ZOLADEX LA 10.8MG INJECTION SAFESYSTEM

Active substance: GOSERELIN ACETATE

View full screen / Print PDF » Download PDF ⇩

Transcript
(leaflet continued)
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.
4. Possible side effects
Like all medicines Zoladex LA 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.
Other possible side effects:
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.
Hot flushes and sweating
A reduced sex drive and impotence
Thinning of your bones
Rises in blood sugar levels
Tingling in your fingers or toes
Skin rashes
Hair loss
Weight gain
Pain, bruising, bleeding, redness or
swelling where Zoladex LA is injected
Pain in the joints
Reduced heart function or heart attack.
Changes in blood pressure
Swelling and tenderness of your breasts
Changes in your mood (including
depression)
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).
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.

PL 20774/0729

POM

Manufactured by AstraZeneca UK Limited,
Macclesfield Cheshire SK10 2NA. Procured
from within the EU. Product Licence holder:
Quadrant Pharmaceuticals Ltd, Lynstock
House, Lynstock Way, Lostock, Bolton,
BL6 4SA. Repackaged by Maxearn Ltd,
Bolton, BL6 4SA.
Leaflet prepared 23rd April 2013
Zoladex is a registered trademark of
AstraZenenca UK Ltd.
PP3/0729/V1

Do not be concerned by this list of possible
side effects. You may not get any of them.
If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor, nurse or pharmacist.
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 out of the sight and reach of children.
Do not store it above 25°C
Keep it in a safe place where children
cannot see it or reach it.
Your medicine should not be used after the
expiry date on the carton.
If your medicine is not used, take it back to
your pharmacist.
6. Further information
What Zoladex LA 10.8mg Implant contains
The active substance is goserelin. Each
Zoladex LA 10.8mg Implant contains 10.8mg
of goserelin. The other ingredients is
lactide/glycolide copolymer which is an inactive
substance.
What Zoladex LA 10.8mg Implant looks like
and contents of the pack
It contains a sterile white to cream coloured,
cylindrical depot in which the active ingredient
Goserelin acetate, equivalent to 10.8 mg
Goserelin, is dispersed, in long acting,
sustained release form in a special biodegradable matrix of lactide-glycolide copolymer.

Zoladex LA should not be given to children.
2. Before you are given Zoladex LA
Do not have Zoladex LA if:
You are allergic (hypersensitive) to
goserelin or any of the other ingredients of
this medicine (listed in section 6: Further
information).
You are a women.
Do not have Zoladex LA if any of the above
apply to you. If you are not sure, talk to your
doctor or pharmacist before having Zoladex
LA.
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.
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’.
In this leaflet:
1. What Zoladex LA is and what it is used for
2. Before you are given Zoladex LA
3. How Zoladex LA will be given
4. Possible side effects
5. How to store Zoladex LA
6. Further information
Read all of this leaflet carefully before you
start using this medicine.
Keep this leaflet. You may need to read it
again.
If you have any further questions, ask your
doctor, nurse 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 get serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor, nurse or
pharmacist.
The name of your medicine is called ‘Zoladex
LA 10.8mg Injection ‘Safe System’ but will be
referred to as Zoladex LA throughout the
remainder of this leaflet.

(leaflet continued overleaf)
3. How Zoladex LA will be given
The Zoladex LA 10.8mg 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.
Driving and using machines
Zoladex LA is not likely to affect you being able
to drive or use any tools or machines.
Taking other medicines
Please tell your doctor or nurse if you are
taking or have recently taken any other
medicines. This includes medicines that you
buy without a prescription and herbal
medicines.
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.
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.
Take special care with Zoladex LA
Check with your doctor or nurse before you
have Zoladex LA if:
You have problems passing urine (water)
or problems with your back.
You have diabetes
You have high blood pressure
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).

ZOLADEX® LA 10.8MG INJECTION ‘Safe System™’
(goserelin)
PACKAGE LEAFLET: INFORMATION FOR THE USER

PP3/0729/V1

If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor, nurse or pharmacist.
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 out of the sight and reach of children.
Do not store it above 25°C
Keep it in a safe place where children
cannot see it or reach it.
Your medicine should not be used after the
expiry date on the carton.
If your medicine is not used, take it back to
your pharmacist.
6. Further information
What Zoladex LA 10.8mg Implant contains
The active substance is goserelin. Each
Zoladex LA 10.8mg Implant contains 10.8mg
of goserelin. The other ingredients is
lactide/glycolide copolymer which is an inactive
substance.
What Zoladex LA 10.8mg Implant looks like
and contents of the pack
It contains a sterile white to cream coloured,
cylindrical depot in which the active ingredient
Goserelin acetate, equivalent to 10.8 mg
Goserelin, is dispersed, in long acting,
sustained release form in a special biodegradable matrix of lactide-glycolide copolymer.

In this leaflet:
1. What Zoladex LA is and what it is used for
2. Before you are given Zoladex LA
3. How Zoladex LA will be given
4. Possible side effects
5. How to store Zoladex LA
6. Further information
Read all of this leaflet carefully before you
start using this medicine.
Keep this leaflet. You may need to read it
again.
If you have any further questions, ask your
doctor, nurse 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 get serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor, nurse or
pharmacist.
The name of your medicine is called ‘Zoladex
LA 10.8mg Injection ‘Safe System’ but will be
referred to as Zoladex LA throughout the
remainder of this leaflet.

Other possible side effects:
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.
Hot flushes and sweating
A reduced sex drive and impotence
Thinning of your bones
Rises in blood sugar levels
Tingling in your fingers or toes
Skin rashes
Hair loss
Weight gain
Pain, bruising, bleeding, redness or
swelling where Zoladex LA is injected
Pain in the joints
Reduced heart function or heart attack.
Changes in blood pressure
Swelling and tenderness of your breasts
Changes in your mood (including
depression)
Changes in your blood
Liver problems

Do not be concerned by this list of possible
side effects. You may not get any of them.

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’.

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.

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.

4. Possible side effects
Like all medicines Zoladex LA can cause side
effects, although not everybody gets them.

2. Before you are given Zoladex LA
Do not have Zoladex LA if:
You are allergic (hypersensitive) to
goserelin or any of the other ingredients of
this medicine (listed in section 6: Further
information).
You are a women.
Do not have Zoladex LA if any of the above
apply to you. If you are not sure, talk to your
doctor or pharmacist before having Zoladex
LA.

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.

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).
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.

Zoladex LA should not be given to children.

(leaflet continued)

PL 20774/0729

POM

Manufactured by AstraZeneca UK Limited,
Macclesfield Cheshire SK10 2NA. Procured
from within the EU. Product Licence holder:
Quadrant Pharmaceuticals Ltd, Lynstock
House, Lynstock Way, Lostock, Bolton,
BL6 4SA. Repackaged by Maxearn Ltd,
Bolton, BL6 4SA.
Leaflet prepared 23rd April 2013
Zoladex is a registered trademark of
AstraZenenca UK Ltd.
PP3/0729/V1

(leaflet continued overleaf)
3. How Zoladex LA will be given
The Zoladex LA 10.8mg 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.
Driving and using machines
Zoladex LA is not likely to affect you being able
to drive or use any tools or machines.
Taking other medicines
Please tell your doctor or nurse if you are
taking or have recently taken any other
medicines. This includes medicines that you
buy without a prescription and herbal
medicines.
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.
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.
Take special care with Zoladex LA
Check with your doctor or nurse before you
have Zoladex LA if:
You have problems passing urine (water)
or problems with your back.
You have diabetes
You have high blood pressure
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).

ZOLADEX® LA 10.8MG INJECTION ‘Safe System™’
(goserelin)
PACKAGE LEAFLET: INFORMATION FOR THE USER

PP3/0729/V1

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
(web3)