Package leaflet: Information for the patient

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

Keep this leaflet, as you may need to read it again.
If you have any further questions, please 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 other people, 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 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 adverse effects observed and improves patient compliance. The slow release of the drug allows iron ions to reach the distal 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(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 such anemia that is associated with excess iron 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. Tardyferon is not recommended for 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 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 passage connecting the mouth to the stomach). These may subsequently lead to bronchial narrowing. Symptoms such as persistent cough, coughing up blood, and/or shortness of breath may occur, even if aspiration occurred several days to several months before the onset of these symptoms.
In case of improper swallowing of the medicine and occurrence of one or more of the above symptoms in the patient, contact a doctor or the nearest emergency department immediately 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 drugs for these conditions and were receiving 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, but 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 above the age of 10 years.
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 weakened bones (bisphosphonates);
medicines used to treat joint diseases or Wilson's disease (penicillamine, trientine);
medicines that neutralize gastric acid (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 (nonsteroidal 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 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 (e.g. from eggs), or foods and drinks containing calcium (cheese, milk, etc.). A minimum interval of 2 hours should be maintained between administration of 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.
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 professional literature nor during the post-marketing period have any cases of congenital malformations been reported. Numerous published data regarding 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 less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free."

3. How to use Tardyferon

This medicine should always be taken as directed by a physician or pharmacist. In case of 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, if necessary, may be extended in consultation with the
physician.
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 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
In case of overdose, seek immediate medical attention from a doctor or the nearest emergency department
for 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).
signs of impaired kidney function (marked decrease in urine output) and liver function (pain in the right upper abdomen, jaundice, dark urine color).

Long-term consequences of overdose may also occur, including gastrointestinal strictures (stenosis), characterized by nausea, bloating, constipation, and abdominal distension.
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.
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 the physician. 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions 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 1 out of 100 patients)
Throat swelling (laryngeal oedema), abnormal stools, dyspepsia, vomiting, inflammation of the gastric mucosa, itching, red rash (erythematous rash).
Frequency not known (cannot be estimated from available data)
Allergic reaction (hypersensitivity reaction), itchy rash (urticaria), death of lung cells or tissue (pulmonary necrosis)*, inflammation of lung tissue (pulmonary granulomatosis)*, narrowing of the airways (bronchial stenosis)*, oesophageal ulceration*, changes in the oesophagus*, oesophageal ulcer*, tooth discoloration**, oral mucosal ulcers**, gastrointestinal discoloration (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 cases 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 glucose levels), and/or hypertension (high blood pressure), who were treated with multiple medications for these conditions and 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tardyferon

Keep this medicine out of sight and reach of children.
No special storage instructions apply.
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 required. Such measures help protect the environment.

6. Package contents 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.
Other ingredients: maltodextrin, microcrystalline cellulose, triethyl citrate, talc, ammonium methacrylate copolymer (type A) (Eudragit RL 30D), ammonium methacrylate copolymer (type B) (Eudragit RS 30D), glyceryl dibehenate.
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 tablets in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Spain, country of export:
Pierre Fabre Ibérica, S.A.
Ramón Trias Fargas, 7-11
08005 Barcelona, Spain

Manufacturer:
Pierre Fabre Médicament Production
Site PROGIPHARM
Rue du Lycée, 45500 Gien
France

Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland

Repackaged by:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland

Spanish marketing authorisation number (country of export): 672908.3
Parallel import authorisation number: 427/15