Gonapeptyl Depot 3.75mg

GONAPEPTYL Depot 3.75mg

Powder and solvent for suspension

for injection

triptorelin

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

The Courtyard

Waterside Drive

Langley

Berks

SL3 6EZ

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:

• 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 treatment-

• For 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.

In Children:

• The dose is adjusted according to body weight. Children weighing less than 20kg are given 1.875mg (half a dose); children weighing 20 - 30kg are given 2.5mg (two thirds of a 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.

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 and mood changes, muscle pain, joint pain, breast enlargement, 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, and mood changes, muscle pain, joint pain, 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:

• 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 container in 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 September 2004.

3009000297-01