Skip to Content

UK Edition. Click here for US version.

ZOLADEX LA 10.8MG

Active substance(s): GOSERELIN

View full screen / Print PDF » Download PDF ⇩
Transcript
P040324

Package leaflet: Information for the user

Zoladex LA® 10.8 mg Implant
goserelin

Read all of this leaflet carefully
before you start using 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, pharmacist
or nurse.
• 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 side effects, talk to
your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See
section 4.

Zoladex LA might interfere with
some medicines used to treat heart
rhythm problems (e.g. quinidine,
procainamide, amiodarone and
sotalol) or might increase the risk
of heart rhythm problems when
used with some other drugs (e.g.
methadone (used for pain relief and
part of drug addiction detoxification),
moxifloxacin (an antibiotic),
antipsychotics used for serious mental
illnesses).
Driving and using machines
Zoladex LA is not likely to affect you
being able to drive or use any tools or
machines.
3. How to use Zoladex LA
• The Zoladex LA 10.8 mg Implant
will be injected under the skin on
your stomach every 12 weeks.
This will be done by your doctor
or nurse.
• It is important that you keep having
Zoladex LA treatment, even if you
are feeling well.
• Keep having this treatment until
your doctor decides that it is time
for you to stop.
Your next appointment
• You should be given a Zoladex LA
injection every 12 weeks.
• Always remind the doctor or nurse
to set up an appointment for your
next injection.
• If you are given an appointment for
your next injection which is earlier or
later than 12 weeks from your last
injection, tell your doctor or nurse.
• If it has been more than 12 weeks
since your last injection, contact
your doctor or nurse so that you
can receive your injection as soon
as possible.

What is in this leaflet:
1. What Zoladex LA is and what it is
used for
2. What you need to know before you
use Zoladex LA
3. How to use Zoladex LA
4. Possible side effects
5. How to store Zoladex LA
6. Contents of the pack and other
information
1. What Zoladex LA is and what it
is used for
Zoladex LA contains a medicine
called goserelin. This belongs to a
group of medicines called ‘LHRH
analogues’.
Zoladex LA is used to treat prostate
cancer. It works by reducing the
amount of ‘testosterone’ (a hormone)
that is produced by your body.
Zoladex LA is a long-acting form
of Zoladex and it is given every
12 weeks.
2. What you need to know before
you use Zoladex LA
Do not use Zoladex LA:
• if you are allergic to goserelin or
any of the other ingredients of this
medicine (listed in section 6).
• if you are a woman.
Do not have Zoladex LA if any of the
above apply to you. If you are not
sure, talk to your doctor, pharmacist or
nurse before having Zoladex LA.
Warnings and precautions
Talk to your doctor, pharmacist or
nurse before using Zoladex LA:
• if you have problems passing urine
(water) or problems with your back.
• if you have diabetes.
• if you have high blood pressure.
• if you have any condition that
affects the strength of your bones,
especially if you are a heavy
drinker, a smoker, have a family
history of osteoporosis (a condition
that affects the strength of your
bones) or take anticonvulsants
(medicines for epilepsy or fits) or
corticosteroids (steroids).
• if you have any heart or blood
vessel conditions, including heart
rhythm problems (arrhythmia), or
are being treated with medicines for
these conditions. The risk of heart
rhythm problems may be increased
when using Zoladex LA.
There have been reports of
depression in patients taking
Zoladex which may be severe. If
you are taking Zoladex and develop
depressed mood, inform your doctor.
Medicines of this type can cause a
reduction in bone calcium (thinning of
bones).
If you go into hospital, tell the medical
staff that you are having Zoladex LA.
Children
Zoladex LA should not be given to
children.
Other medicines and Zoladex LA
Tell your doctor, pharmacist or nurse
if you are taking, have recently taken
or might take any other medicines.
This includes medicines that you buy
without a prescription and herbal
medicines.

4. Possible side effects
Like all medicines, this medicine
can cause side effects, although not
everybody gets them.
Allergic reactions:
These are rare. The symptoms can
include sudden onset of:
• Rash, itching or hives on the skin.
• Swelling of the face, lips or tongue
or other parts of the body.
• Shortness of breath, wheezing or
trouble breathing.
If this happens to you, see a doctor
straight away.
Injection site injury (including damage
to blood vessels in the abdomen)
has been reported following injection
of Zoladex LA. In very rare cases
this has caused severe bleeding.
Contact your doctor immediately
if you experience any of the following
symptoms:
• Abdominal pain.
• Abdominal distension.
• Shortness of breath.
• Dizziness.
• Low blood pressure and/or any
altered levels of consciousness.
Other possible side effects:
Very common (may affect more
than 1 in 10 people)
• Hot flushes and sweating.
Occasionally these side effects may
continue for some time (possibly
months) after stopping Zoladex.
• A reduced sex drive and
impotence.
Common (may affect up to 1 in
10 people)
• Pain in your lower back or problems
passing urine. If this happens, talk
to your doctor.
• Bone pain at the beginning of
treatment. If this happens, talk to
your doctor.
• Thinning of your bones.
• Rises in blood sugar levels.
• Tingling in your fingers or toes.
• Skin rashes.
• Weight gain.
• Pain, bruising, bleeding, redness
or swelling where Zoladex LA is
injected.
• Reduced heart function or heart
attack.
• Changes in blood pressure.
• Swelling and tenderness of your
breasts.
• Changes in your mood (including
depression).

251583
UK
02
25 May 2015
P040324
630170L4
Pharma Code:

08:53

Black

Profile

Technical
Info

1903
Zoladex Leaflet

Font information
Font family: Nimbus Sans
Body text size: 12.0 pt

Uncommon (may affect up to 1 in
100 people)
• Pain in the joints.
Very rare (may affect up to 1 in
10,000 people)
• Psychiatric problems called
psychotic disorders which may
include hallucinations (seeing, feeling
or hearing things that are not there),
disordered thoughts and personality
changes. This is very rare.
• The development of a tumour of
the pituitary gland in your head or,
if you already have a tumour in
your pituitary gland, Zoladex LA
may make the tumour bleed or
collapse. These effects are very
rare. Pituitary tumours can cause
severe headaches, feeling or being
sick, loss of eyesight and becoming
unconscious.

Please be ready to give the
following information:
Product name
Zoladex LA 10.8 mg
Implant
Reference number
17901/0065
This is a service provided by
the Royal National Institute
of Blind People.
This leaflet was last revised in
May 2015
© AstraZeneca 2015
Zoladex is a trade mark of the
AstraZeneca group of companies.
ONC 15 0008a

Not known (frequency cannot be
estimated from the available data)
• Hair loss.
• Changes in your blood.
• Liver problems.
• A blood clot in your lungs causing
chest pain or shortness of breath.
• Inflammation of the lungs. The
symptoms may be like pneumonia
(such as feeling short of breath and
coughing).
• Changes in ECG (QT prolongation).
Do not be concerned by this list of
possible side effects. You may not get
any of them.
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, Website:
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 Zoladex LA
• Your doctor may give you a
prescription so that you can get
your medicine from the pharmacy
and give it to your doctor when you
see him or her again.
• Keep this medicine out of the sight
and reach of children.
• Keep it in its original package and
do not break the seal.
• Do not store it above 25°C.
• Do not use this medicine after the
expiry date which is stated on the
carton. The expiry date refers to the
last day of that month.
• Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help protect
the environment.
6. Contents of the pack and other
information
What Zoladex LA 10.8 mg Implant
contains
The active substance is goserelin.
Each Zoladex LA 10.8 mg Implant
contains 10.8 mg of goserelin.
The other ingredient is lactide/
glycolide copolymer which is an
inactive substance.
What Zoladex LA 10.8 mg Implant
looks like and contents of the pack
Zoladex LA 10.8 mg Implant comes
as an implant (a very small pellet) in a
pre-filled syringe, ready to be used by
the doctor or nurse.
Zoladex LA 10.8 mg Implant is
produced in packs of one implant
(injection).
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation for
Zoladex LA 10.8 mg Implant is
held by AstraZeneca UK Limited,
600 Capability Green, Luton,
LU1 3LU, UK.
Zoladex LA 10.8 mg Implant is
manufactured by AstraZeneca UK
Limited, Silk Road Business Park,
Macclesfield, Cheshire, SK10 2NA, UK.

To listen to or request a
copy of this leaflet in Braille,
large print or audio please
call, free of charge:
0800 198 5000 (UK only)

P040324

251583
UK
02
25 May 2015
P040324
630170L4
Pharma Code:

08:53

Black

Profile

Technical
Info

1903
Zoladex Leaflet

Font information
Font family: Nimbus Sans
Body text size: 12.0 pt

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.

Hide