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REFOLINON 15MG TABLETS

Active substance(s): CALCIUM FOLINATE / CALCIUM FOLINATE

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Refolinon

®

148

Leucovorin calcium

15 mg tablets

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, even if their
signs of illness are the same as yours.
• If you get any of the side effects, talk
to your doctor or pharmacist. This
includes any side effects not listed in
this leaflet. See section 4.
Whats is in this leaflet

Refolinon is and what it is
1. What
used for

you need to know before you
2. What
take Refolinon

3. How
to take Refolinon
4. Possible

side effects
5. How

to store Refolinon

6. Contents
of the pack and other
information

1. What

Refolinon is and what it is
used for
Refolinon contains the active substance
leucovorin calcium which is chemically
related to a vitamin called folic acid.
Refolinon increases the levels of 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.

Other medicines and Refolinon
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines, including medicines
obtained without a prescription.

2. What you need to know before you
take Refolinon
Do not take Refolinon if:
• you are allergic (hypersensitive) to
leucovorin calcium or any of the other
ingredients of this medicine (listed in
section 6).
• you have pernicious anaemia or other
megaloblastic anaemia where vitamin
B12 is deficient.

Pregnancy, breast-feeding and fertility
Pregnancy
If you are pregnant, think you may be
pregnant or planning to have a baby,
ask your doctor or pharmacist for advice
before you take this medicine.

Some medicines can affect the way
Refolinon works, or Refolinon itself
can reduce the effectiveness of other
medicines taken at the same time.
• T
 he effectiveness of Refolinon can be
reduced by chloramphenicol (an
antibiotic).
• R
 efolinon can reduce the effectiveness
of drugs used to treat epilepsy
(phenobarbital, phenytoin or primidone)
and lead to more frequent seizures (fits).
• R
 efolinon may increase the side effects
of fluorouracil (used to treat cancer).

Breast-feeding
If you are breast-feeding, speak to your
doctor who will advise whether you should
use an alternative method of feeding your
baby.

Driving and using machines
Refolinon is not expected to affect your
ability to drive or use machines.
Refolinon contains lactose
Refolinon contains lactose, a type of sugar.
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 Refolinon
Always take this medicine exactly as you
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:
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: 15mg
(1 tablet) every 6 hours for 48 hours. Refolinon
for leucovorin rescue therapy is usually started
24 hours after the start of methotrexate
treatment.
Refolinon for megaloblastic anaemia:
15mg (1 tablet) daily until your doctor tells
you to stop.

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 medicine, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, this medicine 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.
• s udden 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.
Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. 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 Refolinon
Keep this medicine out of the sight and
reach of children.
Do not use Refolinon after the expiry date
which is stated on the carton and label

after EXP. The expiry date refers to the last
day of that month.
Store below 25 °C. Do not refrigerate or
freeze.
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. Content of the pack and other
information
What Refolinon contains
The active substance in Refolinon tablets is
leucovorin (folinic acid) as the calcium salt.
Each tablet contains 15mg of leucovorin.
The other ingredients are: microcrystalline
cellulose, magnesium stearate and lactose
(see section 2 Refolinon contains lactose).
What Refolinon looks like and contents
of the pack
Refolinon tablets are light yellow and are
scored and marked CF on one side
The tablets are supplied in plastic containers
of 30 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Pfizer Limited
Ramsgate Road

Sandwich, Kent
CT13 9NJ
United Kingdom
Manufacturer:
Orion Corporation
PO Box 425
SF20101
Turku
Finland
This leaflet was last revised in 09/2016
Ref: RE 7_1

2016‑0005970A

600
Package leaflet: Information for the user

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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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