Tardiferon-fol

LEAFLET INCLUDED IN THE PACKAGE: 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

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 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. Package contents and other information

1. What is Tardyferon-Fol and what is it used for

Tardyferon-Fol is a combined medicine containing iron(II) sulfate and folic acid. Iron is released slowly and evenly, which reduces the risk of local accumulation in the stomach and intestines, and thus improves the tolerance of the medicine. Delayed release has a beneficial effect on iron absorption in the intestines. Folic acid is absorbed quickly.

During pregnancy, the demand for iron increases significantly, and iron deficiency can easily occur in the body. Initially, iron deficiency can lead to general complaints, such as decreased appetite or rapid fatigue, without signs of anemia. Only in the case of significant iron deficiency, i.e., when there is not enough iron for the necessary production of hemoglobin, does obvious iron deficiency anemia occur. General complaints worsen, and additional symptoms such as cracking of the corners of the mouth, brittleness of nails and hair may appear. Significant folic acid deficiency can lead to disorders in the production of red blood cells, white blood cells, and platelets - but this phenomenon occurs rarely.

Tardyferon-Fol is used to prevent and treat iron and folic acid deficiencies in pregnant women.

Tardyferon-Fol is indicated for use in pregnant women.

2. Important information before taking Tardyferon-Fol

When not to take 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 cases of all anemias with causes other than iron deficiency;
• in cases of iron accumulation (hemochromatosis, chronic hemolysis, frequent transfusions);
• in cases of difficulty with iron incorporation (sideroachrestic anemia, lead poisoning-induced anemia, thalassemia, porphyria cutanea tarda);
• in cases of confirmed iron intolerance (e.g., severe inflammatory changes in the digestive tract);
• if there are severe liver and kidney function disorders;
• in children.

Warnings and precautions

Before starting to take Tardyferon-Fol, you should discuss it with your doctor or pharmacist.

Iron preparations should be used after consulting a doctor, especially in cases of stomach and intestinal inflammation, delayed stomach emptying, and other confirmed digestive system diseases.

Hypochromic anemia associated with inflammatory conditions does not respond to iron treatment. Iron treatment must be combined with causal treatment as much as possible.

Tardyferon-Fol should be stored in a place inaccessible to children, as even the smallest package (30 film-coated tablets) contains a total dose of iron that can be life-threatening if taken at once (especially in small children).

Administration of folic acid during treatment with antiepileptic drugs may decrease the concentrations of these drugs in the blood due to the return to normal of their metabolism rate, reduced previously by its deficiency; it is necessary to monitor the concentration of antiepileptic drugs and possibly adjust their dosage.

You should tell your doctor before taking Tardyferon-Fol:

• if the patient has difficulty swallowing.

If the patient accidentally chokes on a tablet, they should immediately contact a doctor, as there is a risk of esophageal or bronchial ulceration if the tablet enters the airways. This can cause persistent cough, hemoptysis, and (or) shortness of breath, even if the choking occurred several days or even several months before the onset of these symptoms. Therefore, it is necessary to quickly assess whether the tablets are not damaging the patient's airways.

In medical literature, gastrointestinal melanosis (discoloration in the digestive system) has been described in elderly patients with chronic kidney disease, diabetes (high blood sugar levels), and (or) hypertension (high blood pressure), treated with several drugs against these diseases and receiving iron supplementation due to accompanying anemia.

Due to the risk of oral mucosa ulceration and tooth discoloration, tablets should not be sucked, chewed, or kept in the mouth, but swallowed whole, washed down with water. If following these instructions is not possible or there are difficulties with swallowing, you should contact a doctor.

Tardyferon-Fol and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Iron

Contraindicated combinations:

Iron (salts)(administered by injection):
Syncope, and even shock associated with rapid release of iron from its complex form and saturation of transferrin with iron.

Concomitant administration of certain antibiotics (tetracyclines) with Tardyferon-Fol reduces their effectiveness.

Absorption of iron from Tardyferon-Fol is reduced if it is 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 taking cholestyramine;
• with antacids (containing aluminum, magnesium trisilicate, calcium - they should be taken at least 2 hours after administration of the iron-containing medicine);
• with calcium and zinc (they 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, the absorption of bisphosphonates, fluoroquinolones, methyldopa, levodopa, and carbodopa, thyroxine, D-penicillamine, and zinc compounds is reduced (they should be taken at least 2 hours after administration of the iron-containing medicine).

The effect of iron-containing medicines irritating the gastric mucosa and intestines may be enhanced by concomitant administration of certain non-steroidal anti-inflammatory drugs (salicylates, phenylbutazone, oxyphenbutazone). These drugs should be taken at least 3-4 hours after administration of 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 have an adverse effect on folic acid absorption.

You should inform your doctor about all medicines you have taken recently, even those that are available without a prescription.

Tardyferon-Fol with food, drink, and alcohol

You should not drink large amounts of tea, coffee, and red wine, as this may reduce iron absorption into the body. It is not recommended to take this medicine with whole grain products (bran, legumes, oilseeds), certain proteins (eggs), or foods and beverages containing calcium (cheese, milk, etc.). You should maintain a gap between taking iron salts and consuming these products (at least 2 hours).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.

This medicine should only be taken if the expected therapeutic benefits outweigh the potential risk 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 not known whether children breastfed by mothers receiving this treatment may experience side effects.

During pregnancy and breastfeeding, Tardyferon-Fol can only be taken with a doctor's prescription (see section 1. What is Tardyferon-Fol and what is it used for).

Driving and using machines

It is unlikely that Tardyferon-Fol will affect your ability to drive or use machines.

3. How to take Tardyferon-Fol

This medicine should always be taken according to the doctor's or pharmacist's recommendations. If you have any doubts, you should consult a doctor or pharmacist.

The recommended dose is one tablet, i.e., 80 mg of iron ions and 0.35 mg of folic acid per day or every other day, in the last two trimesters of pregnancy (or from the 4th month of pregnancy).

Tardyferon-Fol tablets are intended for oral administration.

Tablets should be taken with a large glass of water, before or during meals, depending on the tolerance of the digestive tract (however, you should avoid food products listed in the section "Tardyferon-Fol with food, drink, and alcohol").

The tablet should be swallowed whole, washed down with water. Do not suck, chew, or keep it in your mouth.

Taking a higher dose of Tardyferon-Fol than recommended

Cases of iron salt overdose have been reported, especially in children, as a result of swallowing a large amount of medicine.

Overdose symptoms include signs of gastrointestinal irritation with accompanying abdominal pain, nausea, vomiting, diarrhea, symptoms of cardiovascular shock or metabolic acidosis (rapid or shallow breathing, rapid heartbeat, headache, confusion, drowsiness, fatigue, loss of appetite), and liver and kidney failure.

If you have taken too much medicine, you should immediately contact the emergency department for proper treatment.

Missing a dose of Tardyferon-Fol

If you miss a dose at the usual time, you should take it as soon as possible. However, if it is close to the time for the next dose, you should not take the missed dose and take the next tablet as usual.

You should not take a double dose to make up for the missed dose.

Stopping treatment with Tardyferon-Fol

Tardyferon-Fol should be taken for as long as your doctor recommends. If you stop treatment too early, the disease may recur.

If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tardyferon-Fol can cause side effects, although not everybody gets them.

Side effects are described according to their frequency of occurrence.

Common (may affect up to 1 in 10 people)Constipation
Diarrhea
Feeling of fullness in the stomach
Stomach pain
Discolored stools
Nausea

Uncommon (may affect up to 1 in 100 people)

Throat swelling (laryngeal edema)
Abnormal stools
Discomfort and pain in the upper abdomen (dyspepsia)
Vomiting
Acute gastritis (gastritis)
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 the lips, cheeks, eyelids, tongue, soft palate, throat, or larynx)
Urticaria and allergic skin inflammation (skin allergic reactions)
Pulmonary infarction (lung tissue death)*
Pulmonary granuloma (inflammatory lung disease)*
Bronchial stenosis (narrowing of the airways)*
Esophageal ulceration*
Tooth discoloration**
Oral mucosa ulceration**
Esophageal changes*
Gastrointestinal melanosis (discoloration in the digestive system)***
*Patients, especially the elderly and those with swallowing difficulties, may also be at risk of esophageal or bronchial ulcers (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 can lead to bronchial stenosis.
**In case of improper administration, when tablets are chewed, sucked, or kept in the mouth.
***In medical literature, gastrointestinal melanosis (discoloration in the digestive system) has been described in elderly patients with chronic kidney disease, diabetes (high blood sugar levels), and (or) hypertension (high blood pressure), treated with several drugs against these diseases and receiving iron supplementation due to accompanying anemia.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Tardyferon-Fol

The medicine should be stored in a place 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 in a temperature below 30°C in the original packaging.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Tardyferon-Fol contains

• The active substances of the medicine 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 0.35 mg of folic acid
• Other ingredients are: Tablet core: ammonio methacrylate copolymer, dispersion 30%, type B (Eudragit RS 30D), ammonio methacrylate copolymer, dispersion 30%, type A (Eudragit RL 30D), maltodextrin, triethyl citrate, talc, glycerol dibehenate, microcrystalline cellulose. Tablet coating: titanium dioxide (E 171), iron oxide yellow (E 172), iron oxide red (E 172), sepifilm LP010 (hypromellose, microcrystalline cellulose, stearic acid, triethyl citrate.

What Tardyferon-Fol looks like and what the package contains

A box containing 3 PVC-PVDC/Al blisters with 10 prolonged-release tablets in each.

To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization 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

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Romania, the country of export: 10104/2017/01
Parallel import authorization number: 53/22
Date of leaflet approval: 19.01.2022
[Information about the trademark]