Patient
Information Booklet
Give this
booklet to the patient
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 further questions, please ask your
doctor, nurse or pharmacist.
-
This medicine has been prescribed for you
personally and you should not pass it on to
others. It may harm them, even if their symptoms
are the same as yours.
In
this leaflet
Faslodex ingredients and
manufacturer
What Faslodex is and what it is
used for
Before you use Faslodex
-
Allergies
-
Other medical conditions
-
Pregnancy and breast-feeding
-
Driving and using machines
-
Taking other medicines
How Faslodex is given
Possible side effects
Storing Faslodex
Further information
Faslodex
ingredients and manufacturer
Faslodex 250
mg/5 ml solution for injection.
Fulvestrant
The active
substance is fulvestrant. Each pre-filled syringe (5 ml)
contains 250 mg of fulvestrant.
The other
ingredients are ethanol 96%, benzyl alcohol, benzyl
benzoate and castor oil.
What is
Faslodex and what it is used for
Faslodex is
used to treat breast cancer only in women who have been
through the menopause.
Faslodex is
a medicine that blocks some of the actions of the female
sex hormone, oestrogen, within the body. Oestrogen is
involved in maintaining the growth of organs such as the
breast, uterus and bone. Oestrogen is linked to the
growth of breast cancer.
Faslodex
comes in a container with a syringe that is filled and
ready for injection into the muscle of the buttock. Each
packaging contains a needle for injection.
Before
you use Faslodex
Do
not have Faslodex:
-
If you know you are allergic to fulvestrant or
to any of the ingredients in Faslodex.
-
If you are pregnant or breast-feeding
-
If you have severe liver problems
Take
special care with Faslodex:
Tell
your doctor if you have any of these medical
conditions:
-
If you have any problems with your kidneys or
your liver.
-
If you have a low blood platelet count, a
bleeding disorder or if you use anticoagulants
(medicine to prevent blood clots).
-
If you have had any problems with blood clots
-
If you have had any problems with loss of the
mineral contents of the bones (osteoporosis)
Pregnancy and Breast-feeding
Do not
use Faslodex if you are pregnant or breast-feeding.
Driving and using machines:
Faslodex
is not expected to affect your ability to drive or
use machines, however you may feel tired after
treatment with Faslodex. If this happens to you, do
not drive or use machines.
Taking other medicines:
Tell
your doctor, nurse or pharmacist if you are taking
or have recently taken any other medicines – even
those you have bought without a prescription. This
is important as using more than one medicine at the
same time can strengthen or weaken the effect of the
medicines. Your doctor may need to take special care
or change the dose.
How
Faslodex is given
Your doctor
or nurse will give you the Faslodex injection. It will
be injected slowly into the muscle in your buttock.
The
usual dose is:
-
one injection given once a month.
Possible
side effects
Like all
medicines, Faslodex can have side effects. Do not be
alarmed by this list of possible effects. You may not
have any of them, but tell your doctor as soon as
possible if any of the following side effects bothers
you or continues:
Very common effects (more than
10 of every 100 patients have these):
Common effects (1 to 10 of
every 100 patients have these):
-
Injection site reactions, such as pain and/or
inflammation
-
Headache
-
Weakness and tiredness
-
Gastro-intestinal symptoms (symptoms from the
stomach or the bowels), such as nausea (feeling
sick), vomiting (being sick), diarrhea or loss of
appetite
- Rash
-
Urinary tract infections
- Back
pain
-
Increased risk of blood clots
-
Changes of the levels of the liver enzymes (seen
when a blood test is taken)
Uncommon (less than 1 of every
100 patients have these):
-
Allergic reactions, including swelling
-
Vaginal bleeding
-
Vaginal thrush
-
Vaginal discharge
Other effects
If you
notice any other side effect not mentioned in this
leaflet, please tell your doctor, nurse or
pharmacist as soon as possible.
Storing
Faslodex
Keep out of
the reach and sight of children.
Store at 2°C
– 8°C (in a refrigerator).
Keep
Faslodex in the original pack, in order to protect from
light.
Do not use
after the expiry date on the carton or syringe label.
Your doctor
or hospital will normally keep Faslodex for you. The
medical staff are responsible for the correct storage,
use and disposal of Faslodex.
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