FOLINATE CALCIUM ALTAN 50 mg POWDER FOR INJECTABLE SOLUTION

Introduction

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Calcium Folinate Altan 50 mg powder for injectable solution EFG

folinic acid

Read the entire leaflet carefully before starting to use this medication, as 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 medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Calcium Folinate Altan 50 mg powder for injectable solution EFG and what is it used for
2. Before using Calcium Folinate Altan 50 mg powder for injectable solution EFG
3. How to use Calcium Folinate Altan 50 mg powder for injectable solution EFG
4. Possible side effects
5. Storage of Calcium Folinate Altan 50 mg powder for injectable solution EFG

1. Package contents and additional information

1. What is Calcium Folinate Altan 50 mg powder for injectable solution EFG and what is it used for

Calcium Folinate Altan 50 mg contains calcium folinate, which belongs to the group of medications called detoxifying agents. It is the calcium salt of folinic acid and is related to folic acid vitamin.

Calcium Folinate Altan is indicated for:

• reducing the harmful effects and treating overdose of certain types of cancer medications, such as 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.

Calcium Folinate Altan is presented in the form of powder for injectable solution, which can be administered intramuscularly or intravenously.

2. What you need to know before starting to use Calcium Folinate Altan 50 mg powder for injectable solution EFG

Calcium Folinate Altan should not be injected intrathecally (into the spine).

Do not use Calcium Folinate Altan 50 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 or other megaloblastic anemias due to vitamin B12 deficiency.

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 B12 deficiency.
• 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 antitumor medications such as:

• 5-Fluorouracil:
• • • The combined treatment may increase the toxicity of 5-fluorouracil.
    • Particularly 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.
    • During treatment, your doctor should monitor your blood calcium levels.
  • Methotrexate:
  • • In case of renal failure due to methotrexate, higher doses or longer use of calcium folinate may be necessary.

Using other medications and Calcium Folinate Altan:

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

Certain medications 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 essential that you inform your doctor if you are taking or have recently taken any of the following medications:

• Folic acid 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 reduce the effect of these medications and increase the frequency of epileptic 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 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 medication.

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

Driving and using machines:

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

Calcium Folinate Altan 50 mg powder for injectable solution EFG contains sodium

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

3. How to use Calcium Folinate Altan 50 mg powder for injectable solution EFG

Follow your doctor's instructions for administering this medication exactly. If in doubt, consult your doctor or pharmacist.

Remember to have your medication administered to you.

Your doctor will indicate the duration of your treatment with Calcium Folinate Altan. Do not stop treatment before completing it, 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.

Calcium Folinate Altan should only be administered intravenously and intramuscularly. 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 perfusion, calcium folinate can be diluted with 0.9% sodium chloride solution or 5% glucose solution before use.

If you use more Calcium Folinate Altan 50 mg powder for injectable solution EFG than you should:

If you have been administered more Calcium Folinate 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 calcium folinate than recommended.

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 or accidental ingestion, consult the Toxicology Information Service. Phone 91 562 04 20.

If you forget to use Calcium Folinate Altan 50 mg powder for injectable solution EFG:

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The following side effects may occur:

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

Fever

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.

Gastrointestinal disorders after high doses.

Very rare side 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 applied 5-fluorouracil regimen due to the increased toxicity induced by 5-fluorouracil.

• Monthly regimen:

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

• vomiting and nausea
• mucosal toxicity

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

• Weekly regimen:

Very common (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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Calcium Folinate Altan 50 mg powder for injectable solution EFG

Keep this medication out of sight and reach of children.

Store below 25°C. Store in the original package 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 shown on the package after EXP. 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 wastewater or household waste. Ask your pharmacist how to dispose of medication packages that you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Calcium Folinate Altan 50 mg powder for injectable solution EFG:

• The active ingredient is folinic acid 50mg (in the form of calcium folinate)
• The other ingredients are: sodium chloride.

Appearance of the product and package contents:

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, 1ª planta, oficina F

Edificio Prisma

28230 - Las Rozas (Madrid)

Spain

Manufacturer:

Altan Pharmaceuticals, S.A.

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

45950 Casarrubios del Monte (Toledo)

Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

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

Folinate de Calcium Altan 350 mg powder for injectable solution

Date of the last revision of this leaflet:October 2020

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

This information is intended only for healthcare professionals:

For intravenous and intramuscular administration only.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 perfusion, calcium folinate can be diluted with 0.9% sodium chloride solution or 5% glucose solution before use.

Before administration, calcium folinate should be visually inspected. The injectable solution or perfusion should be a clear, 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 Calcium Folinate Altan, the following incompatibilities should be taken into account:

• Calcium Folinate Altan 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 yellowish, turbid solution forms.

Storage after reconstitution

It is recommended that the reconstituted solution be administered immediately.