NOTICE
ANSM - Updated on : 23/03/2023
Product name
LEDERFOLINE 25 mg, tablet
Calcium folinate
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as instructed in this leaflet or by your doctor, pharmacist or nurse.
- 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, pharmacist or nurse. 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 LEDERFOLINE 25 mg, tablet and what is it used for?
2. What do I need to know before taking LEDERFOLINE 25 mg, tablet?
3. How do I take LEDERFOLINE 25 mg, tablet?
4. What are the possible side effects?
5. How should LEDERFOLINE 25 mg, Tablet be stored?
6. Package contents and other information.
1. WHAT IS LEDERFOLINE 25 mg, tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: DETOXIFYING DRUG FOR CYTOSTATIC TREATMENT - ATC code: V03AF03
This drug is a vitamin derivative from the B vitamin group. It is used with the following drugs: trimethoprim, salazopyrine, pyrimethamine, trimetrexate and methotrexate.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING LEDERFOLINE 25 mg, tablet?
Never take LEDERFOLINE 25 mg, tablet
- if you are allergic to calcium folinate or to any of the other ingredients listed in section 6.
- if you suffer or have suffered from pernicious anemia (disorder characterized by a decrease in the hemoglobin level or number of red blood cells) or megaloblastic anemia due to vitamin B12 deficiency.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking LEDERFOLINE 25 mg, tablet.
Tell your doctor if you have kidney failure.
In the event of vomiting, it is essential to inform your doctor so that he/she can prescribe this medicine in its injectable form.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST.
Children and adolescents
Not applicable.
Other medicines and LEDERFOLINE 25 mg, tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
LEDERFOLINE 25 mg, tablet with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
LEDERFOLINE (calcium folinate) may be used during pregnancy if prescribed by a doctor.
Please also refer to the package inserts for drugs containing folate antagonists (such as trimethoprim, salazopyrin, pyrimethamine, trimetrexate and methotrexate).
Breast-feeding
The passage of calcium folinate into breast milk has not been evaluated. Calcium folinate may be used during breast-feeding if necessary, depending on the therapeutic indications.
Driving and use of machinery
Not applicable.
LEDERFOLINE 25 mg, tablet contains lactose and sodium.
If your doctor has informed you that you are intolerant to certain sugars, contact him/her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially "sodium-free".
3. HOW TO TAKE LEDERFOLINE 25 mg, Tablet
Dosage
Always take this medicine exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage varies according to the indication.
It is strictly individual. Follow your doctor's recommendations.
Method and route of administration
Oral administration.
Use in children and adolescents
Not applicable.
If you have taken more LEDERFOLINE 25 mg, tablet than prescribed
Not applicable.
If you forget to take LEDERFOLINE 25 mg, tablet
Not applicable.
If you stop taking LEDERFOLINE 25 mg, tablet
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor, pharmacist or nurse.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but these do not always occur in everyone.
Very rare allergic reactions (urticaria, angioedema and anaphylactic shock) have been reported.
Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. 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 contribute to providing more information on drug safety.
5. HOW TO USE LEDERFOLINE 25 mg, tablet?
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.
Keep away from light.
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 LEDERFOLINE 25 mg tablet contains
- The active substance is: calcium folinate*.
Quantity corresponding to folinic acid ..................................................................... 25.00 mg
Per tablet
*The amount of calcium folinate should be adjusted according to the folinic acid content of the raw material.
- Other ingredients include: lactose**, microcrystalline cellulose (AVICEL PH 101), sodium carboxymethyl starch (PRIMOGEL), gelling corn starch (STARCH RX 1500), magnesium stearate.
** The amount of lactose is adjusted so that the quantity of calcium folinate and lactose is equal to 266.999 mg.
See section 2 "LEDERFOLINE 25 mg, tablet contains lactose and sodium".
What LEDERFOLINE 25 mg, tablet is and what it contains
This medicine comes in tablet form.
Boxes of 2, 6, 12, 25, 28 or 30 tablets.
Marketing authorization holder
PFIZER HOLDING FRANCE
23-25 AVENUE DU DOCTEUR LANNELONGUE
75014 PARIS
Marketing authorization holder
PFIZER
23-25 AVENUE DU DOCTEUR LANNELONGUE
75014 PARIS
Manufacturer
WYETH MEDICA IRELAND
LITTLE CONNELL
NEWBRIDGE COUNTY KILDARE
IRELAND
or
FARMASIERRA MANUFACTURING S.L.
CTRA. IRUN, KM. 26,200
SAN SEBASTIAN DE LOS REYES
28700 MADRID
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]
< {MM/YYYY}>< {month/YYYY}.>
Other
Detailed information on this drug is available on the ANSM (France) website.