Tardiferon-fol

Leaflet accompanying the packaging: patient information

Tardyferon-Fol, 80 mg + 0.35 mg, prolonged-release coated tablets

Ferrous sulfate + Folic acid

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

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 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. 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. The iron is released slowly and evenly, which means that it is less likely to accumulate locally in the stomach and intestines, and thus improves the tolerance of the medicine. The delayed release has a beneficial effect on iron absorption in the intestines. Folic acid is absorbed quickly.

During pregnancy, the need for iron increases significantly, and it is easy to become deficient in it. 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, brittle 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 (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 treatment with 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.

Hiposideremia 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 coated tablets) contains a total dose of iron that can be life-threatening if taken at once (especially in small children).

Administering 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, which was previously reduced by the 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 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 ulceration and tooth discoloration, tablets should not be sucked, chewed, or held 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 nonsteroidal 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 drinks 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 taking 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 operate machines.

3. How to take Tardyferon-Fol

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, you should 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 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 gastrointestinal tolerance (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 hold 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 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 more than the recommended dose of the 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 almost time for the next dose, do not take the missed dose and take the next tablet as usual.

Do 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 dermatitis (skin allergic reactions)
Pulmonary infarction (lung tissue death)*
Pulmonary granuloma (inflammatory condition of the lungs)*
Bronchial stenosis (narrowing of the airways)*
Esophageal ulceration*
Tooth discoloration**
Oral 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. If a tablet enters the airways, there is a risk of bronchial ulceration, which can lead to bronchial stenosis.
**In case of improper administration, when tablets are chewed, sucked, or held in the mouth.
***Gastrointestinal melanosis (discoloration in the digestive system) has been described in medical literature 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 Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: ndl@urpl.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide 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 carton after EXP. The expiry date refers to the last day of the month.

There are no special precautions for storing the medicine.

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. Contents of the pack and other information

What Tardyferon-Fol contains

• The active substances of the medicine are: iron (II) in the form of dried iron (II) sulfate in a dose of 80 mg and folic acid in a dose of 0.35 mg.
• The other ingredients are: tablet core: ammonium methacrylate copolymer, type B dispersion (Eudragit RS 30 D), ammonium methacrylate copolymer, type A dispersion (Eudragit RL 30 D), maltodextrin, triethyl citrate, talc, glycerol dibehenate, microcrystalline cellulose; coating: titanium dioxide, yellow iron oxide (E 172), red iron oxide (E 172), Sepifilm LP010 (hypromellose, microcrystalline cellulose, stearic acid), triethyl citrate.

The tablet core: ammonium methacrylate copolymer, type B dispersion (Eudragit RS 30 D), ammonium methacrylate copolymer, type A dispersion (Eudragit RL 30 D), maltodextrin, triethyl citrate, talc, glycerol dibehenate, microcrystalline cellulose; coating: titanium dioxide, 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 tablets in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder

Pierre Fabre Medicament Polska Sp. z o.o.

ul. Belwederska 20/22

00-762 Warsaw

Manufacturer

Pierre Fabre Medicament Production

Site Progipharm

Rue du Lycee

45500 Gien

France

To obtain more detailed information, you should contact the marketing authorization holder:

Pierre Fabre Medicament Polska Sp. z o.o.

ul. Belwederska 20/22

00-762 Warsaw

Tel.: 22 559 63 00

Date of last revision of the leaflet: