PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. The 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 this 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 individual. Do not pass it on to others. The 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

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 evenly, thereby reducing the risk of local accumulation in the stomach and intestine, which improves the drug's tolerability. The prolonged release has a beneficial effect on 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 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 worsen, and additional signs such as cracking of the corners of the mouth, brittle nails, and hair may occur. A significant deficiency of folic acid may lead to disturbances in the production of red blood cells, white blood cells, and platelets—although this phenomenon 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 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, 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 treatment with Tardyferon-Fol, consult your doctor or pharmacist.
Iron-containing preparations should be used only after consulting a physician, especially in cases of inflammatory conditions of the stomach and intestines, delayed gastric emptying, or other confirmed gastrointestinal disorders.
Iron deficiency anemia associated with inflammatory states does not respond to iron therapy. Iron treatment should, whenever possible, be combined with treatment of the underlying condition.
Tardyferon-Fol must be stored out of reach of children, as even the smallest package (30 coated tablets) contains a total dose of iron which, if taken at once, may (particularly 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 metabolic rate previously reduced by folic acid 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, coughing up blood, and/or sensation of breathlessness, even if the inhalation occurred several days or even months before the onset of these symptoms. Therefore, rapid assessment is needed to determine 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 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.
Due to the risk of oral mucosal ulceration and tooth discoloration, the tablets should not be sucked, chewed, or held in the mouth. They should be swallowed whole with water. If following these instructions is not possible or if there are difficulties in swallowing, consult your doctor.

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

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

Concomitant 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).

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 irritant effect of iron-containing medicines on the gastric and intestinal mucosa 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 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 negatively affect folic acid absorption.
Inform your doctor about all recently taken 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 into the body. Concurrent intake of this medicine with whole-grain products (bran, legumes, oilseed plants), certain proteins (eggs), or foods and beverages 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 plans 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 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, 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 items listed in the section "Tardyferon-Fol with food, drink and alcohol").
Swallow the tablet 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, lack of appetite), as well as
liver and kidney failure.
If an excessive amount of the medicine has been taken, seek emergency medical attention immediately
for appropriate treatment.

If you forget to take Tardyferon-Fol
If you miss a dose at the usual time, take it as soon as possible. However, if it is nearly 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 forgotten dose.

Stopping Tardyferon-Fol
Continue taking Tardyferon-Fol for as long as your doctor recommends. 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 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
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 (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 vocal cords)
Urticaria and allergic dermatitis (skin allergic reactions)
Pulmonary necrosis (tissue death)*
Pulmonary granuloma (inflammatory condition)*
Bronchial stenosis (narrowing of the airways)*
Oesophageal ulceration*
Tooth discoloration**
Oral ulceration**
Oesophageal changes*
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 (main airway of the lungs), 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.
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 required. These measures 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 247.25 mg of dried iron(II) sulfate, corresponding to a dose of 80 mg of iron(II) ions, and folic acid 0.35 mg.
Other components are:
Tablet core: ammonium methacrylate copolymer dispersion 30%, type B (Eudragit RS 30D), ammonium methacrylate copolymer dispersion 30%, type A (Eudragit RL 30D), maltodextrin, triethyl citrate, talc, glyceryl dibehenate, microcrystalline cellulose.
Tablet 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
Carton containing 3 PVC-PVDC/Al blisters with 10 prolonged-release tablets each.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Romania, the country of export:
Pierre Fabre Médicament
45, Place Abel Gance
92100 Boulogne
France

Manufacturer:
Pierre Fabre Médicament Production
Site Progipharm
Rue du Lycee, BP 77
45500 Gien
France

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Poland
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
Poland
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Poland

Marketing Authorisation number in Romania, the country of export: 10104/2017/01
Parallel Import Licence number: 53/22