Patient Information Leaflet

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!
Tardyferon-Fol (gyno-Tardyferon)
80 mg of 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 the entire leaflet 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, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are identical.
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

What Tardyferon-Fol is and what it is used for
What you need to know before taking Tardyferon-Fol
How to take Tardyferon-Fol
Possible side effects
How to store Tardyferon-Fol
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 iron(II) (in the form of ferrous sulfate, dried) and folic acid. Iron is released slowly and evenly, thereby reducing the risk of local accumulation in the stomach and intestine, which improves the drug's tolerability. The prolonged release has a beneficial effect on iron absorption in the intestine. Folic acid is absorbed rapidly.

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 substantial—i.e., when there is insufficient iron for adequate hemoglobin production—does overt iron deficiency with anemia develop. General symptoms worsen, and additional signs such as cracked corners of the mouth, brittle nails, and hair may appear.

Significant 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 to 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, lead poisoning-induced anemia, thalassemia, porphyria cutanea tarda);
in cases of confirmed iron intolerance (e.g., severe inflammatory changes in the gastrointestinal tract);
if there are severe impairments of liver or kidney function;
in children.

Warnings and precautions
Before starting treatment with 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 inflammatory conditions of the stomach and intestines, delayed gastric emptying, or other confirmed gastrointestinal disorders.
Hypoferremia associated with inflammatory states 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 this package (30 prolonged-release tablets) contains a total dose of iron which, if taken at once, may (especially in young 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 is therefore necessary, and dosage adjustment may be required.
Tell your doctor before taking Tardyferon-Fol:

if the patient has difficulty swallowing.

If the patient accidentally aspirates a tablet, seek immediate medical attention, as there is a risk of bronchial ulceration or narrowing if the tablet enters the respiratory tract. This may cause persistent cough, coughing up blood, and/or shortness of breath, even if aspiration occurred several days or even months before the onset of these symptoms. Therefore, prompt evaluation is needed to determine whether tablets have damaged the patient's airways.
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 medications for these conditions and who received iron supplementation due to concomitant anemia.
Due to the risk of oral cavity ulceration and tooth discoloration, the tablets must not be sucked, chewed, or held in the mouth. They should be swallowed whole with water. If following this instruction is not possible or if difficulty swallowing occurs, contact your doctor.

Tardyferon-Fol and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.

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.

Concomitant 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 antacids (containing aluminum, magnesium trisilicate, calcium) – these should be taken at least 2 hours after administration of the iron-containing medicine;
with calcium and zinc (these should be taken at least 2 hours after administration of the iron-containing medicine).

Concomitant 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 the iron-containing medicine).
The irritating effect of iron-containing medicines on the gastric and intestinal mucosa 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 administration of the iron-containing medicine.

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

Tardyferon-Fol with food, drink, and alcohol
Do not drink large amounts of tea, coffee, or red wine, as this may reduce iron absorption into the body. Concomitant use 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 of at least 2 hours should be maintained between taking iron salts and consuming these products.

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.
This medicine should be administered only if the expected therapeutic benefits outweigh any potential 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 using machines
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 taken exactly as directed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
The recommended dose is one tablet, i.e. 80 mg of ferrous ions and 0.35 mg folic acid, daily or
every other day 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 meals, depending on
gastrointestinal tolerance (however, food products listed in 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.

Taking more Tardyferon-Fol than recommended
Cases of iron salt overdose, particularly in children, have been reported following ingestion of a large
amount of the medicine.
Symptoms of overdose include gastrointestinal irritation with abdominal pain, nausea, vomiting,
diarrhea, cardiovascular shock symptoms, or metabolic acidosis (rapid or shallow breathing, rapid
heartbeat, headache, confusion, drowsiness, fatigue, loss of appetite), as well as liver and kidney failure.
If too much medicine has been taken, contact the emergency department immediately for appropriate treatment.

Missing a 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 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 adverse reactions are listed below in decreasing order of frequency.
Common (may occur in more than 1 in 10 people)
Constipation
Diarrhoea
Feeling of stomach fullness
Stomach pain
Discoloured stools
Nausea
Uncommon (may occur in 1 in 100 people)
Throat swelling (laryngeal oedema)
Unusual stools
Discomfort and pain in the upper abdomen (dyspepsia)
Vomiting
Acute gastritis (irritation of the stomach)
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, soft palate, tongue, throat or larynx)
Urticaria and allergic dermatitis (skin allergic reactions)
Pulmonary necrosis (tissue death)*
Pulmonary granuloma (inflammatory condition)*
Bronchial stenosis (narrowing of the airways)*
Oesophageal ulceration*
Tooth discoloration**
Oral ulceration**
Changes in the oesophagus*
Gastrointestinal melanosis (pigmentation in the gastrointestinal tract)***
*Patients, especially elderly patients and those with swallowing difficulties, may also be at risk of
ulceration of the throat or oesophagus (the tube connecting the mouth to the stomach). If the tablet
enters the airways, there is a risk of bronchial ulceration, which may lead to bronchial sten游戏副本

5. How to store Tardyferon-Fol

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 specified 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 required. This will help protect the environment.

6. Contents of the packaging and other information

What Tardyferon-Fol contains

The active substances are: iron(II) (in the form of iron(II) sulfate, dried) 80 mg and folic acid 0.35 mg.
Other components: ammonio methacrylate copolymer (type B) dispersion (Eudragit RS 30D), ammonio methacrylate copolymer (type A) dispersion (Eudragit RL 30D), maltodextrin, triethyl citrate, talc, glyceryl dibehenate, microcrystalline cellulose; Coating: titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), sepifilm LP010 (hypromellose, microcrystalline cellulose, stearic acid), triethyl citrate.

30 prolonged-release tablets in PVC/PVDC/Al blisters in a cardboard box.
For further detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Greece, country of export:
Pierre Fabre Farmaka A.E.
Leof. Mesogeion 350
153 41 Ag. Paraskevi – Attica
Greece
Manufacturer:
Pierre Fabre Medicament Production
Site Progipharm
Rue du Lycée
45500 Gien, France
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in Greece, country of export: 41914/08/16-1-2009
Parallel import licence number: 123/20