Package leaflet: Information for the patient

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

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are similar.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Tardyferon is and what it is used for
What you need to know before taking Tardyferon
How to take Tardyferon
Possible side effects
How to store Tardyferon
Contents of the pack and other information

1. What Tardyferon is and what it is used for

Tardyferon contains iron.
Iron requirements are increased in women during pregnancy, postpartum, and in breastfeeding mothers, as well as in 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 and excipients, iron(II) ions (Fe²⁺) are released slowly, avoiding sudden absorption of the entire iron dose into the bloodstream.
This reduces the incidence of adverse effects observed and improves patient compliance. The slow release allows iron ions to reach the distal segments of the intestine, which, in addition to the duodenum, are capable of absorbing iron. Absorption limited to the upper intestinal segments is due to saturation with iron. 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 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 iron(II) sulfate or any of the other ingredients of this medicine (listed in section 6);
if the patient has iron overload in the body;
if the patient has a type of anemia (reduced hemoglobin concentration or insufficient number of red blood cells) not caused by iron deficiency, or one associated with iron overload in the body (e.g. thalassemia, anemia resistant to treatment, or anemia caused by bone marrow failure).

Warnings and precautions
Before starting treatment with Tardyferon, discuss it with 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.
If the patient is receiving Tardyferon due to iron-deficiency anemia, the doctor will combine the treatment with diagnosis and management of the underlying cause of the disease.
If iron-deficiency anemia occurs in the course of inflammatory diseases, treatment with Tardyferon will not be effective.
If the patient has difficulty swallowing, they should inform their doctor.
If a tablet accidentally enters the patient's airways (tablet aspiration), it may cause injuries such as necrosis (tissue death) or bronchitis (inflammation of the main airways in the lungs) or esophagitis (inflammation of the esophagus, the tube connecting the mouth to the stomach). These may lead to bronchial stenosis. Symptoms such as persistent cough, coughing up blood, and/or shortness of breath may occur, even if aspiration occurred several days to several months earlier.
If the medicine is swallowed incorrectly and the patient develops one or more of the symptoms listed above, contact a doctor or the nearest emergency department immediately to determine whether there has been damage to the respiratory tract and to initiate appropriate treatment.
Melanosis of the gastrointestinal tract (pigmentation in the digestive system) has been reported in medical literature in elderly patients with renal insufficiency, diabetes (abnormally high blood sugar levels), and/or arterial hypertension (high blood pressure), who were treated with multiple medications for these conditions and who received iron supplementation due to concomitant anemia. If the patient is scheduled for gastrointestinal surgery, the surgeon should be informed about iron intake, as melanosis may complicate the surgical procedure.
Cases of gastric ulceration and gastrointestinal bleeding have been reported in patients taking iron tablets. If such symptoms occur, the doctor may recommend switching from tablets to a liquid formulation (see section 4).
Due to the risk of oral mucosal ulceration and tooth discoloration, 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, the patient should contact their 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.
Inform your doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
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.
Do not take Tardyferon within 2 hours after taking any of the following medicines:

certain antibiotics (tetracyclines, fluoroquinolones, cefdinir);
a medicine used to treat chronic urinary tract infection (acetohydroxamic acid);
medicines used in the treatment of HIV infection (integrase inhibitors, bictegravir [bictegravir should be administered at least 2 hours before iron or taken with food]);
medicines used to treat weak bones (bisphosphonates);
medicines used to treat joint diseases or Wilson’s disease (penicillamine, trientine);
antacids (containing aluminum, calcium, and/or magnesium salts);
a medicine used to treat thyroid disease (thyroxine);
medicines used to treat Parkinson’s disease (methyldopa, levodopa, carbidopa, entacapone);
supplements and/or medicines containing zinc or calcium;
cholestyramine (a medicine used to reduce elevated blood cholesterol levels): 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.

Tardyferon, 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 (e.g. from eggs), or foods and drinks containing calcium (cheese, milk, etc.). A minimum interval of 2 hours should be maintained between taking iron salts and these foods.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
No studies have been conducted in women during the first trimester of pregnancy to assess the risk of developmental abnormalities. However, neither in medical literature nor during the post-marketing period have any cases of congenital malformations been reported. Numerous published data on women in the second and third trimesters of pregnancy do not indicate an increased risk of malformations or fetal or neonatal toxicity. Therefore, Tardyferon may be used during pregnancy if clinically indicated.
Iron passes into breast milk in small amounts. The mother’s diet does not affect its concentration. No adverse effects on newborns/infants are expected.
Tardyferon may be used during breastfeeding.

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

Tardyferon contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Tardyferon

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Tardyferon is indicated for use in 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").
Taking more Tardyferon than recommended
If an overdose occurs, contact a doctor or the nearest emergency department immediately
to initiate appropriate treatment, especially if the overdose occurred in a child.
Symptoms of iron overdose include:

Severe gastrointestinal irritation, which may lead to tissue necrosis (necrosis of gastrointestinal mucosa). Main symptoms are: abdominal pain, nausea, vomiting (sometimes containing blood), and diarrhea (sometimes with black stools). This may be accompanied by metabolic acidosis and shock with the following main symptoms: rapid or shallow breathing, increased heart rate, headache, confusion, drowsiness, fatigue, loss of appetite, stomach pain, vomiting, and sudden drop in blood pressure, which may lead to loss of consciousness with seizures (coma).
Symptoms of impaired kidney function (marked decrease in urine output) and liver function (pain in the upper right abdomen, yellowing of the skin and eyes, dark urine color).

Long-term consequences of overdose with gastrointestinal strictures (stenosis) are also possible,
characterized by nausea, bloating, constipation, and abdominal distension.
If you miss a dose of Tardyferon
If you miss a dose 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.
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 about using this medicine, consult your
doctor or pharmacist.
Stopping Tardyferon
Tardyferon should be taken for as long as prescribed by your doctor. Premature discontinuation of therapy
may lead to recurrence of the condition.
If you have any further doubts about using 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 (may affect up to 1 in 10 people)
Constipation, diarrhoea, feeling of stomach fullness, abdominal pain, dark stools, nausea.
Uncommon (may affect up to 1 in 100 people)
Throat swelling (laryngeal oedema), abnormal stools, dyspepsia, vomiting, gastric mucosal inflammation, itching, red rash (erythematous rash).
Frequency not known (cannot be estimated from available data)
Allergic reaction (hypersensitivity reaction), itchy rash (urticaria), necrosis of lung cells or tissue (pulmonary necrosis)*, lung tissue inflammation (pulmonary granulomatosis)*, narrowing of the airways (bronchial stenosis)*, oesophageal ulceration*, oesophageal lesions*, oesophageal ulceration*, tooth discoloration**, oral ulceration**, gastrointestinal discoloration (gastrointestinal melanosis, see section 2), gastric mucosal ulceration, gastrointestinal haemorrhage (see section 2).
* Patients, especially elderly patients and those with swallowing difficulties, may also be at risk of throat or oesophageal ulceration. If a tablet enters the airways, there is a risk of bronchial ulceration and pulmonary granulomatosis (inflammatory condition), which may lead to bronchial stenosis. 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 are treated with multiple medications for these conditions and who are receiving 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 or pharmacist. Adverse reactions can also 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 reactions helps 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 instructions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine Tardyferon contains

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

What Tardyferon looks like and contents of the pack
Orange-pink, round tablets.
30 modified-release tablets in a cardboard box.
For further information, contact the responsible party or the parallel importer.
Responsible party in the Czech Republic, country of export:
PIERRE FABRE MEDICAMENT
Les Cauquillous
81500 Lavaur
France
Manufacturer:
Pierre Fabre Medicament Production
Site Progipharm
Rue du Lycée
45500 Gien
France
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing authorization number in the Czech Republic, country of export: 12/125/74-C
Parallel import authorization number: 231/22