Lederfoline 25 mg, 30 tablets, available at our natural pharmacy. Share your feedback on usage instructions and dosage with our partner. Reviews are verified after your purchase.
LEDERFOLINE 25 mg tablets are a medication containing calcium folinate, an active derivative offolic acid (vitamin B9). It belongs to a class of medications used to reduce the toxicity of certain antifolate cytostatic treatments.
This medication is used in combination with folate antagonists, including:
It helps correct or prevent adverse effects associated with these treatments, particularly during certain cancer or anti-infective therapies.
Calcium folinate is an active form of folate that plays a direct role in DNA synthesis and cellular function.
Unlike folic acid, it does not require prior metabolic conversion, which allows it to act quickly to:
LEDERFOLINE 25 mg is intended for patients receiving antifolate therapy, particularly in a hospital or specialized care setting.
It should be used according to the recommendations of a doctor or pharmacist.
The dosage is strictly individualized and depends on:
It is essential to:
Before taking this medication, it is recommended that you inform your doctor:
This medication contains lactose and a negligible amount of sodium.
Never take LEDERFOLINE 25 mg:
Like all medications, LEDERFOLINE may cause side effects, including:
rare allergic reactions (hives, angioedema, anaphylactic shock)
If you experience any unusual symptoms, it is recommended that you consult a healthcare professional.
Detailed information is available on the ANSM (France) website.
LEDERFOLINE 25 mg tablets are a calcium folinate-based medication indicated to reduce the toxicity of antifolate therapies, particularly when used in combination with methotrexate. It works by restoring folate metabolism and protecting normal cells. The dosage is individualized, and its use must follow medical recommendations. It is generally well tolerated, with rare allergic reactions.
Lederfoline acts as a “protective measure” to shield the body’s healthy cells from the toxic effects of methotrexate by restoring the folate levels necessary for cell survival.
Calcium folinate may be used during pregnancy if the doctor determines that the benefit to the mother justifies the potential risk to the fetus.
Although rare, allergic reactions such as hives, angioedema, or anaphylactic shock may occur.
Yes, this medication contains lactose. If you have an intolerance to certain sugars, contact your doctor before taking it.
It is crucial to stick to your dosing schedule. If you miss a dose, contact your healthcare provider or doctor immediately, as this may affect the protection your primary treatment provides against toxicity.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on : 23/03/2023
Calcium folinate
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.
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
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
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?
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
23-25 AVENUE DU DOCTEUR LANNELONGUE
75014 PARIS
Marketing authorization holder
23-25 AVENUE DU DOCTEUR LANNELONGUE
75014 PARIS
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}.>
Detailed information on this drug is available on the ANSM (France) website.
This medicine contains folinic acid, a substance derived from folic acid (vitamin B9). Certain cytotoxic drugs can alter the action of folic acid, causing megaloblastic anemia or bone marrow failure. Supplementation with folinic acid reduces the toxicity of these drugs.
Prices do not include dispensing fees.
| p cp | p cp | p cp | |
| Folinic acid | 5 mg | 15 mg | 25 mg |
| Lactose | + | + | + |
When this drug is taken to prevent the toxic effects of methotrexate, it should generally not be taken at the same time; if in doubt, ask your doctor for advice.
If vomiting occurs after taking this drug (methotrexate-induced vomiting), folinic acid should be administered by injection.
Tell your doctor if you are taking phenobarbital, primidone or phenytoin.
This medicine contains a substance presumed safe for use during pregnancy and breast-feeding.
However, drugs associated with folinic acid are contraindicated during pregnancy (drugs containing trimethoprim, pyrimethamine, sulfasalazine, methotrexate).
This medicine may be taken with or without meals.
Correction of megaloblastic anemias induced by trimethoprim or salazopyrin:
Prevention and correction of pyrimethamine-induced megaloblastic anemias:
Prevention of toxic accidents due to trimetrexate or methotrexate: doses vary according to the doses of trimetrexate or methotrexate administered.
The reimbursement rate for this drug depends on the indication for which it is prescribed.
Very rare allergic reactions.
Chemical name for vitamin B9, normally present in the diet and in the body in the form of folate. Folic acid plays an important role in cell renewal and the production of red blood cells. Insufficient folic acid intake can have serious consequences, particularly in childhood and adolescence (anemia) or during pregnancy (fetal malformations).
A particular type of anemia, due to a deficiency of folic acid (vitamin B9), which results in a drop in the number of red blood cells and an increase in their size. It differs from the more common iron-deficiency anemias, which result in a decrease in red blood cell size.
Damage to the bone marrow, which becomes incapable of producing blood cells (red blood cells, white blood cells, platelets).
See also: bone marrow failure.
Lactose is a sugar found in milk and certain milk derivatives. To digest it, the intestine must be able to secrete an enzyme called lactase. Many people lose the ability to produce lactase in adulthood. Lactose then passes into the intestine undigested, and its presence causes intestinal problems such as diarrhoea, bloating and gas. Some medicines contain lactose as an excipient (a component with no therapeutic activity). People who do not digest lactose may suffer adverse intestinal effects when taking this type of medication.
Reaction caused by the body's hypersensitivity to a drug. Allergic reactions can take many forms: urticaria, angioedema, eczema, measles-like rash, etc. Anaphylactic shock is the most common form of anaphylactic shock. Anaphylactic shock is a generalized allergic reaction that causes a sudden drop in blood pressure.
See article: Can you be allergic to medicines?
Can be cut or divided.
A substance essential for growth and proper functioning of the body. Vitamin requirements are normally covered by a varied diet. In developed countries, only vitamin D deficiency in young children or elderly people with little exposure to sunlight justifies systematic supplementation. Intake in excess of requirements, particularly through medication, can lead to overdosage and various disorders (mainly vitamins A and D).
See article: Vitamins.
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