TARDYFERON 80 mg PROLONGED-RELEASE TABLETS

Introduction

Leaflet: information for the user

Tardyferon 80 mg prolonged-release tablets

Iron (in the form of dried ferrous sulfate)

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
  • If you have any doubts, consult your doctor or pharmacist.
  • This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Tardyferon and what is it used for
2. What you need to know before taking Tardyferon
3. How to take Tardyferon
4. Possible side effects
5. Storage of Tardyferon
6. Package contents and additional information

1. What is Tardyferon and what is it used for

This medication contains prolonged-release iron for the prevention and treatment of iron deficiency anemia and iron deficiency states.

It is used in children with a minimum weight of 28 kg and in adults.

2. What you need to know before taking Tardyferon

Do not take Tardyferon:

• If you are allergic to ferrous sulfate or any of the other components of this medication (listed in section 6).
• If you have more iron in your body than you need.
• If you have a type of anemia (insufficient red blood cells) that is not caused by an iron deficiency or that causes an iron overload (e.g., thalassemia, refractory anemia, anemia caused by bone marrow deficiency).

Consult your doctor or pharmacist if you have any doubts about this medication.

Warnings and precautions

• If you are taking this medication for iron deficiency anemia, the cause of this iron deficiency anemia should also be investigated in order to treat it.
• If the iron deficiency is associated with an inflammatory disorder, treatment with Tardyferon will not be effective.
• Consult your doctor or pharmacist before starting to take this medication if you have difficulty swallowing.
• Based on literature data, gastrointestinal wall discoloration has been observed in elderly patients with renal insufficiency, diabetes (high blood sugar levels), and/or hypertension (high blood pressure) who were receiving treatment for these conditions along with iron supplements for anemia. This gastrointestinal wall discoloration may make gastrointestinal surgery more difficult. In light of this risk, if surgery is scheduled, it is recommended to inform the surgeon of the iron supplement intake (see section 4).
• If the medication is accidentally inhaled (goes down the "wrong way"), it can enter your respiratory tract. If the medication comes into contact with the airways, it can cause injuries such as necrosis (tissue death) or inflammation of the bronchi (the airways that lead to the lungs) or the esophagus (the tube that connects the mouth to the stomach). These injuries can cause bronchial narrowing. The signs associated with such injuries may include: persistent cough, coughing up blood, and/or difficulty breathing, even if the inhalation occurred several days or months before these symptoms appear.
• If the medication has entered the airways and you experience one or more of these symptoms, contact your doctor or the nearest emergency service as soon as possible for an assessment by a specialist to ensure that there is no damage to the airways.
• Based on literature data, cases of open gastric ulcer and gastric bleeding have been reported in patients treated with iron tablets. In such cases, it is recommended to switch to a liquid iron formulation (see Section 4).
• Due to the risk of mouth ulcers and tooth discoloration, the tablets should not be sucked, chewed, or left in the mouth, but should be swallowed whole with water. If you cannot follow this instruction or have difficulty swallowing, contact your doctor.
• When taking Tardyferon, the stools may turn dark. This effect is harmless.

Children

This medication should not be administered to children with a weight of less than 28 kg (between 9-10 years).

Other medications and Tardyferon

If you are taking the following medications, do not take this medication unless it has been prescribed by your doctor.

In fact, some medications cannot be used at the same time, while others require specific changes (e.g., in the time of intake).

If you are taking medications that contain iron for injection, you should avoid taking Tardyferon.

If you are taking the following medications, you should separate their administration from Tardyferon by at least 2 hours:

• Certain antibiotics (cyclines, fluoroquinolones, cefdinir)
• Medication for treating chronic urinary tract infections (acetohydroxamic acid)
• Medication for treating HIV infection (integrase inhibitors, bictegravir)
• Medications for treating bone fragility or osteoporosis (bisphosphonates)
• Medications for treating joint diseases, Wilson's disease, or for preventing kidney stones (penicillamine, trientine)
• Medications for treating stomach acidity: mineral gastrointestinal preparations, charcoal, or antacids (aluminum, calcium, and magnesium salts)
• Medications for treating thyroid disease (thyroxine)
• Medications for treating Parkinson's disease (methyldopa, levodopa, carbidopa, entacapone)
• Supplements and/or medications that contain zinc or calcium

If you are taking colestyramine, Tardyferon should be administered 1 to 2 hours before or 4 to 6 hours after the administration of colestyramine.

If you are taking medications with ascorbic acid (vitamin C), the absorption of iron may be increased.

If you are taking medications with chloramphenicol, they may delay the response to iron treatment.

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, even if it is without a prescription.

Taking Tardyferon with food and drinks

Do not drink large amounts of tea, coffee, or red wine, as this may decrease the absorption of iron in your body.

It is not recommended to take this medication at the same time as cereals (bran, legumes, oilseeds), some proteins (eggs), or foods or drinks that contain calcium (cheese, milk, etc.). Leave an interval between taking iron salts and these foods (at least 2 hours).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

There are no specific studies in pregnant women during the first trimester that allow the risk of malformation to be assessed. However, no congenital malformations have been reported in the literature or in post-marketing experience. During the second and third trimesters, there is a large amount of bibliographic data on pregnant women that does not indicate malformations or fetal/neonatal toxicity.

Consequently, this medication can be used during pregnancy if it is clinically necessary.

This medication can be used during breastfeeding.

Driving and using machines

The influence of the medication on the ability to drive and use machines is zero or insignificant.

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Tardyferon

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Posology:

• Mild iron deficiency anemia, iron deficiency states, and increased iron needs: 1 tablet once a day, taken without chewing, preferably 1 hour before or 3 hours after meals.
• Severe iron deficiency anemia, with less than 8-9 g/dl of hemoglobin: 1 tablet in the morning and 1 tablet in the afternoon, for about 3 weeks, and then 1 tablet per day, taken without chewing, preferably 1 hour before or 3 hours after meals.

Pediatric population

This medication should not be administered to children with a weight of less than 28 kg (between 9-10 years).

Duration of treatment

The duration of treatment will depend on the severity of the iron deficiency, generally requiring at least 3 months. The treatment should continue and be extended for the necessary time to saturate the iron reserves, guided by blood parameters for the correction of anemia (Hb, MCV) and the restoration of iron reserves (serum ferritin, serum transferrin receptor, and transferrin saturation coefficient).

Method of administration

The tablets are for oral use.

Swallow the tablets whole with water. Do not suck, chew, or leave the tablet in the mouth.

The tablets should be taken with a large glass of water before or during meals, depending on gastrointestinal tolerance (except with the specific foods mentioned in the section "Taking Tardyferon with food and drinks").

If you take more Tardyferon than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

The symptoms of overdose include signs of gastrointestinal irritation (characterized by abdominal pain, nausea, vomiting, diarrhea, and bleeding), which can evolve into symptoms of metabolic acidosis or cardiovascular shock (characterized by rapid or short breathing, increased heart rate, headache, confusion, drowsiness, fatigue, loss of appetite, hypotension, and even convulsions), followed by renal or hepatic insufficiency.

If you forget to take Tardyferon

If you forget to take a tablet, take it as soon as possible. However, if it is almost time for your next dose, wait for the next dose and then continue as usual.

Do not take a double dose to make up for the forgotten dose.

If you stop taking Tardyferon

Do not stop taking the medication until the end of your treatment. Do not suspend treatment before, even if you feel better.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them.

Common (may affect up to 1 in 10 patients)

Difficulty defecating

Diarrhea

Abdominal enlargement

Abdominal pain

Black-colored stools

Nausea

Uncommon (may affect up to 1 in 100 patients)

Swelling of the throat (laryngeal edema)

Abnormal stools

Indigestion (dyspepsia)

Vomiting

Inflammation of the stomach wall (gastritis)

Itching (pruritus)

Red skin rash (erythematous rash)

Frequency not known (cannot be estimated from available data)

Allergic reaction

Itchy rash (urticaria)

Lung tissue death (pulmonary necrosis)*

Lung tissue inflammation (pulmonary granuloma)*

Narrowing of the airways (bronchostenosis)*

Throat ulceration*

Esophageal lesions*

Esophageal ulceration*

Tooth discoloration**

Mouth ulcers**

Discoloration of the gastrointestinal tract wall (gastrointestinal melanosis) (see section 2)

Open gastric ulcer

Gastric bleeding (see section 2)

• All patients, but especially elderly patients and patients with difficulty swallowing, may be at risk of suffering from throat or esophageal ulcers. If the tablet passes into the airways, there may be a risk of bronchial ulceration and pulmonary granuloma, which can cause bronchial narrowing.

** In case of incorrect use, when the tablets are chewed, sucked, or left in the mouth.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tardyferon

No special storage conditions are required.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Tardyferon

The active ingredient is iron 80 mg (in the form of dried ferrous sulfate 247.25 mg).

The other ingredients are:

• maltodextrin, microcrystalline cellulose, triethyl citrate, talc, ammonio methacrylate copolymer type B (Eudragit RS 30D), ammonio methacrylate copolymer type A (Eudragit RL 30D)*, glycerol dibehenate.

* see section 2 "Tardyferon contains"

• Coating:titanium dioxide (E171), Sepifilm LP010**, yellow iron oxide (E172), red iron oxide (E172).

** Composition of Sepifilm LP010: hypromellose, microcrystalline cellulose, stearic acid.

Appearance of Tardyferon and package contents

Prolonged-release tablets are round and orange-pink in color.

Blister pack with 30 prolonged-release tablets.

Marketing authorization holder

PIERRE FABRE IBÉRICA, S.A.

Ramón Trias Fargas, 7-11

08005 Barcelona

Spain

Manufacturer:

Pierre Fabre Médicament Production

PROGIPHARM site

Rue du Lycée

45500 Gien

France

Date of the last revision of this leaflet:06/2024

"Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/"