Tardiferon

Leaflet attached to the packaging: patient information

Tardyferon, 80 mg, prolonged-release coated tablets

Ferrous sulfate

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

• Keep this leaflet, you may need to read it again.
• 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 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. 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, 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 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 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 the patient has an excess of iron in the 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, 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 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, immediate contact should be made with a doctor or the nearest emergency department to determine if there has been damage to the airways and to provide appropriate 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), who were treated with several medications for these conditions and received 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 gastrointestinal bleeding in patients taking iron tablets. If such symptoms occur, the doctor may recommend changing the tablets to a liquid form (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 there are difficulties with swallowing, contact a doctor.

Children and adolescents

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

Tardyferon and other medicines

Do not take Tardyferon unless your doctor decides to do so.
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
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.
Do 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 bone weakness (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 mucous membrane of the stomach and intestines 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.). A minimum of 2 hours should be allowed 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, 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 birth defects been reported. Numerous literary data on women in the second and third trimesters of pregnancy do not indicate an increased risk of birth defects 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 take Tardyferon

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, 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 a 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 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, drinks, and alcohol" section).

Taking a higher dose of Tardyferon than recommended

In case of taking too much medicine, immediately contact a doctor or the nearest emergency department to receive appropriate 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 heart rate, headache, confusion, drowsiness, fatigue, loss of appetite, stomach pain, vomiting, and 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 you miss a dose at the usual time, take it as soon as possible. However, if it is almost time for the next dose, do 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, consult your doctor or pharmacist.

Stopping Tardyferon

Tardyferon should be taken for as long as your doctor recommends. Stopping therapy too early may lead to a relapse of the disease.
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 (occurring in 1 in 10 patients)

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

Uncommon (occurring in 1 in 100 patients)

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

Frequency not known (cannot be estimated from available data)

Allergic reaction (hypersensitivity reaction), itching rash (urticaria), death of lung tissue or cells (pulmonary necrosis)*, inflammation of lung tissue (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), 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 stenosis. In case of improper administration, immediate contact should be made with a doctor or the nearest emergency department to receive appropriate 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), who were treated with several medications for these conditions and received iron supplementation due to accompanying anemia.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or 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, phone: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information 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 carton after EXP. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
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, ammonio methacrylate copolymer (type A) 30% dispersion, ammonio methacrylate copolymer (type B) 30% dispersion, triethyl citrate, talc, glycerol dibehenate. The composition of the 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 what the package contains

30 or 90 tablets in a cardboard box

Marketing authorization holder

Pierre Fabre Medicament Polska Sp. z o.o.
ul. Belwederska 20/22
00-762 Warsaw

Manufacturer

Pierre Fabre Medicament Production
site Progipharm
Rue du Lycée
45500 Gien
France
To obtain more detailed information, contact the marketing authorization holder:
Pierre Fabre Medicament Polska Sp. z o.o.
ul. Belwederska 20/22
00-762 Warsaw
phone: 22 559-63-00

Date of last revision of the leaflet: