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Oral anti-anemic, Iron(ii) sulfate 80 mg prolonged release tablets

EMRA-MED Pharmaceuticals GmbH

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TARDYFERON Depot-iron(II)-sulfate 80 mg sustained-release tablets, Oral anti-anemic

Pack size:50 pcsDosage form:Sustained-release tablets

TARDYFERON, Iron deficiency, Depot iron (II) sulfate 80 mg prolonged-release 

Dosage form: Extended-Release Tablets

Active ingredient: Depot iron (II) sulfate 

Areas of application:
Therapy of iron deficiency conditions

For use in cases of iron deficiency.

Active ingredients

  • 247.25 mg iron(II) sulfate, dried

ingredients

  • Maltodextrin
  • Iron(III) oxide, red
  • Iron(III) oxide hydrate, yellow
  • Triethyl citrate
  • Ammonium methacrylate copolymer (Type A)
  • Ammonium methacrylate copolymer (Type B)
  • Cellulose, microcrystalline
  • Glycerol dibehenate
  • Sepi film LP 010
  • Titanium dioxide
  • talc
Indication :
  • Iron preparation with blood-forming effects (antianemic). Used to treat iron deficiency conditions.

 

Dosage :
  • Always take the medicine exactly as directed. Please ask your doctor or pharmacist if you are not sure.
  • Unless otherwise prescribed by the doctor, the usual dose is:
    • For mild iron deficiency, swallow 1 prolonged-release tablet whole with a little water before breakfast. For severe iron deficiency, take 1 extended-release tablet in the morning and evening, approximately 1 hour before meals. After 3 weeks, the dose can be reduced to 1 prolonged-release tablet once a day.

 

  • The duration of intake depends on the type and severity of the iron deficiency. To replenish iron reserves, you should continue taking 1 extended-release tablet daily in the morning before breakfast for 1 - 3 months after the values ​​have normalized.
  • Please talk to your doctor or pharmacist if you have the impression that the effect is too strong or too weak.

 

  • If you have taken more than you should
    • If the medicine has been taken in large quantities, the doctor should be informed immediately.

 

  • If you forget to take it
    • Do not take a double dose if you forget to take the previous dose.

 

  • If you have any further questions about using the medicine, ask your doctor or pharmacist.
Way :
  • For mild iron deficiency, swallow 1 prolonged-release tablet whole with a little water before breakfast.
  • For severe iron deficiency, take 1 extended-release tablet in the morning and evening, approximately 1 hour before meals.
Side effects :
  • Like all medicines, this medicine can cause side effects, although not everyone gets them.
    • The frequency information on side effects is based on the following categories:
      • Very common: more than 1 in 10 people treated
      • Common: less than 1 in 10, but more than 1 in 100 people treated
      • Uncommon: less than 1 in 100, but more than 1 in 1,000 people treated
      • Rare: less than 1 in 1,000, but more than 1 in 10,000 people treated
      • Very rare: less than 1 in 10,000 people treated
      • Not known: Frequency cannot be estimated from the available data
    • The frequencies of all side effects listed below cannot be estimated based on the available data.
      • Possible side effects:
        • Gastrointestinal problems or constipation may occur. The darkening of the stool that occurs during treatment is harmless. Allergic skin reactions may occur.
  • Please inform your doctor or pharmacist if any of the side effects listed seriously affects you or if you notice side effects that are not listed.
Interactions :
  • When taken with other medicines:
    • Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they are non-prescription medicines.
      • Iron salts reduce the absorption of tetracyclines, penicillamine, gold compounds, levodopa and methyldopa.
      • Iron salts affect the absorption of quinolone antibiotics (e.g. ciprofloxacin, levofloxacin, norfloxacin, ofloxacin).
      • Iron salts reduce the absorption of thyroxine in patients receiving replacement therapy.
      • The absorption of iron is reduced by the simultaneous use of cholestyramine, antacids (Ca 2+ , Mg 2+ , Al 3+ salts) and calcium and magnesium supplements.
      • The simultaneous intake of iron salts with salts of salicylic acid (salicylates, e.g. acetylsalicylic acid) or non-steroidal anti-inflammatory drugs can increase the irritating effect of iron on the mucous membrane of the gastrointestinal tract.
      • Iron-binding substances such as phosphates, phytates or oxalates as well as milk, coffee and black tea inhibit iron absorption.
    • The medicine should not be taken within 2 - 3 hours after administration of any of the above substances.
  • Take with food and drinks:
    • Ingredients from milk, coffee, black tea and vegetarian food inhibit the absorption of iron and should therefore not be taken at the same time as the medicine.
Contraindications :
  • Must not be taken:
    • if you are hypersensitive (allergic) to iron (II) sulfate or any of the other ingredients.
    • in cases of iron overload (e.g. iron storage disease) and iron utilization disorders (lead anemia, sideroachrestic anemia, thalassemia).
    • of children under 10 years.
Pregnancy and breast feeding period :
  • Before taking/using any medicines, ask your doctor or pharmacist for advice.
  • If you are pregnant, you should only take this medicine if your doctor has diagnosed you with iron deficiency. Treatment with the high dosage of 2 prolonged-release tablets per day should not be carried out over a longer period of time.
  • If you are breast-feeding, you should only take this medicine as directed by your doctor.
Patient information :
  • Take special care when taking:
    • if dietary or other iron salt supplements are used to avoid the risk of possible iron overdose.
    • In the case of pre-existing inflammation or ulcers of the gastrointestinal mucosa, the benefits of treatment should be carefully weighed against the risk of worsening the gastrointestinal disease.
    • Children: Medicines must not be used in children under 10 years of age.