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 iron(II) ions, prolonged-release tablets
Ferrosi sulfas
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. This medicine may harm others, even if their symptoms of illness 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

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, after childbirth, in breastfeeding mothers, and in adolescents during periods of growth. Iron deficiency or iron-deficiency anemia can be prevented or treated using a medicine called Tardyferon.
In the combination of iron with auxiliary substances, Fe ions are released slowly, thus avoiding sudden absorption of the entire iron dose into the blood serum.
This reduces the number of adverse effects observed and makes it easier for the patient to adhere to recommendations. The slow release of the drug enables 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 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 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 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. Tardyferon is not recommended for 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 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 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 receive appropriate treatment.
Melanosis of the gastrointestinal tract (pigmentation in the gastrointestinal system) has been reported 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 who were also receiving 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 mucosal ulceration and tooth staining, 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 aged over 10 years.

Tardyferon with other medicines
Do not take Tardyferon unless advised by a doctor.
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines they 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-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);
• medicines that neutralize stomach acid (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 lower 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 and 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, 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 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 effects on newborns/infants are expected. Tardyferon may be used during breastfeeding.

Driving and operating machinery
It is unlikely that Tardyferon has any influence on the ability to drive or operate machinery.

3. How to use Tardyferon

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
you should 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, can 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 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”).
Taking more Tardyferon than recommended
If you take too much of this medicine, contact your doctor or the nearest emergency department
immediately to receive 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 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, yellowing of the skin and eyes, dark urine).

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 you miss a dose 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
Tardyferon should be taken for as long as your doctor recommends. Premature discontinuation of therapy may lead to 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 decreasing order of 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, acute 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), necrosis of lung cells or tissue (pulmonary necrosis)*, inflammation of lung tissue (pulmonary granulomatosis)*, narrowing of the airways (bronchial stenosis)*, oesophageal ulceration*, oesophageal lesions*, 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 developing ulcers in the throat or oesophagus. If the 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 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 of 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.
Adverse reactions can also be reported to the marketing authorisation holder or parallel importer.
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 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 pack and other information

What Tardyferon contains

• The active substance is iron(II) ions in the form of iron(II) sulfate, dried 247.25 mg, corresponding to a dose of 80 mg of iron(II) ions.
• Other components are: maltodextrin, microcrystalline cellulose, ammonio methacrylate copolymer (type A), ammonio methacrylate copolymer (type B), 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
30 prolonged-release tablets in a cardboard box.
For more detailed information, please contact the responsible party or 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:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
ul. Działkowa 56 ul. Forteczna 35-37 ul. Tymiankowa 24/28
02-234 Warsaw 87-100 Toruń 95-054 Ksawerów
Marketing Authorisation Number in Spain, country of export: 672908.3
Parallel Import Authorisation Number: 302/23