REFOLINON 15MG TABLETS

Active substance: CALCIUM FOLINATE

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Refolinon

®

15 mg tablets

leucovorin calcium

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 any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.

In this leaflet:

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

1. What Refolinon is and
what it is used for

Refolinon contains leucovorin calcium
which is chemically related to a vitamin
called folic acid. Refolinon increases
the levels of a folic acid in your body.
Methotrexate (a medicine used to treat
cancer) can lower your body’s levels of
folic acid. Refolinon is used to reverse
this and help to maintain folic acid levels.
This is known as ‘leucovorin rescue’.
Refolinon is also used to treat a form of
anaemia (megaloblastic) which results
from low levels of folic acid.
You should ask your doctor if you
are unsure why you have been given
Refolinon.

2. Before you take Refolinon
Do not take Refolinon if:
• you are allergic (hypersensitive)
to leucovorin calcium or any of the
other ingredients of Refolinon.

Take special care with Refolinon
• Tell your doctor before taking
Refolinon if you currently have, or
have had anaemia that needed
treatment.

Taking other medicines

Some medicines can affect the way
Refolinon works, or Refolinon itself
can reduce the effectiveness of other
medicines taken at the same time.
• The effectiveness of Refolinon can
be reduced by chloramphenicol
(an antibiotic).
• Refolinon can reduce the effectiveness
of drugs used to treat epilepsy
(phenobarbital, phenytoin or
primidone) and lead to more frequent
seizures (fits).
• Refolinon may increase the side effects
of fluorouracil (used to treat cancer).
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 get
pregnant or are breast-feeding, tell
your doctor before you take Refolinon.
Ask your doctor or pharmacist for
advice before taking any medicine.

Driving and using machines

Refolinon is not expected to affect your
ability to drive or use machines.

Important information about some
of the ingredients of Refolinon
Refolinon contains lactose, a type of
sugar. If you have been told that you
have an intolerance to some sugars,
contact your doctor before taking this
medicinal product.

3. How to take Refolinon

Always take Refolinon exactly as your
doctor has told you. You should check
with your doctor or pharmacist if you
are still not sure.
The usual dose in adults and children
is as follows:
Refolinon for Leucovorin rescue: 15mg
(1 tablet) every 6 hours for 48 hours.
Refolinon for Megaloblastic anaemia:
15mg (1 tablet) daily until your doctor
tells you to stop.
The tablets should be swallowed with
a glass of water.
It is important to take your medicine
at the right times. Refolinon for
Leucovorin rescue therapy is usually
started 24 hours after the start of
methotrexate treatment.
You will find more about REFOLINON on
the back of this leaflet

110792-6

PATIENT INFORMATION LEAFLET

If you take more Refolinon than
you should
If you accidentally take too much
Refolinon contact your doctor. Side
effects with Refolinon are rare, since
it is similar to a naturally occurring
vitamin.

If you forget to take Refolinon

If you forget to take a dose, take it
as soon as you remember unless it is
time for your next dose. Do not take
a double dose to make up for a
missed dose.

If you stop taking Refolinon

Do not stop taking Refolinon unless
your doctor tells you to. If you
suddenly stop taking this medicine
your condition may return.
If you have any further questions on
how to take this product, ask your
doctor or pharmacist.

4. Possible side effects

Like all medicines, Refolinon can cause
side effects, although not everybody
gets them.
Tell your doctor immediately if
you experience any of the following
symptoms after taking this medicine.
Although they are very rare, these
symptoms can be serious.
• sudden wheeziness, difficulty in
breathing, swelling of eyelids, face
or lips, rash or itching (especially
affecting the whole body).
If Refolinon is given with another drug
called fluorouracil (to treat cancer)
the following side effects have been
reported:
• decreased white blood cell count or
low platelets in the blood. Symptoms
may include bruising, nose bleeds
or rash. Your doctor will take regular
blood tests to check these.
• sore and inflamed mouth (stomatitis)
and/or diarrhoea.
If you have received Refolinon by
injection, prior to receiving the tablets,
you can also get a high temperature.
If any of the side effects gets serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.

5. How to store Refolinon

Keep your tablets out of the reach and
sight of children.
Do not use Refolinon after the expiry
date which is stamped on the pack
after EXP. The expiry date refers to the
last day of that month.
Store your Refolinon Tablets below
25°C. Do not refrigerate or freeze
them.
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.

6. Further Information
What Refolinon contains

The active substance in Refolinon
tablets is 15mg of leucovorin (folinic
acid) as the calcium salt.
The other ingredients are: Avicel PH101,
magnesium stearate and lactose.

What Refolinon looks like and
contents of the pack

Refolinon tablets are yellow in colour
and are scored and marked CF on
one side
The tablets are supplied in plastic
containers of 30 or 100 tablets.

Marketing Authorisation Holder
Pharmacia Ltd., Ramsgate Road,
Sandwich, Kent CT13 9NJ, UK.

Manufacturer:

Orion Corporation, PO Box 425,
SF20101, Turku, Finland.

Company Contact Address:

For further information on your
medicine please contact Medical
Information at the following address:
Pfizer Ltd, Walton Oaks, Dorking Road,
Tadworth, Surrey, KT20 7NS, UK.
Telephone: 01304 616161.
Leaflet last revised - May 2008

Ref: REB4_0

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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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