TARDYFERON

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Tardyferon
80 mg of iron(II) ions, prolonged-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 so that you can read it again if necessary.
• If you have any doubts, 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 the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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

Tardyferon contains iron.
The need for iron is increased in women during pregnancy, the postpartum period, in breastfeeding mothers, and in adolescents during growth phases. Iron deficiency or iron-deficiency anemia can be prevented or treated using a medicine called Tardyferon.
Due to the combination of iron with auxiliary substances, Fe ions are released slowly, avoiding sudden absorption of the entire iron dose into the blood serum.
This reduces the frequency of observed adverse effects and facilitates patient compliance with recommendations. The slow release of the drug enables iron ions to reach the distal segments of the intestine, which, in addition to the duodenum, have the ability to absorb iron. Limiting iron absorption to the upper intestinal segments is caused by iron saturation. 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 ferrous sulfate or any of the other ingredients of this medicine (listed in section 6);
• if the patient has been diagnosed with iron overload;
• 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 that is associated with iron overload (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 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, this should be reported to the doctor.

If a tablet accidentally enters the patient's airways (tablet aspiration), it may cause injury 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 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.

In case of improper swallowing of the medicine and occurrence of one or more of the symptoms listed above, the patient should immediately contact a doctor or the nearest emergency department to determine whether airway damage has occurred and to receive appropriate treatment.

Melanosis of the gastrointestinal tract (pigmentation in the gastrointestinal system) has been described in the 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 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 over 10 years of age.

Tardyferon and other medicines

Do not take Tardyferon unless advised by a doctor.

Inform your doctor about all medicines currently or recently taken, as well as any medicines you plan 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 preparations.

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 together with food]);
• medicines used to treat weakened bones (bisphosphonates);
• medicines used to treat joint diseases and 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 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 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 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 medical literature nor during the post-marketing period have any cases of congenital malformations been reported. Numerous published data in 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 sodium

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 as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Tardyferon is indicated for children over 10 years of age and adults.
Tardyferon 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 a doctor.
Prophylactic treatment

• Latent iron deficiency: 1 tablet (corresponding to 80 mg Fe) per day or on alternate days.
• 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 too much medicine is taken, contact a doctor or the nearest emergency department immediately
to initiate appropriate treatment, especially if overdose occurs in a child.
Symptoms of 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 diarrhoea (sometimes with passage of black stools). Metabolic acidosis and shock may also occur, 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, yellowing of the skin and eyes, darkening of urine).

Long-term consequences of overdose may also include gastrointestinal strictures (stenosis),
characterized by nausea, bloating, constipation and abdominal distension.
If you forget to take 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 about the use of this medicine, consult your doctor or pharmacist.
Stopping Tardyferon
Tardyferon should be taken for as long as directed by your doctor. Stopping treatment too early 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 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 (affects 1 in 10 patients)
Constipation, diarrhoea, feeling of stomach fullness, abdominal pain, dark stools, nausea.
Uncommon (affects 1 in 100 patients)
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), cell or lung tissue necrosis (pulmonary necrosis)*, lung tissue inflammation (pulmonary sarcoidosis)*, narrowing of the airways (bronchial stenosis)*, oesophageal ulceration*, changes in the oesophagus*, oesophageal ulceration*, tooth discoloration**, oral mucosal ulcers**, gastrointestinal discoloration (gastrointestinal melanosis, see section 2), gastric mucosal ulceration, gastric bleeding (see section 2).
* Patients, especially elderly patients and those with swallowing difficulties, may also be at risk of throat or oesophageal ulceration. If the tablet enters the airways, there is a risk of bronchial ulceration and pulmonary sarcoidosis (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 cases 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 received iron supplementation due to concomitant anaemia.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 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 the 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 conditions are required.
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 iron(II) sulfate, dried, 247.25 mg, corresponding to a dose of 80 mg.
• The other ingredients are: maltodextrin, microcrystalline cellulose, ammonio methacrylate copolymer (type A) (Eudragit RL 30D), ammonio methacrylate copolymer (type B) (Eudragit RS 30D), triethyl citrate, talc, glyceryl dibehenate. 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 responsible party 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Spain, country of export: 672908.3
Parallel Import Authorisation Number: 126/15