LEDFOLIN 15 mg TABLETS

2. What you need to know before you take Lederfolin

Do not take Lederfolin:

• If you are allergic to the active substance or to any of the other ingredients of this medicine (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 treatment with Lederfolin.

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

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

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

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

Taking Lederfolin with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Certain medicines may interact with Lederfolin; in these cases, it may be necessary to change the dose or interrupt treatment with one of them.

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

• Folic acid antagonists (e.g., cotrimoxazole, trimethoprim, pyrimethamine, methotrexate). In this case, it is essential that you strictly follow the dose of Lederfolin prescribed by your doctor, as non-compliance may cause excessive toxicity or lack of efficacy of these medicines.
• Antiepileptic medications: phenobarbital, primidone, phenytoin, and succinimides. Calcium folinate hydrate may decrease the effect of these medications and may increase the frequency of epileptic seizures.
• Chloramphenicol (in patients with folate deficiency)
• Fluorouracil

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

It is not known whether calcium folinate hydrate is excreted in breast milk.

Driving and using machines

There is no evidence that this medicine affects the ability to drive or use machines.

Lederfolin contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

3. How to take Lederfolin

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

Remember to take your medicine.

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

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

The tablets are scored. The score line should not be used to divide 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 hydrate than recommended.

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

If you forget to take Lederfolin

Do not take a double dose to make up for forgotten doses.

If you stop treatment with Lederfolin

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any side effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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

Frequency not known(cannot be estimated from available data):

• Allergic reactions
• Urticaria
• Fever

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

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

Toxic epidermal necrolysis is a widespread rash with blisters and peeling of the skin, 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 side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that the side effects are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lederfolin

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

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the packaging after "EXP". The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Lederfolin

• The active substance is folinic acid (in the form of calcium folinate hydrate). Each tablet contains 15 mg of folinic acid.
• The other ingredients are: lactose, microcrystalline cellulose, sodium starch glycolate, corn starch pregelatinized, and magnesium stearate.

Appearance of the product and pack contents

White, circular, scored tablets; available in PVC/Aluminum blister packs containing 10 tablets.

Marketing authorization holder

Pfizer, S.L.

Avda. de Europa, 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Pfizer Logo

Manufacturer

FARMASIERRA MANUFACTURING S.L.

Ctra. Irún, km.26, 200.

San Sebastián de los Reyes (Madrid) 28700 Spain

Date of last revision of this leaflet:July 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.es/