Tardyferon

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Tardyferon, 80 mg 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 individual. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any 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. What you need to know 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, postpartum, and in breastfeeding mothers, as well as in adolescents during periods of growth. Iron deficiency or iron-deficiency anemia can be prevented or treated using a medicine called Tardyferon. Due to its formulation combining iron with excipients, iron(II) ions (Fe²⁺) are released slowly, thus avoiding sudden absorption of the entire iron dose into the bloodstream.
This reduces the frequency of observed adverse effects and improves patient compliance. The slow release allows iron ions to reach the terminal segments of the intestine, which—apart from the duodenum—have the capacity to absorb iron. Limiting iron absorption to the upper intestinal segments is due to iron saturation mechanisms. 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 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 anaemia (reduced haemoglobin concentration or insufficient number of red blood cells) not caused by iron deficiency, or one associated with excess iron in the body (e.g. thalassaemia, anaemia resistant to treatment, or anaemia caused by 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 anaemia, the doctor will combine therapy with diagnosis and treatment of the underlying cause of the disease.
If iron-deficiency anaemia 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 oesophagitis (inflammation of the oesophagus – 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 these symptoms, contact a doctor or the nearest emergency department immediately to determine whether airway damage has occurred and to initiate appropriate treatment.
Melanosis of the gastrointestinal tract (pigmentation in the gastrointestinal system) has been reported in the medical literature in elderly patients with renal failure, diabetes (abnormally 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. 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 ulceration and tooth staining, tablets should not be sucked, chewed, or held in the mouth, but should be swallowed whole with water. If following this instruction is not possible or if swallowing difficulties occur, contact a 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 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 taking 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 to treat HIV infection (integrase inhibitors, bictegravir [bictegravir should be taken at least 2 hours before iron or together with food]);
• medicines used to treat weakened bones (bisphosphonates);
• medicines used to treat joint diseases or Wilson's disease (penicillamine, trientine);
• antacids (containing aluminium, 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 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.). 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 post-marketing surveillance 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 the breast milk of nursing mothers in small amounts. The mother's diet does not affect its concentration. No 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 use Tardyferon

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your 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 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
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 the section “Tardyferon with food, drink, and alcohol”).
Use of a higher than recommended dose of Tardyferon
If an excessive dose is taken, contact your doctor or the nearest emergency department immediately
to initiate appropriate treatment, especially if overdose occurs 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 diarrhoea (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 colour).

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 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. Premature discontinuation of
treatment 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 will experience them.
The following adverse reactions may occur, listed in order of decreasing frequency:
Common (may occur in up to 1 in 10 people)
Constipation, diarrhoea, feeling of stomach fullness, abdominal pain, darkening of the stool, nausea.
Uncommon (may occur in 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 constriction)*, throat ulceration*, oesophageal changes*, oesophageal ulceration*, tooth discoloration**, oral cavity ulcerations**, gastrointestinal tract 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 constriction. 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 receive 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 for Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 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.
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 apply.
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Tardyferon contains

• The active substance is iron(II) ions in the form of 247.25 mg of dried iron(II) sulfate, corresponding to a dose of 80 mg of iron(II) ions.
• Other ingredients: maltodextrin, microcrystalline cellulose, ammonium methacrylate copolymer (type A) dispersion 30% (Eudragit RL30D), ammonium methacrylate copolymer (type B) dispersion 30% (Eudragit RS30D), triethyl citrate, talc, glycerol 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
Orange-pink coated tablets.
30 prolonged-release tablets in a cardboard box.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Romania, the 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.
Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorization Number in Romania, the country of export: 11514/2019/01
Parallel Import Authorization Number: 31/21