Tardyferon

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Tardyferon
80 mg iron(II) ions, modified 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 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. The 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, pharmacist, or nurse. See section 4.

Table of contents

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.
Iron requirements are increased in women during pregnancy, the postpartum period, and in breastfeeding mothers, as well as in adolescents during periods of growth. Iron deficiency or iron-deficiency anaemia can be prevented or treated using a medicine called Tardyferon.
In the combination of iron and excipients, iron ions (Fe) are released slowly, avoiding sudden absorption of the entire iron dose into blood serum.
This reduces the incidence of observed adverse effects and improves patient compliance with treatment recommendations. The slow release allows iron ions to reach the terminal segments of the intestine, which, in addition to the duodenum, have the capacity to absorb iron. Limiting iron absorption to the upper intestinal segments is due to iron saturation processes. Like all iron-containing medicines, Tardyferon has no effect on erythropoiesis (production of red blood cells) or on anaemia caused by factors other than iron deficiency.
Tardyferon is used in the treatment of iron-deficiency anaemia 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 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 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,
  refractory anaemia, 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 the tablet accidentally enters the patient's airways (tablet aspiration), it may cause injury such as necrosis (tissue death) or inflammation of the bronchi (main airways in the lungs) or oesophagus (the passage connecting the oral cavity with 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 symptoms, the patient should immediately contact a doctor or the nearest emergency department 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 arterial hypertension (high blood pressure), who were treated with multiple drugs for these conditions and who 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 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 cavity ulceration and tooth discoloration, 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, 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 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 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 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, oilseed grains), 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 administration 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 child, she should consult her doctor or pharmacist before using this medicine.

Studies in women during the first trimester of pregnancy to assess the risk of developmental abnormalities have not been conducted. 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/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 neonates/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 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 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) 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 more than the recommended dose of Tardyferon
If an excessive dose is taken, contact a doctor or the nearest emergency department immediately for 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 right upper abdomen, yellowing of the skin and eyes, dark urine colour).

Long-term consequences of overdose may also include gastrointestinal strictures (stenosis), characterised 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 therapy may lead to recurrence of the condition.
If you have any further doubts 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 everybody will get them.
The following side effects may occur, listed in order of decreasing frequency:
Common (may affect up to 1 in 10 people)
Constipation, diarrhoea, feeling of stomach fullness, abdominal pain, darkening of stool, nausea.
Uncommon (may affect up to 1 in 100 people)
Throat swelling (laryngeal oedema), abnormal stools, indigestion, 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 death (pulmonary necrosis)*, lung tissue inflammation (pulmonary granulomatosis)*, narrowing of airways (bronchial stenosis)*, oesophageal ulceration*, changes in the oesophagus*, oesophageal ulcer*, tooth discoloration**, oral ulceration**, gastrointestinal discoloration (gastrointestinal melanosus, 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 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 melanosus (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 were receiving iron supplementation due to concomitant anaemia.
Reporting of side effects
If any side effects occur, including any unlisted side effects not mentioned in this leaflet, inform your doctor, pharmacist, or nurse. Side effects 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 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.
There are no special storage instructions.
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. This will help protect the environment.

6. Contents of the packaging and other information

What Tardyferon contains

• The active substance is iron(II) in the form of 247.25 mg of dried ferrous sulfate (hydrated ferrous sulfate) (Ferrosi sulfas), corresponding to a dose of 80 mg of ferrous ions (Fe²⁺).
• Other ingredients: maltodextrin, microcrystalline cellulose, ammonium methacrylate copolymer (type A) 30% dispersion, ammonium methacrylate copolymer (type B) 30% dispersion, triethyl citrate, talc, glyceryl dibehenate.
  Film 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
30 modified-release tablets in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

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

Marketing authorisation number in the Czech Republic, country of export: 12/125/74-C
Parallel import authorisation number: 11/22