Ledercfolin 15 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Lederfolin 15 mg tablets
Folinic Acid
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Lederfolin is and what it is used for
- What you need to know before taking Lederfolin
- How to take Lederfolin
- Possible side effects
- How to store Lederfolin
- Contents of the pack and other information
1. What Lederfolin is and what it is used for
Lederfolin belongs to a group of medicines called detoxifying agents used in tumor treatment.
This medicine is used for:
- Megaloblastic anemia due to folate deficiency.
- Reducing toxicity and counteracting the effect of folic acid antagonist medicines.
2. What you need to know before taking 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 reduced number of red blood cells and/or hemoglobin in the blood) or other megaloblastic anemias due to vitamin B12 deficiency.
Warnings and precautions:
Talk to your doctor or pharmacist before starting to use Lederfolin
-
Because treatment with Lederfolin may mask pernicious anemia and other megaloblastic anemias resulting from vitamin B12 deficiency.
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If you have epilepsy and are being treated with phenobarbital, phenytoin, primidone, or succinimides, as there is a risk of increased frequency of epileptic seizures.
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If you are being treated with antineoplastic medicines such as:
- Methotrexate: it is important that you strictly follow the dose of Lederfolin prescribed by your doctor, since failure to comply may cause excessive toxicity or reduced efficacy of methotrexate.
- In cases of methotrexate-induced renal impairment, higher doses or prolonged use of Lederfolin may be required.
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If severe nausea, vomiting, or diarrhea occur, consult your doctor, as it may be necessary to administer Lederfolin by the parenteral route.
Taking Lederfolin with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Certain medicines may interact with Lederfolin; in such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.
It is important 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 important that you strictly follow the dose of Lederfolin prescribed by your doctor, since failure to comply may cause excessive toxicity or reduced efficacy of these medicines.
- Antiepileptic medicines: phenobarbital, primidone, phenytoin, and succinimides. Calcium folinate hydrate may reduce the effect of these medicines 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 unknown 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 operate machinery.
Lederfolin contains lactose and sodium
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, essentially “sodium-free”.
3. How to take Lederfolin
Follow exactly the instructions for using this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.
Remember to take your medicine.
Your doctor will tell you how long to take Lederfolin. Do not stop treatment earlier, as you will not achieve the desired therapeutic effect.
- For the treatment of megaloblastic anemia due to folate deficiency, the usual dose is 15 mg of folinic acid (one tablet) daily, taken 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 break the tablet.
If you take more Lederfolin than you should:
If you have taken more Lederfolin than you should, contact your doctor or pharmacist immediately. No significant harm has been reported in patients who have received substantially higher doses of calcium folinate hydrate than recommended.
In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone: 91/562.04.20.
If you forget to take Lederfolin
Do not take a double dose to make up for missed doses.
If you stop taking Lederfolin
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
The following adverse effects are described according to their frequency in treated patients:
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 the available data):
- Allergic reactions
- Urticaria
- Fever
Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some of them fatal, have been reported in patients treated with calcium folinate monohydrate in combination with other agents known to be associated with these disorders. A possible contribution of calcium folinate monohydrate in these SJS/TEN cases cannot be ruled out.
Stevens-Johnson syndrome is a widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals.
Toxic epidermal necrolysis is a widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitales, causing widespread skin detachment (more than 30% of body surface area).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Lederfolin
Keep this medicine out of sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the container, following “EXP”. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Unwanted medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the container and other 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 components are: Lactose, microcrystalline cellulose, sodium starch glycolate, pregelatinized corn starch, and magnesium stearate.
Appearance of the product and contents of the container
White, round tablets, scored on one side; supplied 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 the most recent review of this leaflet: July 2023
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/