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CALCIUM FOLINATE 10 MG/ML SOLUTION FOR INJECTION

Active substance(s): CALCIUM FOLINATE / CALCIUM FOLINATE / CALCIUM FOLINATE

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Package leaflet: Information for the user

Calcium Folinate 10 mg/ml
Solution for injection or infusion
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, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Calcium Folinate is and what it is used for
2. What you need to know before you use Calcium Folinate
3. How to use Calcium Folinate
4. Possible side effects
5. How to store Calcium Folinate
6. Contents of the pack and other information

1. What Calcium Folinate is and what it is used for
Calcium Folinate solution for injection or infusion contains calcium folinate, which is one of a group
of medicine called detoxifying agents. It is a calcium salt of folinic acid, which is related to the
vitamin folic acid.
Calcium Folinate is used to:
• reduce the harmful effects and treat overdose of certain types of anti-cancer medicines for
instance methotrexate and other folic acid antagonists. This is known as “calcium folinate rescue”.
• treat cancer in combination with 5-fluorouracil (an anti-cancer medicine). 5-fluorouracil works
better when it is given together with Calcium Folinate.

2. What you need to know before you use Calcium Folinate
Calcium Folinate must not be injected intrathecally (into the spine).
Do not use Calcium Folinate:
• if you are allergic to calcium folinate or any of the other ingredients of this medicine (listed in
section 6).
• if you have a type of anaemia caused by too little vitamin B12
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Calcium Folinate.
If you are to receive calcium folinate and fluorouracil treatment at the same time take special care if:
• you have had radiotherapy
• you have stomach or bowel trouble
Special care is also needed if you are elderly and you are to receive calcium folinate and fluorouracil
treatment at the same time.
Calcium Folinate contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per
dose, i.e. essentially “sodium free”.
Other medicines and Calcium Folinate
Tell your doctor if you are using, have recently used or might use any other medicines.
Special care is needed if you are taking/using other medicines as some could interact with Calcium
Folinate, for example:
• folic acid antagonists (see section 1) – the effectiveness of these medicines will be reduced by
calcium folinate;
• fluorouracil (anti-cancer medicine) – the effectiveness and side effects of this medicine will be
increased by calcium folinate;
• medicines used to treat epilepsy (phenobarbitone, phenytoin, primidone or succinimides) – the
effectiveness of these medicines may be reduced by calcium folinate. Your doctor may check
blood levels of these medicines and change your dose to prevent increased convulsions (fits).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine.
It is unlikely that your doctor will ask you to take/use a folic acid antagonist or fluorouracil whilst
you are pregnant or breast-feeding. However, if you have taken/used a folic acid antagonist whilst
pregnant or breast-feeding, this medicine (calcium folinate) may be used to reduce its side effects.

3. How to use Calcium Folinate
This medicine may be given by injection (using a syringe) into muscle. Alternatively it may be given
by injection or infusion (drip) into a vein. If it is given by infusion Calcium Folinate will be diluted first.
Your doctor will work out the correct dose of Calcium Folinate for you and how often it must be
given. It will depend upon the medical condition which is being treated.
If you use more Calcium Folinate than you should
This medicine will be given to you in a hospital, under the supervision of a doctor. It is unlikely that
you will be given too much or too little, however, tell your doctor or nurse if you have any concerns.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare: may affect up to 1 in 10,000 people
• severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands,
feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing),
and you may feel you are going to faint. This is a serious side effect. You may need urgent
medical attention.

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The following information is intended for healthcare professionals only:

Calcium Folinate 10 mg/ml
Solution for injection or infusion
Folinic acid

Further to the information included in section 3, practical information on the preparation/handling of
the medicinal product is provided here.
Incompatibilities
Incompatibilities have been reported between injectable forms of calcium folinate and injectable
forms of droperidol, fluorouracil, foscarnet and methotrexate.
Droperidol
1. Droperidol 1.25 mg/0.5 ml with calcium folinate 5 mg/0.5 ml, immediate precipitation in direct
admixture in syringe for 5 minutes at 25° C followed by 8 minutes of centrifugation.
2. Droperidol 2.5 mg/0.5 ml with calcium folinate 10 mg/0.5 ml, immediate precipitation when the
drugs were injected sequentially into a Y-site without flushing the Y-side arm between injections.

Uncommon: may affect up to 1 in 100 people
• fever
Rare: may affect up to 1 in 1,000 people
• an increase in convulsions (fits) in patients with epilepsy
• depression
• agitation
• problems with the digestive system
• difficulty sleeping (insomnia)
Combination therapy with 5-fluorouracil only:
If you receive calcium folinate in combination with an anticancer medicine containing fluoropyrimidines, it is more likely that you experience the following side effects of this other medicine:
Very common: may affect more than 1 in 10 people
• nausea
• vomiting
• severe diarrhea
• drying out which may be due to diarrhea
• inflammation of the lining of the intestine and mouth (life-threatening conditions have occurred)
• reduction in the number of blood cells (including life-threatening conditions)
Common: may affect up to 1 in 10 people
• redness and swelling of the palms of the hands or the soles of the feet which may cause the skin
to peel (hand-foot syndrome)
Not known: frequency cannot be estimated from the available data
• elevated ammonia level in the blood
Reporting of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme,
website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Calcium Folinate
Store in a refrigerator (2ºC – 8ºC).
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
The expiry date refers to the last day of that month.
The vials should be stored in the outer carton, in order to protect from light.
Unopened vials: 18 months.
After first opening: 28 days at both room temperature and 2-8° C.
After dilution: chemical and physical in-use stability after dilution to 0.5 mg/ml and 4 mg/ml with
either 0.9% sodium chloride solution or 5% glucose solution was demonstrated for up to 28 days at
both room temperature and 2-8° C.
From a microbial point of view, the product should be used immediately. If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would normally
not be longer than 24 hours at 2 to 8ºC, unless reconstitution/dilution has taken place in controlled
and validated aseptic conditions.

6. Contents of the pack and other information
What Calcium Folinate contains
• The active substance is calcium folinate. Each ml contains 10 mg of folinic acid provided as
calcium folinate.
Each 5, 10, 30 and 50 ml solution contains 50, 100, 300 and 500 mg of folinic acid respectively
(provided as calcium folinate).
• The other ingredients are trometamol, hydrochloric acid, sodium hydroxide and water for
injections.
What Calcium Folinate looks like and contents of the pack
Calcium Folinate is a clear, pale yellow solution for injection which comes in glass containers
called vials.
It is supplied in packs containing:
1 or 5 x 5 ml of Calcium Folinate in vials of 10 ml
1 or 5 x 10 ml of Calcium Folinate in vials of 10 ml
1 or 5 x 30 ml of Calcium Folinate in vials of 50 ml
1 or 5 x 50 ml of Calcium Folinate in vials of 50 ml
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Hikma Farmacêutica (Portugal) S.A.
Estrada do Rio da Mó, nº8, 8A e 8B,
Fervença, 2705-906 Terrugem SNT
Portugal
Manufacturer
Hikma Italia S.p.A.
Viale Certosa, 10,
27100 - Pavia
Italia
Distributed by:
Consilient Health (UK) Ltd.
No. 1 Church Road,
Richmond upon Thames, Surrey,
TW9 2QE
This leaflet was last revised in March 2017

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P0587

Fluorouracil
Calcium folinate must not be mixed in the same infusion as 5-fluorouracil because a precipitate may
form. Fluorouracil 50 mg/ml with calcium folinate 20 mg/ml, with or without dextrose 5% in water,
has been shown to be incompatible when mixed in different amounts and stored at 4ºC, 23ºC, or
32°C in polyvinyl chloride containers.
Foscarnet
Foscarnet 24 mg/ml with calcium folinate 20 mg/ml; formation of a cloudy yellow solution reported.
Instructions for use and handling, and disposal
Calcium Folinate is intended only for single use. Any unused portion of the solution should be
disposed of in accordance with the local requirements.
Prior to administration, calcium folinate should be inspected visually. The solution for injection should
be a clear and yellowish solution. If cloudy in appearance or particles are observed, the solution
should be discarded.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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