PATIENT
INFORMATION LEAFLET
This
leaflet contains important information about your
medicine; read it carefully.
Keep
this leaflet; you may want to read it again.
If you
have any questions or are not sure about anything,
ask your doctor or pharmacist.
1. What
Calcium Folinate Injection is and what it is used for
Calcium
Folinate Injection is a vitamin from the B group in the
form of a solution for injection.
This
medicine is presented in glass containers called vials.
Each ml of
solution in the vials contains 10 mg of folinic acid as
calcium folinate. The 5ml vial contains 50mg of folinic
acid as calcium folinate, the 10ml vial contains 100mg
folinic acid as calcium folinate and the 30ml vial
contains 300mg of folinic acid as calcium folinate. It
is available in single packs.
Calcium
folinate is used:
- to
reduce the harmful effects and treat overdose of
certain types of anti-cancer medicines e.g.
methotrexate and other folic acid antagonists
- to
increase the effect of 5-fluorouracil, an
anti-cancer medicine.
2.
Before Calcium Folinate Injection is used
Calcium Folinate Injection should not be used:
-
if you suffer from particular type of anaemia
caused by too little of the vitamin B12
(pernicious anaemia)
-
if you have shown signs of hypersensitivity
(severe allergy) to calcium folinate on previous
occasions
Tell
your doctor if:
-
if you are pregnant or breastfeeding
-
you are taking, or have recently taken any
medicines including ones that are not prescribed
for you including;
-
methotrexate – a medicine used in the
treatment of cancer and certain disorders
where depression of the immune system is
required (Calcium Folinate will not be given
at the same time as this medicine, as it may
stop it from working properly. It will be
given 12-24 hours afterwards).
-
medicines used for epilepsy e.g.
phenobarbital, phenytoin, primidone or
succinimides
-
5-fluorouracil- a medicine used in the
treatment of cancer (calcium folinate can be
given at the same time as this medicine,
although the dose may need to be changed.)
3. How
Calcium Folinate Injection is used
The dose of
medicine given to you will depend on your medical
condition and the dose of methotrexate you have been
given.
When used to
reduce the harmful effects of methotrexate it will be
given 12-24 hours after methotrexate treatment starts.
The first dose of calcium folinate is 15 mg given 12 to
24 hours after methotrexate treatment starts, followed
by 15mg every 6 hours for the next 72 hours.
When used to
treat overdosage of methotrexate, doses of up to 75mg
within 12 hours will be given, followed by 12mg every 6
hours for 4 doses.
48 hours
after treatment with methotrexate starts, the level of
methotrexate in your body will be measured and your dose
of calcium folinate may need to be adjusted.
In
combination with 5-fluorouracil:
You may have
to take calcium folinate twice monthly, weekly or
monthly.
For twice
monthly doses calcium folinate will be given as a slow
injection via a drip into a vein over 2 hours. This will
be followed by your dose of 5-fluorouracil. The
treatment will be for 2 consecutive days, every 2 weeks
on days 1 and 2.
For weekly
doses, calcium folinate will be given as a single
injection into a vein or by a slow injection via a drip
into a vein over 2 hours. Your dose of 5-fluorouracil
will be given as a single injection in the middle or at
the end of your dose of calcium folinate.
For monthly
doses, calcium folinate can be given as a single
injection into a vein or as a slow injection via a drip
into a vein over 2 hours. This will be immediately
followed by your dose of 5-fluorouracil as a single
injection during 5 consecutive days.
Your doctor
will decide how many times you will have to take calcium
folinate with 5-fluorouracil.
If you are
taking trimetrexate, calcium folinate should be given
everyday during treatment and for 72 hours after the
last dose of trimetrexate. Calcium folinate may be given
to you as a tablet to be taken 4 times a day.
If you have
been given a high dose of trimetrexate, calcium folinate
will be given as an injection into a vein every 6 hours
for 3 days once you have stopped taking trimetrexate.
To reduce
the harmful effects of trimethoprim, 3-10 mg per day of
calcium folinate will be given after stopping taking
trimethoprim until your blood count returns to normal.
To reduce
the harmful effects of pyrimethamine, 5 – 50 mg per day
of calcium folinate will be given at the same time as
your pyrimethamine.
This
medicine can be given as an injection into the muscle or
vein or as a slow injection via a drip into a vein
(infusion). If it is given via a drip then it may be
diluted with 5% glucose injection or 0.9% sodium
chloride injection.
As this
medicine will be given to you whilst you are in hospital
is unlikely that you will be given too little or too
much, however, tell your doctor or pharmacist if you
have any concerns.
4.
Possible side effects
Like all
medicines, calcium folinate can have side effects.
If
the following happens, tell your doctor immediately:
-
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.
These
are very serious side effects. You may need urgent
medical attention. All of these very serious side
effects are rare.
If you
are taking calcium folinate at the same time as
5-fluorouracil:
-
Vomiting and Nausea (being sick or feeling sick)
are common side effects.
-
Diarrhoea may be experienced if you are taking
calcium folinate every week.
Other
side-effects are rare, although you may feel
feverish after the injection. You may have
difficulty sleeping (insomnia) or you might suffer
from depression after high doses of calcium folinate.
If you are epileptic, you may have an increase in
the frequency of your fits which may be due to an
interaction with your epilepsy medicines. If you do
experience this tell your doctor as soon as
possible.
If you
notice any side effects not mentioned in this
leaflet, please tell your doctor or pharmacist.
5.
Storing Calcium Folinate Injection
Keep out of
the reach and sight of children.
Store the
vials in a refrigerator (+2°C to +8°C)
Store vials
in the outer carton in order to protect from light.
This
medicine should not be used after the expiry date
printed on the vial label and carton.