Tardyferon 80 mg prolonged-release tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Tardyferon 80 mg prolonged-release tablets
Iron (as dried ferrous sulfate)
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Tardyferon is and what it is used for
- What you need to know before taking Tardyferon
- How to take Tardyferon
- Possible adverse effects
- How to store Tardyferon
- Contents of the pack and other information
1. What Tardyferon is and what it is used for
This medicinal product contains prolonged-release iron for the prevention and treatment of iron deficiency anemias 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 medicine (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 iron deficiency or that causes 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 medicine.
Warnings and precautions
- If you are taking this medicine for iron deficiency anemia, the underlying cause of the iron deficiency should also be investigated so that it can be properly treated.
- If iron deficiency is associated with inflammatory disorders, treatment with Tardyferon will not be effective.
- Consult your doctor or pharmacist before starting this medicine if you have difficulty swallowing.
- Based on literature data, gastrointestinal wall pigmentation 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 supplementation for anemia. This gastrointestinal pigmentation may complicate gastrointestinal surgery. Due to this risk, if surgery is planned, it is advisable to inform the surgeon about iron supplement use (see section 4).
- If the medicine is inadvertently aspirated (goes the "wrong way"), it may enter your respiratory tract. If the medicine comes into contact with the airways, it may cause injuries such as necrosis (tissue death) or inflammation of the bronchi (air passages through the lungs) or esophagus (the tube connecting the mouth to the stomach). These injuries may lead to bronchial narrowing. Signs associated with such injuries may include: persistent cough, coughing up blood and/or feeling short of breath, even if aspiration occurred several days or months before symptoms appear.
- If the medicine has entered the airways and you experience one or more of these symptoms, contact your doctor or nearest emergency service as soon as possible for evaluation by a specialist to ensure 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, switching to a liquid iron formulation is recommended (see Section 4).
- Due to the risk of mouth ulcers and tooth discoloration, the tablets must not be sucked, chewed, or held in the mouth; they should be swallowed whole with water. If you are unable to follow this instruction or have difficulty swallowing, contact your doctor.
- While taking Tardyferon, your stools may become dark. This effect is harmless.
Children
This medicine must not be given to children weighing less than 28 kg (approximately 9–10 years of age).
Other medicines and Tardyferon
If you are taking any of the following medicines, do not take this medicine unless prescribed by your doctor.
Some medicines cannot be used together, while others require specific adjustments (e.g., timing of administration).
If you are receiving injectable iron-containing medications, you must avoid taking Tardyferon.
If you are taking the following medicines, their administration must be separated from that of Tardyferon by at least 2 hours:
- Certain antibiotics (tetracyclines, fluoroquinolones, cefdinir)
- Medication used to treat chronic urinary tract infection (acetohydroxamic acid)
- Medication used to treat HIV infection (integrase inhibitors, bictegravir)
- Medications used to treat osteoporosis or bone fragility (bisphosphonates)
- Medications used to treat joint diseases, Wilson’s disease, or to prevent kidney stones (penicillamine, trientine)
- Medications used to treat stomach acidity: gastrointestinal mineral preparations, charcoal, or antacids (aluminum, calcium, and magnesium salts)
- Medications used to treat thyroid disease (thyroxine)
- Medications used to treat Parkinson’s disease (methyldopa, levodopa, carbidopa, entacapone)
- Supplements and/or medications containing zinc or calcium
If you are taking colestyramine, Tardyferon should be administered 1 to 2 hours before or 4 to 6 hours after colestyramine.
If you are taking medications containing ascorbic acid (vitamin C), iron absorption may be increased.
If you are taking medications containing chloramphenicol, they may delay the response to iron treatment.
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, even if they are over-the-counter.
Taking Tardyferon with food and drinks
Do not drink large amounts of tea, coffee, or red wine, as this may reduce iron absorption in your body.
It is not recommended to take this medicine at the same time as cereals (bran, legumes, oilseeds), certain proteins (eggs), or foods or drinks containing calcium (cheese, milk, etc.). Maintain an interval of at least 2 hours between taking iron salts and these foods.
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 medicine.
There are no specific studies in pregnant women during the first trimester to assess the risk of malformation. However, congenital malformations have not been reported in the literature or in post-marketing experience. During the second and third trimesters, a large amount of bibliographic data in pregnant women does not indicate malformations or fetal/neonatal toxicity.
Therefore, this medicine may be used during pregnancy if clinically necessary.
This medicine may be used during breastfeeding.
Driving and using machines
The effect of this medicine on the ability to drive and operate machinery is none or negligible.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.
3. How to take Tardyferon
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Dosage:
- Mild iron deficiency anemias, iron deficiency states, and increased iron requirements: 1 tablet once daily, taken without chewing, preferably 1 hour before or 3 hours after meals.
- Severe iron deficiency anemias, with hemoglobin levels below 8–9 g/dL: 1 tablet in the morning and another in the afternoon for about 3 weeks, followed by 1 tablet daily, taken without chewing, preferably 1 hour before or 3 hours after meals.
Paediatric population
This medicine must not be given to children weighing less than 28 kg (approximately 9–10 years of age).
Duration of treatment
The duration of treatment depends on the severity of iron deficiency. Generally, at least 3 months are required. Treatment should continue and be prolonged as long as necessary to replenish iron stores, guided by blood parameters indicating correction of anemia (Hb, MCV) and 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 hold 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 drink").
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 at 91 562 04 20, indicating the medicine and the amount ingested.
Symptoms of overdose include signs of gastrointestinal irritation (characterized by abdominal pain, nausea, vomiting, diarrhea, and bleeding), which may progress to 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 seizures), followed by renal or hepatic failure.
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, skip the missed dose and take the next one at the usual time. Continue your treatment as normal.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Tardyferon
Do not stop taking the medicine before the end of your treatment. Do not discontinue treatment early, even if you feel better.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Frequent (may affect up to 1 in 10 patients)
Difficulty defecating
Diarrhea
Abdominal swelling
Abdominal pain
Black 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
Rash with itching (urticaria)
Death of lung cells or tissue (pulmonary necrosis)*
Inflammation of lung tissue (pulmonary granuloma)*
Narrowing of the airways (bronchostenosis)*
Throat ulceration*
Esophageal lesions*
Esophageal ulceration*
Dental 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 those with swallowing difficulties, may be at risk of developing ulcers in the throat or esophagus (the tube connecting the mouth to the stomach). If the tablet enters the airways, there may be a risk of bronchial ulceration and pulmonary granuloma (inflammation), which could lead to bronchial narrowing.
** In case of incorrect use, when tablets are chewed, sucked, or held in the mouth.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Tardyferon
No special storage conditions are required.
Keep this medicine out of the 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 indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Tardyferon
The active substance is iron 80 mg (as dried ferrous sulfate 247.25 mg).
The other components are:
- Core: maltodextrin, microcrystalline cellulose, triethyl citrate, talc, methacrylic acid copolymer type B (Eudragit RS 30D), methacrylic acid 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 pack contents
Orange-pink, round, prolonged-release tablets.
Blister pack containing 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
Site PROGIPHARM
Rue du Lycée
45500 Gien
France
Date of the most recent review of this leaflet: 06/2024
"Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) https://www.aemps.gob.es/"