Tardyferon-fol

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
Tardyferon-Fol (Ferro-Tardyferon Fol)
80 mg of iron(II) ions + 0.35 mg, prolonged-release tablets
Ferrosi sulfas + Acidum folicum
Tardyferon-Fol and Ferro-Tardyferon Fol are different brand names for the same medicinal product.
Please read this leaflet carefully before taking 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. It may harm someone else, even if their symptoms are similar.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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 uniformly, thereby reducing the risk of local accumulation in the stomach and intestine, which improves the drug's tolerability. The prolonged release positively affects iron absorption in the intestine. Folic acid is rapidly absorbed.
During pregnancy, the body's demand for iron increases significantly, making deficiency more likely. Initially, iron deficiency may cause general symptoms such as reduced appetite or easy fatigue, without signs of anemia. Only when iron deficiency becomes severe—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. 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, lead poisoning-induced anemia, 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 treatment with Tardyferon-Fol, discuss this 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 disorders.
Iron deficiency associated with inflammatory conditions does not respond to iron therapy. Iron treatment should, whenever possible, be combined with treatment of the underlying cause.
Tardyferon-Fol must be stored out of reach of children, as even the smallest package (30 coated tablets) contains a total iron dose 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 normalization of their previously reduced metabolic rate; monitoring of antiepileptic drug levels and possible dose adjustment are therefore necessary.
You should inform 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 narrowing if the tablet enters the respiratory tract. This may cause persistent cough, coughing up blood, and/or a sensation of breathlessness, even if aspiration occurred several days or even months before the onset of these symptoms. Therefore, it is important to promptly assess whether tablets have damaged the patient's airways.
Melanosis of the gastrointestinal tract (pigmentation in the gastrointestinal system) has been described 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 received iron supplementation due to concomitant anemia.
Due to the risk of oral mucosal ulceration and tooth discoloration, tablets should not be sucked, chewed, or held in the mouth, but swallowed whole with water. If following these instructions 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 used, recently used, or planned for use.

Iron
Contraindicated combinations:
Iron (salts) (administered by injection):
Fainting, and even shock due to rapid release of iron from its complex form and transferrin saturation with iron.

Simultaneous intake of certain antibiotics (tetracyclines) with Tardyferon-Fol reduces their effectiveness.
Iron absorption from Tardyferon-Fol is reduced when administered simultaneously:

• with magnesium, phosphate, calcium, 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 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 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 folic acid content in Tardyferon-Fol, concomitant administration with other medicines 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. Concurrent intake of this medicine with whole-grain products (bran, legumes, oilseed plants), 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 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 possible risks to the fetus.
The amount of iron and folic acid that passes from Tardyferon-Fol 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 affects the ability to drive or operate machinery.

3. How to take Tardyferon-Fol

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
you should 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 meals, depending on gastrointestinal
tolerance (however, avoid the food and drink products listed in the section "Tardyferon-Fol with food, drink and
alcohol").
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 large amounts
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, loss of appetite), as well as liver
and kidney failure.
If too much medicine has been taken, seek emergency medical attention 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 treatment
Tardyferon-Fol should be taken for as long as your doctor recommends. Stopping treatment too early 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 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 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 vocal cords)
Urticaria and allergic dermatitis (skin allergic reactions)
Pulmonary necrosis (tissue death)*
Pulmonary granulomatosis (inflammatory condition)*
Bronchial stenosis (narrowing of 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 throat or oesophageal ulceration (the tube connecting the mouth to the stomach). If a tablet enters the airways, there is a risk of bronchial ulceration (main airway of the lungs), which may lead to bronchial stenosis.
**In case of improper administration, when tablets are chewed, sucked, or held in the mouth.
*** Medical literature has reported gastrointestinal melanosis (pigmentation in the gastrointestinal tract) 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 received 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 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.: +48 22 49 21 301
Fax: +48 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-Fol

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Store in the original packaging in order to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Tardyferon-Fol contains

• The active substances in the medicine are: iron(II) (in the form of ferrous sulfate, dried) in a dose of 80 mg, folic acid in a dose of 0.35 mg.
• Other components are: 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.

What Tardyferon-Fol looks like and contents of the pack
PVC/PVDC/Al blisters containing 30 or 100 prolonged-release tablets in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Portugal, the country of export
Pierre Fabre Médicament Portugal, Lda.
Rua Rodrigo da Fonseca, n.° 178 - 2° Esq.
1099-067 Lisbon
Portugal
Manufacturer
Pierre Fabre Médicament Production
Etablissement 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 Portugal, the country of export: 4979480
Parallel import authorisation number: 228/24