Tardiferon

Leaflet accompanying the packaging: patient information

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

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

Ferrous sulfate

The leaflet content should be carefully read before using the medicine, 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, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for 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 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 using Tardyferon
• 3. How to use 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

Tardyferon contains iron.
The need for iron is increased in women during pregnancy, postpartum, as well as in breastfeeding mothers and 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 slowly released, 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 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 in the patient's body;
• if the patient has a type of anemia (reduced hemoglobin concentration or insufficient number of red blood cells) that is not caused by iron deficiency or is related to excess iron in the body (e.g., thalassemia, anemia resistant to treatment, or caused by bone marrow failure).

Warnings and precautions

Before starting Tardyferon, the patient should discuss it with their 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.
If the patient is taking Tardyferon due to iron deficiency anemia, the doctor will combine therapy with diagnosis and treatment of the cause of the disease.
If iron deficiency anemia occurs in the course of inflammatory diseases, treatment with Tardyferon will not be effective.
If the patient has difficulty swallowing, they should inform their doctor.
If the tablet accidentally enters the patient's airways (aspiration of the tablet), it may cause injuries such as necrosis (tissue death) or bronchitis (inflammation of the main airways in the lungs) or esophagitis (inflammation of the esophagus). These, in turn, can lead to bronchial stenosis. It is possible for symptoms such as persistent cough, hemoptysis, and (or) shortness of breath to occur, even if aspiration occurred several days to several months before the onset of these symptoms.
In the event of improper swallowing and the occurrence of one or more of the aforementioned symptoms in the patient, the patient should immediately contact their doctor or the nearest emergency department to determine if there has been damage to the airways and to receive proper treatment.
There have been reports in the medical literature of gastrointestinal melanosis (discoloration of the gastrointestinal tract) in elderly patients with renal failure, diabetes (abnormally high blood sugar levels), and (or) hypertension (high blood pressure) treated with several medications for these conditions and receiving iron supplementation due to accompanying anemia. If the patient is to undergo surgery in the gastrointestinal tract, the surgeon should be informed about iron intake, as melanosis may make the surgical procedure more difficult.
There have been reports of gastric ulcers and gastric bleeding in patients taking iron tablets. If such symptoms occur, the doctor may recommend changing the tablets to a liquid form of the medicine (see section 4).
Due to the risk of oral ulcers and tooth discoloration, the tablets should not be sucked, chewed, or kept in the mouth, but swallowed whole, washed down with water. If following these instructions is not possible or if there are difficulties with swallowing, the patient should contact their doctor.

Children and adolescents

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

Tardyferon and other medicines

Tardyferon should not be taken unless prescribed by a doctor.
The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines should not be taken at the same time, while others may require special changes (e.g., time of intake).
The patient should avoid taking Tardyferon if they are taking iron injections.
The patient should not take Tardyferon within 2 hours of taking any of the following medicines:

• certain antibiotics (tetracyclines, fluoroquinolones, cefdinir);
• a medicine used to treat chronic urinary tract infections (acetohydroxamic acid);
• medicines used to treat HIV infection (integrase inhibitors, bictegravir [bictegravir should be administered at least 2 hours before iron administration or with a meal]);
• medicines used to treat osteoporosis (bisphosphonates);
• medicines used to treat joint diseases, Wilson's disease (penicillamine, trientine);
• antacids (containing aluminum, calcium, and (or) magnesium salts);
• a medicine used to treat thyroid disease (thyroxine);
• medicines used to treat Parkinson's disease (methyldopa, levodopa, carbidopa, entacapone);
• supplements and (or) medicines containing zinc or calcium;
• cholestyramine (a medicine used to reduce high cholesterol levels in the blood): Tardyferon should be administered 1-2 hours before or 4-6 hours after cholestyramine;
• NSAIDs (nonsteroidal anti-inflammatory drugs) - they should be taken with a meal to reduce irritation of the gastric mucosa and intestines and lower the risk of bleeding associated with their use.

Tardyferon with food, drink, and alcohol

Consuming large amounts of coffee, tea, or red wine may reduce iron absorption.
The patient should not take this medicine at the same time as whole grain products (bran, legumes, oilseeds), certain proteins (e.g., eggs), or foods and beverages containing calcium (cheese, milk, etc.). The patient should maintain a 2-hour interval between taking iron salts and these foods.

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 using this medicine.
There are no studies in pregnant women in the first trimester that would allow assessing the risk of developmental anomalies. However, neither in the medical literature nor during the post-marketing period have any cases of congenital anomalies been reported. Numerous literary data on women in the second and third trimesters of pregnancy do not indicate an increased risk of anomalies or toxicity to the fetus or newborn.
Therefore, Tardyferon can be used during pregnancy if clinically indicated.
Iron passes into breast milk in small amounts. The mother's diet does not affect its concentration.
No effect on newborns/infants is expected.
Tardyferon can be used during breastfeeding.

Driving and using machines

It is unlikely that Tardyferon will affect the ability to drive and use machines.
Tardyferon contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to use Tardyferon

This medicine should always be used as directed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
Tardyferon is indicated for children over 10 years of age and adults. The medicine is administered 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 the doctor.
Prophylactic treatment

• Latent iron deficiency: 1 tablet (corresponding to 80 mg of Fe) once a 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 administered orally.
The tablet should be swallowed whole, washed down with water. It should not be sucked, chewed, or kept in the 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).

Using a higher dose of Tardyferon than recommended

In case of taking too much of the medicine, the patient should immediately contact their doctor or the nearest emergency department to receive proper treatment, especially if the overdose occurred in a child.
Symptoms of iron overdose include:

• severe gastrointestinal irritation, which can lead to tissue necrosis (necrosis of the mucous membranes of the gastrointestinal tract). The main symptoms are: abdominal pain, nausea, vomiting (sometimes with blood) and diarrhea (sometimes with black stools). This may be accompanied by metabolic acidosis and shock with the following main symptoms: rapid or shallow breathing, rapid heartbeat, headache, confusion, drowsiness, fatigue, loss of appetite, stomach pain, vomiting, and a sudden decrease in blood pressure, which can lead to loss of consciousness with seizures (coma).
• symptoms of abnormal kidney function (significant decrease in urine output) and liver function (pain in the right upper abdomen, yellowing of the skin and eyes, dark urine color).

Long-term consequences of overdose, such as narrowing of the gastrointestinal tract (stenosis), characterized by nausea, bloating, constipation, and abdominal distension, are also possible.

Missing a dose of Tardyferon

If a dose is missed, the patient should take it as soon as possible. However, if the time for the next dose is near, the missed dose should not be taken. The next tablet should be taken as usual.
The patient should not take a double dose to make up for the missed dose.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

Stopping Tardyferon

Tardyferon should be used 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 using this medicine, the patient should consult their 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 fullness in the stomach, abdominal pain, dark stools, nausea.

Uncommon (occurring in 1 in 100 patients)

Throat swelling (pharyngeal edema), abnormal stools, indigestion, vomiting, gastritis, itching, red rash (erythematous rash).

Frequency not known (cannot be estimated from available data)

Allergic reaction (hypersensitivity reaction), itchy rash (urticaria), death of lung tissue cells (pulmonary necrosis)*, lung tissue inflammation (pulmonary granuloma)*, narrowing of the airways (bronchial stenosis)*, throat ulcers*, changes in the esophagus*, esophageal ulcers*, tooth discoloration**, oral ulcers**, discoloration of the gastrointestinal tract (gastrointestinal melanosis, see section 2), gastric ulcers, gastric bleeding (see section 2).
* Patients, especially the elderly and those with swallowing difficulties, may also be at risk of throat or esophageal ulcers. If the tablet enters the airways, there is a risk of bronchial ulcers and pulmonary granuloma (inflammatory condition), which can lead to bronchial stenosis. In case of improper administration, the patient should immediately contact their doctor or the nearest emergency department to receive proper treatment.
** In case of improper administration, when tablets are chewed, sucked, or kept in the mouth.
There have been reports in the medical literature of gastrointestinal melanosis (discoloration of the gastrointestinal tract) in elderly patients with chronic kidney disease, diabetes (high blood sugar levels), and (or) hypertension (high blood pressure) treated with several medications for these conditions and receiving iron supplementation due to accompanying anemia.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
phone: 22 49-21-301
fax: 22 49-21-309
website: https://smz.ezdrowie.gov.pl
Reporting side effects will 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.
There are no special recommendations for storage.
The medicine should not be used after the expiration date stated on the packaging. The expiration date indicates the last day of the specified month.
Medicines should not be disposed of in the sewage system or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer used. 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, which corresponds to a dose of 80 mg of iron(II) ions.
• The other ingredients are: maltodextrin, microcrystalline cellulose, ammonium methacrylate copolymer (type A) dispersion 30% (Eudragit RL 30D), ammonium 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, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

Pierre Fabre Medicament
Les Cauquillous
81500 Lavaur
France

Manufacturer:

Pierre Fabre Medicament Production
Site Progipharm
Rue du Lycée
45500 Gien
France

Parallel importer:

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

Repackaged by:

Delfarma Sp. z o.o.
Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Romania, the country of export: 11514/2019/01

Parallel import authorization number: 293/21

Date of leaflet approval: 28.01.2025

[Information about the trademark]