Tardiferon

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Tardyferon(Ferro-Tardyferon) , 80 mg of iron(II) ions, prolonged-release tablets
Ferrous sulfate
Tardyferon and Ferro-Tardyferon are different trade names for the same drug.

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 specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Tardyferon and what is it used for
• 2. Important information before using Tardyferon
• 3. How to use Tardyferon
• 4. Possible side effects
• 5. How to store Tardyferon
• 6. Contents of the packaging 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 medicine called Tardyferon.
In combination with iron and auxiliary substances, Fe ions are released slowly, which allows avoiding the sudden absorption of the entire dose of iron 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 medicine 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 medicines, 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 of age and adults.

2. Important information before using Tardyferon

When not to use Tardyferon:

• if the patient is allergic to iron sulfate or any of the other ingredients of this medicine (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 use 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 of age.
Iron deficiency supplementation should be, if possible, combined with treatment of the cause of the 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 kept in the mouth, but swallowed whole, with water. If following these instructions is not possible or there are difficulties with swallowing, you should contact a doctor.

Children and adolescents

Tardyferon can be used in children over 10 years of age.

Tardyferon and other medicines

You should not take Tardyferon unless your doctor decides to do so.
Some medicines cannot be used at the same time, while others require special changes (e.g. time of administration).
You should avoid taking Tardyferon if you are taking iron-containing injections.
The following medicines may require a dose adjustment. You should not take Tardyferon within 2 hours of taking a dose of any of the following medicines:

• certain antibiotics (tetracyclines or fluoroquinolones);
• medicines used to treat weakened bones (bisphosphonates);
• a medicine used to treat joint diseases (penicillamine);
• medicines used to treat excess acid in the stomach: mineral preparations acting on the gastrointestinal tract, charcoal, or antacids (aluminum, calcium, and magnesium salts);
• a medicine used to treat thyroid disease (thyroxine);
• a medicine used to treat Parkinson's disease (methyldopa, levodopa, carbidopa);
• supplements and (or) medicines containing zinc or calcium;
• cholestyramine - Tardyferon should be taken 1-2 hours before or 4 to 6 hours after cholestyramine;
• NSAIDs (non-steroidal 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 you are currently taking or have recently taken another medicine that is available without a prescription, you should tell your doctor or pharmacist.

Tardyferon with food, drinks, and alcohol

Consuming large amounts of coffee, tea, or red wine may reduce iron absorption.
It is not recommended to take this medicine at the same time as whole grain products (bran, legumes, oilseeds), some proteins (eggs), or foods and drinks containing calcium (cheese, milk, etc.). You should keep a gap between taking iron salts and these foods (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 using this medicine.
Tardyferon can be used during pregnancy and breastfeeding.

Driving and using machines

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

3. How to use Tardyferon

This medicine should always be used exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist.
Tardyferon is indicated for children over 10 years of age and adults. The medicine is taken orally.
Treatment of iron deficiency anemia
Children over 10 years of age 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 consultation with your 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.
You should swallow the tablet whole, with water. Do not suck, chew, or keep it in your 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 mentioned in the section "Tardyferon with food, drinks, and alcohol").

Using more than the recommended dose of Tardyferon

There have been reports of iron salt overdoses, 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 too much of the medicine, you should immediately contact the emergency department for proper treatment.

Missing a dose of Tardyferon

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

Stopping the use of Tardyferon

Tardyferon should be used for as long as your doctor recommends. If you stop the therapy too early, the disease may recur.
If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tardyferon 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, dark stool color, nausea.

Uncommon (occurring in 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 kept 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 you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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, you can help gather more information on the safety of the medicine.

5. How to store Tardyferon

The medicine should be stored 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.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste containers. 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 packaging and other information

What Tardyferon contains

• The active substance of the medicine is iron(II) ions in the form of iron(II) sulfate, dried 247.25 mg, which corresponds to a dose of 80 mg of iron(II) ions.
• The other ingredients are: maltodextrin, microcrystalline cellulose, ammonio methacrylate copolymer (type A), 30% dispersion (Eudragit RL 30D), ammonio methacrylate copolymer (type B), 30% dispersion (Eudragit RS 30D), triethyl citrate, talc, glycerol dibehenate. The composition of the coating: 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 packaging 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. 121-123
Queluz de Baixo
2734-501 Barcarena
Portugal

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Portuguese marketing authorization number, country of export:8504100
4979381

Parallel import authorization number: 203/23

Date of leaflet approval: 21.09.2023

[Information about the trademark]