Tardyferon-fol

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Tardyferon-Fol
80 mg iron(II) ions + 0.35 mg, prolonged-release tablets
Ferrosi sulfas + Acidum folicum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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 local accumulation in the stomach and intestine, which improves the drug's tolerability. The delayed release has a beneficial effect on iron absorption in the intestine. Folic acid is rapidly absorbed.
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 essential production of hemoglobin—does overt iron deficiency with anemia develop. General symptoms worsen, and additional signs such as cracking at the corners of the mouth, brittle nails, and hair may appear.
Significant folic acid deficiency 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 incorporation (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 of liver or kidney function;
• in children.

Warnings and precautions
Before starting treatment with 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 gastric or intestinal inflammation, delayed gastric emptying, or other confirmed gastrointestinal disorders.
Hypochromic anemia associated with inflammatory conditions does not respond to iron therapy. Iron treatment should, whenever possible, be combined with treatment of the underlying cause.
Tardyferon-Fol must be stored out of reach of children, as even the smallest package (30 prolonged-release tablets) contains a total iron dose which, if taken at once (especially in small children), may 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 is required and dosage adjustment may be necessary.
Tell your doctor before taking Tardyferon-Fol:

• if the patient has difficulty swallowing.

If the patient accidentally inhales the 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 sensation of breathlessness, even if the inhalation occurred several days or even months before the onset of these symptoms. Therefore, prompt evaluation is needed to determine whether tablets have damaged the patient's airways.
Melanosis of the gastrointestinal tract (pigmentation in the gastrointestinal system) has been reported in medical literature in elderly patients with chronic kidney disease, diabetes (high blood sugar), 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 difficulty swallowing occurs, contact your doctor.

Tardyferon-Fol and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.

Iron
Combinations not recommended:
Iron (salts) (administered by injection):
Fainting or even shock due to rapid release of iron from its complex 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, 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 gastric and intestinal mucosa-irritating effect of iron-containing drugs may be intensified by concomitant use of certain non-steroidal anti-inflammatory drugs (NSAIDs) (salicylates, phenylbutazone, oxyphenbutazone). These drugs 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 used medicines, including those available without a prescription.

Tardyferon-Fol, food, drink, and alcohol
Do not drink large amounts of tea, coffee, or red wine, as this may reduce iron absorption into the body. Concomitant intake of this medicine with whole-grain products (bran, legumes, oilseeds), certain proteins (eggs), or foods and drinks 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 or breastfeeding, suspects she may be pregnant, or is planning 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 possible 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 taken only on prescription by a doctor (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 use Tardyferon-Fol

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose is one tablet, i.e. 80 mg of ferrous(II) ions and 0.35 mg 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 a meal, depending on
gastrointestinal tolerance (however, avoid food and drink mentioned in section “Tardyferon-Fol with food, drink and alcohol”).
The tablet should be swallowed whole with water. Do not suck, chew, or hold the tablet in the mouth.

Use of a higher than recommended dose of Tardyferon-Fol
Cases of iron salt overdose, particularly in children, have been reported following ingestion of a
large quantity of the medicine.
Symptoms of overdose include gastrointestinal irritation with abdominal pain, nausea, vomiting,
diarrhea, signs of cardiovascular shock, or metabolic acidosis (rapid or shallow breathing, fast heartbeat, headache, confusion, drowsiness, fatigue, loss of appetite), as well as liver and kidney failure.
If too much medicine has been taken, contact an emergency department immediately for appropriate treatment.

Missed dose of Tardyferon-Fol
If a dose is missed at the usual time, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and take the next tablet at the regular 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. Premature discontinuation of treatment may result in recurrence of the disease.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
The side effects are listed below in order of decreasing frequency of occurrence.

Common (may affect more than 1 in 10 people)
Constipation
Diarrhoea
Feeling of stomach fullness
Stomach pain
Discoloured stools
Nausea

Uncommon (may affect up to 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**
Oesophageal lesions*
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 a tablet enters the airways, there is a risk of bronchial ulceration, which may lead to bronchial stenosis.
**In cases of improper administration, when tablets are chewed, sucked, or held in the mouth.
***Gastrointestinal melanosis (pigmentation in the gastrointestinal tract) has been reported in medical literature in elderly patients with chronic kidney disease, diabetes (high blood sugar levels) and/or hypertension (high blood pressure), who were treated with multiple medications for these conditions and received iron supplementation due to concomitant anaemia.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Poland, Tel: +48 (22) 49 21 301, Fax: +48 (22) 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting side effects helps to provide more information on the safety of this medicine.

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 properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Tardyferon-Fol contains

• The active substances are: iron(II) ions in the form of dried ferrous sulfate and folic acid. Each tablet contains 80 mg of iron(II) ions in the form of dried ferrous sulfate and 0.35 mg of folic acid.
• Other ingredients: ammonium methacrylate copolymer (type B) (Eudragit RS 30D), ammonium methacrylate copolymer (type A) (Eudragit RL 30D), maltodextrin, triethyl citrate, talc, glyceryl dibehenate, microcrystalline cellulose; 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
Extended-release tablets: 30 or 100 tablets in a cardboard box.
For more detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing authorization holder in Romania, country of export:
Pierre Fabre Médicament
45, place Abel Gance
92100 Boulogne
France
Manufacturer:
Pierre Fabre Medicament Production – Site Progipharm
Rue du Lycée, BP 77
45500 Gien
France
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Romania, country of export: 10104/2017/01
Parallel import authorization number: 254/18