Tardyferon fol

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Tardyferon Fol, 80 mg iron(II) ions + 0.35 mg, prolonged-release tablets
Ferrosi sulfas + Acidum folicum
Please read the entire leaflet carefully before using 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 questions, please consult your doctor or pharmacist.
• 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 or pharmacist. See section 4.

Table of Contents

1. What is Tardyferon Fol and what is it 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 is Tardyferon Fol and what is it 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 delayed 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 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 pronounced—when there is insufficient iron for the necessary 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.
Significant folic acid deficiency may lead to disturbances in the production of red blood cells, white blood cells, and platelets—although such effects 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 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 incorporation (sideroachrestic anemia, lead poisoning-induced anemia, thalassemia, late porphyria cutanea);
• 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.
Hypoferremia 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 reach of children, as even the smallest package (30 prolonged-release tablets) contains a total iron dose 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 increase the metabolism of these drugs back to normal levels (previously reduced due to folic acid deficiency), thereby lowering their blood concentrations. Monitoring of antiepileptic drug levels and possible dose adjustment are therefore required.
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 narrowing if the tablet enters the respiratory tract. This may cause persistent cough, coughing up blood, and/or a sensation of breathlessness, even if the inhalation occurred several days or even months before these symptoms appear. Therefore, prompt evaluation is necessary to determine whether tablets may 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 medications for these conditions and who were receiving iron supplementation due to concomitant anemia.
Due to the risk of oral ulceration and tooth discoloration, do not suck, chew, or hold the tablets in the mouth. Swallow them 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 used, recently used, or planned for use.

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

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 the iron-containing medicine).
The gastric and intestinal mucosa-irritating effect of iron-containing medicines may be intensified by concurrent 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, 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 medicines recently taken, including those available without a prescription.

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 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 should 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 your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The recommended dose is one tablet, i.e. 80 mg of iron(II) 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 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 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, 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 treatment
Tardyferon Fol should be taken for as long as directed by your doctor. Premature discontinuation of
treatment may lead to recurrence of the disease.
If you have any further doubts regarding 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 by 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)
• 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 unknown (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 larynx)
• Urticaria and allergic dermatitis (skin allergic reactions)
• Pulmonary necrosis (tissue death)*
• Pulmonary granuloma (inflammatory condition)*
• Bronchial constriction (narrowing of airways)*
• Throat ulceration*
• Tooth discoloration**
• Oral ulceration**
• Esophageal changes*
• Gastrointestinal melanosiderosis (pigmentation in the gastrointestinal tract)***

*Patients, especially elderly patients and those with swallowing difficulties, may also be at risk of throat or esophageal (the tube connecting the mouth to the stomach) ulceration. If a tablet enters the airways, there is a risk of bronchial ulceration (main lung airway), which may lead to bronchial constriction.
**In cases of incorrect administration, when tablets are chewed, sucked, or held in the mouth.
*** Gastrointestinal melanosiderosis (pigmentation in the gastrointestinal tract) has been described in medical literature in elderly patients with chronic kidney disease, diabetes (high blood sugar), and/or hypertension (high blood pressure), who are treated with multiple medications for these conditions and who receive 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 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, 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 stated month.
Store below 30°C, in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps 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 dried ferrous sulfate and folic acid. Each tablet contains 80 mg of iron(II) ions in the form of dried ferrous sulfate and 0.35 mg of folic acid.
• Other components: ammonio methacrylate copolymer (type B), 30% dispersion (Eudragit RS 30D), ammonio methacrylate copolymer (type A), 30% 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
30 or 100 prolonged-release tablets in a cardboard box.
For further information, please contact the responsible party or parallel importer.
Responsible party in Romania, 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:
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 authorization number in Romania, country of export: 10104/2017/01
Parallel import authorization number: 54/15