Composition, form of production and packaging
? Capsules of prolonged action 1 caps.
iron sulfate 150 mg
pyridoxine hydrochloride 3 mg
folic acid 1.5 mg
cyanocobalamin 15 Ојg
zinc sulfate monohydrate 61.8 mg
10 pieces. - packings of cellular contour (1) - packs cardboard.
10 pieces. - packings cellular planimetric (3) - packs cardboard.
10 pieces. - packings cellular planimetric (6) - packs cardboard.
30 pcs. - polyethylene bottles (1) - cardboard packs.
60 pcs. - polyethylene bottles (1) - cardboard packs.
90 pcs. - polyethylene bottles (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
PHARMACHOLOGIC EFFECT
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 the transport of oxygen and oxidative metabolic processes, and is an important 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 important element of the human body, which is mainly found in erythrocytes in the form of zinc-metalloenzyme carboangillase and, to a lesser extent, in blood plasma in a bound state with? -2-macroglobulin. It is part of more than 70 enzymes that catalyze the key steps in the synthesis of DNA, RNA, proteins. Has a pronounced effect on the processes of growth and maturation of tissues, positively affects the retardation of mental and physical development in children. Stabilizes cell membranes, affects regeneration processes, transmits nerve impulses, enhances the action of insulin. Stimulates hair growth, has an immunomodulating effect on the T-cell link of immunity and increases the factors of nonspecific immune defense. It is a powerful antioxidant. Effective in the treatment of acne and alopecia.
Pyridoxine as a coenzyme is involved in the metabolism of amino acids, proteins, the synthesis of neurotransmitters.
Folic acid - a vitamin B group is involved in key biological processes, namely: in the synthesis of DNA, RNA and proteins. In pregnancy, folic acid prevents the development of neural tube defects in the fetus. Deficiency of folate leads to the development of megaloblastic anemia. With a deficiency of folic acid, abortion, premature birth and mental disability can be observed.
Cyanocobalamin in the form of methyl cobalamin is a cofactor of reactions involving methionine synthetase. With a deficiency of B 12, the formation of thymidylic acid and purine nucleosides, the precursors of DNA synthesis, necessary for normal cell division, decreases. Megaloblastic anemia is a consequence of vitamin B deficiency 12 .
PHARMACOKINETICS
Suction
Iron is absorbed, mainly from the duodenum and jejunum. Maximal absorption is observed when iron is absorbed. Absorption varies greatly and depends on iron stores in the body and physiological needs. In iron deficiency states, its absorption increases. The total amount of assimilated iron in the body increases with the increase of its vine. 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 iliac.
Distribution
After absorption, the bulk 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 is 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 due to deficiency of iron, zinc and folic acid, incl. before, during and after pregnancy (during lactation) and in children;
- in the complex treatment of skin diseases (juvenile acne, alopecia areata, atopic dermatitis).
DOSING MODE
Inside. Dosage and duration of therapy depends on the severity of iron deficiency. The daily dose of the drug can be taken 1 time / day. Take during or immediately after a meal; to wash down with water.
Treatment of clinically pronounced iron deficiency of mild to moderate degree (iron deficiency anemia): 2 capsules / day for 3-5 months before the normalization of hemoglobin level in the blood. After normalizing the hemoglobin level in the blood, the maintenance dose is prescribed at the doctor's recommendation.
Treatment of concomitant deficiency of iron, zinc and folic acid - 2 capsules / day. Pregnant women should take 1-2 capsules / day before the normalization of hemoglobin. Then the therapy should be continued at a dosage of 1 capsule / day, at least until the birth to restore iron stores.
For therapy and prevention of latent iron deficiency, zinc deficiency and folic acid, patients should take 1 capsule / day as part of complex treatment of skin diseases (youthful acne, alopecia areata, atopic dermatitis) .
SIDE EFFECT
Very rarely (? 0.01% and <0.01%) may be signs of gastrointestinal irritation, such as a feeling of overflow, pressure in the epigastric region, nausea, constipation or diarrhea, and allergic reactions.
Rarely - headache, metallic taste in the mouth.
Perhaps the dark staining of the stool, caused by the release of non-sucked iron (a clinical value does not matter).
CONTRAINDICATIONS
- stenosis of the esophagus and / or obstructive changes in the digestive tract;
- increased iron content in the body (eg, hemochromatosis, hemosiderosis);
- violation of iron utilization (lead anemia, sideroblastic anemia, thalassemia);
- non-iron deficiency anemia (hemolytic anemia or megablastic 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: peptic ulcer of the stomach and duodenum, inflammatory bowel disease (enteritis, diverticulitis, ulcerative colitis, Crohn's disease).
PREGNANCY AND LACTATION
Pregnant women should take 1-2 capsules / day a day before the normalization of hemoglobin. Then the therapy should be continued at a dosage of 1 capsule / day, at least until the birth to restore iron stores.
APPLICATION FOR CHILDREN
Contraindicated in children under 12 years of age (due to lack of clinical data).
SPECIAL INSTRUCTIONS
It is not recommended simultaneous use of other multivitamin and mineral complexes in order to avoid an overdose.
It should be taken 1 hour before or 2 hours after consuming milk, dairy products, complexing drugs (bicarbonates, carbonates, oxalates, phosphates, tstratsikliny and copper).
With prolonged use of zinc preparations, the probability of a Cu + 2 deficiency should be considered. When taking more than 3-4 months, it is recommended to prescribe medications for copper.
You should avoid the use of ethanol-containing beverages.
In 1 tab. Fenulles Zinc contains approximately 45 mg of elemental iron.
OVERDOSE
To date, no cases of drug overdose have been reported.
DRUG INTERACTION
It should not be prescribed simultaneously with antacids containing salts of aluminum, magnesium, calcium, t. decreases the absorption of iron.
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 combined with any vitamin and mineral complexes.
Pharmaceutically incompatible with salts of silver, lead, quinine, citral (forms poorly soluble compounds).
Thiazide diuretics increase the excretion of Zn +2 in the urine.
High doses of iron, penicillamine and other complexing drugs significantly reduce the absorption of Zn +2 .
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The preparation should be stored in a dry place at a temperature not exceeding 25 В° C. Keep out of the reach of children. Shelf life - 3 years. Do not use after the date shown on the package.
