Lederfoline 5 mg provides an active form of vitamin B9 to support cellular metabolism, prevent certain types of anemia, and reduce hematotoxicity associated with certain treatments. It is also used in women at risk before and during early pregnancy.
When the body undergoes certain treatments—particularly in oncology or in treatments requiring specific molecules—cellular metabolism can become unbalanced. Lederfoline 5 mg provides folinic acid, an active form of the B vitamins, which is helpful in situations where blood cell production becomes compromised.
Think of folinic acid as a “backup system”: certain medications can inhibit the body’s use of folates, and Lederfoline 5 mg helps get the system back on track. This action helps maintain more stable cell synthesis, particularly in the bone marrow, where blood cells are produced.
This medication is used in conjunction with treatments such as trimethoprim, salazopyrin, pyrimethamine, trimetrexate, and methotrexate. In these contexts, Lederfoline 5 mg helps prevent and correct the hematotoxicity caused by these drugs, particularly during long-term or high-dose regimens.
It is also used to prevent and correct toxic side effects caused by methotrexate in the treatment of leukemias and malignant tumors. In practice, it helps the body better tolerate certain treatment regimens by supporting folate-related biological mechanisms.
Folic acid (vitamin B9) remains essential for metabolism, and a deficiency can lead to certain forms of anemia. Furthermore, in women at risk for neural tube defects, an adequate intake of folate before and at the start of pregnancy helps promote healthy embryonic development. To boost your vitamin B9 intake while trying to conceive, you can take Fertifol Folic Acid 400 µg 90 tablets, whose supplemental dose works synergistically with folate to support your needs during early pregnancy.
Directions for Use
The dosage depends on the indication and therapeutic context. In typical situations, the recommended dose is between 1 and 3 tablets per day.
Expectant mothers: 1 tablet per day, to be taken at least 1 month before conception and during the first 3 months of pregnancy.
Treatment of hematotoxicity induced by trimethoprim or salazopyrine therapy:
In adults, a daily dose of 5 mg of folinic acid (dl) for the duration of treatment with the agent causing the hematotoxicity is usually sufficient.
In children, the dosage is 5 mg of folinic acid (dl) every 2 to 4 days.
Prevention and correction of hematotoxicity induced by long-term or high-dose pyrimethamine: dosing regimens depend on the doses of pyrimethamine administered.
Share your feedback on the usage instructions and dosage of Lederfoline 5 mg with our partner Avis Vérifiés after your purchase.
Precautions
Folinic Acid 5 mg, in the form of calcium folinate; Active Ingredient: Folic Acid; Excipients: Modified Corn Starch, Microcrystalline Cellulose, Magnesium Stearate, Dicalcium Phosphate, Anhydrous Colloidal Silica.
Packaging
PVC/PVDC/aluminum blister pack(s) containing 30 tablets.
CIP Code: 347 549-4 or 34009 347 549 4 4.
If this medication is part of a cytostatic treatment or a complex drug regimen, be sure to follow the recommended dosing schedule and duration of treatment, as consistency helps maintain folate balance. If you experience unusual fatigue, paleness, shortness of breath during physical activity, or signs suggestive of intolerance, contact a healthcare professional promptly to adjust your treatment and, if necessary, check your blood count.
Can Lederfoline 5 mg be taken long-term?
Yes, when clinically indicated, this medication can be used for an extended period under medical supervision.
Why is Lederfoline 5 mg combined with certain treatments?
Because certain medications can interfere with the body’s use of folates. Folinic acid helps support these mechanisms and limit hematotoxicity in the indicated uses.
Can vitamin B9 supplementation be used when planning a pregnancy?
Depending on the circumstances, a product such as Fertifol Folic Acid 400 µg 90 tablets can supplement vitamin B9 intake, working in synergy with folate, particularly before and at the beginning of pregnancy.
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 it is prescribed 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 5 mg, tablet and what is it used for?
2. What do I need to know before taking LEDERFOLINE 5 mg, tablet?
3. How do I take LEDERFOLINE 5 mg, tablet?
4. What are the possible side effects?
5. How should LEDERFOLINE 5 mg, Tablet be stored?
6. Package contents and other information.
1. WHAT IS LEDERFOLINE 5 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 5 mg, tablet?
Never take LEDERFOLINE 5 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 5 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 5 mg, tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
LEDERFOLINE 5 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 5 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 5 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 5 mg, tablet than you should have
Not applicable.
If you forget to take LEDERFOLINE 5 mg, tablet
If you stop taking LEDERFOLINE 5 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 CONSERVE LEDERFOLINE 5 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 5 mg tablet contains
- The active substance is: calcium folinate*.
Quantity corresponding to folinic acid...................................................................... 5,000 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**, magnesium stearate, pregelatinized corn starch (STARCH RX 1500), sodium carboxymethyl starch (PRIMOGEL), microcrystalline cellulose (AVICEL PH 101).
**The total amount of calcium folinate and lactose should be 53.4 mg.
See section 2 "LEDERFOLINE 5 mg, tablet contains lactose and sodium".
What LEDERFOLINE 5 mg, tablet is and what it contains
This medicine comes in tablet form.
Box of 20, 28, 30, 60 or 120 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
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}.>
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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