TARDYFERON

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Tardyferon (Ferro-Tardyferon) , 80 mg of iron(II) ions, prolonged-release tablets
Ferrosi sulfas
Tardyferon and Ferro-Tardyferon are different brand names for the same medicinal product.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
• If you experience any adverse effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Tardyferon is and what it is used for
2. Important information before taking Tardyferon
3. How to take Tardyferon
4. Possible side effects
5. How to store Tardyferon
6. Contents of the pack and other information

1. What Tardyferon is and what it is used for

The need for iron is increased in women during pregnancy, postpartum, in breastfeeding mothers, and in adolescents during growth periods. Iron deficiency or iron-deficiency anemia can be prevented or treated using a medicine called Tardyferon.
In this formulation combining iron with excipients, Fe ions are released slowly, thus avoiding sudden absorption of the entire iron dose into blood serum.
This reduces the number of adverse effects observed and facilitates patient compliance with treatment recommendations. The slow release allows iron ions to reach the terminal segments of the intestine, which, in addition to the duodenum, are capable of absorbing iron. Limiting iron absorption to the upper intestinal segments is caused by iron saturation processes. Like all iron-containing medicines, Tardyferon has no effect on erythropoiesis (red blood cell production) or on anemia caused by factors other than iron deficiency.
Tardyferon is indicated for the treatment of iron-deficiency anemia and for the prevention of iron deficiency in pregnant women with inadequate dietary intake.
Tardyferon is indicated for use in children over 10 years of age and in adults.

2. Important information before using Tardyferon

When not to use Tardyferon:

• if the patient is allergic to ferrous sulfate or any of the other ingredients of this medicine (listed in section 6);
• if there is excess iron, e.g. hemochromatosis, thalassemia, refractory anemia, or bone marrow failure.

Warnings and precautions
Before starting treatment with Tardyferon, consult your doctor or pharmacist.
The toxic dose of iron is lower in children than in adults. Administration of Tardyferon is not recommended in children under 10 years of age.
Correction of iron deficiency should, whenever possible, be combined with treatment of the underlying cause of the deficiency.
If a tablet enters the airways, patients—especially elderly individuals and those with swallowing difficulties—may be at risk of ulcers in the throat, esophagus (the tube connecting the mouth to the stomach), or bronchi (the main airways leading to the lungs). Bronchial necrosis (tissue death) or granuloma (inflammatory condition) may lead to bronchial stenosis (narrowing of the airways). In case of improper swallowing of the tablet, contact your doctor or the nearest emergency department immediately for appropriate treatment.
In medical literature, gastrointestinal melanosis (pigmentation in the gastrointestinal tract) has been reported in elderly patients with chronic kidney disease, diabetes (high blood sugar), and/or hypertension (high blood pressure), who were treated with multiple medications for these conditions and who received iron supplementation due to concomitant anemia.
Due to the risk of oral ulceration and tooth staining, tablets should not be sucked, chewed, or held in the mouth. They should be swallowed whole with water. If following this instruction is not possible or if swallowing difficulties occur, contact your doctor.

Children and adolescents
Tardyferon may be used in children over 10 years of age.

Tardyferon with other medicines
Do not take Tardyferon unless advised by a doctor.
Some medicines cannot be used together, while others require special adjustments (e.g. timing of administration).
Avoid using Tardyferon if the patient is receiving parenteral iron-containing medications.
The following medicines may require dose adjustments. Do not take Tardyferon within 2 hours after taking any of the following medicines:

• certain antibiotics (tetracyclines or fluoroquinolones);
• drugs used to treat weakened bones (bisphosphonates);
• a drug used in the treatment of joint diseases (penicillamine);
• drugs used to treat excess stomach acid: mineral preparations acting on the gastrointestinal tract, charcoal, or antacids (aluminum, calcium, and magnesium salts);
• a drug used in the treatment of thyroid disorders (thyroxine);
• a drug used in the treatment of Parkinson's disease (methyldopa, levodopa, carbidopa);
• supplements and/or drugs containing zinc or calcium;
• cholestyramine – Tardyferon should be administered 1–2 hours before or 4 to 6 hours after cholestyramine;
• NSAIDs (non-steroidal anti-inflammatory drugs) – these should be taken with food to reduce irritation of the gastric and intestinal mucosa and to lower the risk of bleeding associated with their use.

If the patient is currently taking or has recently taken any other medicine, including over-the-counter medicines, inform the doctor or pharmacist.

Tardyferon with food, drink, and alcohol
Consuming large amounts of coffee, tea, or red wine may reduce iron absorption.
It is not recommended to take this medicine simultaneously with whole-grain products (bran, legumes, oilseeds), certain proteins (eggs), or foods and beverages containing calcium (cheese, milk, etc.). An interval of at least 2 hours should be maintained between the administration of iron salts and these foods.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Tardyferon may be used during pregnancy and breastfeeding.

Driving and operating machinery
It is unlikely that Tardyferon will affect the ability to drive or operate machinery.

3. How to use Tardyferon

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Tardyferon is indicated for children over 10 years of age and adults. The medicine is administered
orally.
Treatment of iron deficiency anemia
Children over 10 years of age and adults: 1 to 2 tablets per day.
The duration of treatment should be sufficiently long to correct anemia and replenish
iron stores.
Treatment may last at least 3 to 6 months and, if necessary, may be extended in consultation
with a doctor.
Prophylactic treatment

• Latent iron deficiency: 1 tablet (corresponding to 80 mg Fe) per day or every other day.
• Pregnant women: 1 tablet every other day during the last two trimesters of pregnancy (or from the 4th month of pregnancy).

Tardyferon tablets are taken orally.
The tablet should be swallowed whole with water. Do not suck, chew, or hold the tablet in the mouth.
Tablets should be taken with a large glass of water, preferably before or during a meal, depending on gastrointestinal tolerance (except for specific foods mentioned in the section “Tardyferon with food, drink and alcohol”).
Use of a higher than recommended dose of Tardyferon
Cases of iron salt overdose have been reported, particularly in children, due to ingestion of a large
amount of the medicine.
Symptoms of overdose include signs of gastrointestinal irritation with accompanying
abdominal pain, nausea, vomiting, diarrhea, cardiovascular shock symptoms or metabolic acidosis (rapid or shallow breathing, increased heart rate, headache, confusion, drowsiness, fatigue, loss of appetite), as well as liver and kidney failure.
If an excessive amount of the medicine has been taken, contact an emergency department immediately for appropriate treatment.
Missed dose of Tardyferon
If a dose is missed at the usual time, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and take the next tablet at the regular time.
Do not take a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.
Stopping Tardyferon
Tardyferon should be taken for as long as directed by a doctor. Premature discontinuation of therapy may result in recurrence of the condition.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur, listed in order of decreasing frequency:

Common (affects 1 in 10 people)
Constipation, diarrhoea, feeling of stomach fullness, abdominal pain, darkening of the stool, nausea.

Uncommon (affects 1 in 100 people)
Throat swelling (laryngeal oedema), abnormal stools, discomfort and pain in the upper abdomen (dyspepsia),
vomiting, acute gastritis, itching, red rash (erythematous rash).

Frequency not known (cannot be estimated from available data)
Allergic reaction (hypersensitivity reaction), rash with accompanying itching (urticaria),
pulmonary necrosis (tissue death)*, pulmonary granuloma (inflammatory condition)*, bronchial stenosis (narrowing of the airways)*, tooth discoloration**, oral mucosal ulceration**, oesophageal lesions*, gastrointestinal pigmentation (gastrointestinal melanoza)*.

*Patients, especially elderly individuals and those with swallowing difficulties, may also be at risk of laryngeal, oesophageal or bronchial ulceration if the tablet enters the respiratory tract. Bronchial necrosis (tissue death) or granuloma (inflammatory condition) may lead to bronchial stenosis (airway narrowing). In case of improper administration, contact a doctor or the nearest emergency department immediately for appropriate treatment.

** In case of improper administration, when tablets are chewed, sucked, or held in the mouth.

In medical literature, gastrointestinal melanoza (pigmentation in the gastrointestinal tract) has been reported in elderly patients with chronic kidney disease, diabetes (high blood sugar levels) and/or hypertension (high blood pressure), who are treated with multiple medications for these conditions and who receive iron supplementation due to concomitant anaemia.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Tardyferon

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Tardyferon contains

• The active substance is iron(II) ions in the form of iron(II) sulfate, dried, 247.25 mg, corresponding to a dose of 80 mg of iron(II) ions.
• The other components are: maltodextrin, microcrystalline cellulose, ammonio methacrylate copolymer (type A), 30% dispersion (Eudragit RL 30D), ammonio methacrylate copolymer (type B), 30% dispersion (Eudragit RS 30D), triethyl citrate, talc, glycerol dibehenate.
  Coating composition: Sepifilm LP010 (hypromellose, microcrystalline cellulose, stearic acid), triethyl citrate, iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171).

What Tardyferon looks like and contents of the pack
30 prolonged-release tablets in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Portugal, the country of export:
Pierre Fabre Médicament Portugal, Lda.
Rua Rodrigo da Fonseca, n. 178 – 2 Esq.
1099-067 Lisbon
Portugal
Manufacturer:
Pierre Fabre Médicament Production
Rue du Lycée – 45500 Gien
France
Iberfar – Indústria Farmacêutica S.A.
Rua Consiglieri Pedroso n. 121-123
Queluz de Baixo
2734-501 Barcarena
Portugal
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Portugal, the country of export: 8504100
Parallel import authorisation number: 203/23