Tardiferon

Leaflet attached to the packaging: patient information

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

Tardyferon

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

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.
• If you have any doubts, consult a doctor, pharmacist, or nurse.
• 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 Tardyferon.
In combination with iron and excipients, 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 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 due to 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

Warnings and precautions

Before starting treatment with Tardyferon, discuss it with your doctor or pharmacist.
The 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 enters 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 (tissue death) or granuloma (inflammation) can lead to bronchial stenosis (narrowing of the airways). In case of improper swallowing, 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.
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 swallowing difficulties, consult a doctor.

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).
Avoid taking Tardyferon if you are taking iron injections.
The following medicines may require a 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);
• medicine used to treat joint diseases (penicillamine);
• medicines used to treat excess stomach acid: mineral preparations affecting the gastrointestinal tract, charcoal, or antacids (aluminum, calcium, and magnesium salts);
• medicine used to treat thyroid disease (thyroxine);
• 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 stomach and intestinal irritation and lower the risk of bleeding associated with their use.

If you are currently taking or have recently taken any other medicine, including those available without a prescription, 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), certain proteins (eggs), or foods and drinks containing calcium (cheese, milk, etc.). There should be 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, 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

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your 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 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.
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 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, due to 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.
If you have taken too much of the medicine, contact the emergency department immediately for proper treatment.

Missing a dose of Tardyferon

If you miss a dose at the usual time, 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 the missed dose.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

Stopping treatment with Tardyferon

Tardyferon should be taken for as long as your doctor recommends. If treatment is stopped too early, the condition may recur.
If you have any further doubts about taking this medicine, 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 (affecting 1 in 10 patients)

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

Uncommon (affecting up to 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 stenosis (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 swallowing difficulties, may also be at risk of throat ulcers, esophageal ulcers, or bronchial ulcers if the tablet enters the airways. Pulmonary necrosis (tissue death) or granuloma (inflammatory condition) can lead to bronchial stenosis (narrowing of the airways). In case of improper administration, 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 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 the leaflet, tell 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, you can help gather more information on the safety of this medicine.

5. How to store Tardyferon

Keep the medicine out of sight and reach of children.
There are no special storage instructions.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 247.25 mg of dried iron(II) sulfate, corresponding 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: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 package contents

30 prolonged-release tablets in a cardboard box.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Greece, the country of export:

Pierre Fabre Farmaka A.E., 350 Mesogeion Ave., 153 41 Agia Paraskevi, Attica, Greece

Manufacturer:

Pierre Fabre Medicament Production, 45, Place Abel Gance, 92100 Boulogne, France
Pierre Fabre Medicament Production, Rue du Lycée, 45502 Gien Cedex, France
Famar ABE (S.A.), PLANT B’, 7 Anthoussas Ave., 15344 Anthoussa, Greece

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
Greek marketing authorization number: 8554/6-2-2007

Parallel import authorization number: 23/07 Date of approval of the leaflet: 28.04.2022

[Information about the trademark]