Tardyferon-fol

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the 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
Read the following information 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 individual. 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 adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 evenly, thereby reducing the risk of local accumulation in the stomach and intestine, which improves the drug's tolerability. The modified release positively affects iron absorption in the intestine. Folic acid is absorbed rapidly.
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 easy fatigue, without signs of anemia. Only when iron deficiency becomes severe—that is, when insufficient iron is available for the essential production of hemoglobin—does overt iron deficiency with anemia develop. General symptoms intensify, and additional signs such as cracked corners of the mouth, brittle nails, and hair may occur. Severe deficiency of folic acid 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, porphyria cutanea tarda);
• 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 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 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.
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 lead to life-threatening poisoning (especially in young children).
Administration of folic acid during treatment with antiepileptic drugs may reduce blood concentrations of these drugs due to normalization of their metabolism previously slowed by folic acid deficiency. Monitoring of antiepileptic drug levels and possible dose adjustment are 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 stricture if the tablet enters the respiratory tract. This may cause persistent cough, coughing up blood, and/or a feeling of breathlessness, even if the inhalation occurred several days or even months before these symptoms appear. Therefore, it is essential to promptly assess whether tablets may 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 glucose), and/or hypertension (high blood pressure), who were treated with multiple drugs for these conditions and 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 this instruction is not possible or if swallowing difficulties occur, contact your doctor.

Tardyferon-Fol and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Iron
Combinations not recommended:
Iron (salts) (administered by injection):
Fainting, and even shock, related to rapid release of iron from its complexed form and transferrin saturation 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, 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).

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 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, co-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 recently taken medicines, 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, oilseed seeds), certain proteins (eggs), or foods and beverages 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 or breastfeeding, suspects she may be pregnant, or plans to become pregnant, 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 taken 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 take Tardyferon-Fol

This medicine should always be taken exactly 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 ions and 0.35 mg of folic acid, taken 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, 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.

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 you have taken too much medicine, contact the emergency department immediately for appropriate treatment.

Missing a dose of Tardyferon-Fol

If you miss a dose at your usual time, take it as soon as possible. However, if it is almost time for your 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The reactions are listed below in decreasing order of frequency.
Common (may occur in more than 1 in 10 people)
Constipation
Diarrhea
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 (gastric irritation)
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, tongue, soft palate, throat or larynx)
Urticaria and allergic dermatitis (skin allergic reactions)
Pulmonary necrosis (tissue death)*
Pulmonary granuloma (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 pharyngeal or oesophageal ulceration (the tube connecting the mouth to the stomach). If the tablet enters the respiratory tract, 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 stated month.
No special storage conditions are required.
Medicines should 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 package and other information

What Tardyferon-Fol contains

• 1 modified-release tablet contains 80 mg iron(II) ions (in the form of iron(II) sulfate, dried 247.25 mg) ( Ferrosi sulfas ) and 0.35 mg folic acid ( Acidum folicum ).
• Other ingredients: tablet core: ammonium methacrylate copolymer (type B), 30% dispersion, ammonium methacrylate copolymer (type A), 30% dispersion, maltodextrin, triethyl citrate, talc, glyceryl dibehenate, microcrystalline cellulose; coating: titanium dioxide, yellow iron oxide, red iron oxide, 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 further 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 Lyceé
45500 Gien
France
Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland
Marketing authorisation number in the Czech Republic, country of export: 12/135/92-S/C
Parallel import authorisation number: 63/25