Label: information for theuser

Folinic Acid Normon 350 mg powder for injectable solutionEFG

folinicacid

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label as you may need to read it again.

• If you have any doubts, consult your doctor or pharmacist.

•This medication has been prescribed to you and should not be given 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 not listed in this label. See section 4.

1. What is Folinic Acid Normon and for what it is used

2. What you need to know before using Folinic Acid Normon

3. How to use Folinic Acid Normon

4. Possible adverse effects

5. Storage of Folinic Acid Normon

6. Contents of the package and additional information.

Calcium folinate belongs to a group of medicines called detoxifying agents for the treatment of tumors.

Calcium folinate Normon is indicated for:

•Reducing toxicity and counteracting the effect of other medicines used in the treatment of tumors and overdose in adults and children.

•The treatment of certain tumors in combination with 5-fluorouracil in adults.

No use Folinato cálcico Normon:

•If you are allergic to folic acid 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 hemoglobin or the number of red blood cells in the blood) or other megaloblastic anemias due to a lack of vitamin B12.

Warnings and precautions

• Folic acid should only be administered by intravenous or intramuscular injection (see

This information is intended solely for doctors or healthcare professionals).

•The treatment with folic acid may mask pernicious anemia and other megaloblastic anemias resulting from a deficiency in vitamin B12.

Consult your doctor or pharmacist before starting to use folic acid:

• 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:

5-Fluorouracil:

?The combined treatment may increase the toxicity of 5-Fluorouracil.

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

?Since diarrhea may be a symptom of gastrointestinal toxicity.

?Because your doctor will need to monitor your blood calcium levels during treatment.

Methotrexate:

?In cases of renal insufficiency due to methotrexate, higher doses or prolonged use of folic acid may be necessary.

Other medications and Folinato cálcico Normon

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Certain medications may interact with folic acid; in these cases, the dose may need to be changed or the treatment interrupted with one of them.

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

• Antifolate antagonists (e.g. cotrimoxazole, pyrimethamine) as their effectiveness may be reduced when administered with folic acid.

• Antiepileptic medications: phenobarbital, primidone, phenytoin, and succinimides. Folic acid may decrease the effect of these medications and increase the frequency of epileptic seizures.

• 5-Fluorouracil, as the combined administration of folic acid with 5-Fluorouracil has been shown to increase the efficacy and toxicity of 5-Fluorouracil.

Pregnancy and lactation

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

Driving and operating machines

Folic acid Normon has no effect on the ability to drive vehicles or operate machines.

Folic acid Normon contains sodium

Thismedication contains 62.3 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 3.11% of the maximum daily sodium intake recommended for an adult.

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

Remember to have your medication administered.

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

Since calcium folinate increases the toxicity of 5-Fluorouracil, treatment with the combination of both should be supervised by an experienced doctor in the use of anticancer medications.

If you use more Calcium Folinic Acid Normon than you should:

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

Follow the instructions for 5-fluorouracil overdose in case of overdose of the combination of 5-fluorouracil and calcium folinate.

In case of overdose, consult the Toxicological Information Service (Phone 91 562 04 20), indicating the medication and the amount administered.

If you forgot to use Calcium Folinic Acid Normon

Do not use a double dose to compensate for missed doses.

If you interrupt Calcium Folinic Acid Normon

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

Like all medications, this medication may have adverse effects, although not all people may experience them.

The following adverse effects may occur:

Infrequent Adverse Effects: may affect up to 1 in 100 people

Fever has been observed after the 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 epileptics.

Very Rare Adverse Effects:may affect up to 1 in 10,000 people

Allergic reactions including urticaria.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.Mediating the reporting of adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

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

Do not use this medication if you observe particles in suspension after reconstitution or if you observe discoloration.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Folinic Acid Calcium Normon:

•The active principle is folic acid, each vial contains 350 mg of folic acid (in the form of calcium folinate).

• The other components (excipients) are: sodium chloride and sodium hydroxide.

Aspect of the product and content of the packaging:

Folinic Acid Calcium Normon 350 mg is presented in the form of a powder for injectable solution. Each package contains 1 or 25 vials (clinical package). After reconstitution, the solution contains a concentration of

20 mg/ml.

It may not be commercially available in all package sizes.

Holder of the marketing authorization and responsible for manufacturing:

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

THIS INFORMATION IS INTENDED ONLY FOR DOCTORS OR HEALTHCARE PROFESSIONALS:

Reconstitution

Reconstitute the vial with 17.5 ml of injection water.

Administration form

Only for intravenous or intramuscular administration. In case of intravenous administration, do not inject more than 160 mg of calcium folinate per minute due to the calcium content of the solution. For intravenous perfusion, calcium folinate can be diluted with sodium chloride solution 0.9% or glucose solution 5%, before use.

For intramuscular administration, note the volume restriction of this administration route.

Incompatibilities

When using Folinic Acid Calcium Normon, the following incompatibilities should be taken into account: Folinic Acid Calcium Normon should not be mixed with injectable forms of droperidol, fluorouracil, foscarnet, and methotrexate. When mixed with droperidol, immediate precipitation occurs. When mixed in the same perfusion with 5-fluorouracil, a precipitate may form. When mixed with foscarnet, a yellow turbid solution forms.

Conservation after reconstitution

It is recommended that the reconstituted solution be administered immediately. However, it can be stored for 8 hours at a temperature not exceeding 25°C or in a refrigerator (2°C-8°C) for a maximum of 24 hours.

OTHER PRESENTATIONS

Folinic Acid Calcium Normon 50 mg powder and solvent for injectable solution EFG

Last review date of this prospectus:February 2021.

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