GONAPEPTYL 3.75 mg Powder and solvent for injectable suspension

Зміст інструкції

1. GONAPEPTYL DEPOT 3,75 mg
   1. What GONAPEPTYL Depot is and what it is used for
   2. Before using GONAPEPTYL Depot
   3. How to use GONAPEPTYL Depot
   4. Possible side effects
   5. How to store GONAPEPTYL Depot
   6. Package Contents and Other Information
   7. Preparation

GONAPEPTYL DEPOT 3,75 mg

Powder and solvent for injectable suspension
Triptorelin

Read this leaflet carefully before you start to use this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If any side effects get serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. See section
• 4. Contents of this leaflet:
• 1. What GONAPEPTYL Depot is and what it is used for
• 2. What you need to know before you use GONAPEPTYL Depot
• 3. How to use GONAPEPTYL Depot
• 4. Possible side effects
• 5. How to store GONAPEPTYL Depot
• 6. Contents of the pack and other information

1. What GONAPEPTYL Depot is and what it is used for

GONAPEPTYL Depot contains triptorelin (in the form of triptorelin acetate). Triptorelin belongs to a
group of medicines called GnRH analogues. One of its actions is to decrease the production of
sex hormones in the body.
What it is used for:

In men:

• For the treatment of hormone-dependent prostate cancer in locally advanced or metastatic stage.

In women:
To decrease the levels of ovarian hormones in order to:

• reduce the size of uterine fibroids (commonly known as fibromas), which are non-malignant tumors that develop on the myometrium (smooth muscle tissue) of the uterus.
• treat endometriosis (formation of uterine tissue outside the uterus).

In children:

• Treatment of central precocious puberty (puberty that manifests prematurely but with physical and hormonal changes typical of normal puberty).

2. Before using GONAPEPTYL Depot

Do not use GONAPEPTYL Depot

• If you are allergic to triptorelin or any of the excipients of GONAPEPTYL Depot.
• If you are allergic to gonadotropin-releasing hormone (GnRH) or other GnRH analogues.

In women:

• If you are pregnant or breastfeeding.

Special care with GONAPEPTYL Depot
Women and Men:

• Cases of depression have been reported in patients taking GONAPEPTYL Depot which can be severe. If you are taking GONAPEPTYL Depot and develop a depressed mood, tell your doctor.
• Because GONAPEPTYL Depot may cause mood changes.
• Because treatment with GONAPEPTYL Depot in rare cases can cause cerebral haemorrhage (pituitary apoplexy). Contact your doctor immediately if you experience sudden headache, vomiting or visual disturbances.
• Because treatment with GONAPEPTYL Depot can cause bone thinning which increases the risk of fractures.
• If you have additional risk factors for bone thinning (osteoporosis) you should inform your doctor before using GONAPEPTYL Depot. Risk factors include:
• If a close family member suffers from bone thinning.
• If you excessively consume alcohol, follow a poor diet and/or smoke heavily.
• If you are also being treated with certain medications that can alter bone strength.

In men:
Tell your doctor:

• If you have bone pain, or experience difficulty urinating.
• If you have a secondary spinal or urinary tract tumor.
• If you have been castrated.
• If you have been diagnosed with diabetes.
• If you are at high risk of heart disease, such as a diagnosis of high blood pressure or heart rhythm problems (arrhythmia).
• If you have heart or vascular problems, including heart rhythm problems (arrhythmia), or if you are being treated with medications for these conditions. The risk of heart rhythm problems may be increased when using GONAPEPTYL.

During treatment:
At the beginning of therapy with GONAPEPTYL Depot you may notice a worsening of the symptoms of the disease.
If your symptoms worsen, contact your doctor.

In women:
Tell your doctor:

• If you experience mid-cycle bleeding during treatment (excluding the first month).

During treatment:

• During the first month after the first injection, non-hormonal contraceptive methods such as condoms or diaphragms should be used. The same methods should also be used for the 4 weeks following the last injection until the return of your cycle (menstruation).
• During treatment your cycle will stop. Once you have finished the treatment, your cycle (menstruation) will resume 7-12 weeks after the last injection.
• If your cycle (menstruation) persists during treatment, tell your doctor.

In children:
Tell your doctor:

• If your child suffers from severe or recurrent headaches, vision problems and ringing or buzzing in the ears, contact a doctor immediately (see section 4)
• Therapy should only be started in girls under 9 years of age and boys under 10 years of age.

During treatment:
During the first month of treatment, girls may experience episodes of mild to
moderate vaginal bleeding.
At the end of treatment, the development of pubertal characteristics will be observed. In many girls, menstruation occurs on average one year after the end of therapy, and in most cases they are
regular.
For possible adverse effects, read section 4.

Other medicines and GONAPEPTYL Depot
Tell your doctor or pharmacist if you are taking or have recently taken other medicines, including
over-the-counter medicines.
GONAPEPTYL Depot may interfere with some medicines used to treat heart rhythm disorders (e.g. quinidine, procainamide, amiodarone and sotalol) or may increase the risk of
heart rhythm problems when used with other medicines (e.g. methadone (used to relieve
pain and in detoxification from drug addiction), moxifloxacin (an antibiotic), antipsychotics
used for severe mental illnesses).

Pregnancy and Breastfeeding
GONAPEPTYL Depot should not be used during pregnancy and breastfeeding (see section “Do not
use GONAPEPTYL Depot”). If there is a possibility that you are pregnant, pregnancy must be ruled out by
your doctor before starting treatment with GONAPEPTYL Depot.
Women of childbearing potential should use an effective non-hormonal contraceptive method, such as a condom or
diaphragm, during treatment with GONAPEPTYL Depot until the return of menstruation.

Driving and operating machinery
No effects on the ability to drive or operate machinery have been observed. However, it cannot be
excluded that the ability to drive or use machinery may be impaired during treatment, due to some of the adverse effects such as dizziness, sleep disorders/insomnia and visual disturbances. Be very
careful if you experience these adverse effects.
For those who engage in sports: the use of the drug without a therapeutic need constitutes doping and may
still result in a positive doping test.

3. How to use GONAPEPTYL Depot

The powder and solvent are normally mixed and injected by a healthcare professional.
Depending on the cause of treatment, the appropriate dose will be administered with intramuscular injection
(into the muscle) or with subcutaneous injection (just below the skin).
In men

• For long-term treatment, an injection of GONAPEPTYL Depot is normally administered every 4 weeks. In women
• An injection of GONAPEPTYL Depot is normally administered once every four weeks for up to 6 months.
• Treatment should be started within the first 5 days of the menstrual cycle. In children
• At the beginning of treatment, a triptorelin injection should be administered on days 0, 14 and 28.
• The dose must be established based on body weight. Children weighing less than 20 kg should receive a dose of 1.875 mg (half dose), children weighing between 20 and 30 kg

body weight will receive a dose of 2.5 mg (two-thirds dose), children weighing more than 30 kg
will receive a dose of 3.75 mg (full dose).

• Following this, one injection every 3-4 weeks, according to the effect.

The duration of treatment must be monitored by your doctor.

If you take more GONAPEPTYL Depot than you should
It is unlikely that an overdose of GONAPEPTYL Depot will occur. If
you have taken an excessive dose of GONAPEPTYL Depot, contact your doctor or pharmacist as soon as
possible.

If you stop taking GONAPEPTYL Depot
Therapy with GONAPEPTYL Depot should only be stopped if requested by your doctor. For any
questions regarding the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, GONAPEPTYL Depot can cause side effects, although not everybody gets them.
General (all patients):
If you experience swelling of the face, lips, mouth or throat which causes difficulty in swallowing or
breathing, inform your doctor immediately or go to the nearest emergency room.
Cases of enlargement of a pre-existing pituitary tumour have been reported during treatment with LH-RH
agonists, however this has not yet been observed following treatment with triptorelin.

In men:
Due to the increase in testosterone levels at the beginning of treatment, a worsening of
several symptoms and disorders may be observed (e.g.: urinary obstruction, skeletal pain, spinal cord
compression, muscle fatigue and leg edema, weakness and tingling in feet and hands).

Very common, more than 1 in 10 patients treated:most of the side effects of
GONAPEPTYL Depot in men are due to the decrease in testosterone levels. You may
experience impotence, decreased libido, hot flushes, bone pain and difficulty and pain when
urinating.

Common, between 1 and 10 patients in 100 patients treated:allergic reactions, depressed mood, mood
changes, sleep disorders, nausea, muscle and joint pain, fatigue, reactions at the
injection site, pain at the injection site, irritability, excessive sweating, headache and
breast enlargement in men.

Uncommon, between 1 and 10 patients in 1000 patients treated:elevated levels of some liver
enzymes, anaphylactic reactions, testicular atrophy, hypertension, decreased appetite, dry mouth,
upper abdominal pain, worsening of asthma, changes in body weight, embolism, hair loss and
decreased hair growth.

Not known: frequency cannot be estimated from available data:

• Common cold - Diabetes mellitus
• Gout - Abdominal swelling
• Dizziness - Constipation
• Diarrhoea - Shortness of breath
• Redness at the injection site - Flu-like symptoms
• Drowsiness - Blurred vision
• Sensation of tingling, prickling or numbness - Memory impairment
• Taste disturbances - Vision impairment
• Abnormal eye sensation - Tinnitus
• Increased appetite - General malaise
• Anxiety - Loss of libido
• Vertigo - Insomnia
• Chest pain - Confusion
• Chills - Decreased activity
• Breast pain - Fever
• Testicular pain - Weakness
• Joint swelling - Lack of ejaculation
• Musculoskeletal stiffness - Osteoarthritis
• Back pain - Shortness of breath when lying down
• Purplish skin discoloration - Joint stiffness
• Musculoskeletal pain - Limb pain
• Flatulence - Muscle weakness
• Blisters - Urticaria
• Angioedema (swelling under the skin) - Muscle spasms
• Vomiting - Pruritus
• Abdominal pain - Acne
• Low blood pressure - Nosebleed
• Euphoria - Difficulty maintaining an upright position
• Increased body temperature - Elevated liver and kidney enzyme levels
• Increased blood pressure
• Changes in ECG tracing (prolongation
• Inflammation at the injection site

of the QT interval)

• Pain

In women:

Very common, more than 1 in 10 patients treated:decreased libido, mood changes,
sleep disorders, hot flushes, abdominal pain, bone pain, excessive sweating,
vaginal bleeding/spotting, vulvovaginal dryness, pain during sexual intercourse, painful
menstruations, ovarian enlargement, pelvic pain, weakness and headache.

Common, between 1 and 10 patients in 100 patients treated:allergic reactions, depressed
mood, depression, nausea, muscle and joint pain, fatigue, reactions at the
injection site, pain at the injection site, irritability .

Uncommon, between 1 and 10 patients in 1000 patients treated:anaphylactic reactions,
impaired vision, sensations of tingling, prickling or numbness, back pain, increased
blood cholesterol, elevated levels of some liver enzymes.

Not known: frequency cannot be estimated from available data:

• Abdominal discomfort - Fever
• Painful, prolonged and/or irregular menstruation - Dizziness
• Angioedema (swelling under the skin) - Increased blood pressure
• Absence of menstrual cycle - Breast pain
• Loss of bone mineral with increased fragility - Bone injection site redness
• Pruritus - Skin rash
• Anxiety - General malaise
• Diarrhoea - Vomiting
• Vertigo - Muscle weakness
• Blurred vision - Urticaria
• Confusion - Shortness of breath
• Weight changes - Muscle spasms
• Inflammation at the injection site

In children:

Common, between 1 and 10 patients in 100 patients treated:mood changes, depression.

Uncommon, between 1 and 10 patients in 1000 patients treated:in girls, vaginal bleeding or
discharge may occur. Nausea, vomiting and anaphylactic reactions have been observed.

Not known: frequency cannot be estimated from available data:

• Allergic reactions - Pain
• Nervousness - Headache
• Abdominal pain - Blurred vision
• Vision impairment - Abdominal discomfort
• Nosebleed - Genital bleeding
• Hot flushes - Increased blood pressure
• Skin rash - Weight gain
• Urticaria - Pain, inflammation and redness at the injection site
• Hair loss - General malaise
• Loosening or separation of the growth zone - Long bone muscle pain
• Angioedema (swelling under the skin) - Emotional lability
• Redness - Idiopathic intracranial hypertension (increased pressure inside the skull around the brain characterized by headache, double vision and other visual symptoms, ringing or buzzing in the ears)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet. You can also report side effects directly through the national reporting
system at . By reporting
side effects you can help provide more information on the safety of this
medicine.

5. How to store GONAPEPTYL Depot

Keep out of sight and reach of children.
Do not use GONAPEPTYL Depot after the expiry date which is indicated on the packaging. The expiry date refers to the last day of the month.
Store in a refrigerator (2°C-8°C). Keep the primary container in the outer carton.
Medicines should not be disposed of via the sink or with other household waste. Ask your
pharmacist how to dispose of unused products. These measures are taken in defense of the environment.

6. Package Contents and Other Information

What GONAPEPTYL Depot contains

• The powder in each pre-filled syringe contains triptorelin acetate 4.12 mg equivalent to 3.75 mg of active substance, triptorelin.
• The other excipients are poly-(d,l lactide co-glycolide), propylene glycol dicaprylate/caprate.

The solvent contains:

• dextran 70, polysorbate 80, sodium chloride, disodium hydrogen phosphate dihydrate, sodium hydroxide, water for injections.

This medicine contains less than 1 mmol of sodium (3.69 mg/ml or 0.160 mmol/ml) per dose, therefore it is
essentially “sodium-free”.

Description of the appearance of GONAPEPTYL Depot and package contents
It is available in packs consisting of the following set: 1 or 3 pairs of pre-filled syringes (powder and solvent).

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ferring S.p.A. - via C. Imbonati, 18 - 20159 Milano

Manufacturer
Ferring GmbH - Wittland 11 - D-24109 Kiel – Germany

This medicinal product is authorised in the Member States of the European Community with the following
names:
GONAPEPTYL Depot (Belgium, Greece, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United
Kingdom), GONAPEPTYL 3.75 mg (France), GONAPEPTYL Depot 3.75 mg (Ireland), DECAPEPTYL Depot
(Bulgaria, Czech Republic, Denmark, Iceland, Lithuania, Poland, Slovakia), DECAPEPTYL N
(Germany),DECAPEPTYL GYN (Germany), DECAPEPTYL CR (Croatia), DECAPEPTYL CR 3.75
(Netherlands), DECAPEPTYL Depot-Retardmikrokapseln und Suspensionsmittel für Einmalspritzen (Austria),
DECAPEPTYL Depot injection (Hungary), DECAPEPTYL Retard injectionspräparat i.m/s.c (Switzerland).
The following information is intended for healthcare professionals only:

INSTRUCTIONS FOR USE

Important information:
Store the GONAPEPTYL Depot pack in a refrigerator.
Ensure that GONAPEPTYL Depot is injected within 3 minutes of reconstitution.

Overview of the components of GONAPEPTYL Depot:

1. Preparation

To ensure the correct preparation of the suspension, it is necessary to follow the following instructions scrupulously:
instructions:

The following information is intended exclusively for healthcare professionals:

Reconstitution
To mix the suspension:
Inject all the liquid into the syringe with the powder.
Gently push the suspension back and forth in the two syringes until it becomes homogeneous
from milky white to slightly yellow. Be careful to keep the syringes straight; do not bend them.

Injection
Unscrew the syringe with the suspension ready for injection from the connector.
Screw the injection needle onto the syringe.
Inject the suspension within 3 minutes.

GONAPEPTYL Depot is for single use and any unused suspension must be discarded