Calcium folinate Altan 50 mg powder for injection solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Folinato cálcico Altan 50 mg powder for injectable solution EFG

leucovorin acid

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

2. Before using Folinato cálcico Altan 50 mg powder for injectable solution EFG

3. How to use Folinato cálcico Altan 50 mg powder for injectable solution EFG

4. Possible adverse effects

5. How to store Folinato cálcico Altan 50 mg powder for injectable solution EFG

6. Contents of the container and other information

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

Folinato Cálcico Altan 50 mg contains calcium folinate, which belongs to a group of medicines called antidotes. It is the calcium salt of folinic acid and is related to folic acid vitamin.

Folinato Cálcico Altan is indicated for:

• reducing harmful effects and treating overdose of certain types of anticancer medicines, for example, methotrexate and other folic acid antagonists. This is known as "calcium folinate rescue".
• treating cancer in combination with 5-fluorouracil (an anticancer medicine). 5-fluorouracil works better when administered together with calcium folinate.

Folinato Cálcico Altan is supplied as a powder for injectable solution that can be administered by intramuscular or intravenous route.

2. What you need to know before using Folinato Cálcico Altan 50 mg powder for injectable solution EFG

Folinato cálcico Altan must not be injected intrathecally (into the spine).

Do not use Folinato cálcico Altan 50 mg powder for injectable solution EFG:

• If you are allergic to calcium folinate or to 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

Talk to your doctor, pharmacist, or nurse before using Folinato cálcico 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 have epilepsy and are being treated with phenobarbital, phenytoin, primidone, or succinimides, as there is a risk of increased seizure frequency.

• If you are being treated with antitumor medicines such as:

• 5-Fluorouracil:

  • • Combination therapy may increase the toxicity of 5-fluorouracil.
    • Particularly in elderly or weakened patients, a dose reduction may be necessary.
    • If you develop diarrhea, as this may be a sign of gastrointestinal toxicity.
    • During treatment, your doctor should monitor your blood calcium levels.
  • Methotrexate:
    • Higher doses or prolonged use of calcium folinate may be required in cases of methotrexate-induced renal impairment.

Use of other medicines and Folinato cálcico Altan:

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Certain medicines may interact with calcium folinate; in such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

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.
• 5-Fluorouracil, as co-administration of calcium folinate with 5-fluorouracil has been shown to increase both the efficacy and toxicity of 5-fluorouracil.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and using machines:

There is no evidence that Folinato cálcico Altan affects the ability to drive or operate machinery.

Folinato cálcico Altan 50 mg powder for injectable solution EFG contains sodium

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

3. How to use Folinato Cálcico Altan 50 mg powder for injectable solution EFG

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

Remember to have your medication administered.

Your doctor will determine the duration of your treatment with Folinato Cálcico Altan. Do not stop the treatment prematurely, as you will not achieve the desired therapeutic effect.

Since this medicine increases the toxicity of 5-Fluorouracil, treatment with the combination of both agents must be supervised by a physician experienced in the use of anticancer drugs.

Folinato Cálcico Altan must be administered only by intravenous or intramuscular route. 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 may be diluted with 0.9% sodium chloride solution or 5% glucose solution prior to use.

If you use more Folinato Cálcico Altan 50 mg powder for injectable solution EFG than you should:

If you have been administered more Folinato Cálcico Altan than prescribed, consult your doctor or pharmacist immediately. Significant harm has not been reported in patients who have received substantially higher doses of calcium folinate than recommended.

In case of overdose with the combination of 5-fluorouracil and calcium folinate, follow the overdose instructions for 5-fluorouracil.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.

If you forget to use Folinato Cálcico Altan 50 mg powder for injectable solution EFG:

Do not use a double dose to make up for a missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects may occur:

Uncommon 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 disorders 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 used, due to increased 5-fluorouracil-induced toxicity.

• 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 grades of toxicity and dehydration, leading to hospitalization for treatment and even death.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Folinato Cálcico Altan 50 mg powder for injectable solution EFG

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

Store below 25°C. Keep 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 medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you observe particles in suspension after reconstitution or if discoloration is present.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and other information

Composition of Folinato cálcico Altan 50 mg powder for injectable solution EFG:

• The active substance is folinic acid 50 mg (in the form of calcium folinate).
• The other component is sodium chloride.

Appearance of the product and contents of the container:

Each pack contains 1 vial of lyophilized powder.

Other pack sizes: 25 vials.

Not all pack 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, Polígono Industrial Monte Boyal
45950 Casarrubios del Monte (Toledo)
Spain

This medicinal product 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 most recent review of this leaflet: October 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/

This information is intended for healthcare professionals only:

For intravenous and intramuscular administration only. When administered intravenously, no more than 160 mg of calcium folinate per minute should be injected due to the calcium content of the solution.

For intravenous infusion, calcium folinate may be diluted with 0.9% sodium chloride solution or 5% glucose solution prior to use.

Before administration, calcium folinate should be inspected visually. The solution or injectable infusion must be a clear, slightly yellowish solution. If the solution appears cloudy or particulate matter is observed, the solution must be discarded. The calcium folinate solution for injection or infusion is intended for single use only.

Incompatibilities

The following incompatibilities must be considered when using Folinato cálcico Altan:

• Folinato cálcico Altan must not be mixed with injectable forms of droperidol, fluorouracil, foscarnet, or methotrexate. Mixing with droperidol results in immediate precipitation. Mixing in the same infusion with 5-fluorouracil may result in precipitate formation. Mixing with foscarnet produces a cloudy yellow solution.

Storage after reconstitution

It is recommended that the reconstituted solution be administered immediately.