FOLINATE CALCIUM NORMON 50 mg POWDER AND SOLVENT FOR INJECTABLE SOLUTION

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

Do not use Calcium Folinate Normon:

• If you are allergic to calcium folinate or 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

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

Talk to your doctor or pharmacist before starting to use Calcium Folinate Normon:

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

o 5-Fluorouracil:

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

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

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

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

o Methotrexate:

? In case of renal failure due to methotrexate, higher doses or longer use of calcium folinate may be necessary.

Other medicines and Calcium Folinate Normon

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

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 with calcium folinate.
• Antiepileptic medicines: phenobarbital, primidone, phenytoin, and succinimides. Calcium folinate may reduce the effect of these medicines and may increase the frequency of epileptic seizures.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

Calcium folinate has no effects on the ability to drive or use machines.

Calcium Folinate Normon contains sodium

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

3. How to use Calcium Folinate Normon

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. Remember that they will administer your medicine.

Your doctor will indicate the duration of your treatment with calcium folinate. Do not stop treatment before completing it, 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 medicines.

If you use more Calcium Folinate Normon than you should:

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

If an overdose of the combination of 5-fluorouracil and calcium folinate occurs, the overdose instructions for 5-fluorouracil should be followed.

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

If you forget to use Calcium Folinate Normon

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

If you stop using Calcium Folinate Normon

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

4. Possible side effects

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

The following side effects may occur:

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

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

Rare side 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 side effects: may affect up to 1 in 10,000 people

Allergic reactions including urticaria.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Calcium Folinate 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 pack after EXP. The expiry date is the last day of the month stated.

Do not use this medicine if you notice particles in suspension after reconstitution or if you notice discoloration.

Medicines should not be disposed of via wastewater or household waste. 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 Calcium Folinate Normon

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

Appearance of the product and pack contents:

Calcium Folinate Normon 50 mg is presented as a powder and solvent for solution for injection. Each pack contains 1 vial and 1 ampoule or 25 vials and 25 ampoules (clinical pack). After reconstitution with the solvent ampoule, the solution contains a concentration of 10 mg/ml.

Not all pack 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 ONLY FOR HEALTHCARE PROFESSIONALS:

Reconstitution

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

Method of administration

Calcium Folinate Normon should only be administered by intravenous and intramuscular routes. 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 can be diluted with 0.9% sodium chloride solution or 5% glucose solution before use.

Incompatibilities

When using Calcium Folinate Normon, the following incompatibilities should be taken into account:

Calcium Folinate 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 yellowish 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

Calcium Folinate Normon 350 mg powder for solution for injection EFG.

Date of last revision of this leaflet:February 2021.

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

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