NOTICE
ANSM - Updated on : 17/05/2024
Product name
FUMAFER 66 mg, film-coated tablet
Ferrous fumarate
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
You must always take this medicine exactly as instructed in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- 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 FUMAFER 66 mg, film-coated tablet and what is it used for?
2. What do I need to know before taking FUMAFER 66 mg, film-coated tablet?
3. How do I take FUMAFER 66 mg, film-coated tablet?
4. What are the possible side effects?
5. How do I keep FUMAFER 66 mg, film-coated tablet?
6. Package contents and other information.
1. WHAT IS FUMAFER 66 mg, film-coated tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: ANTIANEMIC - ORAL IRON FUMARATE (B: blood and blood-forming organs) - ATC code: B03AA02
This medicine contains iron.
It is recommended for the treatment of anemia due to iron deficiency in adults and children aged 10 and over, and as a preventive treatment for iron deficiency in pregnant women.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING FUMAFER 66 mg, film-coated tablet?
Never take FUMAFER 66 mg, film-coated tablet in the following cases:
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
Consult your doctor or pharmacist before taking FUMAFER.
- FUMAFER is not recommended 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.
- The prevention of iron deficiency in infants is based on the early introduction of a diversified diet.
- Heavy tea consumption inhibits iron absorption.
- It is advisable to check the efficacy of FUMAFER after 3 months of treatment.
Other medicines and FUMAFER 66 mg, film-coated tablet
TO AVOID INTERACTIONS BETWEEN MEDICATIONS, REPORT ANY OTHER CURRENT TREATMENT TO YOUR PHARMACIST OR DOCTOR, especially injectable iron-containing drugs.
FUMAFER 66 mg, film-coated tablet with food and drink
Not applicable.
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.
FUMAFER 66 mg, film-coated tablet contains sodium
This medicine contains less than 1 mmol (23mg) of sodium per tablet, i.e. it is essentially "sodium-free".
3. HOW TO TAKE FUMAFER 66 mg, film-coated tablet
Dosage
RESERVED FOR ADULTS AND CHILDREN AGED 10 AND OVER
Curative treatment :
- FOR ADULTS AND CHILDREN FROM 30 KG (APPROXIMATELY 10 YEARS OF AGE): on average, 2 to 3 tablets a day.
Preventive treatment :
- IN PREGNANT WOMEN: 1 tablet per day, during the last two trimesters of pregnancy (or from the 4th month onwards).
Method of administration
Oral administration.
Frequency of administration
Dosage schedule and distribution should be adapted according to digestive tolerance.
To limit undesirable effects, it is advisable to divide the dose into several daily doses.
Duration of treatment
The duration of treatment should be sufficient to correct anemia and restore iron reserves (around 3 to 6 months).
If you have taken more FUMAFER 66 mg, film-coated tablet than you should have
In the event 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 FUMAFER 66 mg, film-coated tablet
Not applicable.
If you stop taking FUMAFER 66 mg, film-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.
- Nausea, constipation or diarrhoea may occur.
- Stools usually turn black or grayish-black.
- Possible allergic reactions.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
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 Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO STORE FUMAFER 66 mg, film-coated tablet?
Store at a temperature not exceeding 25°C.
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging.
The expiration date refers to the last day of that month.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What FUMAFER 66 mg, film-coated tablet contains
- The active substance is :
Ferrous fumarate............................................................................................................ 200 mg
Corresponding amount of iron......................................................................................... 66 mg
Per film-coated tablet
One tablet contains 66 mg (1.177 mmoles) of iron.
- Other components: carboxymethyl starch sodium, corn starch, povidone K90, docusate sodium, magnesium stearate.
Film coating : hypromellose, macrogol 6000.
What FUMAFER 66 mg, film-coated tablet is and what it contains
This medicine takes the form of a film-coated tablet.
Box of 50 (hospital model) and box of 100.
Marketing authorization holder
CHEPLAPHARM ARZNEIMITTEL GMBH
ZIEGELHOF 24
17489 GREIFSWALD
GERMANY
Marketing authorization holder
CHEPLAPHARM FRANCE
105 RUE ANATOLE FRANCE
92300 LEVALLOIS-PERRET
Tel : 0809 54 20 23
Manufacturer
SANOFI WINTHROP INDUSTRIE
1 RUE DE LA VIERGE
AMBARES ET LAGRAVE
33565 CARBON BLANC CEDEX
or
SANOFI AVENTIS S.A
CTRA. LA BATLLORIAA HOSTALRIC, KM 63,09
RIELLS I VIABREA
(GIRONA)
SPAIN
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
Detailed information on this drug is available on the ANSM (France) website.