FOLINATE CALCIUM ALTAN 350 mg POWDER FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Calcium Folinate Altan 350 mg Powder for Injection EFG

folinic acid

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Calcium Folinate Altan 350 mg Powder for Injection EFG is and what it is used for
2. Before you use Calcium Folinate Altan 350 mg Powder for Injection EFG
3. How to use Calcium Folinate Altan 350 mg Powder for Injection EFG
4. Possible side effects
5. Storage of Calcium Folinate Altan 350 mg Powder for Injection EFG

1. Contents of the pack and further information

1. What is Calcium Folinate Altan 350 mg Powder for Injection EFG and what is it used for

Calcium Folinate Altan 350 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.

Calcium Folinate Altan is indicated for:

• reducing the harmful effects and treating overdose of certain types of cancer medicines, such as methotrexate and other folic acid antagonists. This is known as "Calcium Folinate Rescue".
• treating cancer in combination with 5-fluorouracil (a cancer medicine). 5-fluorouracil works better when given with calcium folinate.

Calcium Folinate Altan is presented as a powder for injection which can be administered by intramuscular or intravenous route.

2. What you need to know before you start using Calcium Folinate Altan 350 mg Powder for Injection EFG

Calcium Folinate Altan must not be injected into the spine (intrathecal).

Do not use Calcium Folinate Altan 350 mg Powder for Injection EFG:

• 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 (a disorder characterized by a decrease in hemoglobin or red blood cell count) or other 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 anticancer medicines 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.

Other medicines and Calcium Folinate Altan:

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.
• 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 are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

It is unlikely that your doctor will ask you to use a folic acid antagonist or fluorouracil while you are pregnant 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 Calcium Folinate Altan has effects on the ability to drive or use machines.

Calcium Folinate Altan 350 mg Powder for Injection EFG contains sodium

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

3. How to use Calcium Folinate Altan 350 mg Powder for Injection EFG

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

Remember that you are given your medicine.

Your doctor will tell you how long your treatment with Calcium Folinate Altan will last. Do not stop treatment before, as you will not achieve the desired therapeutic effect.

Since this medicine 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.

Calcium Folinate Altan should only be administered by intravenous or intramuscular route. In 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 350 mg Powder for Injection EFG than you should:

If you have been given 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 350 mg Powder for Injection EFG:

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

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

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

Rare side 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 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 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 via the Spanish Medicines Surveillance System for Human Use: 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 Altan 350 mg Powder for Injection EFG

Keep this medicine out of the 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 medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

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 Altan 350 mg Powder for Injection EFG:

• The active substance is folinic acid 350 mg (as calcium folinate)
• The other ingredients are: sodium chloride.

Appearance and Pack Size:

Each pack contains 1 vial of lyophilized powder.

Other presentations: 25 vials.

Not all pack sizes may be marketed

Marketing Authorisation 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 medicine is authorised in the Member States of the European Economic Area under the following names:

France: Folinate de Calcium Altan 50 mg poudre pour solution injectable

Folinate de Calcium Altan 350 mg poudre pour solution injectable

Date of last revision of this leaflet: October 2020

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.es

This information is intended only for healthcare professionals:

For intravenous and intramuscular use only.In 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 injection or perfusion solution should be a clear yellow solution. If it is turbid in appearance 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 yellow turbid solution forms.

Storage after Reconstitution

It is recommended that the reconstituted solution be administered immediately.