Tardyferon-fol

Patient Information Leaflet

Warning! Keep this leaflet! The information on the outer packaging is in a foreign language.
Tardyferon-Fol (Gyno-Tardyferon), 80 mg iron(II) ions + 0.35 mg
prolonged-release tablets
Ferrosi sulfas + Acidum folicum
Tardyferon-Fol and Gyno-Tardyferon are different brand names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The 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 or pharmacist. See section 4.

Table of contents

1. What Tardyferon-Fol is and what it is used for
2. Important information before taking Tardyferon-Fol
3. How to take Tardyferon-Fol
4. Possible side effects
5. How to store Tardyferon-Fol
6. Contents of the pack and other information

1. What Tardyferon-Fol is and what it is used for

Tardyferon-Fol is a combination medicine containing ferrous sulfate and folic acid. Iron is released slowly and evenly, reducing the risk of local accumulation in the stomach and intestine, thereby improving the drug's tolerability. The prolonged release has a beneficial effect on iron absorption in the intestine. Folic acid is rapidly absorbed.
During pregnancy, the body's demand for iron increases significantly, making iron deficiency common. Initially, iron deficiency may cause general symptoms such as reduced appetite or rapid fatigue, without signs of anemia. Only when iron deficiency becomes severe—i.e., when there is insufficient iron for the essential production of hemoglobin—does overt iron deficiency with anemia develop. General symptoms worsen, and additional signs such as cracking at the corners of the mouth, brittle nails, and hair may appear.
Severe folic acid deficiency may lead to disturbances in the production of red blood cells, white blood cells, and platelets; however, this condition is rare.
Tardyferon-Fol is used for the prevention and treatment of iron and folic acid deficiencies in pregnant women.
Tardyferon-Fol is indicated for use in pregnant women.

2. Important information before using Tardyferon-Fol

When not to use Tardyferon-Fol:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• in all cases of anemia due to causes other than iron deficiency;
• in cases of iron accumulation (hemochromatosis, chronic hemolysis, frequent transfusions);
• in cases of impaired iron utilization (sideroachrestic anemia, anemia caused by lead poisoning, thalassemia, late cutaneous porphyria);
• in cases of confirmed iron intolerance (e.g. severe inflammatory changes in the gastrointestinal tract);
• if severe liver or kidney function disorders are present;
• in children.

Warnings and precautions
Before starting to use Tardyferon-Fol, discuss it with your doctor or pharmacist.
Iron-containing preparations should be used only after consultation with a doctor, especially in cases of gastrointestinal inflammation, delayed gastric emptying, or other confirmed gastrointestinal diseases.
Iron deficiency associated with inflammatory conditions does not respond to iron therapy. Iron treatment should, whenever possible, be combined with causal treatment.
Tardyferon-Fol must be stored out of the reach of children, as even the smallest package (30 coated tablets) contains a total dose of iron which, if taken at once, may (especially in small children) lead to life-threatening poisoning.
Administration of folic acid during treatment with antiepileptic drugs may reduce blood concentrations of these drugs due to restoration of their metabolic rate, previously reduced by folic acid deficiency. Monitoring of antiepileptic drug levels and possible adjustment of dosage are therefore necessary.
Tell your doctor before taking Tardyferon-Fol:

• if the patient has difficulty swallowing.

If the patient accidentally inhales a tablet, contact a doctor immediately, as there is a risk of bronchial ulceration or stricture if the tablet enters the respiratory tract. This may cause persistent cough, coughing up blood, and/or a feeling of breathlessness, even if aspiration occurred several days or even months before the onset of these symptoms. Therefore, a prompt assessment of whether tablets may have damaged the patient's airways is essential.
Melanosis of the gastrointestinal tract (pigmentation in the gastrointestinal system) has been reported in medical literature in elderly patients with chronic kidney disease, diabetes (high blood sugar), and/or hypertension (high blood pressure), who were treated with multiple drugs for these conditions and who were also receiving iron supplementation due to concomitant anemia.
Due to the risk of oral 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, contact your doctor.

Tardyferon-Fol and other medicines
Inform your doctor or pharmacist about all medicines currently or recently used, as well as any medicines you plan to use.

Iron
Combinations not recommended:
Iron (salts) (administered by injection):
Fainting or even shock due to rapid release of iron from its complex form and saturation of transferrin with iron.
Concurrent administration of certain antibiotics (tetracyclines) with Tardyferon-Fol reduces their effectiveness.
Iron absorption from Tardyferon-Fol is reduced when administered simultaneously:

• with magnesium, phosphate, calcium preparations, or gold salts;
• if the patient is taking cholestyramine, Tardyferon-Fol should be administered 1 to 2 hours before or 4 to 6 hours after cholestyramine;
• with gastric acid-neutralizing drugs (containing aluminum, magnesium trisilicate, calcium – these should be taken at least 2 hours after administration of iron-containing medicine);
• with calcium and zinc (these should be taken at least 2 hours after administration of iron-containing medicine).

Concurrent administration of chloramphenicol may delay the therapeutic effect of iron and its compounds.
During treatment with iron preparations, absorption of bisphosphonates, fluoroquinolones, methyldopa, levodopa and carbidopa, thyroxine, D-penicillamine, and zinc compounds is reduced (these should be taken at least 2 hours after administration of iron-containing medicine).
The gastric and intestinal mucosa-irritating effect of iron-containing medicines may be intensified by concomitant use of certain non-steroidal anti-inflammatory drugs (salicylates, phenylbutazone, oxyphenbutazone). These medicines should be taken at least 3–4 hours after taking the iron-containing medicine.

Due to the presence of folic acid in Tardyferon-Fol, co-administration with other medicines also requires special precautions.
Sulfonamides, sulfasalazine, methotrexate, antiepileptic drugs (such as phenobarbital, phenytoin, primidone, fosphenytoin), and sedatives adversely affect folic acid absorption.
Inform your doctor about all recently used medicines, including those available without a prescription.

Food, drink, and alcohol with Tardyferon-Fol
Do not drink large amounts of tea, coffee, or red wine, as this may reduce iron absorption into the body. Concurrent intake of this medicine with whole-grain products (bran, legumes, oilseeds), certain proteins (eggs), or foods and drinks containing calcium (cheese, milk, etc.) is not recommended. An interval should be maintained between taking iron salts and consuming these products (at least 2 hours).

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
This medicine should only be administered if the expected therapeutic benefits outweigh any possible risks to the fetus.
The amount of iron and folic acid from Tardyferon-Fol that passes into breast milk has not been established, and it is unknown whether adverse effects may occur in infants breastfed by mothers receiving this treatment.
During pregnancy and breastfeeding, Tardyferon-Fol may be used only on a doctor's prescription (see section 1. What Tardyferon-Fol is and what it is used for).

Driving and operating machinery
It is unlikely that Tardyferon-Fol will affect the ability to drive or operate machinery.

3. How to use Tardyferon-Fol

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.
The recommended dose is one tablet, i.e. 80 mg of iron ions and 0.35 mg of folic acid daily or on alternate days, during the last two trimesters of pregnancy (or from the 4th month of pregnancy).
Tardyferon-Fol tablets are intended for oral administration.
The tablets should be taken with a large glass of water, before or during a meal, depending on gastrointestinal tolerance (however, food products listed in the section "Tardyferon-Fol with food, drink and alcohol" should be avoided).
The tablet should be swallowed whole with water. Do not suck, chew or hold the tablet in the mouth.

Use of a higher than recommended dose of Tardyferon-Fol
Cases of iron salt overdose, particularly in children, have been reported following ingestion of a large quantity of the medicine.
Symptoms of overdose include signs of gastrointestinal irritation with accompanying abdominal pain, nausea, vomiting, diarrhoea, cardiovascular shock symptoms, or metabolic acidosis (rapid or shallow breathing, increased heart rate, headache, confusion, drowsiness, fatigue, lack of appetite), as well as liver and kidney failure.
If too much medicine has been taken, contact the emergency department immediately for appropriate treatment.

Missed dose of Tardyferon-Fol
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.

Stopping Tardyferon-Fol
Tardyferon-Fol should be taken for as long as your doctor recommends. Premature discontinuation of treatment 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects are listed below in order of decreasing frequency of occurrence.
Common (may affect more than 1 in 10 people)
Constipation
Diarrhoea
Feeling of stomach fullness
Stomach pain
Discoloured stools
Nausea
Uncommon (may affect up to 1 in 100 people)
Throat swelling (laryngeal oedema)
Unusual stools
Discomfort and pain in the upper abdomen (dyspepsia)
Vomiting
Acute gastritis (inflammation of the stomach lining)
Itching (pruritus)
Red skin rash (erythematous rash)
Frequency not known (frequency cannot be estimated from the available data)
Hypersensitivity reactions including anaphylactic reactions (severe, potentially life-threatening allergic reactions)
Angioedema (sudden swelling of lips, cheeks, eyelids, tongue, soft palate, throat or larynx)
Urticaria and allergic dermatitis (skin allergic reactions)
Pulmonary necrosis (tissue death)*
Pulmonary granulomatosis (inflammatory condition)*
Bronchial stenosis (narrowing of the airways)*
Oesophageal ulceration*
Tooth discoloration**
Oral cavity ulceration**
Oesophageal changes*
Gastrointestinal melanosis (pigmentation in the gastrointestinal tract)***
*Patients, especially elderly patients and those with swallowing difficulties, may also be at risk of pharyngeal or oesophageal ulceration (the tube connecting the mouth to the stomach). If a tablet enters the respiratory tract, there is a risk of bronchial ulceration, which may lead to bronchial stenosis.
**In cases of improper use, when tablets are chewed, sucked, or held in the mouth.
*** Gastrointestinal melanosis (pigmentation in the gastrointestinal tract) has been reported in medical literature 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 side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects 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 Warszawa
Tel.: 22 49-21-301
Fax: 22 49-21-309
https://smz.ezdrowie.gov.pl
Reporting side effects helps provide more information on the safety of using this medicine.

5. How to store Tardyferon-Fol

Keep the medicine out of the 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 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 packaging and other information

What Tardyferon-Fol contains

• The active substances are: iron(II) ions in the form of 247.25 mg of dried ferrous sulfate, corresponding to a dose of 80 mg of iron(II) ions, and folic acid at a dose of 0.35 mg.
• Other components are: tablet core: ammonium methacrylate copolymer, dispersion type B (Eudragit RS 30 D), ammonium methacrylate copolymer, dispersion type A (Eudragit RL 30 D), maltodextrin, triethyl citrate, talc, glyceryl dibehenate, microcrystalline cellulose; coating: titanium dioxide (E 171), yellow iron oxide, red iron oxide, Sepifilm LP010, triethyl citrate.

What Tardyferon-Fol looks like and contents of the pack
30 tablets in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Greece, country of export:
PIERRE FABRE FARMAKA A.E.
Leof. Mesogeion 350
153 41 Ag. Paraskevi
Greece
Manufacturer:
PIERRE FABRE MEDICAMENT PRODUCTION
45 Place Abel Gance
92100 Boulogne
France
Parallel importer:
Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Czeski Cieszyn
Czech Republic
Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Production site: Euceryny Laboratorium Farmaceutyczne COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45
31-353 Kraków
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Marketing authorization number in Greece, country of export: 41914/08/16-1-2009
Parallel import authorization number: 31/22
[Trademark information protected]