Tardiferon

Leaflet attached to the packaging: patient information

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

Tardyferon(Tardyferon 80 mg)

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

Ferrous sulfate
Tardyferon and Tardyferon 80 mg 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 to a specific person. It should not be given to others. The medicine 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 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. 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 process of iron saturation. 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 taking Tardyferon

When not to take 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, such as 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 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 bronchial tubes (main airways leading to the lungs). Necrosis of the bronchi (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 medicines for these diseases and receiving iron supplementation due to accompanying anemia, gastrointestinal melanosis (discoloration of the gastrointestinal tract) has been described.

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 should not be taken at the same time, while others may require special changes (e.g., time of administration).
You should avoid taking Tardyferon if you are taking iron-containing medicines for injection.
The following medicines may require a dose adjustment. You should not take Tardyferon within 2 hours of taking 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 digestive system, 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 (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 you are currently taking or have recently taken another medicine that seems to be without a prescription, you should tell your 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 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 taking 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 take Tardyferon

This medicine 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 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 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.
You should swallow the tablet whole, with a glass of water. Do not suck, chew, or hold 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 listed in the "Tardyferon with food, drink, and alcohol" section).

Taking 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 medicine.
Symptoms of overdose 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.
In case of taking too much medicine, you should immediately contact the emergency department for proper treatment.

Missing a dose of Tardyferon

In case of missing a dose at the usual time, you should take it as soon as possible. However, if it is close to the time of taking 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.
In case of any further doubts about taking this medicine, you should consult a doctor or pharmacist.

Stopping Tardyferon treatment

Tardyferon 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 about taking this medicine, you should consult a 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 discoloration of stools, 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 the 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 bronchial tubes 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 medicines for these diseases and receiving iron supplementation due to accompanying anemia, gastrointestinal melanosis (discoloration of the gastrointestinal tract) has been described.

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 Adverse Reaction Monitoring of Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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 specified 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) in the form of dried iron(II) sulfate 247.25 mg, which corresponds to a dose of 80 mg.
• The other ingredients are: maltodextrin, microcrystalline cellulose, ammonio methacrylate copolymer dispersion type A (Eudragit RL 30D), ammonio methacrylate copolymer dispersion type B (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, iron oxide yellow, titanium dioxide.

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 the parallel importer.

Marketing authorization holder in Greece, the country of export:

PIERRE FABRE FARMAKA A.E.
Leof. Mesogeion 350
153 41 Ag. Paraskevi
Greece

Manufacturer:

PIERRE FABRE MEDICAMENT PRODUCTION
45, Place Abel Gance
92100 Boulogne
France

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
Marketing authorization number in Greece, the country of export:8554/6-2-2007

Parallel import authorization number: 216/22 Date of leaflet approval: 16.05.2022

[Information about the trademark]