Folinic acid Normon 50 mg powder and solvent for solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Folinato cálcico Normon 50 mg powder and solvent for solution for injection EFG

Folinic acid

Read all of this leaflet carefully before you start using 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 and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Folinato cálcico Normon is and what it is used for
2. What you need to know before using Folinato cálcico Normon
3. How to use Folinato cálcico Normon
4. Possible adverse effects
5. How to store Folinato cálcico Normon
6. Contents of the pack and other information

1. What Folinato cálcico Normon is and what it is used for

Folinato cálcico belongs to a group of medicines called antidotes used in tumor treatment.

Folinato cálcico Normon is indicated for:

• Reducing toxicity and counteracting the effects of other medications used in tumor treatment, as well as in cases of overdose in adults and children.
• The treatment of certain tumors in combination with 5-fluorouracil in adults.

2. What you need to know before using Calcium Folinate Normon

Do not use Folinato cálcico Normon:

• If you are allergic to calcium folinate or to any of the other ingredients of this medicine (listed in section 6).
• If you have or have had pernicious anemia or other megaloblastic anemias due to vitamin B12 deficiency.

Warnings and precautions

• Folinato cálcico Normon must only be administered by intramuscular or intravenous injection.
• Treatment with Folinato cálcico Normon may mask pernicious anemia and other megaloblastic anemias resulting from vitamin B12 deficiency.

Consult your doctor or pharmacist before starting to use Folinato cálcico Normon:

• If you have epilepsy and are being treated with phenobarbital, phenytoin, primidone, or succinimides, as there is a risk of increased seizure frequency.
• If you are being treated with antitumor medicines such as:

o 5-Fluorouracil:

? Combination therapy may increase the toxicity of 5-fluorouracil.

? In elderly or debilitated patients, a dose reduction may be necessary.

? If you develop diarrhea, as this may be a symptom of gastrointestinal toxicity.

? Because your doctor should monitor your blood calcium levels during treatment.

o Methotrexate:

? Higher doses or prolonged use of calcium folinate may be required in cases of methotrexate-induced renal impairment.

Other medicines and Folinato cálcico Normon

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 calcium folinate; in such cases, it may be necessary to adjust the dose or interrupt 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, pyrimethamine), as their efficacy may be reduced when administered together with calcium folinate.
• Anti-epileptic medicines: phenobarbital, primidone, phenytoin, and succinimides. Calcium folinate may reduce the effect of these medicines and may increase the frequency of epileptic seizures.
• 5-Fluorouracil, as concomitant administration of calcium folinate with 5-fluorouracil has been shown to increase both the efficacy and toxicity of 5-fluorouracil.

Pregnancy and breastfeeding

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

Driving and using machines

Calcium folinate has no effect on the ability to drive or operate machinery.

Folinato cálcico Normon contains sodium.

This medicine contains less than 23 mg (1 mmol) of sodium per vial and is therefore considered essentially “sodium-free”.

3. How to use Calcium Folinate Normon

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Remember to have your medicine administered.

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

Since calcium folinate increases the toxicity of 5-fluorouracil, treatment with the combination of both must be supervised by a physician experienced in the use of anticancer drugs.

If you use more Folinato cálcico Normon than you should:

If you are administered more calcium folinate than recommended, your doctor will treat you appropriately. No significant harm has been reported in patients who have received substantially higher doses of calcium folinate than recommended. If too much calcium folinate is administered in combination with methotrexate, it may reduce the effect of this medicine.

In case of overdose with the combination of 5-fluorouracil and calcium folinate, the overdose instructions for 5-fluorouracil should be followed.

In case of overdose, contact the Toxicology Information Service (Telephone 91 562 04 20), indicating the medicine and the amount administered.

If you forget to use Folinato cálcico Normon:

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

If you interrupt Folinato cálcico Normon:

When calcium folinate is administered in combination with methotrexate and treatment is abruptly interrupted, adverse effects of methotrexate that were previously counteracted by calcium folinate may reappear. Therefore, it is not advisable to abruptly interrupt the administration of calcium folinate.

4. Possible adverse effects

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

The following adverse effects may occur:

Uncommon adverse effects: may affect up to 1 in 100 people

Fever has been observed after administration of calcium folinate as an injection solution.

Rare adverse effects: may affect up to 1 in 1,000 people

Insomnia, agitation, and depression after high doses. Increased frequency of seizures in epileptic patients.

Very rare adverse effects: may affect up to 1 in 10,000 people

Allergic reactions including urticaria.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Folinato cálcico Normon

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the container following
EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if you observe particles in suspension after reconstitution or if discoloration is present.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Folinato cálcico Normon

• The active substance is folinic acid. Each vial contains 50 mg of folinic acid (in the form of calcium folinate).
• The other components (excipients) are: sodium chloride and sodium hydroxide. The solvent ampoule contains 5 ml of water for injection.

Appearance of the product and contents of the container:

Folinato cálcico Normon 50 mg is presented as a powder and solvent for injectable solution. Each package contains 1 vial and 1 ampoule, or 25 vials and 25 ampoules (hospital pack). After reconstitution with the solvent ampoule, the solution has a concentration of 10 mg/ml.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

THIS INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY:

Reconstitution

Reconstitute the vial with the 5 ml ampoule of water for injection.

Route of administration

Folinato cálcico Normon must only be administered by intravenous or intramuscular route. In the case of intravenous administration, no more than 160 mg of calcium folinate should be injected per minute due to the calcium content of the solution.

For intravenous infusion, calcium folinate may be diluted with 0.9% sodium chloride solution or 5% glucose solution prior to use.

Incompatibilities

The following incompatibilities must be considered when using Folinato cálcico Normon:

Folinato cálcico Normon must not be mixed with injectable forms of droperidol, fluorouracil, foscarnet, or methotrexate. Mixing with droperidol causes immediate precipitation. When mixed in the same infusion with 5-fluorouracil, a precipitate may form. Mixing with foscarnet results in a cloudy yellow solution.

Storage after reconstitution

It is recommended that the reconstituted solution be used immediately. However, it may be stored for up to 8 hours at a temperature not exceeding 25°C or in a refrigerator (2°C–8°C) for up to 24 hours.

OTHER PRESENTATIONS

Folinato cálcico Normon 350 mg powder for injectable solution EFG.

Date of latest revision of this leaflet: February 2021.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/70341/P_70341.html