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GONAPEPTYL DEPOT 3.75MG POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

Active substance: TRIPTORELIN ACETATE

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GONAPEPTYL® Depot 3.75mg
Powder and solvent for suspension
for injection
triptorelin

PATIENT INFORMATION

Read all of this leaflet carefully before you start using
this medicine. This leaflet contains information on
®
GONAPEPTYL Depot 3.75mg.
Keep this leaflet, you may need to use it again
If you have any further questions, or if you are not sure
about anything, please ask your doctor or pharmacist
GONAPEPTYL Depot should only be used under the
supervision of an appropriate specialist.
Your medicine is called GONAPEPTYL Depot 3.75mg Powder
and solvent for suspension for injection. It will be referred to as
GONAPEPTYL Depot in this leaflet.
It is presented in packs of 1 set of the following: 1 pair of
pre-filled syringes, one with powder and the other with 1ml
solvent, a connector and 2 injection needles.
The powder contains 3.75mg of the active ingredient,
triptorelin (as triptorelin acetate). The other ingredients are
poly-(d,l lactide coglycolide) and propyleneglycol octanoate
decanoate.
The solvent contains: Dextran 70, Polysorbate 80, sodium
chloride, sodium hydrogen phosphate dihydrate, sodium
hydroxide and water for injection.
The powder and solvent are normally mixed and injected by
a healthcare professional.
Marketing Authorisation Holder:
Ferring Pharmaceuticals Limited, Drayton Hall,
Church Road, West Drayton, UB7 7PS , UK.
Manufacturer:
Ferring GmbH, Wittland 11, D-24109 Kiel, Germany.

What GONAPEPTYL Depot is and what it is used for

GONAPEPTYL Depot contains triptorelin (as triptorelin acetate).
One of its actions is to decrease the production of sex
hormones in the body.
It is used:
In Men:
For the treatment of hormone dependent prostate cancer.
In Women:
To suppress the levels of ovarian hormones in order to Reduce the size of uterine myomas, (commonly known as
fibroids) which are non-cancerous tumours arising from the
myometrium (smooth muscle layer) of the uterus.
Treat endometriosis (the formation of uterine tissue outside
the uterus).
In Children:
For the treatment of central precocious puberty (puberty that
occurs prematurely but with the physical and hormonal
changes of normal puberty).

Before you are given GONAPEPTYL Depot

You must not be given GONAPEPTYL Depot:
If you are allergic to triptorelin or any of the other ingredients
of GONAPEPTYL Depot.
In Men:
If you have hormone independent prostate cancer.
If you have had one or both testes removed.
In Women:
If you are pregnant or are breast feeding.
If you have been diagnosed with osteoporosis.
In Children:
If you have a progressive brain tumour.
You will need to take special care with GONAPEPTYL Depot:
In Men and women:
There have been reports of depression in patients taking
Gonapeptyl Depot which may be severe. If you develop
depressed mood while taking this product, inform your doctor.
In Men:
If you have pains in your bones, or difficulty passing urine.
If you have a secondary spinal or urinary tract tumour.
In Women:
If you are experiencing bleeding mid-cycle during treatment
(except for the first month).
If you are at an increased risk from loss of bone density.
During treatmentFor uterine myomas, the size of the uterus and myoma should
be monitored using techniques such as ultrasound.
Non-hormonal methods of contraception should be used until
normal periods are resumed.
Do not use products containing oestrogen during treatment
with GONAPEPTYL Depot.
In Children:
Pseudo precocious puberty (incomplete premature puberty)
and gonadotrophin independent precocious puberty should
be excluded prior to treatment.
Treatment should first be started only in girls under 9 years
and boys under 10 years old.

How you will be given GONAPEPTYL Depot

The powder and solvent are normally mixed and injected by a
healthcare professional.
Depending on the condition you are being treated for, the
appropriate dose will be administered by intramuscular injection
(into a muscle) or subcutaneous injection (just under the skin).
In Men:
One injection of GONAPEPTYL Depot is normally given
every 4 weeks as a long-term therapy.
In Women:
One injection of GONAPEPTYL Depot is normally given
every 4 weeks for up to six months.
Treatment must be started during the first 5 days of the
menstrual cycle.

Possible side effects

Like all medicines, GONAPEPTYL Depot can have side effects.
If you experience these or any other side effects not mentioned
in this leaflet, please inform your doctor or pharmacist.
General (all patients):
Pain or discomfort may occur at the injection site.
Although not common, allergic reactions have been reported
in adults and children e.g. reaction at the injection site. If you
experience swelling of the face, lips, mouth or throat which
may cause difficultly in swallowing or breathing, tell your
doctor immediately or go to your nearest casualty department.
In Men:
The symptoms you are being treated for may worsen initially,
due to the increased levels of testosterone at the start of
treatment.
Most of the side effects of GONAPEPTYL Depot in men
result from lowered testosterone levels.
Frequent side effects include hot flushes, loss of libido and
impotence, headache, nausea, perspiration, tiredness, sleep
disorders, muscle and joint pain, breast enlargement,
depressed mood, mood changes and depression, and allergic
reactions such as itching, skin rash and fever.
Other possible side effects include, testicular wasting,
high blood pressure, recurrence of asthma, increased blood
enzymes, thrombo-embolic disorders (blood clots), reduced
body hair, injection site reactions, weight changes, loss of
appetite, stomach pain and dry mouth.

In Women:
Most of the side effects of GONAPEPTYL Depot in women
result from lowered oestrogen levels.
Frequent side effects include hot flushes, sweating, vaginal
dryness and/or pain or difficulty during sexual intercourse,
bleeding, spotting, loss of libido, tiredness, nausea, sleep
disorders, muscle and joint pain, depressed mood, depression,
and allergic reactions such as itching, skin rash and fever.
Other possible side effects include backache, bone mass
loss, increased blood enzymes or cholesterol, tingling in the
legs, and visual disturbances.
In Children:

Frequent side effects include mood changes and depression.
In girls, vaginal bleeding or discharge may occur.
Other possible side effects include bone growth changes,
nausea and vomiting.

Storing GONAPEPTYL Depot

Keep out of the reach and sight of children.

Store at 2°C - 8°C (in a refrigerator). Keep containerin the outer
carton.
Do not use after the expiry date stated on the packaging.
GONAPEPTYL® Depot 3.75mg Powder and solvent for
suspension for injection: PL 03194/0085
This leaflet was revised in October 2012.

2009050465

In Children:
The dose is adjusted according to body weight. Children
weighing less than 20kg are given 1.875mg (1/2 dose); children
weighing 20 - 30kg are given 2.5mg (2/3 dose); children weighing
more than 30kg are given 3.75mg.
One injection of GONAPEPTYL Depot is normally given every
2 weeks for the first month.
Thereafter, injections are given every 3 - 4 weeks, according
to effect.

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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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