Tardiferon

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is 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 medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• 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 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. Contents of the packaging 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, and 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 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 drug 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 inadequate 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 ferrous sulfate or any of the other ingredients of this medicine (listed in section 6);
• if the patient has an excess of iron in the body;
• if the patient has a type of anemia (decreased hemoglobin concentration or insufficient number of red blood cells) that is not caused by iron deficiency or is related to an excess of iron in the body (e.g., thalassemia, anemia resistant to treatment or caused by bone marrow failure).

Warnings and precautions

Before starting treatment with 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.
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 tell 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 inflammation of the bronchi (main airways in the lungs) or esophagus (the section connecting the mouth cavity to the stomach). These, in turn, can lead to bronchial narrowing. It is possible for symptoms such as persistent cough, coughing up blood, 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 of the medicine and the occurrence of one or more of the mentioned symptoms in the patient, you should immediately contact a doctor or the nearest emergency department to determine whether there has been damage to the airways and to receive proper treatment.
There have been reports in the medical literature of gastrointestinal melanosis (discoloration in 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 the use of iron, as melanosis may make the surgical procedure more difficult.
There have been reports of stomach ulcers and stomach 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 held in the mouth, but swallowed whole, washed down with water. If following these instructions is not possible or if there are difficulties with swallowing, you should contact your 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.
You should tell your doctor about all the medicines you are taking now or have taken recently, as well as the medicines you plan to take.
Some medicines cannot be taken at the same time, while others require special changes (e.g., time of administration).
You should avoid taking Tardyferon if you are taking iron injections.
You 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 weak bones (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 stomach and intestinal mucosa and lower the risk of bleeding associated with their use.

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), certain proteins (e.g., eggs), or foods and drinks containing calcium (cheese, milk, etc.). You should maintain a 2-hour interval between taking iron salts and these foods.

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.
There are no studies in pregnant women in the first trimester that would allow assessing the risk of birth defects. However, neither in the medical literature nor during the post-marketing period have any cases of congenital defects been reported. Numerous literary data on women in the second and third trimesters of pregnancy do not indicate an increased risk of defects or toxicity to the fetus or newborn. Therefore, Tardyferon can be used during pregnancy if it is 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 your ability to drive or 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 take Tardyferon

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, you should consult 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) 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 taken orally.
You should swallow the tablet whole, washed down with 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, drinks, and alcohol" section).

Taking a higher dose of Tardyferon than recommended

If you have taken too much of the medicine, you should immediately contact your doctor or the nearest emergency department to receive proper treatment, especially if the overdose occurred in a child.
Symptoms of iron overdose include:

• severe irritation of the gastrointestinal tract, 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 sudden decrease in blood pressure, which can lead to loss of consciousness with convulsions (coma).
• symptoms of abnormal kidney function (significant decrease in the amount of urine excreted) 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 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.
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, you should 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 disease may recur.
If you have any further doubts about taking 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, indigestion, vomiting, stomach inflammation, itching, red rash (erythematous rash).

Frequency not known (cannot be estimated from the available data)

Allergic reaction (hypersensitivity reaction), itchy rash (urticaria), death of lung tissue or cells (pulmonary necrosis)*, lung tissue inflammation (pulmonary granuloma)*, narrowing of the airways (bronchial narrowing)*, throat ulcers*, changes in the esophagus*, esophageal ulcers*, tooth discoloration**, oral ulcers**, discoloration of the gastrointestinal tract (gastrointestinal melanosis, see section 2), stomach ulcers, stomach 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 narrowing. In the event of improper administration, you should immediately contact your doctor or the nearest emergency department to receive proper treatment.
** In the event of improper administration, when tablets are chewed, sucked, or held in the mouth.
There have been reports in the medical literature of gastrointestinal melanosis (discoloration in 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 you experience any side effects, including any side effects not listed in this leaflet, you should 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 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 month stated.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. 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 ferrous sulfate 247.25 mg, which corresponds to a dose of 80 mg.
• The other ingredients are: maltodextrin, microcrystalline cellulose, ammonium methacrylate copolymer (type A) 30% dispersion, ammonium methacrylate copolymer (type B) 30% dispersion, triethyl citrate, talc, glycerol dibehenate.
• The composition of the coating is: 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 pack contains

30 tablets in PVC/PVDC/Al blisters in a cardboard box.
For more detailed information, you 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:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź

Marketing authorization number in Romania, the country of export: 11514/2019/01

Parallel import authorization number: 381/22

Date of leaflet approval: 17.02.2025

[Information about the trademark]