Tardiferon

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Tardyferon (Ferro-Tardyferon)

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

Ferrosi sulfas
Tardyferon and Ferro-Tardyferon are different trade names for the same drug.

It is necessary to carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This drug has been prescribed for a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Tardyferon and what is it used for
• 2. Important information before taking Tardyferon
• 3. How to take Tardyferon
• 4. Possible side effects
• 5. How to store Tardyferon
• 6. Package contents and other information

1. What is Tardyferon and what is it used for

The need for iron is increased in women during pregnancy, postpartum, breastfeeding, and in adolescents during growth. Iron deficiency or iron deficiency anemia can be prevented or treated with a drug called Tardyferon.
In combination with iron and auxiliary substances, Fe ions are released slowly, which allows avoiding the sudden absorption of the entire iron dose into the blood serum.
This reduces the number of observed side effects and makes it easier for the patient to follow the recommendations. The slow release of the drug allows iron ions to reach the final sections of the intestine, which, in addition to the duodenum, have the ability to absorb iron.
The limitation of iron absorption to the upper segments of the intestine is caused by the iron saturation process. Like all iron-containing drugs, Tardyferon has no effect on erythropoiesis (red blood cell production) or anemia caused by factors other than iron deficiency.
Tardyferon is used to treat iron deficiency anemia and to prevent iron deficiency in pregnant women with insufficient dietary intake.
Tardyferon is indicated for use in children over 10 years old and adults.

2. Important information before taking Tardyferon

When not to take Tardyferon

• if the patient is allergic to iron sulfate or any of the other ingredients of this drug (listed in section 6);
• if there is an excess of iron, e.g., hemochromatosis, thalassemia, anemia resistant to treatment, or bone marrow failure.

Warnings and precautions

Before starting to take Tardyferon, you should discuss it with your doctor or pharmacist.
A toxic dose of iron is lower for children than for adults.
It is not recommended to give Tardyferon to children under 10 years old.
Iron deficiency supplementation should be, if possible, combined with treatment of the cause of this deficiency.
If the tablet gets into the airways, patients, especially the elderly and those with difficulty swallowing, may also be at risk of throat ulcers, esophagus (connecting the mouth to the stomach), or bronchi (main airways leading to the lungs). Bronchial necrosis (tissue death) or granuloma (inflammatory condition) can lead to bronchial narrowing (narrowing of the airways). In case of improper swallowing, you should immediately contact a doctor or the nearest emergency department for proper treatment.
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 for these diseases and receiving iron supplementation due to accompanying anemia, gastrointestinal melanosis (discoloration in the gastrointestinal tract) has been described.
Due to the risk of oral ulcers and tooth discoloration, tablets should not be sucked, chewed, or held in the mouth, but swallowed whole, with water. If following these instructions is not possible or there are difficulties with swallowing, you should contact your doctor.

Children and adolescents

Tardyferon can be used in children over 10 years old.

Tardyferon and other drugs

Tardyferon should not be taken if the doctor has not decided on it.
Some drugs cannot be taken at the same time, while others require special changes (e.g., time of administration).
It is not recommended to take Tardyferon if the patient is taking iron-containing drugs for injection.
The following drugs may require a dose adjustment. Tardyferon should not be taken within 2 hours of taking any of the following drugs:

• certain antibiotics (tetracyclines or fluoroquinolones);
• drugs used to treat weakened bones (bisphosphonates);
• a drug used to treat joint diseases (penicillamine);
• drugs used to treat excess stomach acid: mineral preparations acting on the gastrointestinal tract, charcoal, or antacids (aluminum, calcium, and magnesium salts);
• a drug used to treat thyroid disease (thyroxine);
• a drug used to treat Parkinson's disease (methyldopa, levodopa, carbidopa);
• supplements and (or) drugs containing zinc or calcium;
• cholestyramine - Tardyferon should be taken 1-2 hours before or 4 to 6 hours after cholestyramine;
• NSAIDs (nonsteroidal anti-inflammatory drugs) - they should be taken with food to reduce irritation of the stomach and intestinal mucosa and lower the risk of bleeding associated with their use.

If the patient is currently taking or has recently taken another drug that is available without a prescription, they should tell their doctor or pharmacist.

Tardyferon with food, drink, and alcohol

Consuming large amounts of coffee, tea, or red wine may reduce iron absorption.
It is not recommended to take this drug at the same time as whole grain products (bran, legumes, oilseeds), certain proteins (eggs), or foods and drinks containing calcium (cheese, milk, etc.). An interval should be maintained between taking iron salts and these foods (at least 2 hours).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects that they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this drug.
Tardyferon can be used during pregnancy and breastfeeding.

Driving and using machines

It is unlikely that Tardyferon will affect the ability to drive and use machines.

3. How to take Tardyferon

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.
Tardyferon is indicated for children over 10 years old and adults. The drug is taken orally.
Treatment of iron deficiency anemia
Children over 10 years old and adults: 1 to 2 tablets per day.
The duration of treatment should be long enough to correct anemia and replenish iron stores.
Treatment may last at least 3 to 6 months and can be extended if necessary in agreement with the doctor.
Preventive treatment

• Latent iron deficiency: 1 tablet (corresponding to 80 mg of Fe) per day or every other day.
• Pregnant women: 1 tablet every other day during the last two trimesters of pregnancy (or from the 4th month of pregnancy).

Tardyferon tablets are taken orally.
The tablet should be swallowed whole, with water. It should not be sucked, chewed, or held in the mouth.
Tablets should be taken with a large glass of water, preferably before or during a meal, depending on gastrointestinal tolerance (except for specific foods listed in the "Tardyferon with food, drink, and alcohol" section).

Using a higher dose of Tardyferon 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, symptoms 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

If a dose is missed at the usual time, it should be taken as soon as possible. However, if it is close to the time for the next dose, the missed dose should not be taken, and the next tablet should be taken as usual.
A double dose should not be taken to make up for a missed dose.
In case of any further doubts about taking this drug, you should consult a doctor or pharmacist.

Stopping Tardyferon treatment

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

4. Possible side effects

Like all drugs, this drug can cause side effects, although not everybody gets them.
The following side effects may occur, listed in order of decreasing frequency:

Common (occurring in 1 in 10 patients)

Constipation, diarrhea, feeling of stomach fullness, abdominal pain, darkening of stool, nausea.

Uncommon (occurring in up to 1 in 100 patients)

Throat swelling (laryngeal edema), abnormal stools, discomfort and pain in the upper abdomen (dyspepsia), vomiting, acute gastritis, itching, red rash (erythematous rash).

Frequency not known (cannot be estimated from available data)

Allergic reaction (hypersensitivity reaction), rash with itching (urticaria), pulmonary necrosis (tissue death)*, pulmonary granuloma (inflammatory condition)*, bronchial narrowing (narrowing of the airways)*, tooth discoloration**, oral ulcers**, changes in the esophagus*, discoloration of the gastrointestinal tract (gastrointestinal melanosis)*.
*Patients, especially the elderly and those with difficulty swallowing, may also be at risk of throat ulcers, esophagus, or bronchi if the tablet gets into the airways. Pulmonary necrosis (tissue death) or granuloma (inflammatory condition) can lead to bronchial narrowing (narrowing of the airways). In case of improper administration, you should immediately contact a doctor or the nearest emergency department for proper treatment.
**In case of improper administration, when tablets are chewed, sucked, or held in the mouth.
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 for these diseases and receiving iron supplementation due to accompanying anemia, gastrointestinal melanosis (discoloration in the gastrointestinal tract) has been described.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, you should inform your doctor, pharmacist, or nurse. 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:
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: 22 49-21-301
fax: 22 49-21-309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the drug.

5. How to store Tardyferon

The drug should be stored out of sight and reach of children.
There are no special storage recommendations.
This drug should not be used after the expiration date stated on the packaging. The expiration date is the last day of the specified month.
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 contains

• The active substance of the drug is iron(II) in the form of 247.25 mg of dried iron(II) sulfate, which corresponds to a dose of 80 mg of iron(II) ions.
• Other ingredients are: maltodextrin, microcrystalline cellulose, ammonio methacrylate copolymer (type A) dispersion 30% (Eudragit RL 30D), ammonio methacrylate copolymer (type B) dispersion 30% (Eudragit RS 30D), triethyl citrate, talc, glycerol dibehenate. Coating composition:Sepifilm LP010 (hypromellose, microcrystalline cellulose, stearic acid), triethyl citrate, iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171).

What Tardyferon looks like and what the package contains

30 prolonged-release tablets in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or 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, Rue du Lycée - 45500 Gien, France
IBERFAR – Indústria Farmacêutica S.A., Rua Consiglieri Pedroso n.º 121-123, Queluz de Baixo -
Barcarena, Portugal

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Portuguese marketing authorization number, country of export: 4979381
8504100
4979282

Parallel import authorization number: 273/22 Date of leaflet approval: 07.07.2022

[Information about the trademark]