Fenules 100 - instructions for use, dose, side effects, contraindications

Active substanceIron sulphate + Ascorbic acidIron sulphate + Ascorbic acid

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Dosage form: & nbsp

Tablets of prolonged action, covered with a film membrane.

Composition:

1 tablet contains:

Active substances:

Iron (II) sulfate 372.0 mg equivalent to elemental iron 100.0 mg; Ascorbic acid in the form of a coated granulate, 72.0 mg; corresponding to ascorbic acid 60.0 mg.

Excipients:

Carbomer (carbopol 934 P) - 49.0 mg, povidone - 46.0 mg, isopropanol * - q.s., magnesium stearate - 5.0 mg.

Film Sheath:

Red color opacred brown (OY 56524) - 26.0 mg, isopropanol * - q.s., dichloromethane * - q.s.

The composition of the dye brown (OY56524):

Iron dye oxide red, iron oxide yellow oxide, hypromellose, macrogol, titanium dioxide.

* evaporates in the production process.

Description:Round, biconvex tablets, covered with film shell reddish brown; on the fracture, a homogeneous mass of light gray color.

Pharmacotherapeutic group:The drug is iron + vitamin.

ATX: & nbsp

B.03.A.E.03 Iron preparations in combination with multivitamins

Pharmacodynamics:

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 Fenyuls® 100 tablet with the presence of micropores in the matrix provides a 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 Fenyuls® 100 tablet matrix 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 absorption of iron, conversion of Fe³⁺ in Fe²⁺.

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. The time to reach the maximum concentration in the blood is 1-2 hours.

Distribution. After absorption, the bulk of the iron binds to transferrin and is transported to the bone marrow, where it is captured by the erythroid brain 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 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 convalescence after prolonged serious illnesses;
prolonged bleeding (including with peptic ulcer of stomach and duodenum, hyperpolymenorrhea, metrorrhagia);
inadequate and unbalanced nutrition.

Contraindications:

Hypersensitivity to any component of the drug.
Stenosis of the esophagus and / or obstructive changes in the digestive tract.
Elevated iron content in the body (hemochromatosis, hemosiderosis).
Disruption 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.
Peptic ulcer of stomach and duodenum in the stage of exacerbation.
Bleeding.

Carefully:

Peptic ulcer of stomach and duodenum outside exacerbation, inflammatory bowel diseases (enteritis, diverticulitis, ulcerative colitis, Crohn's disease).

Dosing and Administration:

Fenyuls® 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 a 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 (morning and 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 once a day.

III trimester of pregnancy: 1 tablet 1-2 times a 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 effects:

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.

Overdose:

Acute intoxication with iron proceeds in 4 stages.

Early symptoms (in the first 6 hours after an overdose): nausea, vomiting and diarrhea with a dash of blood, abdominal pain, pale skin, cold sticky sweat, acidosis, weak pulse, lowering of blood pressure, palpitations, depression of the central nervous system of varying severity, including coma, convulsions, coagulopathy.

Asymptomatic period in 6-12 hours.

Delayed symptoms (after 12-48 hours): renal and hepatic insufficiency, metabolic acidosis, collapse, fever.

Late symptoms (in a few weeks): defeat of the liver, intestinal stricture.

Treatment: cancel the drug, wash the stomach and intestines, inside the raw egg, milk (to bind iron ions in the gastrointestinal tract); symptomatic and supportive therapy, in severe cases - parenteral drug administration deferoxamine.

Interaction:

Fenules®100 can reduce the absorption of concurrently applied1, enoxacin, clodronic acid, levodopa, methyldopa, penicillamine, tetracyclines, thyroid hormones and fluoroquinolones, incl. gepafloksatsina, levofloxacin.

Antacids and drugs 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.

Special instructions:

There may be a darkening of the stool, which has no clinical significance.

Fenyuls® 100 tablets can be taken after meals if there are diarrheal symptoms from the gastrointestinal 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 impair iron absorption.

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.

Effect on the ability to drive transp. cf. and fur:Not studied.

Form release / dosage:

Tablets of prolonged action, covered with a film membrane.

10 tablets in a blister of PVC / PVDNH; 1, 3 or 6 blisters in a cardboard box together with instructions for use.

Packaging:

10 tablets in a blister of PVC / PVDNH; 1, 3 or 6 blisters in a cardboard box together with instructions for use.

Storage conditions:

In a dry place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package

Terms of leave from pharmacies:On prescription

Registration number:LP-000110

Date of registration:27.12.2010

The owner of the registration certificate:Ranbaxy Laboratories LimitedRanbaxy Laboratories Limited India

Manufacturer: & nbsp

RANBAXY LABORATORIES, Ltd. India

Representation: & nbspRABBAYS LABORATORY LIMITEDRABBAYS LABORATORY LIMITED

Information update date: & nbsp27.12.2010

Illustrated instructions

Instructions

Fenules® 100 (Fenules® 100)