Leaflet: information for the user

Lederfolin 15 mg tablets

Folic Acid

Read this leaflet carefully before you start taking the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.

Lederfolin belongs to a group of medications known as detoxifying agents for the treatment of tumors.

This medication is used for:

• Megaloblastic anemia due to folate deficiency.
• To reduce toxicity and counteract the effect of folic acid antagonists.

Do not take Lederfolin:

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• If you have or have had pernicious anemia (a disorder characterized by a decrease in the number of red blood cells and/or hemoglobin in the blood) or other megaloblastic anemias due to vitamin B12 deficiency.

Warnings and precautions:

Consult your doctor or pharmacist before starting to use Lederfolin.

• Since Lederfolin treatment may mask pernicious anemia and other megaloblastic anemias resulting from vitamin B12 deficiency.

• If you are epileptic and being treated with phenobarbital, phenytoin, primidone, and succinimides, as there is a risk of increased seizure frequency.

• If you are being treated with anticancer medications such as:
• • Methotrexate: it is essential to follow the Lederfolin dose prescribed by your doctor strictly, as non-compliance may cause excessive toxicity or lack of methotrexate efficacy.
  • In cases of methotrexate-induced renal insufficiency, higher doses or prolonged use of Lederfolin may be necessary.

• If you experience intense nausea, vomiting, or diarrhea, consult your doctor as it may be necessary to administer Lederfolin parenterally.

Taking Lederfolin with other medications:

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication.

Certain medications may interact with Lederfolin; in these cases, it may be necessary to adjust the dose or discontinue treatment with one of them.

It is essential to inform your doctor if you are taking or have taken recently any of the following medications:

• Antifolic antagonists (e.g., cotrimoxazole, trimethoprim, pyrimethamine, methotrexate). In this case, it is essential to follow the Lederfolin dose prescribed by your doctor strictly, as non-compliance may cause excessive toxicity or lack of efficacy of these medications.
• Antiepileptic medications: phenobarbital, primidone, phenytoin, and succinimides. Folinic acid may reduce the effect of these medications and increase seizure frequency.
• Chloramphenicol (in patients with folate deficiency)
• Fluorouracil

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

The excretion of folinic acid in breast milk is unknown.

Driving and operating machinery:

There is no evidence that this medication affects the ability to drive vehicles or operate machinery.

Lederfolin contains lactose and sodium:

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Lederfolin. Do not discontinue treatment prematurely, as you will not achieve the desired therapeutic effect.

• For the treatment of megaloblastic anemia due to folate deficiency, the usual dose is 15mg of folic acid (one tablet) per day, taken orally, usually for 10 or 15 days.
• For the treatment of neutralization of the effect of methotrexate or other folic acid antagonists, your doctor will indicate the dose you should take.

The tablets are scored. The score should not be used to break the tablet.

If you take more Lederfolin than you should:

If you have taken more Lederfolin than you should, consult your doctor or pharmacist immediately. No significant harm has been reported in patients who have received significantly higher doses of calcium folinate than those recommended.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone: 91/562.04.20.

If you forgot to take Lederfolin

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Lederfolin

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you consider that any of the side effects you are experiencing are severe or if you notice any other side effect not mentioned in this leaflet, inform your doctor or pharmacist.

The following side effects are described according to their frequency of occurrence in patients treated:

Rare(at least 1 in 10,000 but less than 1 in 1,000 patients):

• Seizures and/or syncope
• Increased frequency of seizures in epileptic patients
• Insomnia, agitation, and depression after high doses

Very rare(at least 1 in 10,000 patients):

• Anaphylactoid reactions
• Anaphylactic reactions
• Anaphylactic shock

Unknown frequency(cannot be estimated from available data):

• Allergic reactions
• Urticaria
• Fever

Cases of Stevens-Johnson syndrome (SSJ) and toxic epidermal necrolysis (TEN), some of which were fatal, have been reported in patients treated with levofolinate calcium hydrate in combination with other agents whose association with these disorders is known. It cannot be ruled out that levofolinate calcium hydrate may have contributed to some of these cases of SSJ/TEN.

Stevens-Johnson syndrome is a generalized rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals.

Toxic epidermal necrolysis is a generalized rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals, causing widespread skin peeling (more than 30% of the body surface).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly to the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the packaging, after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Lederfolin

• The active principle is folic acid (in the form of calcium folinatehydrate). Each tablet contains 15 mg of folic acid.
• The other components are: Lactose, microcrystalline cellulose, sodium starch glycolate, pregelatinized cornstarch and magnesium stearate.

Appearance of the product and content of the packaging

White, scored, circular tablets; they are presented in PVC/Aluminum blister packs, which contain 10 tablets.

Holder of the marketing authorization

Pfizer, S.L.

Avda. de Europa, 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Pfizer logo

Responsible for manufacturing:

FARMASIERRA MANUFACTURING S.L.

Ctra. Irún, km.26, 200.

San Sebastián de los Reyes (Madrid) 28700 España

Last review date of this leaflet:July 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/