• 0.35 mg folic acid (film)
• 247.25 mg ferrous sulfate, dried (core, prolonged release)

• 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

TARDYFERON 80 mg Iron (II) 100 pc anti-anemic indication

• The drug is an iron preparation with a blood-forming effect (anti-anaemic) with folic acid. It is used to treat latent iron deficiency and anemia caused by iron deficiency with a folic acid deficit during pregnancy, childbirth and breastfeeding.
• If you do not feel better or if you feel worse after 4 weeks, contact your doctor.

dosage TARDYFERON 80 mg Iron (II) 100 pc anti-anemic

• Always take this medicine exactly as described or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• The preparation is used in children over 10 years of age and in adults. It is taken orally.
• The recommended dose is:
  • For iron deficiency with mild anemia and latent iron deficiency with folic acid deficiency 1 film-coated tablet.
  • In the case of iron deficiency with severe anemia and folic acid deficiency and with a body weight > 32 kg, 1 film-coated tablet each morning and evening. A daily dose of 5 mg Fe ²⁺ / kg body weight should not be exceeded.
  • After 3 weeks, the dose can be reduced to 1 film-coated tablet once a day.

• duration of use
  • The duration of intake depends on the type and severity of the iron and folic acid deficiency.
  • The doctor determines the duration of the treatment. This duration must be sufficient to correct the anemia and restore iron stores. Depending on the depletion of reserves, three to six months are often required, which may be longer if the cause of the anemia is not controlled.

• If you take more than you should
  • There have been reports of cases, particularly in younger children, of poisoning with iron salts as a result of taking a few tablets.
  • Symptoms of overdose include signs such as: gastrointestinal irritation accompanied by abdominal pain, nausea, vomiting, diarrhea, symptoms of cardiovascular shock or metabolic acidosis of the body (metabolic acidosis; rapid or short breathing, increased heart rate, headache, confusion, drowsiness, tiredness, loss of appetite, nausea, vomiting) followed by liver or kidney failure.
  • If you take too much, or if your child, especially your young child, accidentally takes some tablets, you should contact a doctor or the nearest emergency department immediately for appropriate treatment.

• If you forget to take a dose
  • Do not take a double dose to make up for a forgotten dose.

• If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

TARDYFERON 80 mg Iron (II) 100 pc anti-anemic way

• Swallow the tablet whole with water. Do not suck or chew the tablet, and do not leave the tablet in your mouth any longer.
• The tablets should be swallowed with a large glass of water before or during meals, depending on gastrointestinal tolerance (except for certain foods listed under Interactions category).

side effects

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• The following side effects, listed in descending order of frequency, may occur:
• Iron Side Effects:
  • Common side effects (affects 1 to 10 users in 100)
    • diarrhoea, constipation, flatulence, abdominal pain, discolored stools, nausea
  • Uncommon side effects (affects 1 to 10 users in 1000)
    • swelling of the throat (laryngeal oedema)
    • abnormal stools, feeling unwell and upper abdominal discomfort (indigestion), vomiting, acute inflammation of the lining of the stomach (gastritis)
    • itching (pruritus), rash with reddening of the skin (erythematous rash).
  • Not known (cannot be estimated from the available data)
    • Hypersensitivity reactions including serious, potentially life-threatening allergic reactions (anaphylactic reactions), sudden swelling of the lips, cheeks, eyelids, tongue, soft palate, throat or around the vocal cords (angioedema), itchy rash (urticaria), allergic skin reactions (allergic dermatitis) , death of lung tissue (lung necrosis)*, inflammation-related nodular tissue growth of lung tissue (pulmonary granuloma)*, narrowing of the airways (bronchostenosis)*, edema of the larynx*, tooth discoloration**, oral ulcer**, injuries to the esophagus (oesophageal lesions, oesophageal ulcerations)* *, darkening of the gastrointestinal tract (gastrointestinal melanosis)***
  • * All patients, but particularly elderly patients or those with difficulty swallowing, are also at risk of developing throat or esophagus (the passage between the mouth and stomach) ulcers. If the tablets get into the airways, there is a risk of ulcers in the main airways of the lungs (bronchi), causing them to narrow.
  • ** In case of misuse, when the tablets are chewed, sucked or left in the mouth for a long time.
  • *** Based on literature data, darkening of the gastrointestinal tract (gastrointestinal melanosis) has been observed in elderly patients with chronic kidney disease, diabetes (high blood sugar levels) and/or high blood pressure who were treated with various drugs for these diseases and at the same time received iron supplements to treat anemia.
  • Investigations:
    • Certain tests to detect blood in the stool can be falsified. Before such a test, the preparation must be discontinued.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

interactions

• Taking with other medicines
  • If you are already taking any of the following medicines, do not take this medicine unless your doctor tells you to.
  • Some medications must not be taken at the same time; other medications require certain changes in use (e.g. in the time of ingestion).
  • Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
  • If you are taking any of the following medicines, you should leave the medicine at least 2 hours apart:
    • antibiotics (tetracyclines or related antibiotics),
    • medicines to treat osteoporosis (bisphosphonates),
    • medicines to treat joint disorders (penicillamine),
    • Medicines to treat excess stomach acid: mineral supplements for the stomach/intestines, charcoal or antacids (aluminum, calcium and magnesium salts),
    • medicines to treat a thyroid disorder (thyroxine),
    • Medicines used to treat Parkinson's disease (methyldopa, levodopa, carbidopa),
    • dietary supplements and/or medicines containing zinc, magnesium or calcium,
    • gold connections.
  • The simultaneous intake of iron salts with salts of salicylic acid (salicylates, eg acetylsalicylic acid) or non-steroidal anti-inflammatory drugs (medicines against pain or inflammation) can increase the irritating effect of iron on the mucous membrane of the gastrointestinal tract.
  • Iron salts affect the absorption of quinolone antibiotics (e.g. ciprofloxacin, levofloxacin, norfloxacin, ofloxacin).
  • If you are taking cholestyramine: the preparation should be given 1 to 2 hours before or 4 to 6 hours after the cholestyramine.
  • If you are given iron-containing medicines for injection, you should avoid taking them.
  • Anticonvulsant therapy can lead to an increase in the likelihood of convulsions.
  • When high doses are administered, it cannot be ruled out that folic acid and simultaneously administered folic acid antagonists, such as chemotherapeutic agents (trimethoprim, proguanil, pyrimethamine) and cytostatics (methotrexate), inhibit each other's effects.
  • High doses given with fluorouracil can cause severe diarrhea.
  • Chloramphenicol can prevent response to treatment and should therefore not be used in patients with severe folic acid deficiency.
  • Cytostatics, sulfonamides, antiepileptics and barbiturates impair folic acid absorption.
• Take with food, drink and alcohol
  • You should not drink large amounts of tea (eg black tea, green tea, other teas containing thein), coffee or red wine as this will inhibit the absorption of iron in your body.
  • You should not take the preparation at the same time as dairy products, whole grains (bran, legumes, oily cereals), some proteins (eggs) or foods containing calcium (cheese, milk, etc.) as these inhibit iron absorption.
  • Maintain a time interval of at least 2 hours between iron intake and intake of these foods.

Contraindications

• The medicine must not be taken
  • if you are allergic to ferrous sulfate, folic acid or any of the other ingredients of this medicine.
  • if you have iron overload such as haemochromatosis, hereditary anemia (thalassemia) or other forms of anemia (refractory anemia or medullary insufficiency). If you have anemia due to vitamin B12 deficiency. A vitamin B12 deficiency must therefore be ruled out before starting treatment.
  • by children under the age of 10.

pregnancy TARDYFERON 80 mg Iron (II) 100 pc anti-anemic and breast feeding period

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
• During pregnancy and lactation, the preparation can be used in the recommended dosage to treat combined iron and folic acid deficiencies. However, you should only take the medicine if your doctor tells you to.
• If there is an increased need for iron during pregnancy, the preparation should not be taken over a long period of time at the high dosage of 1 film-coated tablet twice a day.

patient notes

• Warnings and Precautions
  • Talk to your doctor or pharmacist before taking this medicine
    • if dietary or other iron salt supplements are used to avoid the risk of possible iron overdose.
    • In case of pre-existing inflammation or ulceration of the gastrointestinal mucosa, the benefit of the treatment should be carefully weighed against the risk of aggravation of the gastrointestinal disease. This preparation is ineffective in anemia associated with an inflammatory disease.
    • As far as possible, treatment with iron must be combined with treatment of the cause.
    • If there is an increased need for iron during pregnancy, the preparation should not be taken over a long period of time at the high dosage of 1 film-coated tablet twice a day.
    • If you have difficulty swallowing.
    • If you accidentally swallow a tablet, please contact your doctor as soon as possible. If the tablet gets into the airways, there is a risk of ulcers and narrowing of the bronchi. This can lead to persistent coughing, coughing up blood, and/or shortness of breath, even if ingestion happened days to months before these symptoms. Therefore you need to be examined urgently to make sure that the tablet has not damaged your airways.
    • Because of the risk of mouth ulcers (mouth ulcers) and tooth discolouration, the tablets should not be sucked, chewed or left in the mouth for a long time, but should be swallowed whole with water. If you cannot follow these instructions or have difficulty swallowing, talk to your doctor.
  • children
    • The medicine should not be used in children under 10 years of age. Cases of overdose with iron salts, particularly in children, have been reported as a result of accidental ingestion. Symptoms of overdose include signs such as: gastrointestinal irritation accompanied by abdominal pain, nausea, vomiting, diarrhea, symptoms of cardiovascular shock or metabolic acidosis of the body (rapid or short breathing, increased heart rate, headache, confusion, drowsiness, tiredness, loss of appetite, nausea, vomiting) followed by liver or kidney failure.
    • If your child, especially your toddler, accidentally takes some tablets, you should contact a doctor or the nearest emergency department immediately for appropriate treatment.

• Ability to drive and use machines
  • It is unlikely that taking the product will affect your ability to drive or use machines.