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Lederfoline 25mg 30 tablets
Over-the-counter medication

Lederfoline 25mg 30 tablets

Brand : OCP OCP
product contains :

Lederfoline 25mg 30 tablets in our organic pharmacy. Give your opinion on how to use and dosage with our partner Verified opinions after your purchase.

€34.17 EXCL. VAT €34.89 INCL. VAT
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Medical description of Léderfoline 25 mg

LEDERFOLINE 25 mg, tablet is a drug containing calcium folinate, an active derivative offolic acid (vitamin B9). It belongs to the class of drugs used to reduce the toxicity of certain antifolic cytostatic treatments.

Therapeutic indications

This drug is used in association with folate antagonists, in particular :

  • methotrexate
  • trimethoprim
  • salazopyrine
  • pyrimethamine
  • trimetrexate

It helps to correct or prevent undesirable effects associated with these treatments, in particular during certain anti-cancer or anti-infectious therapies.

Mechanism of action

Calcium folinate is an active form of folate, directly involved in DNA synthesis and cell function.

Unlike folic acid, it requires no prior metabolic transformation, enabling it to act rapidly to :

  • restore folate reserves
  • limit the toxicity of antifolates
  • protect normal cells

Target audience

LEDERFOLINE 25 mg is intended for patients receiving antifolic therapy, particularly in hospital or specialized settings.

It should be used in accordance with the recommendations of your doctor or pharmacist.

How to use LEDERFOLINE 25 mg

Route of administration

  • Oral administration
  • Swallow the tablet with a glass of water.

Dosage

Dosage is strictly individual and depends on

  • therapeutic indication
  • associated treatment
  • the patient's clinical situation

It is essential to :

  • scrupulously follow your doctor's instructions
  • do not modify the dose without medical advice

Directions for use

  • Take treatment as prescribed
  • In the event of vomiting, inform your doctor: injectable administration may be necessary.
  • If in doubt, seek advice from a healthcare professional

Pharmacist's advice on Léderfoline 25 mg

Precautions for use

Before taking this medicine, it is advisable to inform your doctor:

  • in case ofrenal insufficiency
  • in case ofintolerance to certain sugars (lactose)
  • in the event of associated treatments

This medicine contains lactose and a negligible amount of sodium.

Contraindications

Never take LEDERFOLINE 25 mg :

  • in case ofallergy to calcium folinate
  • in case ofpernicious anemia
  • megaloblastic anemia due to vitamin B12 deficiency.

Pregnancy and breast-feeding

  • Calcium folinate may be used during pregnancy on medical advice.
  • It may be used duringbreast-feeding if necessary, depending on the indication.

Side effects

Like all medicines, LEDERFOLINE may cause undesirable effects, in particular

  • rare allergic reactions (urticaria, angioedema, anaphylactic shock).

In the event of unusual symptoms, it is advisable to consult a healthcare professional.

Situations requiring medical advice

  • no improvement
  • worsening of symptoms
  • onset of vomiting
  • appearance of undesirable effects

Léderfoline 25 mg regulatory information

  • Pharmacotherapeutic class: detoxifying drug for cytostatic treatment (ATC code: V03AF03)
  • Active substance: calcium folinate corresponding to 25 mg folinic acid
  • Pharmaceutical form: tablet
  • Route of administration: oral

Composition

  • calcium folinate
  • lactose
  • microcrystalline cellulose
  • sodium carboxymethyl starch
  • corn starch
  • magnesium stearate

Storage

  • Keepaway from light
  • Keep out of reach of children
  • Do not use after expiration date

Further information

Detailed information is available on the ANSM (France) website.

Medical summary of product

LEDERFOLINE 25 mg, tablet is a calcium folinate-based medicine indicated for reducing the toxicity of antifolate treatments, particularly in association with methotrexate. It acts by restoring folate metabolism and protecting normal cells. Its dosage is individualized and its use must follow medical recommendations. It is generally well tolerated, with rare allergic reactions.

Frequently asked questions

Why take Lederfoline with methotrexate?

Lederfoline acts as a "rescue" to protect the body's healthy cells from the toxic effects of methotrexate, by restoring the folate levels necessary for cell survival.

Can Lederfoline 25 mg be taken during pregnancy?

Calcium folinate may be used during pregnancy if, in the doctor's opinion, the benefit to the mother justifies the potential risk to the fetus.

What are the possible side effects?

Although rare, allergic reactions such as urticaria, angioedema or anaphylactic shock may occur.

Does Lederfoline contain sugar?

Yes, it contains lactose. If you are intolerant to certain sugars, contact your doctor before taking it.

What should I do if I miss a dose of Lederfoline?

It's vital to take your Lederfoline as scheduled. If you forget to take a dose, contact your health center or doctor immediately, as this may affect the protection against toxicity of your main treatment.

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

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.

VIDAL DE LA FAMILLE

LEDERFOLINE

Revised on June 25, 2007
Drug family : Antianemic

Indications

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.

It is used to :
  • correct megaloblastic anemia caused by drugs containing pyrimethamine, trimethoprim or sulfasalazine;
  • prevent and correct the toxic effects of trimetrexate or methotrexate.

Presentations

LEDERFOLINE 5 mg: tablet (pale yellow); box of 30
Optional prescription - 65% reimbursable - Price: €8.52
LEDERFOLINE 15 mg : scored tablet (pale yellow) ; box of 30
Optional prescription - 65% reimbursable - Price: € 17.3
LEDERFOLINE 25 mg : tablet (pale yellow) ; box of 30
Optional prescription - Reimbursable at 65% - Price : 26.08 €

Prices do not include dispensing fees.

Composition

p cpp cpp cp
Folinic acid5 mg15 mg25 mg
Lactose+++

Warning

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.

Drug interactions

Tell your doctor if you are taking phenobarbital, primidone or phenytoin.

Fertility, pregnancy and breast-feeding

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).

Directions for use and dosage

This medicine may be taken with or without meals.

Usual dosage :

Correction of megaloblastic anemias induced by trimethoprim or salazopyrin:

  • Adult: 5 mg daily for the duration of treatment with trimethoprim or salazopyrine.
  • Children: 5 mg every 2 to 4 days.

Prevention and correction of pyrimethamine-induced megaloblastic anemias:

  • Adults: 10 and 25 mg daily in the case of high doses of pyrimethamine, or 30 to 75 mg weekly in the case of long-term pyrimethamine treatment.
  • Children: 5 to 10 mg every 2 to 4 days.

Prevention of toxic accidents due to trimetrexate or methotrexate: doses vary according to the doses of trimetrexate or methotrexate administered.

Advice

The reimbursement rate for this drug depends on the indication for which it is prescribed.

Possible side effects

Very rare allergic reactions.

LEXICON

folic acid

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).

megaloblastic anemia

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.

bone marrow failure

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

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.

allergic reaction

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?

scored

Can be cut or divided.

vitamin

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.

route
  • The route used to administer drugs: oral, sublingual, subcutaneous, intramuscular, intravenous, intradermal, transdermal.
  • A set of hollow organs through which air (respiratory tract), food (digestive tract), urine (urinary tract), bile (biliary tract), etc. can pass.
product contains :
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