• Prevention of hypovitaminosis and mineral deficiency in women during pregnancy and lactation.

ICD codes

Dosage Regimen

Take one tablet once daily with a full glass of water.

Administer the tablet orally after a meal to improve tolerability and enhance absorption of the components.

Initiate therapy as recommended by a physician, typically upon confirmation of pregnancy.

Continue administration throughout the entire duration of pregnancy to support maternal and fetal nutritional demands.

Continue use during the postpartum period while breastfeeding to replenish maternal nutrient stores.

The standard course duration is 30 to 40 days of continuous intake.

Adhere strictly to the one tablet per day dosage; do not exceed this recommended intake.

Repeat courses of therapy are permissible only on the explicit recommendation of a supervising physician.

Do not use concomitantly with other multivitamin or multimineral preparations to avoid the risk of overdose.

Consult a doctor prior to use to confirm the absence of contraindications, especially in cases of pre-existing medical conditions or concurrent medication use.

Adverse Reactions

Allergic reactions to the components of the drug are possible.

Urine may turn an intense yellow color, which is not dangerous, as it is due to the presence of riboflavin in the drug.

Stool may turn black, which is due to the excretion of unabsorbed iron and has no clinical significance.

Gastrointestinal disorders (constipation) may be observed during administration, but these disorders do not require discontinuation of the drug.

Contraindications

• Diseases accompanied by increased accumulation of iron in the body;
• Hypercalcemia (elevated calcium levels in the blood);
• Hypercalciuria (elevated calcium levels in the urine);
• Hypervitaminosis A and/or D;
• Concomitant use with drugs containing vitamins A and D;
• Hypervitaminosis K, concomitant use with drugs containing vitamin K, because the drug contains Phytomenadione;
• Children under 18 years of age;
• Individual intolerance to the components of the drug.

Use with caution in patients with B₁₂-deficiency anemia.

Use in Pregnancy and Lactation

Used for the prevention of hypovitaminosis and mineral deficiency in women during pregnancy and lactation.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Special Precautions

It is not recommended to use concomitantly with other drugs containing vitamins and minerals. Do not exceed the recommended dosage.

If you are taking any other medications, consult your doctor.

Overdose

In case of accidental overdose, consult a doctor immediately.

Symptoms: dizziness; headache; feeling of dryness, burning and tingling of the skin; redness of the skin of the face and neck; skin rashes; thirst; decreased appetite; abdominal pain; nausea; vomiting; diarrhea; flatulence; muscle weakness.

Treatment: activated charcoal orally, gastric lavage, symptomatic treatment.

Drug Interactions

It enhances the effect of other drugs containing vitamins and minerals; overdose is possible with concomitant use.

Ascorbic acid (vitamin C) slows down the excretion and enhances the action and side effects of sulfonamides, slows down the excretion of barbiturates, salicylates.

Laxative medicines containing mineral oil and cholestyramine reduce the absorption of retinol (vitamin A), colecalciferol (vitamin D) and vitamin E.

Fluorouracil, vinblastine, bleomycin, cisplatin impair the absorption of retinol (vitamin A), thiamine (vitamin B₁), pyridoxine (vitamin B₆); penicillamine, isoniazid reduce the effectiveness of thiamine by increasing its excretion.

Isoniazid also reduces the effectiveness of pyridoxine.

The drug contains Iron and Calcium, therefore it delays the absorption in the intestine of antibiotics from the tetracycline group (tetracycline, doxycycline), as well as antimicrobial agents – fluoroquinolone derivatives (ciprofloxacin, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, sparfloxacin).

Antacid preparations containing aluminum, Magnesium, Calcium reduce the absorption of iron.

With simultaneous use of diuretics from the thiazide group, the likelihood of hypercalcemia increases.

Storage Conditions

Store in a dry place protected from light at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.