It is used to treat combined iron and folic acid deficiency, especially during pregnancy and lactation, as well as in cases of malnutrition and undernutrition.
Active Ingredients
1 mg folic acid, 454.13 mg iron(II) sulfate-glycine complex (enteric).
Excipients
Magnesium stearate, hyprolose, hypromellose, Iron(III) oxide hydrate, black methacrylic acid-ethyl acrylate copolymer (1:1), Triethyl 2-acetoxypropane-1,2,3-tricarboxylate, Silicon dioxide, highly dispersed, Microcrystalline cellulose, iron(III) oxide, carboxymethyl starch, sodium, gelatin, ascorbic acid, sodium dodecyl sulfate, 30.9 mg lactose monohydrate,
Polysorbate 80, titanium dioxide, talc.
The medicine should not be taken
if you are allergic to iron, folic acid or any other ingredient of this medicine, if you have esophageal stenosis, if you suffer from a hereditary iron storage disease (hemochromatosis), if you suffer from iron overload (chronic hemolysis, thalassemia, other hemoglobinopathies), if you suffer from iron utilization disorders (eg, sideroachrestic anemia, lead anemia), if you receive repeated or chronic blood transfusions, if you have megaloblastic anemia due to isolated vitamin B12 deficiency, in children under 6 years of age, in children aged 6 years and older with a body weight of less than 20 kg.
Dosage
For all age groups, weight categories and dosage groups, the dosage should be adjusted according to the patient’s needs and the doctor should monitor the response of clinical parameters (eg, hemoglobin, ferritin, transferrin).
Do not exceed a daily dose of 5 mg Fe2+/kg body weight.
Unless otherwise prescribed by a doctor, the usual dose is
for adults and children aged 6 years and over (weighing at least 20 kg): 1 hard capsule per day.
For severe iron deficiency in adults and adolescents aged 15 years or weighing more than 50 kg in the initial phase:
Take 2-3 capsules per day during the day.
Use in elderly patients
There are no clinical data indicating the need for dosage adjustment in elderly patients.
Use in patients with renal or hepatic insufficiency.
There are no clinical data indicating the need for dosage adjustment in patients with renal or hepatic insufficiency.
The drug should be used with caution in patients with impaired liver function and in patients suffering from alcoholism.
In patients with chronic kidney disease who require erythropoietin, iron should be administered intravenously.
The duration of use is determined by the doctor.
Replenishment of iron stores in the body usually takes from 3 to 6 months, depending on the severity of the anemia and individual circumstances.
Please take the medicine whole with a sufficient amount of water (preferably a glass).
The drug should be taken either in the morning on an empty stomach (approximately 1 hour before breakfast) or at a sufficient interval of about 2 hours before or after meals.
If you have difficulty swallowing or do not want to swallow the capsule, you can take its contents without the shell. To do this, carefully spread the capsule shells over a spoon and collect the contents of the capsules (granules and mini-tablets) on the spoon. After taking the granules and mini-tablets, you should drink plenty of water.
Side effects
Common:
gastrointestinal complaints, Diarrhea, constipation, heartburn, nausea, vomiting.
Rare:
Reversible discolouration of the dental area
Hypersensitivity reactions (e.g. skin reactions, exanthema, rash and urticaria)
In high doses – central nervous system disorders.
Unknown: frequency cannot be estimated from the available data – stomach pain, upper abdominal pain, gastrointestinal bleeding. Reversible discolouration of the tongue. Reversible discolouration of the oral mucosa, anaphylactic reaction.
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