Folinato calcico normon 50 mg polvo y disolvente para solucion inyectable efg

Label: information for theuser

Folinic Acid Normon 50 mg powder and solvent 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 questions, consult your doctor or pharmacist.

•This medication has been prescribed to you and should not be given to others, 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 what it is used for

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 pack and additional information.

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

Calcium folinate Normon is indicated for:

•To reduce toxicity and counteract 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 calcium folinate 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

•Folinato cálcico Normon should only be administered by intramuscular or intravenous injection.

•Treatment with Folinato cálcico Normon may mask pernicious anemia and other megaloblastic anemias resulting from a deficiency in vitamin B12.

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

•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:

o5-Fluorouracil:

?Combined treatment may increase the toxicity of 5-Fluorouracil.

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

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

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

oMetotrexate:

?In cases of renal insufficiency caused by metotrexate, higher doses or prolonged use of calcium folinate 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 calcium folinate; in these cases, the dose may need to be changed or one of the medications discontinued.

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

•Antifolate medications (e.g. cotrimoxazole, pyrimethamine) as their effectiveness may be reduced when administered with calcium folinate.

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

•5-Fluorouracil, as the combined administration of calcium folinate 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 machinery

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

Folinato cálcico Normon contains sodium.

This medication contains less than 23 mg (1 mmol) of sodium per vial, making it essentially "sodium-free".

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 inform you of the duration of your treatment with calcium folinate. Do not discontinue 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 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 reduce 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 (Telephone 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 recommended 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 may also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products 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 unused medications. In this way, you will help protect the environment.

Folinic Acid Calcium Normon Composition

•The active principle is folic acid, each vial contains 50 mg of folic acid (in the form of calcium folinate).

•The other components (excipients) are: sodium chloride and sodium hydroxide. The ampoule of solvent contains 5 ml of injection water.

Appearance of the product and contents of the package:

Folinic Acid Calcium Normon 50 mg is presented in the form of powder and solvent for injectable solution. Each package contains 1 vial and 1 ampoule or 25 vials and 25 ampoules (clinical package). After reconstitution with the ampoule of solvent, the solution contains a concentration of 10 mg/ml.

Not all package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer:

Laboratorios Normon, S.A.

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

THIS INFORMATION IS INTENDED ONLY FOR MEDICAL PROFESSIONALS OR HEALTHCARE PROFESSIONALS:

Reconstitution

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

Administration form

Folinic Acid Calcium Normon should only be administered intravenously and intramuscularly. In the case of intravenous administration, no more than 160 mg of calcium folinate per minute should be injected due to the calcium content of the solution.

To administer intravenously, folinic acid calcium can be diluted with 0.9% sodium chloride solution or 5% glucose solution before use.

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 infusion with 5-fluorouracil, a precipitate may form. When mixed with foscarnet, a yellow turbid solution forms.

Storage 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 350 mg powder 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/