Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging is 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 trade names for the same medicinal product.
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 person. 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 or pharmacist. See section 4.

Table of contents of the leaflet

What Tardyferon-Fol is and what it is used for
Important information 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 ferrous sulfate and folic acid. Iron is released slowly and uniformly, thereby reducing the risk of local accumulation in the stomach and intestine, thus 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 more likely. Initially, iron deficiency may cause general symptoms such as reduced appetite or rapid fatigue, without signs of anemia. Only when iron deficiency becomes substantial—that is, when there is insufficient iron for the necessary production of hemoglobin—does overt iron deficiency with anemia develop. General symptoms intensify, and additional signs such as cracking of the 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 anaemia due to causes other than iron deficiency;
in cases of iron accumulation (hemochromatosis, chronic hemolysis, frequent transfusions);
in cases of impaired iron incorporation (sideroachrestic anaemia, lead poisoning-induced anaemia, thalassemia, porphyria cutanea tarda);
in cases of confirmed iron intolerance (e.g. severe inflammatory changes in the gastrointestinal tract);
if there are severe liver or kidney function disorders;
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 diseases.
Hypochromic anaemia associated with inflammatory conditions does not respond to iron therapy. Iron treatment should, whenever possible, be combined with causal treatment.
Keep Tardyferon-Fol out of the reach of children, as even the smallest package (30 prolonged-release 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 deficiency. Monitoring of antiepileptic drug levels and possible dose adjustment are therefore necessary.
Tell your doctor before taking Tardyferon-Fol:

if the patient has difficulty swallowing.

If the patient accidentally inhales a tablet, seek immediate medical attention, as there is a risk of bronchial ulceration or stricture if the tablet enters the respiratory tract. This may cause persistent cough, haemoptysis, and/or dyspnoea, even if aspiration occurred several days or even months before the onset of these symptoms. Therefore, prompt evaluation is needed to determine whether tablets are damaging 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 glucose levels), and/or hypertension (high blood pressure), who were treated with multiple drugs for these conditions and who were receiving iron supplementation due to concomitant anaemia.
Due to the risk of oral 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, 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
Contraindicated combinations:
Iron (salts) (administered by injection):
Fainting, and even shock due to rapid release of iron from its complex form and saturation of transferrin 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 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 aluminium, 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 gastrointestinal mucosa-irritating effect of iron-containing medicines may be intensified by concomitant use of certain nonsteroidal 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, concomitant 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 medicines recently taken, 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, 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 or 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 foetus.
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 taken as directed by a physician or pharmacist. If in doubt,
consult your doctor or pharmacist.
The recommended dose is one tablet, i.e. 80 mg of ferrous ions (Fe²⁺) and 0.35 mg 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 food products listed in 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.

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
amount of the medicine.
Symptoms of overdose include gastrointestinal irritation with abdominal pain, nausea, vomiting, diarrhoea,
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 an excessive amount of the medicine has been taken, contact the emergency department immediately for appropriate treatment.

Missed dose of Tardyferon-Fol
If a dose has been 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 regular scheduled 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 directed by your doctor. 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 they do not occur in everyone.
The reactions are listed below in order of decreasing frequency of occurrence.

Common (may occur in more than 1 in 10 people)
Constipation
Diarrhea
Feeling of stomach fullness
Stomach pain
Discolored stools
Nausea

Uncommon (may occur in 1 in 100 people)
Throat swelling (laryngeal edema)
Abnormal stools
Discomfort and pain in the upper abdomen (dyspepsia)
Vomiting
Acute gastritis (gastric irritation)
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 the lips, cheeks, eyelids, tongue, soft palate, throat, or larynx)
Urticaria and allergic dermatitis (skin allergic reactions)
Pulmonary necrosis (tissue death)*
Pulmonary sarcoidosis (inflammatory condition)*
Bronchial stenosis (airway narrowing)*
Esophageal ulceration*
Tooth discoloration**
Oral ulceration**
Changes in the esophagus*
Gastrointestinal melanosis (pigmentation in the gastrointestinal tract)***

*Patients, especially elderly patients and those with swallowing difficulties, may also be at risk of pharyngeal or esophageal ulceration (the tube connecting the oral cavity to the stomach). If the tablet enters the respiratory tract, there is a risk of bronchial ulceration, which may lead to bronchial stenosis.
**In case of improper administration, 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 glucose levels), and/or hypertension (high blood pressure), who were treated with multiple medications for these conditions and received iron supplementation due to concomitant anemia.

Reporting of adverse reactions
If any adverse reactions occur, including any possible 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, 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 packaging. The expiry date refers to the last day of the specified month.
Store below 30°C. Keep in the original packaging 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 are: iron(II) ions (in the form of 247.25 mg of dried ferrous sulfate) in a dose of 80 mg and folic acid in a dose of 0.35 mg.
Other components are: tablet core: ammonium methacrylate copolymer dispersion, type B (Eudragit RS 30D), ammonium methacrylate copolymer dispersion, type A (Eudragit RL 30D), maltodextrin, triethyl citrate, talc, glycerol 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
30 or 100 tablets in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Portugal, the country of export:
Pierre Fabre Médicament Portugal, Lda.
Rua Rodrigo da Fonseca, n.º 178 - 2º Esq.
1099-067 Lisbon, Portugal
Manufacturer:
Pierre Fabre Médicament Production
Etablissement Progipharm - Rue du Lycée
45500 Gien, France
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in Portugal, the country of export: 4979480
Parallel Import Authorisation Number: 98/16