TARDYFERON-Fol Depot-Iron(II)-sul.m.Fols.Filmtab., 50 pcs

Instructions for use for the article Tardyferon-Fol Depot-Iron(II)-Sul.with folic acid film tablet.

Tardyferon®-Fol is an iron preparation with blood-building effects that contains folic acid.It is used to treat latent iron deficiency and anemia caused by iron deficiency with folic acid deficiency during pregnancy, the postpartum period and breastfeeding.The film-coated tablets are suitable for adults and children aged 10 and over.

No prescription is required for this product.

Active ingredients and composition

The active ingredients in Tardyferon®-Fol are dried iron (II) sulfate and folic acid.One film-coated tablet contains 247.25 mg of dried iron(II) sulfate, which corresponds to 80 mg of iron(II) ions, and 0.35 mg of folic acid.The other ingredients include maltodextrin, microcrystalline cellulose, ammonium methacrylate copolymer types A and B, talc, triethyl citrate, glycerol dibehenate, Sepifilm LP010, hypromellose, stearic acid, iron (III) oxide yellow and red, titanium dioxide and triethyl citrate.

Areas of application

Tardyferon®-Fol is used to treat latent iron deficiency and anemia caused by iron deficiency with folic acid deficiency during pregnancy, postpartum period and breastfeeding.

Dosage and application

The recommended dose for iron deficiency with mild anemia and for latent iron deficiency with folic acid deficiency is 1 film-coated tablet of Tardyferon®-Fol, unchewed, with a glass of water before breakfast.In the case of iron deficiency with severe anemia and folic acid deficiency and with a body weight over 32 kg, 1 film-coated tablet should be taken in the morning and evening about one hour before meals.The daily dose of 5 mg Fe²⁺ per kg body weight should not be exceeded.After 3 weeks the dose can be reduced to 1 film-coated tablet daily.

The film-coated tablets should not be sucked, chewed or left in the mouth for a long time, but should be swallowed whole immediately with a glass of water.The duration of intake depends on the type and severity of the iron and folic acid deficiency.After the values have normalized, taking 1 film-coated tablet daily in the morning before breakfast should be continued for 1-3 months.

Side effects

Common side effects include diarrhea, constipation, bloating, abdominal pain, discoloration of stool, and nausea.Uncommon side effects include laryngitis, gastritis, abnormal stools, epigastric discomfort, vomiting, itching and rash with red skin.Hypersensitivity reactions, hives, reversible tooth discoloration and inflammatory mucosal defects in the mouth can also occur, especially if used incorrectly.

Contraindications and precautions

Tardyferon®-Fol must not be taken in the case of allergies to iron (II) sulfate, folic acid or other components, in the case of iron overload, iron utilization disorders, in children under 10 years of age and without simultaneous vitamin B12 therapy in the case of megaloblastic anemia due to vitamin B12 deficiency.Caution is advised if there is pre-existing inflammation or ulcers in the gastrointestinal mucosa.The tablets should not be sucked, chewed or left in the mouth for long periods of time.

Interactions

The simultaneous use of Tardyferon®-Fol with certain medicines such as tetracyclines, penicillamine, gold compounds, levodopa, methyldopa, carbidopa, L-thyroxine, cholestyramine, antacids, calcium and magnesium supplements, salicylates, non-steroidal anti-inflammatory drugs, quinolone antibiotics, anticonvulsants, chemotherapy drugs,Cytostatics, fluorouracil, chloramphenicol, sulfonamides, antiepileptics and barbiturates can influence the effect or increase side effects.Injectable iron salts should not be taken at the same time.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding or planning to become pregnant, ask your doctor or pharmacist for advice before taking Tardyferon®-Fol.Tardyferon®-Fol should not be taken for a long period of time in the high dosage of 2 x 1 film-coated tablet per day if there is an increased iron requirement during pregnancy.

Storage

Keep Tardyferon®-Fol out of the reach of children and do not use it after the expiry date stated on the carton and container.The medicine should not be stored above 30 °C and should be kept in the original packaging protected from light.