Tardyferon

Package leaflet: Information for the patient

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• 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, in breastfeeding mothers, and in adolescents during periods of growth. Iron deficiency or iron deficiency anaemia can be prevented or treated using a medicine called Tardyferon.
In this iron compound with auxiliary substances, Fe ions are slowly released, avoiding sudden absorption of the entire iron dose into the 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 segments of the intestine, which, in addition to the duodenum, have the capacity to absorb iron.
Absorption of iron in the upper intestinal segments is limited by iron saturation processes. Like all iron-containing medicines, Tardyferon has no effect on erythropoiesis (production of red blood cells) or on anaemia caused by factors other than iron deficiency.
Tardyferon is used in the treatment of iron deficiency anaemia and in the prevention of iron deficiency in pregnant women with inadequate dietary iron 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.
Iron deficiency correction should, whenever possible, be combined with treatment of the underlying cause of this deficiency.
If a tablet enters the respiratory tract, patients—especially elderly individuals 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 stricture (airway narrowing). In case of improper swallowing of the tablet, 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 received iron supplementation due to concomitant anemia.
Due to the risk of oral 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 you experience difficulty swallowing, 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 directed 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-containing medicines.
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 in treating joint diseases (penicillamine);
• medicines used to treat excess stomach acid: mineral preparations acting on the gastrointestinal tract, charcoal, or acid-neutralizing agents (aluminum, calcium, and magnesium salts);
• a medicine used to treat thyroid disorders (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 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 your 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 taking 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 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 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 prolonged in consultation with
your doctor.
Prophylactic treatment

• Latent iron deficiency: 1 tablet (equivalent 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 section “Tardyferon with food, drink and alcohol”).
Taking more Tardyferon than recommended
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, 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.
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 at the usual time.
Do not take 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 Tardyferon treatment
Tardyferon should be taken for as long as directed by your doctor.
Premature discontinuation of therapy may result in recurrence of the condition.
If you have any further doubts regarding 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 adverse effects may occur, listed in order of decreasing 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 upper abdomen (dyspepsia),
vomiting, acute gastritis, itching, red rash (erythematous rash).

Frequency unknown (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 mucosal ulceration**, changes in the oesophagus*, gastrointestinal pigmentation (gastrointestinal melanosis)*.

*Patients, especially elderly individuals 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 (airway narrowing). In case of incorrect administration, contact a doctor or the nearest emergency department immediately for appropriate treatment.

**In case of incorrect 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 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
Website: https://smz.ezdrowie.gov.pl

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Tardyferon

Keep Tardyferon out of the sight and reach of children.
No special storage instructions are required.
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.
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 247.25 mg of dried iron(II) sulfate, corresponding to a dose of 80 mg of iron(II) ions.
• The other ingredients are: maltodextrin, microcrystalline cellulose, ammonio methacrylate copolymer (type A) dispersion 30% (Eudragit RL 30D), ammonio methacrylate copolymer (type B) dispersion 30% (Eudragit RS 30D), triethyl citrate, talc, glyceryl dibehenate. Film 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, 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.º 121-123, Queluz de Baixo -
Barcarena, Portugal
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Portugal (country of export) marketing authorisation number: 4979381
Parallel import authorisation number: 273/22