Tardiferon-fol

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Tardyferon-Fol(Ferro-Tardyferon Fol)

80 mg of iron(II) ions + 0.35 mg, prolonged-release tablets

Ferrosi sulfas + Acidum folicum
Tardyferon-Fol and Ferro-Tardyferon Fol are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the drug, 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 drug has been prescribed to a specific person. Do not pass it on to others. The drug may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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 combination drug containing iron(II) sulfate and folic acid. Iron is released slowly and evenly, which reduces the likelihood of local accumulation in the stomach and intestines, and thus improves the tolerance of the drug. Delayed release has a beneficial effect on iron absorption in the intestine. Folic acid is absorbed quickly.
During pregnancy, the demand for iron increases significantly, and it is easy to develop a deficiency 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 to produce the necessary 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 drug (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 (sideroblastic 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 taken after consulting a doctor, especially in cases of stomach and intestinal inflammation, delayed stomach emptying, and other confirmed digestive system diseases.
Hyposideremia 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 levels of these drugs in the blood due to the return to normal of their metabolism rate, which was previously reduced by its deficiency; it is necessary to monitor the levels 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 their 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 damaging the patient's airways.
In the 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 your doctor.

Tardyferon-Fol and other drugs

You should tell your doctor or pharmacist about all the drugs you are currently taking or have recently taken, as well as any drugs 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 iron administration);
• with calcium and zinc (they should be taken at least 2 hours after iron administration).

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 iron administration).
The effect of iron drugs irritating the gastric mucosa and intestines may be enhanced by concomitant administration of certain nonsteroidal anti-inflammatory drugs (salicylates, phenylbutazone, oxyphenbutazone). These drugs should be taken at least 3-4 hours after iron administration.

Due to the presence of folic acid in Tardyferon-Fol, concomitant administration with other drugs 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 the drugs 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 drug with whole grain products (bran, legumes, oilseeds), certain proteins (eggs), or foods and beverages containing calcium (cheese, milk, etc.). You should maintain an interval between taking iron salts and consuming these products (at least 2 hours).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this drug.
This drug should only be administered 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 side effects may occur in breastfed children.
During pregnancy and breastfeeding, Tardyferon-Fol can be taken only 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 the ability to drive and use machines.

3. How to take Tardyferon-Fol

This drug should always be taken according to the doctor's or pharmacist's recommendations. In case of 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 the 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 the drug.
Overdose symptoms include signs of gastrointestinal irritation with accompanying abdominal pain, nausea, vomiting, diarrhea, signs of cardiovascular shock or metabolic acidosis (rapid or shallow breathing, rapid heartbeat, headache, confusion, drowsiness, fatigue, loss of appetite), as well as liver and kidney failure.
In case of taking too much of the drug, you should immediately contact the emergency department for proper treatment.

Missing a dose of Tardyferon-Fol

If you miss a dose, you should take it as soon as possible. However, if it is almost 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 Tardyferon-Fol treatment

Tardyferon-Fol should be taken for as long as the doctor recommends. If the treatment is stopped too early, the disease may recur.
In case of any further doubts related to the use of this drug, you should consult a doctor or pharmacist.

4. Possible side effects

Like all drugs, this drug can cause side effects, although they may not occur in everyone.
Side effects are described according to their 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)
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 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 (tissue death)*
Pulmonary granuloma (inflammatory condition)*
Bronchial narrowing (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 main airway of the lungs). If a tablet enters the airways, there is a risk of bronchial ulceration, which can lead to bronchial narrowing.
**In case of improper administration, when tablets are chewed, sucked, or kept in the mouth.
***In the 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 or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +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 the drug.

5. How to store Tardyferon-Fol

The drug should be stored in a place invisible and inaccessible to children.
Do not use this drug after the expiration date stated on the box after: EXP. The expiration date means the last day of the specified month.
Do not store above 30°C.
Store in the original packaging to protect from light.
Drugs should not be disposed of in the sewage system or household waste containers. You should ask your pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Package contents and other information

What Tardyferon-Fol contains

• The active substances of the drug are: iron(II) (in the form of iron(II) sulfate, dried) in a dose of 80 mg, folic acid in a dose of 0.35 mg.
• Other ingredients are: ammonium methacrylate copolymer (type B), dispersion (Eudragit RS 30D); ammonium methacrylate copolymer (type A), dispersion (Eudragit RL 30D); maltodextrin; triethyl citrate; talc; glycerol dibehenate; microcrystalline cellulose. 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

PVC/PVDC/Al blisters containing 30 or 100 prolonged-release tablets in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export

Pierre Fabre Médicament Portugal, Lda.
Rua Rodrigo da Fonseca, n.° 178 - 2° Esq.
1099-067 Lisbon
Portugal

Manufacturer

Pierre Fabre Médicament Production
Etablissement Progipharm
Rue du Lycée
45500 Gien
France

Parallel importer:

Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o
Zbąszyńska Street 3
91-342 Łódź
Marketing authorization number in Portugal, the country of export: 4979480
8504126
4979589

Parallel import authorization number: 228/24

Date of leaflet approval: 06.06.2024

[Information about the trademark]