Composition, form of production and packaging
? Tablets of prolonged action, covered with a film membrane 1 tab.
iron (in the form of sulphate) 100 mg
ascorbic acid 60 mg
10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (3) - packs of cardboard.
10 pieces. - blisters (6) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
PHARMACHOLOGIC EFFECT
Anti-anemia drug prolonged action.
Iron, being a part of numerous cellular structures and participating in the activity of many enzymatic systems (cytochromes, catalases) plays a very 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 drug is used to eliminate iron deficiency. The structure of the Fenules 100 tablet with the presence of micropores in the matrix provides prolonged release of iron, which can significantly reduce the symptoms of gastric irritation and maintain a constant concentration of iron in the blood plasma for 12 hours. The matrix of the Fenules 100 tablet is completely inert in the digestive juice, but completely disintegrates under the action of intestinal peristalsis, where the active ingredient is completely released. Ascorbic acid improves the absorption of iron, the conversion of Fe 3+ into Fe 2+ .
PHARMACOKINETICS
Suction
Iron is absorbed, mainly from the 12-finger and jejunum. Maximum absorption is observed with iron on an empty stomach. 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 increasing dose. TC max in the blood is 1-2 h.
Distribution
After absorption, the bulk of the iron binds to the transferrin and is transported to the bone marrow, where it is captured by bone marrow erythroid cells for the synthesis of hemoglobin; 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 removed from the body after the cyclic destruction of the hemoglobin molecule.
INDICATIONS
Iron deficiency anemia (treatment and prevention), caused by various causes:
- increased need for iron during pregnancy and lactation, during the period of intensive growth and reconvalescence after prolonged serious illnesses;
- prolonged bleeding (including with peptic ulcer of stomach and duodenum, hyperpolymenorrhea, metrorrhagia);
- Inadequate and unbalanced nutrition.
DOSING MODE
Fenules 100 tablets should be taken orally, before eating, with a glass of water. The tablet can not be broken or chewed.
Adults and teenagers over 12 years of age
1 tablet 1-2 times / day, depending on the severity of iron deficiency anemia. If necessary, the dose can be increased to 3-4 tablets per day for two doses (in the morning and in the evening) for 3-4 months (before replenishing the iron depot in the body).
Iron deficiency anemia of moderate and severe severity in pregnant women
II trimester of pregnancy: 1 tablet 1 time / day.
III trimester of pregnancy: 1 tablet 1-2 times / day.
Treatment is long. The duration of treatment depends on the severity of iron deficiency anemia, and it should be carried out before the normalization of serum ferritin, usually at least 3 months. After normalizing the hemoglobin level to restore internal iron reserves, therapy should be continued for several weeks.
Prevention of iron deficiency in pregnancy and lactation
1 tablet once a day.
SIDE EFFECT
Nausea, vomiting, constipation, diarrhea, abdominal pain. The frequency of side effects from the gastrointestinal tract may increase with increasing doses from 100 to 400 mg.
Rarely (<1/100) the following side effects can occur: ulcerative esophagitis, esophageal stenosis, allergic reactions (pruritus, rash), flushing of the skin, headache, dizziness, weakness.
CONTRAINDICATIONS
- stenosis of the esophagus and / or obstructive changes in the digestive tract;
- increased iron content in the body (hemochromatosis, hemosiderosis);
- violation of iron utilization (lead anemia, sideroblastic anemia), hemolytic anemia;
- Children under 12 years of age (due to lack of clinical data);
- condition after resection of the stomach;
- Stomach ulcer and duodenal ulcer in the stage of exacerbation;
bleeding;
- Hypersensitivity to any component of the drug.
With caution: peptic ulcer of the stomach and duodenum without exacerbation, inflammatory bowel disease (enteritis, diverticulitis, ulcerative colitis, Crohn's disease).
PREGNANCY AND LACTATION
The application is possible according to the dosing regimen.
APPLICATION FOR CHILDREN
Contraindicated in children under 12 years.
SPECIAL INSTRUCTIONS
There may be a darkening of the stool, which has no clinical significance.
Fenules 100 tablets can be taken after meals if there are dyspeptic symptoms from the digestive tract (nausea, vomiting, constipation, diarrhea, abdominal pain). The drug should be taken 1 hour before or 2 hours after taking the product or other medications that worsen the absorption of iron. Avoid concomitant administration with other iron-containing drugs (risk of overdose). Fenules 100 is prescribed only for iron deficiency anemia and can not be used for anemia of other etiology. If you miss one dose of the drug, it should be taken at the first opportunity, however, if the time of taking the missed dose coincides with the time taken to receive the next dose, you should take only the next pill without doubling the dose of the drug. Treatment of iron deficiency anemia should be carried out under the control of serum ferritin, the total iron binding capacity of the serum.
OVERDOSE
Acute intoxication with iron proceeds in 4 stages.
Early symptoms (in the first 6 hours after an overdose): nausea, vomiting and diarrhea with blood, abdominal pain, pale skin, cold sticky sweat, acidosis, weak pulse, low blood pressure, palpitation, CNS depression of varying degrees of severity up to coma, convulsions, coagulopathy.
The asymptomatic period after 6-12 hours.
Delayed symptoms (after 12-48 h): renal and hepatic insufficiency, metabolic acidosis, collapse, fever.
Late symptoms (a few weeks later): liver damage, intestinal stricture.
Treatment: to cancel a preparation, to spend lavage of a stomach and an intestine, inside raw egg, milk (for binding of ions of iron in GASTROINTESTINAL TRACT); symptomatic and supportive therapy, in severe cases - parenteral administration of deferoxamine.
DRUG INTERACTION
Fenules 100 can reduce the absorption of simultaneously used enoxacin, clodronic acid, levodopa, methyldopa, penicillamine, tetracyclines, thyroid hormones and fluoroquinolones, incl. grefafloksatsina, levofloxacin Antacids and preparations containing calcium, carbonates, bicarbonates, oxalates or phosphates, reduce iron absorption. Incompatible with iron preparations for parenteral administration. Food products - eggs, whole grain bread, cereals, milk and dairy products, tea, coffee reduce iron absorption. Fenules 100 should not be combined with the following drugs: ciprofloxacin, doxycycline, norfloxacin and ofloxacin.
TERMS OF RELEASE FROM PHARMACY
On prescription.
TERMS AND CONDITIONS OF STORAGE
In a dry place at a temperature of no higher than 25 В° C. Keep out of the reach of children. Shelf life - 2 years.
