Fenules^® Zinc (Capsules) Instructions for Use

Marketing Authorization Holder

Ranbaxy Laboratories, Ltd. (India)

ATC Code

B03AE03 (Iron preparations in combination with multivitamins)

Dosage Form

Fenules® Zinc

Extended-release capsules: 10, 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
30 pcs. – polyethylene bottles (1) – cardboard packs.
60 pcs. – polyethylene bottles (1) – cardboard packs.
90 pcs. – polyethylene bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Antianemic drug. Vitamin complex with a trace element

Pharmacotherapeutic Group

Iron preparation + multivitamin

Pharmacological Action

Iron, being a part of numerous cellular structures and participating in the activity of many enzymatic systems (cytochromes, catalases, etc.), plays an important role in oxygen transport and oxidative metabolic processes, and is also an essential element of the human body, which is especially necessary for the formation of hemoglobin. The iron content in the body is maintained at a constant level due to the regulation of its absorption and loss. The drug is used to eliminate iron deficiency.

Zinc is an essential element of the human body, which is mainly found in erythrocytes in the form of the zinc-metallo enzyme carbonic anhydrase and, to a lesser extent, in the blood plasma in a bound state with α-2-macroglobulin. It is part of more than 70 enzymes that catalyze key stages of DNA, RNA, and protein synthesis. It has a pronounced effect on the processes of growth and tissue maturation, has a positive effect on delayed mental and physical development in children. It stabilizes cell membranes, affects regeneration processes, nerve impulse transmission, and enhances the action of insulin. It stimulates hair growth, has an immunomodulatory effect on the T-cell link of immunity and increases the factors of nonspecific immune defense. It is a powerful antioxidant. It is effective in the treatment of acne and alopecia.

Pyridoxine as a coenzyme participates in the metabolism of amino acids, proteins, and the synthesis of neurotransmitters.

Folic acid is a B vitamin that participates in key biological processes, namely: the synthesis of DNA, RNA, and proteins. During pregnancy, folic acid prevents the development of neural tube defects in the fetus. Folate deficiency leads to the development of megaloblastic anemia. With folic acid deficiency, miscarriage, premature birth, and impaired mental development of the child can be observed.

Cyanocobalamin in the form of methylcobalamin is a cofactor for reactions involving methionine synthase. With B₁₂ deficiency, the formation of thymidylic acid and purine nucleosides, precursors of DNA synthesis necessary for normal cell division, decreases. Megaloblastic anemia is a consequence of vitamin B₁₂ deficiency.

Pharmacokinetics

Absorption

Iron is absorbed mainly from the duodenum and jejunum. Maximum absorption is observed when iron is taken on an empty stomach. Absorption varies significantly and depends on the body’s iron stores and physiological needs. In iron deficiency conditions, its absorption increases. The total amount of assimilated iron in the body increases with increasing its dose. The time to reach C_max in the blood is 1-2 hours. Zinc is absorbed in the small intestine: 40-65% in the duodenum, 15-21% in the jejunum and ileum.

Distribution

After absorption, the main part of iron binds to transferrin and is transported to the bone marrow, where it is captured by erythropoiesis cells for hemoglobin synthesis; the rest is contained in the blood and deposited in organs in the form of ferritin, hemosiderin, or myoglobin.

Excretion

A small amount of iron is excreted from the body through the kidneys after the cyclic destruction of the hemoglobin molecule.

Indications

• Treatment and prevention of conditions caused by deficiency of iron, zinc, and folic acid, including before, during, and after pregnancy (during lactation) and in children;
• As part of complex therapy for skin diseases (juvenile acne, alopecia areata, atopic dermatitis).

ICD codes

Dosage Regimen

Orally. The dosage of the drug and the duration of therapy depend on the severity of iron deficiency. The daily dose of the drug can be taken once a day. Take during or immediately after a meal; drink with water.

Treatment of clinically pronounced mild to moderate iron deficiency (iron deficiency anemia) 2 capsules/day for 3-5 months until the hemoglobin level in the blood normalizes. After normalization of the hemoglobin level in the blood, a maintenance dose is prescribed as recommended by a doctor.

Treatment of combined deficiency of iron, zinc, and folic acid – 2 capsules/day. Pregnant women should take 1-2 capsules/day until hemoglobin normalizes. Then therapy should be continued at a dosage of 1 capsule/day, at least until delivery to restore iron stores.

For therapy and prevention of latent iron deficiency, zinc and folic acid deficiency, as part of complex therapy for skin diseases (juvenile acne, alopecia areata, atopic dermatitis) patients should take 1 capsule/day.

Adverse Reactions

Very rarely (≥0.01% and <0.01%) signs of gastrointestinal irritation, such as a feeling of fullness, pressure in the epigastric region, nausea, constipation or diarrhea, as well as allergic reactions may be noted.

Rarely – headache, metallic taste in the mouth.

Dark staining of the stool is possible due to the excretion of unabsorbed iron (of no clinical significance).

Contraindications

• Esophageal stenosis and/or obstructive changes in the digestive tract;
• Increased iron content in the body (e.g., hemochromatosis, hemosiderosis);
• Impaired iron utilization (lead anemia, sideroblastic anemia, thalassemia);
• Non-iron deficiency anemias (hemolytic anemia or megaloblastic anemia, anemia caused by vitamin B₁₂ deficiency);
• Children under 12 years of age (due to lack of clinical data);
• Hypersensitivity to any component of the drug.

With caution gastric and duodenal ulcer, inflammatory bowel diseases (enteritis, diverticulitis, ulcerative colitis, Crohn’s disease).

Use in Pregnancy and Lactation

Pregnant women should take 1-2 capsules/day until hemoglobin normalizes. Then therapy should be continued at a dosage of 1 capsule/day, at least until delivery to restore iron stores.

Pediatric Use

Contraindicated in children under 12 years of age (due to lack of clinical data).

Special Precautions

Concomitant use of other multivitamin and mineral complexes is not recommended to avoid overdose.

Should be taken 1 hour before or 2 hours after consumption of milk, dairy products, complexing drugs (bicarbonates, carbonates, oxalates, phosphates, tetracyclines, and copper).

With long-term use of zinc preparations, the likelihood of Cu⁺² deficiency should be taken into account. When taken for more than 3-4 months, it is recommended to prescribe copper preparations.

Consumption of ethanol-containing beverages should be avoided.

1 tab. Fenules^® Zinc contains approximately 45 mg of elemental iron.

Overdose

To date, no cases of drug overdose have been reported.

Drug Interactions

Should not be prescribed simultaneously with antacids containing aluminum, magnesium, calcium salts, because iron absorption is reduced.

Iron reduces the absorption of tetracycline drugs.

Pyridoxine reduces the therapeutic effect of levodopa.

Zn⁺² reduces the absorption of tetracyclines and copper.

Zn⁺² is compatible with any vitamin and mineral complexes.

Pharmaceutically incompatible with silver, lead salts, quinine, citral (forms poorly soluble compounds).

Thiazide diuretics enhance the excretion of Zn⁺² in the urine.

High doses of iron, penicillamine, and other complexing drugs significantly reduce the absorption of Zn⁺².

Storage Conditions

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

Shelf Life

Shelf life – 3 years. Do not use after the date indicated on the packaging.

Dispensing Status

The drug is dispensed by prescription.

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.