Tardiferon

Leaflet accompanying the packaging: patient information

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

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

release
Ferrous sulfate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, 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, 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 medicine called Tardyferon.
In combination with iron and auxiliary substances, Fe ions are released slowly, which allows avoiding 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 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 prevent iron deficiency in pregnant women with inadequate 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 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 take Tardyferon, 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 the deficiency.
If the tablet gets into the airways, patients, especially the elderly and those with swallowing difficulties, may also be at risk of throat ulcers, esophageal ulcers, or bronchial ulcers. Bronchial necrosis or granuloma can lead to bronchial narrowing. In case of improper swallowing, contact a doctor or the nearest emergency department immediately for proper treatment.
In medical literature, in elderly patients with chronic kidney disease, diabetes, and (or) hypertension, treated with several medicines for these diseases and receiving iron supplementation due to accompanying anemia, gastrointestinal melanosis (gastrointestinal discoloration) has been described.

Children and adolescents

Tardyferon can be used in children over 10 years old.

Tardyferon and other medicines

Do not take Tardyferon unless your doctor decides to.
Some medicines cannot be taken at the same time, while others require special changes (e.g., time of administration):
It is recommended to avoid taking Tardyferon if the patient is taking iron injections.
The following medicines may require dose adjustment. Do not take Tardyferon within 2 hours of taking any of the following medicines:

• certain antibiotics (tetracyclines or fluoroquinolones);
• medicines used to treat weak bones (bisphosphonates);
• a medicine used to treat joint diseases (penicillamine);
• medicines used to treat excess stomach acid: mineral preparations, 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 stomach and intestinal irritation and lower the risk of bleeding associated with their use.

If the patient is currently taking or has recently taken any other medicine, including those 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 medicine with whole grain products (bran, legumes, oilseeds), certain proteins (eggs), or foods and drinks containing calcium (cheese, milk, etc.). A gap 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, thinks they may be pregnant, or plans to have a child, they should consult their 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 the ability to drive and use machines.

3. How to take Tardyferon

This medicine should always be taken as directed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
Tardyferon is indicated for children over 10 years old and adults. The medicine 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 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 a glass of water. Do not suck, chew, or hold it in your mouth. The 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, contact the emergency department immediately for proper treatment.

Missing a dose of Tardyferon

If a dose is missed, take it as soon as possible. However, if it is close to the 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 a missed dose.
In case of any further doubts about taking this medicine, 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 condition may recur.
In case of any further doubts about taking this medicine, 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 to 10 patients)

Constipation, diarrhea, feeling of stomach fullness, abdominal pain, dark stool color, nausea

Uncommon (occurring in less than 1 in 100 patients)

Throat swelling (laryngeal edema), abnormal stools, discomfort and pain in the upper abdomen (indigestion), 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 (airway narrowing)*, tooth discoloration**, oral ulcers**, esophageal changes*, gastrointestinal melanosis (gastrointestinal discoloration)*.
*Patients, especially the elderly and those with swallowing difficulties, may also be at risk of throat ulcers, esophageal ulcers, or bronchial ulcers if the tablet gets into the airways. Pulmonary necrosis or granuloma can lead to bronchial narrowing. In case of improper administration, contact a doctor or the nearest emergency department immediately 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, and (or) hypertension, treated with several medicines for these diseases and receiving iron supplementation due to accompanying anemia, gastrointestinal melanosis (gastrointestinal discoloration) has been described.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse.
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, https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Tardyferon

Keep the 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 specified month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents 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, ammonium methacrylate copolymer dispersion type B (Eudragit RS 30D), ammonium methacrylate copolymer dispersion type A (Eudragit RL 30D), glycerol dibehenate, triethyl citrate, talc. The composition of the coating: Sepifilm LP010 (hypromellose, microcrystalline cellulose, stearic acid), yellow iron oxide, red iron oxide, triethyl citrate, titanium dioxide.

What Tardyferon looks like and package contents

30 tablets in a cardboard box.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Greece, the country of export:

PIERRE FABRE PHARMACEUTICALS S.A.
Leof. Mesogeion 350
153 41 Ag. Paraskevi
Greece

Manufacturer:

PIERRE FABRE MEDICAMENT PRODUCTION
45 Place Abel Gance
92100 Boulogne
France

Parallel importer:

Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Czeski Cieszyn
Czech Republic

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Euceryna Laboratory Pharmaceutical COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45
31-353 Kraków
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw

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

Parallel import authorization number: 58/22

Date of leaflet approval:31.01.2022
[Information about the registered trademark]