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CALCIUM FOLINATE TABLETS 15MG

Active substance(s): LEUCOVORIN CALCIUM

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United Kingdom
281888
Part No: LL0424AG
Calcium Folinate 15 mg 10
52 x 101mm Pages: 24 PCode: 15

15
mg

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03 AUG 2016 13:36

Proof No. (4)
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Black
PMS
Rhodamine Red

PMS 7402
PMS 306

Calcium
Folinate 15 mg
tablets
10 tablets

Each tablet contains: calcium folinate 19.07 mg,
which is equivalent to 15 mg folinic acid
Also contains: lactose. See leaflet for further
information. Dosage: For oral use. Read the
package leaflet before use. Keep out of the sight
and reach of children. Store below 25°C. Store in
the original package in order to protect from light.
PL 04569/0212 POM LL0424AG 900830
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

1

15
mg

Calcium
Folinate 15 mg
tablets
10 tablets

Each tablet contains: calcium folinate 19.07 mg,
which is equivalent to 15 mg folinic acid
Also contains: lactose. See leaflet for further
information. Dosage: For oral use. Read the
package leaflet before use. Keep out of the sight
and reach of children. Store below 25°C. Store in
the original package in order to protect from light.
PL 04569/0212 POM LL0424AG 900830
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

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Package leaflet: Information for the patient
Calcium Folinate 15 mg Tablets
(calcium folinate)
Read all of this leaflet carefully before you
start taking 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,

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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.
What is in this leaflet:
1. What Calcium Folinate is and what it is used for
2. What you need to know before you take
Calcium Folinate
3. How to take Calcium Folinate
4. Possible side effects
5. How to store Calcium Folinate
6. Contents of the pack and other information

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1. What Calcium Folinate is and what it is
used for
This medicine contains Calcium Folinate which
belongs to the B group of vitamins.
Calcium Folinate is used to reduce the harmful
effects of certain types of medicines called ‘folic
acid antagonists’ e.g. methotrexate.
Calcium Folinate may also be used to treat some
types of anaemia (megaloblastic anaemias)
when they occur during pregnancy and infancy
or they are caused by liver disease, inadequate
food intake or poor food absorption.

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2. What you need to know before you take
Calcium Folinate
Do not take 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.
Tell your doctor if any of the above applies
to you.
Other medicines and Calcium Folinate
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other

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medicines, including the following:
• anti-neoplastic folic acid antagonists, such as
methotrexate;
• phenobarbitone, phenytoin and primidone (used
to treat epilepsy), as their effectiveness may be
reduced by calcium folinate. Your doctor may
• check blood levels of these medicines and change
your dose to prevent increased seizures (fits);
• the anti-cancer medicines capecitabine or
fluorouracil, or medicines of the same family
(fluoropyrimidines). Taking these together with
calcium folinate may be linked to seizures (fits)
and fainting.

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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.
Driving and using machines
Calcium Folinate should not affect your ability
to drive or operate machines.
Calcium Folinate tablets contain lactose
If you have been told by your doctor that you have
an intolerance to some sugars such as lactose,
contact your doctor before taking this medicine.

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3. How to take Calcium Folinate
Always take Calcium Folinate exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Swallow your tablets whole with a glass of water.
Your doctor may also ask you to drink more than
usual.
The dose of medicine given to you will depend
on your medical condition and the dose of
methotrexate you have been given.

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Dose - Reduction of harmful effects of folic
acid antagonists
If used to reduce the harmful effects of folic acid
antagonist medicines such as methotrexate,
treatment with Calcium Folinate is usually
started 24 hours after the folic acid antagonist
has been given. The dose is usually one 15 mg
tablet every 6 hours for 2 days. You will probably
also be asked to take another medicine to make
your urine alkaline at the same time, as this will
also help reduce the toxic effects of the folic
acid antagonist.

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Where high doses of folic acid antagonists have
been used, or where there has been an overdose
of such medicines, Calcium Folinate treatment is
usually given by injection.
Dose - Megaloblastic anaemia
Adults: the dose is one 15 mg tablet daily.
Children: these tablets are not suitable for
treating children with megaloblastic anaemia.
If you take more Calcium Folinate than
you should
Contact your doctor or nearest hospital
emergency department immediately. Take the
container and any remaining tablets with you.

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If you forget to take Calcium Folinate
Take the next dose as soon as you remember
unless it is almost time for your next dose.
Do not take a double dose to make up for a
forgotten dose.
If you stop taking Calcium Folinate
Do not stop taking Calcium Folinate suddenly
unless your doctor tells you.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

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4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If you experience any of the following side
effects, stop taking Calcium Folinate and tell
your doctor immediately or go to your nearest
hospital emergency department:
• severe allergic reaction: you may experience a
sudden itchy rash (hives), swelling of the hands,
feet, ankles, lips, mouth or throat (which may
cause difficulty in swallowing or breathing),

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• and you may feel you are going to faint. Severe
allergic reactions are very rare (they may affect
up to 1 in 10,000 people).
The following side effects may also occur:
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 digestive system
• difficulty sleeping (insomnia)

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Combination therapy with 5-fluorouracil only:
If you receive Calcium Folinate in combination
with an anti-cancer medicine containing
fluoropyrimidines, it is more likely that you will
experience the following side effects of this
other medicine:
Very common (may affect more than 1 in
10 people)
• nausea
• vomiting
• severe diarrhoea
• dehydration which may be due to diarrhoea
• inflammation of the lining of the intestine and

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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;
symptom may include lethargy, vomiting,
seizures (fits).

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If you have received Calcium Folinate by
injection, prior to receiving the tablets, you can
also get a high temperature.
Reporting of side effects
If you get 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 Yellow Card
Scheme, at www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.

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5. How to store Calcium Folinate
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 container after EXP. The
expiry date refers to the last day of that month.
Do not store above 25ºC. Store in the original
packaging in order to protect from light.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

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6. Contents of the pack and other information
What Calcium Folinate contains
Each tablet contains 19.07 mg of the active
ingredient calcium folinate, which is equivalent
to 15 mg folinic acid.
The other ingredients are lactose monohydrate
(see section 2, ‘Calcium Folinate tablets contain
lactose’), maize starch and magnesium stearate.
What Calcium Folinate looks like and contents
of the pack
Calcium Folinate 15 mg Tablets are off white to
pale yellow scored biconvex tablets marked with
"CF/15" on one side and "G" on the other.

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Calcium Folinate Tablets are available in
containers of 7, 10, 14, 20, 21, 28 or 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial
Estate, Grange Road, Dublin 13, Ireland.
Generics [UK] Ltd, Station Close, Potters Bar,
Hertfordshire, EN6 1TL, United Kingdom
This leaflet was last revised in July 2016.

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United Kingdom
281888
Part No: LL0424AG
Calcium Folinate 15 mg 10
52 x 101mm Pages: 24 PCode: TBC

Colours (4)
Black
Varnish Free

03 AUG 2016 13:36

Proof No. (4)
Customer:
Job No:
Job Ref:
Size:

Colours (4)

United Kingdom
281888
Part No: LL0424AG
Calcium Folinate 15 mg 10
52 x 101mm Pages: 24 PCode: TBC

calcium
folinate
#15 mg
tablets

Braille

03 AUG 2016 13:36

Proof No. (4)
Customer:
Job No:
Job Ref:
Size:

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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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