Label: information for the user

Folinic acid Altan 350 mg powder for injectable solution EFG

Folic acid

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 only to you and should not be given to others, even if they have the same symptoms as you, 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.

6. Contents of the container and additional information

Folinato cálcico Altan 350 mg contains calcium folinate which belongs to a group of medicines called detoxifying agents. It is the calcium salt of folic acid and is related to vitamin folic acid.

Folinato cálcico Altan is indicated for:

- reducing the harmful effects and treating overdoses of certain types of cancer medications, for example, methotrexate and other folic acid antagonists. This is known as "Calcium folinate rescue".

- treating cancer in combination with 5-fluorouracil (a cancer medication). 5-fluorouracil works better when administered with calcium folinate.

Folinato cálcico Altan is presented in the form of powder for injectable solution that can be administered via intramuscular or intravenous routes.

Calcium Folinate Altan should not be administered intrathecally (into the spinal column).

Do not use Calcium Folinate Altan 350 mg powder for injectable solution EFG:

• 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 anemias due to a lack of vitamin B12.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before using Calcium Folinate Altan.

• Calcium folinate should only be administered by intramuscular or intravenous injection.
• Treatment with calcium folinate may mask pernicious anemia and other megaloblastic anemias resulting from vitamin B12deficiency.
• 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:

Other medications and Calcium Folinate Altan:

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 antagonists (e.g., cotrimoxazole, pyrimethamine) as their efficacy 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.

It is unlikely that your doctor will ask you to use an antifolate antagonist or fluorouracil while pregnant or breastfeeding. However, if you have used an antifolate antagonist during pregnancy or breastfeeding, this medication (calcium folinate) may be used to reduce its side effects.

Driving and operating machinery:

There is no evidence that Calcium Folinate Altan affects the ability to drive vehicles or operate machinery.

Calcium Folinate Altan 350 mg powder for injectable solution EFG contains sodium

This medication contains 55.1 mg of sodium (main component of table salt/for cooking) in each vial. This corresponds to 2.75% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Remember to have your medication administered.

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

Since this medication 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.

Folinato cálcico Altan should only be administered via intravenous and intramuscular routes. In case of intravenous administration, do not inject more than 160 mg of folinic acid per minute due to the calcium content of the solution.

For intravenous perfusion, folinic acid can be diluted with 0.9% sodium chloride solution or 5% glucose solution before use.

If you use more Folinato cálcico Altan 350 mg powder for injectable solution EFG than you should:

If you have been administered more Folinato cálcico Altan than you should, consult your doctor or pharmacist immediately. No significant harm has been reported in patients who have received significantly higher doses of folinic acid than recommended.

If a overdose of the combination of 5-fluorouracil and folinic acid occurs, follow the instructions for 5-fluorouracil overdose.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forgot to use Folinato cálcico Altan 350 mg powder for injectable solution EFG:

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medicationmay cause adverse effects, although not all people will experience them.

The following adverse effects may occur:

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

Fever

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.

Gastrointestinal disturbances after high doses.

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

Allergic reactions including anaphylactoid reactions and urticaria.

Combination therapy with 5-fluorouracil:

Generally, the safety profile depends on the 5-fluorouracil regimen applied due to the increased toxicity induced by 5-fluorouracil.

a)Monthly regimen:

Very frequent (may affect more than 1 in 10 people)

-Vomiting and nausea

-Mucosal toxicity

No increase in other toxicities induced by 5-fluorouracil (e.g., neurotoxicity).

b)Weekly regimen:

Very frequent (may affect more than 1 in 10 people)

-Diarrhea with higher degrees of toxicity and dehydration, resulting in hospital admission for treatment and even death.

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 of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting 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.

Store below 25°C. Store in the original container to protect from light.

After dilution, chemical and physical stability has been demonstrated for 8 hours at 25°C.

Do not use this medication after the expiration date appearing on the container 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.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of unused medication containers. This will help protect the environment.

Composition ofFolinic Acid Calcium Altan 350 mg powder for injectable solution EFG:

• The active ingredient is folic acid 350 mg (in the form of calcium folinate)
• The other components are: sodium chloride.

Appearance of the product and contents of the package:

Each package contains 1 vial of lyophilized powder.

Other presentations: 25 vials.

Not all package sizes may be marketed

Marketing Authorization Holder:

Altan Pharmaceuticals, S.A.

C/ Cólquide Nº 6. Portal 2, 1st floor, office F

Edificio Prisma

28230 - Las Rozas (Madrid)

Spain

Manufacturer:

Altan Pharmaceuticals, S.A.

Avda. de la Constitución 198-199, Industrial Estate Monte Boyal

45950 Casarrubios del Monte (Toledo)

Spain

This medicine is authorized in the Member States of the European Economic Area with the following names:

France: Folinate de Calcium Altan 50 mg powder for injectable solution

Folinate de Calcium Altan 350 mg powder for injectable solution

Last review date of this leaflet: October 2020

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

This information is intended solely for medical professionals or healthcare professionals:

Only for intravenous and intramuscular administration.In the 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 0.9% solution or glucose 5% solution before use.

Before administration, calcium folinate should be visually inspected. The injectable solution or perfusion should be a clear and yellowish solution. If it appears turbid or particles are observed, the solution should be discarded. The calcium folinate solution for injection or perfusion is intended for single use.

Incompatibilities

When using Folinic Acid Calcium Altan, the following incompatibilities should be taken into account:

• Folinic Acid Calcium Altan should not be mixed with the injectable forms of droperidol, fluorouracil, foscarnet, and methotrexate. Mixing with droperidol results in immediate precipitation. Mixing with 5-fluorouracil in the same perfusion can form a precipitate. Mixing with foscarnet forms a yellowish turbid solution.

Storage after reconstitution

It is recommended that the reconstituted solution be administered immediately.