Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Tardyferon-Fol
80 mg of iron(II) ions + 0.35 mg, modified-release tablets
Ferrosi sulfas + Acidum folicum
Please read the entire leaflet carefully before taking this 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, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm someone else, even if their symptoms are the same.
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 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 dried 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. Delayed release has a beneficial effect on iron absorption in the intestine. Folic acid is rapidly absorbed.

During pregnancy, the body's requirement for iron increases significantly, making iron deficiency common. Initially, iron deficiency may cause general symptoms such as reduced appetite or easy fatigue, without signs of anemia. Only when iron deficiency becomes substantial—that is, 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, such occurrences are 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 components 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 there are severe impairments in liver or kidney function;
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 gastric or intestinal inflammation, delayed gastric emptying, or other confirmed gastrointestinal disorders.
Hypoferremia 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 reach of children, as even the smallest pack (30 modified-release tablets) contains a total dose of iron which, if taken at once (especially in small children), may lead to life-threatening poisoning.
Administration of folic acid during antiepileptic drug therapy may increase the metabolism of these drugs (previously reduced due to folic acid deficiency) back to normal, thereby decreasing their blood concentrations. Monitoring of antiepileptic drug levels is required, and dosage adjustments may be 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, hemoptysis, and/or dyspnea, 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 glucose levels), 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 ulceration and tooth discoloration, 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 swallowing difficulties occur, consult a doctor.

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

Iron
Contraindicated combinations:
Iron (salts) (administered by injection):
Fainting or even shock due to rapid release of iron from its complexed form and saturation of transferrin with iron.
Simultaneous 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, 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 drugs that neutralize gastric acid (containing aluminum, magnesium trisilicate, or 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 iron therapy, 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 (NSAIDs) (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 use 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.

Tardyferon-Fol with food, drink, and alcohol
Do not drink large amounts of tea, coffee, or red wine, as this may reduce iron absorption. 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. A time 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 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 has any influence on 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 you are unsure,
you should consult your doctor or pharmacist.
The recommended dose is one tablet, i.e. 80 mg of ferrous(II) ions 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, either 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
amount 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 an excessive amount of the medicine has been taken, seek immediate medical attention at an emergency department for appropriate treatment.

Missed dose of Tardyferon-Fol
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 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. Stopping treatment too early 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The adverse effects are listed below in order of decreasing frequency.
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 (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 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 throat or oesophageal ulceration (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 stenosis.
**In case of incorrect administration, when tablets are chewed, sucked or held in the mouth.
***Gastrointestinal melanosis (pigmentation in the gastrointestinal tract) has been described 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 adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can also 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, phone: +48 (22) 49 21 301, fax: +48 (22) 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps 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 stated 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. Such measures will help protect the environment.

6. Contents of the pack and other information

What Tardyferon-Fol contains

The active substances are: iron(II) (in the form of dried iron(II) sulfate) and folic acid. Each tablet contains 80 mg of iron(II) ions in the form of dried iron(II) sulfate and 0.35 mg of folic acid.
Other components: ammonio methacrylate copolymer (type B), ammonio methacrylate copolymer (type A), 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 colourless (hypromellose, microcrystalline cellulose, stearic acid), triethyl citrate.

What Tardyferon-Fol looks like and contents of the pack
Modified-release tablets in cardboard boxes containing 30 or 100 tablets.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in the Czech Republic, country of export:
Pierre Fabre Medicament
Les Cauquillous
81500 Lavaur
France
Manufacturer:
Pierre Fabre Medicament Production
Site Progipharm
Rue du Lycée - 45500 Gien
France
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorisation number in the Czech Republic, country of export: 12/135/92-S/C
Parallel import authorisation number: 10/25