NOTICE
ANSM - Updated on : 17/06/2022
Product name
Timoferol 50 mg, coated tablet
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
You must always take this medicine in strict accordance with the information provided in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is TIMOFEROL 50 mg, coated tablet and what is it used for?
2. What do I need to know before taking TIMOFEROL 50 mg, coated tablet?
3. How do I take TIMOFEROL 50 mg, coated tablet?
4. What are the possible side effects?
5. How do I keep TIMOFEROL 50 mg, coated tablet?
6. Package contents and other information.
1. WHAT IS TIMOFEROL 50 mg, coated tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code: Antianemic, Oral ferrous sulfate
This medicine contains iron.
It is recommended for the curative treatment of anemia due to iron deficiency in adults and children over 6 years of age, and as a preventive treatment for iron deficiency in pregnant women.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING TIMOFEROL 50 mg, coated tablet?
Never take TIMOFEROL 50 mg, coated tablet :
- if you have iron overload, particularly in certain forms of anemia (thalassemia, refractory anemia, bone marrow failure anemia).
If in doubt, ask your doctor or pharmacist for advice.
Warnings and precautions
Tell your doctor or pharmacist before taking TIMOFEROL 50 mg, coated tablet:
- If you have difficulty swallowing.
- If you accidentally choke on a tablet, contact your doctor as soon as possible. If the tablet enters the airways, there is a risk of ulceration and narrowing of the airways. This can lead to persistent coughing, bloody coughing and/or shortness of breath, even if inhalation took place several days or months before the onset of symptoms. You should therefore seek urgent medical attention to ensure that the inhaled tablet has not damaged your airways.
- If your doctor has informed you of an intolerance to certain sugars.
Warnings
- This medicine is not suitable for the treatment of anemia associated with inflammatory diseases.
- A medical consultation is necessary before starting this treatment, in order to investigate the cause of the anemia.
Precautions for use
- High tea consumption inhibits iron absorption. This medicine should not be taken at the same time as tea.
- It is advisable to check the efficacy of this product after 3 months of treatment.
- Due to the presence of sucrose (0.182 g per tablet), this drug is not recommended for patients with fructose intolerance.fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases).
- This medicine contains 30 mg ascorbic acid (vitamin C). In order to limit undesirable effects, and due to the stimulating effect of vitamin C, it is advisable to take this medicine on an empty stomach in the morning or before breakfast, but the timing and dosage should be adjusted according to digestive tolerance.
If in doubt, ask your doctor or pharmacist for advice.
Children and teenagers
Not applicable.
Other medicinal products and TIMOFEROL 50 mg, coated tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines, especially injectable medicines containing iron.
This medicine may reduce the absorption of other drugs.
TIMOFEROL 50 mg, coated tablet with food and drink
With tea (see precautions for use).
Pregnancy and breast-feeding
This medicine should be used during pregnancy only on the advice of your doctor.
This medicine may be used by nursing mothers.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
TIMOFEROL 50 mg, coated tablet contains sucrose.
3. HOW TO TAKE TIMOFEROL 50 mg, coated tablet
Dosage: for children over 6 and adults only.
Curative treatment:
- children over 6: 1 tablet per day,
- children over 12 and adults: 2 to 4 tablets a day.
Preventive treatment:
- pregnant women: 1 tablet per day, during the last two trimesters of pregnancy (i.e. from the 4th month).
In all cases, follow your doctor's prescription.
Method and frequency of administration
Take by mouth.
Take with a glass of water, preferably before or during meals, depending on digestive tolerance.
Duration of treatment
Sufficient to correct anemia and restore iron reserves (3 to 6 months).
In all cases, follow your doctor's prescription.
If you have taken more TIMOFEROL 50 mg, coated tablet than you should have
In case of massive ingestion, consult your doctor or pharmacist immediately, or seek emergency medical attention, especially if you are a child under 2 years of age.
Overdosage may cause intense irritation or death of digestive tissues (necrosis of digestive mucosa). The main symptoms are abdominal pain, vomiting and diarrhoea (often containing traces of blood), which may be accompanied by a rapid drop in blood pressure (shock), loss of consciousness with convulsions (coma), kidney disease (acute renal failure) and liver disease (hepatic impairment).
Longer-term digestive consequences may occur, with narrowing of the digestive tract (digestive stenosis).
If you forget to take TIMOFEROL 50 mg, coated tablet
Not applicable.
If you stop taking TIMOFEROL 50 mg, coated tablet
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
As with all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Digestive disorders such as nausea, constipation or diarrhea may occur.
Stools may be black or grayish-black in color.
Ulcerations of the throat or esophagus (the tube connecting your mouth to your stomach) may occur in all patients, but particularly in the elderly and patients with swallowing disorders. If the tablet enters the respiratory tract, there is a risk of ulceration of the bronchi (the main air passages of the lungs), which may lead to narrowing of the bronchi.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE TIMOFEROL 50 mg, coated tablet
Keep out of sight and reach of children.
Do not use after the expiration date indicated on the box.
No special storage precautions.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What TIMOFEROL 50 mg, coated tablet contains
- The active substance is :
Fer........................................................................................................................... 50,000 mg
As dried ferrous sulfate.................................................................. 136,000 mg
For one coated tablet.
- Other ingredients: ascorbic acid, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, corn starch, polyvinyl acetate, talc, sucrose, gum arabic, titanium dioxide (E 171), carnauba wax.
What TIMOFEROL 50 mg, coated tablet is and what it contains
This medicine comes in the form of white, coated tablets. Boxes of 30, 60, 90 and 120.
Marketing authorization holder
Laboratoires des Réalisations Thérapeutiques ELERTE
181-183 rue André KARMAN
93300 Aubervilliers
Marketing authorization holder
Laboratoires des Réalisations Thérapeutiques ELERTE
181-183 rue André KARMAN
93300 Aubervilliers
Manufacturer
Laboratoires des Réalisations Thérapeutiques ELERTE
181-183 rue André KARMAN
93300 Aubervilliers
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Not applicable.
Detailed information on this drug is available on the ANSM (France) website.