Lactovit forte

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT LACTOVIT FORTE (LACTOVIT FORTE)

Composition:

Active ingredients: folic acid, vitamin B12, Lactic Acid Bacillus (Bacillus coagulans (Lb.sporogenes));

1 capsule contains folic acid 1.5 mg, vitamin B12 15 mcg, Lactic Acid Bacillus (Bacillus coagulans (Lb.sporogenes)) 120 million spores;

Excipients: colloidal anhydrous silicon dioxide, talc, lactose monohydrate; capsule shell: gelatin, purified water, sodium lauryl sulfate, methylparaben (E 218), propylparaben (E 216), brilliant blue (E 133), carmoisine (E 122), tartrazine (E 102), titanium dioxide (E 171).

Pharmaceutical form. Capsules.

Main physicochemical properties: hard gelatin capsules with a yellow body and grey cap, containing a crystalline powder with granules of varying size ranging from light yellow to yellow and/or pink.

Pharmacotherapeutic group. Antidiarrheal microbials. Lactic acid-producing bacteria, combinations.

ATC code A07FA51.

Pharmacological properties.

Pharmacodynamics.

Lacovit Forte is a combination medicinal product containing Lactic Acid Bacillus (Bacillus coagulans (Lb. sporogenes)), folic acid, and vitamin B12.

The therapeutic effect of Lacovit Forte is determined by bacteria producing lactic acid, which exhibit antagonistic activity against pathogenic and conditionally pathogenic microorganisms. Bacterial spores are activated in the stomach, then pass into the duodenum, where they transform into live vegetative forms and create favorable conditions for the development of beneficial intestinal microflora by producing L(+) lactic acid. Lactobacilli enhance enzymatic breakdown of proteins, fats, and complex carbohydrates (including in children with lactase deficiency) and promote the regeneration of the intestinal mucosa.

Folic acid (vitamin B9) is essential for normal leukopoiesis and erythropoiesis, synthesis of amino acids and nucleic acids, purines, and pyrimidines.

Vitamin B12 (cyanocobalamin) participates in carbohydrate, protein, and lipid metabolism, in nucleic acid synthesis, helps normalize impaired functions of the nervous system, and stimulates erythropoiesis.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Lactovit Forte is indicated for the treatment of adults and children aged 6 months and older suffering from chronic colitis of various etiologies, including nonspecific ulcerative colitis; in somatic diseases complicated by dysbacteriosis arising as a result of antibiotic, sulfonamide drugs, or for other reasons; for the treatment of patients with intestinal disorders following acute intestinal infections caused by pathogenic and conditionally pathogenic bacteria; also used in obstetrics and gynecology for nonspecific inflammatory genital diseases and pre-delivery preparation of pregnant women at risk with vaginal secretion purity grade III–IV.

For supportive therapy in cases of urticaria, eczema, infantile diathesis, and atopic dermatitis.

Contraindications.

Hypersensitivity to any component of the medicinal product. Erythremias, erythrocytosis, thromboembolism, malignant neoplasms, malignant anemias, untreated cobalamin deficiency; phenylketonuria; Leber's disease (hereditary optic nerve atrophy).

Interaction with other medicinal products and other forms of interaction.

Folic acid.

Absorption of folic acid is reduced when used concomitantly with analgesics, anticonvulsants, antacids, chloramphenicol, neomycin, polymyxins, antibiotics, sulfonamides, and cytostatics.

When taken concurrently, folic acid reduces the efficacy of phenytoin, primidone, para-aminosalicylic acid, sulfasalazine, oral hormonal contraceptives, and chloramphenicol.

Folic acid increases phenytoin metabolism.

In patients with folate deficiency, administration of folic acid may reduce plasma levels of phenobarbital, phenytoin, and primidone and may provoke epileptic seizures.

Oral contraceptives, ethanol, sulfasalazine, cycloserine, glutethimide, and methotrexate may affect folate metabolism.

Acetylsalicylic acid may increase elimination of folic acid. Folates enhance the effectiveness of lithium. Nitrous oxide can cause acute folic acid deficiency. The following medicinal products may cause folic acid deficiency: antituberculosis agents, folic acid antagonists such as pyrimethamine, triamterene, trimethoprim.

Do not use together with mineral acids, alkaline substances, or reducing agents, as inactivation of folic acid occurs.

Reduced or altered absorption may occur when cholestyramine and folic acid are used concomitantly. Therefore, the drug should be taken 1 hour before or 4–6 hours after cholestyramine administration.

Folic acid may reduce intestinal zinc absorption.

Avoid simultaneous combination with fluorouracil. Antacid preparations containing aluminum or magnesium may reduce folic acid absorption; therefore, patients should be advised to take antacids 2 hours after folic acid administration.

Cyanocobalamin.

Aminoglycosides, salicylates, antiepileptic drugs, colchicine, and potassium preparations reduce cyanocobalamin absorption and affect its kinetics. Simultaneous use with kanamycin, neomycin, polymyxins, and tetracyclines decreases cyanocobalamin absorption.

Concomitant use with thiamine increases the risk of thiamine-induced allergic reactions.

Chloramphenicol reduces the hematopoietic response to the drug.

When used concurrently with cythamen, the effect of cythamen is reduced.

Oral contraceptives reduce cyanocobalamin blood concentration.

Special precautions for use.

To preserve the viability of the active components of the medicinal product, it is advisable not to take Lactovit Forte with hot beverages.

For children aged 6 months and older, the product can be administered immediately before feeding.

Due to the high antibiotic resistance of lactic acid-producing bacteria, use of the product does not interfere with antibiotic therapy.

Lactovit Forte therapy may be prescribed following a course of bacteriophage treatment.

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

Patients with neoplasms, except in cases associated with megaloblastic anemia and vitamin B12 deficiency, should not use the product. The product should not be used in severe or acute forms of cardiac decompensation and angina pectoris.

Excipients.

If you have been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicinal product, as it contains lactose.

Tartrazine (E 102), carmoisine (E 122), methylparaben (E 218), and propylparaben (E 216) contained in the product may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding.

Provided there are indications for use, Lactovit Forte may be taken during pregnancy and breastfeeding in the usual daily doses after consultation with a physician.

Ability to affect reaction speed when driving or operating machinery.

Caution is advised when driving or operating machinery, as dizziness may occasionally occur during use of the product.

Method of Administration and Dosage

For colitis, dysbiosis, and gastrointestinal disorders, the drug should be administered to adults and children aged 6 months and older twice daily, 40 minutes before meals or immediately before eating/feeding.

For children under 2 years of age, open the capsule and dissolve the contents in 10 mL of breast milk or boiled room-temperature water (the water must not be hot) to form a suspension; the single dose is 5 mL of suspension.

For children aged 2 years and older and adults, the single dose is 1 capsule, and the daily dose is 2 capsules.

For adults, the maximum single dose is 2 capsules, and the maximum daily dose is 4 capsules.

In obstetric and gynecological practice, Lactovit Forte should be administered orally in standard doses.

For prenatal preparation of pregnant women at risk, the drug should be administered orally once daily, 2 capsules per dose, for 5–8 days.

Duration of Use:

The treatment course depends on the nature and course of the disease.

In the presence of gastrointestinal disorders, treatment should last at least 4–6 weeks;

in chronic colitis of various etiologies, treatment should last up to 1.5–2 months;

in dysbiosis caused by antibiotics, sulfonamides, or other reasons, treatment should last 3–4 weeks.

To consolidate the achieved clinical effect, 10–14 days after completing the treatment course and in the absence of full microbiota normalization, maintenance doses of the drug (half the daily dose) should be prescribed for 1–1.5 months.

In diseases with recurrent course, repeated treatment courses are advisable. In such cases, a repeat microbiota examination is required before re-prescribing the medication.

Children.

The drug is indicated for use in children aged 6 months and older. For children under 6 years of age, other dosage forms of the drug (powder for oral suspension) are recommended.

Overdose.

No cases of Lactovit Forte overdose have been reported to date. Overdose of folic acid may mask vitamin B12 deficiency. Very high doses of folic acid (15 mg/day) may cause gastrointestinal disturbances (nausea, flatulence, bloating, bitter taste in the mouth).

Overdose of cyanocobalamin may lead to pulmonary edema, congestive heart failure, peripheral vascular thrombosis, and benign forms of acne. Prolonged use in high doses may cause impaired liver enzyme activity, chest pain, and hypercoagulability.

When the drug is used, an increased risk of adverse effects is possible.

Treatment. Discontinue the drug and provide symptomatic therapy.

Side effects.

Gastrointestinal disorders: Dyspepsia, nausea, vomiting, flatulence, abdominal discomfort, loss of appetite, stool softening, diarrhea, bitter taste in the mouth.

Skin and subcutaneous tissue disorders: Skin redness, itching, skin rashes, exanthema, urticaria, acne, bullous eruptions, dermatitis.

Immune system disorders: Hypersensitivity reactions (including anaphylaxis, anaphylactic shock, angioedema, bronchospasm), swelling, breathing difficulties, asthma attacks.

Nervous system disorders: Headache, dizziness, nervous excitement, sleep disturbances, seizures; arterial hypotension.

Cardiac disorders: Chest pain, tachycardia, peripheral vascular thrombosis.

Renal and urinary disorders: Hypertrophy of tubular epithelial cells in kidneys and impairment of their function.

Blood disorders: Hypercoagulation.

Metabolism and nutrition disorders: Purine metabolism disorders.

General disorders: Flushing, general weakness, malaise, sweating, hyperthermia, fever.

Shelf life: 3 years.

Storage conditions:
Store at a temperature not exceeding 25 °C, in the original packaging, in a place inaccessible to children.

Packaging:
7 capsules per blister, 2 blisters per cardboard box; or 7 capsules per blister, 4 blisters per cardboard box; or 10 capsules per blister, 3 blisters per cardboard box.

Supply category: Over-the-counter (without prescription).

Manufacturer:
Mepro Pharmaceuticals Private Limited.

Manufacturer's address:
Unit II, Q-Road, Phase IV, GIDC, Wadhwan, Surendranagar, Gujarat, 363 035, India.

Marketing Authorization Holder:
Mili Healthcare Limited.

Address of the Marketing Authorization Holder:
Second Floor Office Suite, 4 Chartfield House, Castle Street, Taunton, Somerset, England, TA1 4AS, Great Britain.