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, prolonged-release tablets
Ferrosi sulfas
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific person only. 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 or pharmacist. See section 4.

Table of contents of the leaflet

What Tardyferon is and what it is used for
Important information 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.
The need for iron is 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 with excipients, Fe ions are released slowly, avoiding sudden absorption of the entire iron dose into blood serum.
This reduces the number of observed adverse effects and improves patient compliance with treatment recommendations. The prolonged 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 (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 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,
refractory anemia, or anemia due to bone marrow failure).

Warnings and precautions

Before starting treatment with Tardyferon, discuss this 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 therapy with diagnosis and treatment of the underlying condition.
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 respiratory tract (tablet aspiration), it may cause injuries such as necrosis (tissue death) or inflammation of the bronchi (main airways in the lungs) or esophagus (the passage connecting the mouth to the stomach). These may subsequently lead to bronchial stricture. 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.
In case of improper swallowing of the medicine and occurrence of one or more of the above-mentioned symptoms, the patient should immediately contact a doctor or the nearest emergency department to determine whether respiratory tract damage has occurred and to receive appropriate treatment.
Melanosis of the gastrointestinal tract (pigmentation in the gastrointestinal system) has been described in medical literature in elderly patients with renal failure, diabetes (abnormally high blood sugar levels), and/or arterial hypertension (high blood pressure), who were treated with multiple medications for these conditions and 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 receiving 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 directed by a doctor.
Inform your doctor about all medicines currently used or recently taken, as well as any medicines planned for future use.
Some medicines should not be used together, while others may 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 weakened 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 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 gastric and intestinal mucosal irritation and lower the risk of bleeding associated with their use.

Tardyferon with food, drink, and alcohol
Consuming large amounts of coffee, tea, or red wine may reduce iron absorption.
Concurrent intake of this medicine with whole-grain products (bran, legumes, oilseeds), certain proteins (e.g., from eggs), or foods or beverages containing calcium (cheese, milk, etc.) is not recommended. A minimum interval of 2 hours should be maintained between iron salt intake and these foods.

Pregnancy, breastfeeding, and effects on 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.
There are no studies in women during the first trimester of pregnancy that would allow assessment of 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 during 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 less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

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.
Tardyferon 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 may be extended if necessary, in consultation with your doctor.
Prophylactic treatment

Latent iron deficiency: 1 tablet (corresponding to 80 mg Fe) once daily 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
If too much medicine has been taken, contact your doctor or the nearest emergency department immediately to receive appropriate treatment, especially if 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).
Signs 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).

Long-term consequences of overdose may also include gastrointestinal strictures (stenosis), characterized by nausea, bloating, constipation, and abdominal distension.
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. 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 treatment
Tardyferon should be taken for as long as your doctor recommends. Premature discontinuation of therapy may result in recurrence of the condition.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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 stool, nausea

Uncommon (affects 1 in 100 people)
Throat swelling (laryngeal oedema), abnormal stools, indigestion, vomiting, inflammation of the stomach lining, itching, red rash (erythematous rash).

Frequency not known (cannot be estimated from available data)
Allergic reaction (hypersensitivity), itchy rash (urticaria), death of lung cells or tissue (pulmonary necrosis)*, inflammation of lung tissue (pulmonary granulomatosis)*, narrowing of airways (bronchial stenosis)*, throat ulceration*, changes in the oesophagus*, oesophageal ulceration*, tooth discoloration**, oral ulcers**, discoloration of the gastrointestinal tract (gastrointestinal melanosis, see section 2), gastric mucosal ulceration, gastrointestinal bleeding (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 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 side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
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, tel.: 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 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.
There are no special requirements for storage of this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Tardyferon contains

The active substance is 80 mg of iron(II) ions (in the form of 247.25 mg of dried iron(II) sulfate).
Other ingredients are: maltodextrin, microcrystalline cellulose, triethyl citrate, talc, methacrylic acid-ammonium methyl methacrylate copolymer (type B) (Eudragit RS 30D), methacrylic acid-ammonium methyl methacrylate copolymer (type A) (Eudragit RL 30D), glyceryl dibehenate.
Film-coating composition: titanium dioxide, Sepifilm LP010 (hypromellose, microcrystalline cellulose, stearic acid), yellow iron oxide, red iron oxide, triethyl citrate.

What Tardyferon looks like and contents of the pack
30 prolonged-release tablets in a cardboard box.

For further detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Spain, the country of export:
Pierre Fabre Ibérica, S.A.
C/ Ramón Trías Fargas, 7-11
08005 Barcelona
Spain
Manufacturer:
Pierre Fabre Médicament Production
Site PROGIPHARM
Rue du Lycée
45500 Gien
France
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorisation number in Spain, the country of export: 672908.3
Parallel import authorisation number: 293/20