


Ask a doctor about a prescription for FOLINATE CALCIUM ALTAN 350 mg POWDER FOR INJECTABLE SOLUTION
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.
Contents of the pack:
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:
Calcium Folinate Altan is presented as a powder for injection which can be administered by intramuscular or intravenous route.
Calcium Folinate Altan must not be injected into the spine (intrathecal).
Do not use Calcium Folinate Altan 350 mg Powder for Injection EFG:
Consult your doctor, pharmacist or nurse before using Calcium Folinate Altan.
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:
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.
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.
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.
Very common (may affect more than 1 in 10 people)
No increase in other 5-fluorouracil-induced toxicities (e.g. neurotoxicity).
Very common (may affect more than 1 in 10 people)
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.
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.
Composition of Calcium Folinate Altan 350 mg Powder for Injection EFG:
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:
Storage after Reconstitution
It is recommended that the reconstituted solution be administered immediately.
The best alternatives with the same active ingredient and therapeutic effect.
Discuss dosage, side effects, interactions, contraindications, and prescription renewal for FOLINATE CALCIUM ALTAN 350 mg POWDER FOR INJECTABLE SOLUTION – subject to medical assessment and local rules.