Tardyferon

Patient Information Leaflet

Keep this leaflet, information on the immediate packaging in a foreign language.
Tardyferon, 80 mg iron(II) ions, prolonged-release tablets
Ferrosi sulfas
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, so you can read it again if necessary.
• If you have any questions, 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 someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

1. What is Tardyferon and what is it 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 is Tardyferon and what is it used for

Iron requirements are increased in women during pregnancy, postpartum, breastfeeding, 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, avoiding sudden absorption of the entire iron dose into blood serum.
This reduces the incidence of observed adverse effects and improves patient compliance with treatment recommendations. The slow release allows iron ions to reach the terminal portions 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 used in the treatment of iron-deficiency anemia and in 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 to take Tardyferon, discuss this with your doctor or pharmacist.
The toxic dose of iron is lower in children than in adults. Tardyferon is not recommended for 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 respiratory tract, patients—especially elderly patients and those with swallowing difficulties—may be at risk of ulcers in the throat, esophagus (connecting the mouth to the stomach), or bronchi (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 medicine, contact your doctor or 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 were receiving iron supplementation due to concomitant anemia.
Due to the risk of oral mucosal ulceration and tooth discoloration, do not suck, chew, or hold the tablets in the mouth. Swallow them 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 should not be used together, while others require special adjustments (e.g. timing of administration):
Avoid using Tardyferon if the patient is receiving injectable iron preparations.
The following medicines may require dosage adjustments. Do not take Tardyferon within 2 hours after taking any of the following medicines:

• certain antibiotics (tetracyclines or fluoroquinolones);
• medicines used to treat weakened bones (bisphosphonates);
• a medicine used to treat joint diseases (penicillamine);
• medicines used to treat excess stomach acid: mineral preparations acting on the gastrointestinal tract, charcoal, or antacids (aluminum, calcium, and magnesium salts);
• a medicine used to treat thyroid disease (thyroxine);
• medicines used to treat Parkinson's disease (methyldopa, levodopa, carbidopa);
• supplements and/or medicines containing zinc or calcium;
• cholestyramine—Tardyferon should be taken 1–2 hours before or 4 to 6 hours after cholestyramine;
• NSAIDs (non-steroidal anti-inflammatory drugs)—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, they should inform their 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 drinks 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 taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your 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 prolonged in consultation with
your 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 administered 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, especially in children, following 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 the 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, do not take the missed dose and take the next tablet as usual.
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.
Stopping the use of Tardyferon
Tardyferon should be used for as long as directed by your doctor. Premature discontinuation of therapy
may lead to recurrence of the condition.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur, listed in decreasing order of frequency:
Common (occur in 1 to 10 patients)
Constipation, diarrhoea, feeling of stomach fullness, abdominal pain, darkening of stool, nausea.
Uncommon (occur in up to 1 in 100 patients)
Throat swelling (laryngeal oedema), abnormal stools, discomfort and pain in the epigastrium (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 melanosis)*.
*Patients, especially elderly patients and those with swallowing difficulties, may also be at risk of throat, oesophageal or bronchial ulceration if the tablet enters the respiratory tract. Bronchial necrosis (tissue death) or granuloma (inflammatory condition) may lead to bronchial stenosis (narrowing of the airways). 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 melanosis (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 were treated with multiple medications for these conditions and who received iron supplementation due to concomitant anaemia.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: (+48) 22 49 21 301, fax: (+48) 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions may also be reported to the responsible entity or parallel importer.
Reporting adverse reactions helps to provide more information on the safety of this 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 are required for this medicine.
Medicines must 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 pack and other information

What Tardyferon contains

• The active substance is iron(II) in the form of dried ferrous sulfate 247.25 mg, corresponding to a dose of 80 mg of ferrous ions (Fe²⁺).
• Other components are: maltodextrin, microcrystalline cellulose, ammonio methacrylate copolymer (type A) (Eudragit RL 30D), ammonio methacrylate copolymer (type B) (Eudragit RS 30D), triethyl citrate, talc, glyceryl dibehenate.
  Coating composition: Sepifilm LP010 (hypromellose, microcrystalline cellulose, stearic acid), triethyl citrate, red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171).

What Tardyferon looks like and contents of the pack
30 tablets in a cardboard box.
For more detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing authorization holder in Spain, country of export:
Pierre Fabre Iberica, S.A.
C/ Ramón Trias Fargas, 7-11
08005 Barcelona
Spain
Manufacturer:
Pierre Fabre Médicament Production
Site PROGIPHARM
Rue du Lycée, 45500 Gien, France
Parallel importer:
Polypharm S.A.
ul. Barska 33
02-315 Warsaw
Repackaged by:
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Spanish marketing authorization number (country of export): 672908.3
Parallel import authorization number: 88/23