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CALCIUM FOLINATE 15 MG TABLETS

Active substance(s): CALCIUM FOLINATE PENTAHYDRATE

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TEVA UK Ref:

Version:

231-30-88403-B LEA CALCIUM FOLINATE 15MG TAB TUK

1

17 March 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

PACKAGE LEAFLET: INFORMATION
FOR THE USER

Read all of this leaflet carefully before
you start taking this medicine.
• 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. Do not pass it on to others. It
may harm them, even if their
symptoms 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.

• methotrexate (see above, Tell your
doctor before you start to take this
medicine).
Please tell your doctor or pharmacist
if you are taking or have recently
taken any other medicines, including
medicines obtained without a
prescription.
Pregnancy and breast-feeding
If you are pregnant, planning to
become pregnant or breast-feeding,
ask your doctor for advice before
taking this medicine.
Driving and using machines
Calcium Folinate is not expected to
affect your ability to drive or operate
machinery.

IN THIS LEAFLET:

Pharma code 74

1. What Calcium Folinate is and what
it is used for
2. Before you take Calcium Folinate
3. How to take Calcium Folinate
4. Possible side effects
5. How to store Calcium Folinate
6. Further information

Important information about some of
the ingredients of Calcium Folinate
Patients who are intolerant to lactose
should note that Calcium Folinate
tablets contain a small amount of
lactose. If you have been told by your
doctor that you have an intolerance to
some sugars, contact your doctor
before taking this medicinal product.

1 WHAT CALCIUM FOLINATE IS
AND WHAT IT IS USED FOR

Calcium Folinate belongs to a group
of drugs called antidotes. Antidotes
prevent the damage caused by other
substances.
Calcium Folinate is used:
• to reduce the harmful effects of
certain anti-cancer drugs
• to treat certain types of anaemia
due to low levels of folic acid.
Ask your doctor or pharmacist if you
need further information.

2 BEFORE YOU TAKE CALCIUM
FOLINATE

Do NOT take Calcium Folinate if you:
• are allergic (hypersensitive) to
calcium folinate or any of the other
ingredients of this medicine
• suffer from anaemia due to lack of
vitamin B12 (pernicious anaemia or
some megaloblastic anaemias).
Take special care with Calcium
Folinate
Tell your doctor before you start to
take this medicine if you:
• are also being treated with
methotrexate. Calcium Folinate
should only be used after treatment
with methotrexate.
Taking other medicines
Talk to your doctor if you are taking
any of the following:
• anti-epileptics e.g. phenobarbital,
phenytoin or primidone

REG0133309

Version 1.2

3 HOW TO TAKE CALCIUM
FOLINATE

Always take Calcium Folinate exactly
as your doctor has told you. You
should check with your doctor or
pharmacist if you are not sure. The
tablets should be swallowed
preferably with a glass of water. The
usual dose is:
To reduce the harmful effects after
certain anticancer treatments
• Adults and Children:
Following intravenous treatment:
15 mg (1 tablet) every 6 hours for 48
hours.
To treat anaemia due to low levels of
folic acid
• Adults:
15 mg (1 tablet) a day.
• Children up to 12 years:
Your doctor will calculate the
appropriate dose for your child.
If you see another doctor or go into
hospital, let him or the staff know
what medicines you are taking.
If you take more Calcium Folinate
than you should
If you (or someone else) swallow a lot
of the tablets all together, or if you
think a child has swallowed any of the
tablets, contact your nearest hospital
casualty department or your doctor
immediately. Please take this leaflet,
any remaining tablets and the

Approved

Page 1 of 3

Top of page cut-off to middle of registration mark: 44 mm.

CALCIUM FOLINATE
15 mg TABLETS

TEVA UK Ref:

Version:

231-30-88403-B LEA CALCIUM FOLINATE 15MG TAB TUK

1

17 March 2015

PAGE 2: REAR FACE (OUTSIDE OF REEL)

container with you to the hospital or
doctor so that they know which
tablets were consumed.

6

FURTHER INFORMATION

What Calcium Folinate Tablets
contain:
If you forget to take Calcium Folinate • The active ingredient is calcium
folinate (as pentahydrate).
If you forget to take a tablet, take one
as soon as you remember, unless it is • The other ingredients are lactose
monohydrate, maize starch,
nearly time to take the next one. Do
pregelatinised maize starch,
not take a double dose to make up for
magnesium stearate (E572).
a forgotten dose. Take the remaining
doses at the correct time.
What Calcium Folinate Tablets look
like and contents of the pack:
If you have any further questions on
• A standard convex tablet, almost
the use of this product, ask your
white to cream with slight speckling
doctor or pharmacist.
• The Calcium Folinate tablets are
available in blister packs of 10
tablets.
4 POSSIBLE SIDE EFFECTS
Not all pack sizes may be marketed.
Like all medicines, Calcium Folinate
Marketing Authorisation Holder and
can cause side effects, although not
Manufacturer
everybody gets them.
Marketing Authorisation holder and
If the following happens, stop taking company responsible for
manufacture:
the tablets and tell your doctor
TEVA UK Limited, Eastbourne,
immediately or go to the casualty
department at your nearest hospital: BN22 9AG.
• an allergic reaction (swelling of the
This leaflet was last revised:
lips, face or neck leading to severe
February 2015
difficulty in breathing; skin rash or
hives).
PL 00289/0468
This is a very serious but rare side
effect. You may need urgent medical
attention or hospitalisation.
Rarely, fever has been reported
following intravenous or
intramuscular injection with Calcium
Folinate.
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.

5 HOW TO STORE CALCIUM
FOLINATE

Keep out of the reach and sight of
children. Do not store above 25°C.
Keep in the package or container
supplied. Do not transfer to another
container. Do not use Calcium Folinate
after the expiry date that is stated on
the outer packaging. The expiry date
refers to the last day of that month.
Medicines should not be disposed of
via wastewater or household waste.
Ask your pharmacist how to dispose
of medicines no longer required.
These measures will help to protect
the environment.
88403-B
160 x 323

REG0133309

Version 1.2

Approved

Page 2 of 3

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Read all of this leaflet carefully before
you start taking this medicine.
• 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. Do not pass it on to others.
It may harm them, even if their
symptoms 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.

1

WHAT CALCIUM FOLINATE IS
AND WHAT IT IS USED FOR

Calcium Folinate is used:
• to reduce the harmful effects of
certain anti-cancer drugs.
• to treat certain types of anaemia
due to low levels of folic acid.
Ask your doctor or pharmacist if you
need further information.

2

BEFORE YOU TAKE CALCIUM
FOLINATE

Do NOT take Calcium Folinate if you:
• are allergic (hypersensitive) to
calcium folinate or any of the other
ingredients of this medicine
• suffer from anaemia due to lack of
vitamin B12 (pernicious anaemia or
some megaloblastic anaemias).

REG0062647

Driving and using machines
Calcium Folinate is not expected to
affect your ability to drive or operate
machinery.
Important information about some of
the ingredients of Calcium Folinate
Patients who are intolerant to lactose
should note that Calcium Folinate
tablets contain a small amount of
lactose. If you have been told by your
doctor that you have an intolerance to
some sugars, contact your doctor
before taking this medicinal product.

3

HOW TO TAKE CALCIUM
FOLINATE

Always take Calcium Folinate exactly as
your doctor has told you. You should
check with your doctor or pharmacist if
you are not sure. The tablets should be
swallowed preferably with a glass of
water. The usual dose is:
To reduce the harmful effects after
certain anticancer treatments
• Adults and Children:
Following intravenous treatment:
15 mg (1 tablet) every 6 hours for 48
hours.

Version 3.2

Approved

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.

5

HOW TO STORE CALCIUM
FOLINATE

If you take more Calcium Folinate than
you should
If you (or someone else) swallow a lot
of the tablets all together, or if you think
a child has swallowed any of the
tablets, contact your nearest hospital
casualty department or your doctor
immediately. Please take this leaflet,
any remaining tablets and the container
with you to the hospital or doctor so
that they know which tablets were
consumed.

335

335

Calcium Folinate belongs to a group of
drugs called antidotes. Antidotes
prevent the damage caused by other
substances.

If you see another doctor or go into
hospital, let him or the staff know what
medicines you are taking.

Please tell your doctor or pharmacist if
you are taking or have recently taken any
other medicines, including medicines
obtained without a prescription.
Pregnancy and breast-feeding
If you are pregnant, planning to
become pregnant or breast-feeding, ask
your doctor for advice before taking
this medicine.

17 March 2015

• Children up to 12 years:
Your doctor will calculate the
appropriate dose for your child.

Taking other medicines
Talk to your doctor if you are taking any
of the following:
• anti-epileptics e.g. phenobarbital,
phenytoin or primidone
• methotrexate (see above, Tell your
doctor before you start to take this
medicine).

IN THIS LEAFLET:

1. What Calcium Folinate is and what it
is used for
2. Before you take Calcium Folinate
3. How to take Calcium Folinate
4. Possible side effects
5. How to store Calcium Folinate
6. Further information

1

To treat anaemia due to low levels of
folic acid
• Adults:
15 mg (1 tablet) a day.

Take special care with Calcium Folinate
Tell your doctor before you start to take
this medicine if you:
• are also being treated with
methotrexate. Calcium Folinate
should only be used after treatment
with methotrexate.

335

CALCIUM FOLINATE
15 mg TABLETS

Version:

231-30-67868-X LEA CALCIUM FOLINATE 15MG TAB TUK
Keep out of the reach and sight of
children. Do not store above 25°C.
Keep in the package or container
supplied. Do not transfer to another
container. Do not use Calcium Folinate
after the expiry date that is stated on
the outer packaging. The expiry date
refers to the last day of that month.
Medicines should not be disposed of
via wastewater or household waste.
Ask your pharmacist how to dispose of
medicines no longer required. These
If you forget to take Calcium Folinate
measures will help to protect the
If you forget to take a tablet, take one as environment.
soon as you remember, unless it is
nearly time to take the next one. Do not
6 FURTHER INFORMATION
take a double dose to make up for a
forgotten dose. Take the remaining
What Calcium Folinate Tablets contain:
doses at the correct time.
• The active ingredient is calcium
folinate (as pentahydrate).
If you have any further questions on the • The other ingredients are lactose
use of this product, ask your doctor or
monohydrate, maize starch,
pharmacist.
pregelatinised maize starch,
magnesium stearate (E572).

4

POSSIBLE SIDE EFFECTS

What Calcium Folinate Tablets look like
Like all medicines, Calcium Folinate can and contents of the pack:
cause side effects, although not
• A standard convex tablet, almost
everybody gets them.
white to cream with slight speckling.
• The Calcium Folinate tablets are
If the following happens, stop taking the
available in blister packs of 10 tablets.
tablets and tell your doctor immediately
Not all pack sizes may be marketed.
or go to the casualty department at your
nearest hospital:
Marketing Authorisation Holder and
• an allergic reaction (swelling of the
Manufacturer
lips, face or neck leading to severe
Marketing Authorisation holder and
difficulty in breathing; skin rash or
company responsible for manufacture:
hives).
TEVA UK Limited, Eastbourne, BN22 9AG.
This is a very serious but rare side
effect. You may need urgent medical
This leaflet was last revised:
attention or hospitalisation.
February 2015
Rarely, fever has been reported following PL 00289/0468
intravenous or intramuscular injection
with Calcium Folinate.

TEVA UK Limited

Page 1 of 2

322K051980315
67868-X

335

TEVA UK Ref:

Expand view ⇕

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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