Tardyferon

Package leaflet: Information for the patient

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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

Iron requirements are increased in women during pregnancy, the postpartum period, breastfeeding mothers, and adolescents during growth periods. Iron deficiency or iron-deficiency anemia can be prevented or treated using a medicine called Tardyferon.
In the combination of iron with excipients, Fe ions are released slowly, thus avoiding sudden absorption of the entire iron dose into blood serum.
This reduces the incidence of observed adverse effects and improves patient compliance. The prolonged release allows iron ions to reach the distal segments of the intestine, which—besides the duodenum—have the capacity to absorb 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 (production of red blood cells) 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 iron 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.
Iron deficiency correction should, whenever possible, be combined with treatment of the underlying cause of the deficiency.
If a tablet enters the respiratory tract, patients—especially elderly individuals and those with swallowing difficulties—may be at risk of developing 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 levels), and/or hypertension (high blood pressure), who were treated with multiple medications for these conditions and who were also receiving iron supplementation due to concomitant anemia.
Due to the risk of oral mucosal ulceration and tooth staining, the tablets must not be sucked, chewed, or held in the mouth. They should be swallowed whole with water. If following these instructions is not possible or if swallowing difficulties occur, consult 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 taking injectable iron-containing medicines.
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);
• medicines used to treat weakened bones (bisphosphonates);
• a medicine used to treat joint diseases (penicillamine);
• medicines used to treat excess stomach acid: mineral agents 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) – these should be taken with food to reduce gastric and intestinal mucosal irritation 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 those available without prescription, 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 or drinks containing calcium (cheese, milk, etc.). An interval of at least 2 hours should be maintained between the intake 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 take 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 the age of 10 and adults. The medicine is administered orally.

Treatment of iron deficiency anaemia
Children over 10 years of age and adults: 1 to 2 tablets per day.
The duration of treatment should be sufficiently long to correct anaemia and replenish iron stores.
Treatment may last at least 3 to 6 months and, if necessary, may be extended 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 taken orally. Swallow the tablet 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").

Taking more Tardyferon than recommended
Cases of iron salt overdose have been reported, particularly 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, diarrhoea, 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.

Missing a 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 at the usual time.
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

Stopping Tardyferon
Tardyferon should be taken for as long as your doctor recommends. Stopping treatment too early may lead to recurrence of the condition.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

Common (occur in 1 out of 10 patients)
Constipation, diarrhoea, feeling of stomach fullness, abdominal pain, darkening of stool, nausea

Uncommon (occur in up to 1 out of 100 patients)
Throat swelling (laryngeal oedema), abnormal stools, discomfort and pain in the epigastric region (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), lung necrosis (tissue death)*, pulmonary granuloma (inflammatory condition)*, bronchial stenosis (narrowing of airways)*, tooth discoloration**, oral cavity ulceration**, changes in the oesophagus*, gastrointestinal pigmentation (gastrointestinal melanosis)*.

*Patients, especially elderly patients and those with swallowing difficulties, may also be at risk of throat, oesophagus or bronchial ulcers 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 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 are treated with multiple medications for these conditions and who receive iron supplementation due to concomitant anaemia.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse 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, tel.: 22 49-21-301, fax: 22 49-21-309, https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to gather further 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 instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging 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.
• The other ingredients are: maltodextrin, microcrystalline cellulose, ammonio methacrylate copolymer dispersion type B (Eudragit RS 30D), ammonio methacrylate copolymer dispersion type A (Eudragit RL 30D), glyceryl dibehenate, triethyl citrate, talc.
  Coating composition: Sepifilm LP010 (hypromellose, microcrystalline cellulose, stearic acid), yellow iron oxide, red iron oxide, triethyl citrate, titanium dioxide.

What Tardyferon looks like and contents of the pack
30 tablets in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Greece, country of export:
PIERRE FABRE FARMAKA A.E.
Leof. Mesogeion 350
153 41 Ag. Paraskevi
Greece
Manufacturer:
PIERRE FABRE MEDICAMENT PRODUCTION
45 Place Abel Gance
92100 Boulogne
France
Parallel importer:
Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Czesky Tesin
Czech Republic
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Euceryn Pharmaceutical Laboratory COEL S.J. E.Z.M. KONSTANTY
ul. Wl. Zeleńskiego 45
31-353 Kraków
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Marketing authorisation number in Greece, country of export: 8554/6-2-2007
Parallel import authorisation number: 58/22
[Trademark notice]