Gonapeptyl Depot

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

GONAPEPTYL DEPOT 3.75 mg

Powder and solvent for injectable suspension
Triptorelin
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience worsening of side effects or if any side effect occurs, including those not listed in this leaflet, contact 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 using 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 stages.

In women:
To reduce ovarian hormone levels in order to:

• reduce the size of uterine fibroids (commonly known as fibroids), which are non-malignant tumours developing in the myometrium (smooth muscle tissue) of the uterus.
• treat endometriosis (growth of uterine tissue outside the uterus).

In children:

• Treatment of central precocious puberty (puberty occurring early 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 in GONAPEPTYL Depot.
• If you are allergic to gonadotropin-releasing hormone (GnRH) or other GnRH analogues.

In women:

• During pregnancy or breastfeeding.

Take special care with GONAPEPTYL Depot
Women and Men:

• Cases of depression, which may be severe, have been reported in patients taking GONAPEPTYL Depot. If you are taking GONAPEPTYL Depot and develop depressive mood, inform your doctor.
• Because GONAPEPTYL Depot may cause mood changes.
• Because treatment with GONAPEPTYL Depot may rarely cause cerebral haemorrhage (pituitary apoplexy). Contact your doctor immediately if sudden headache, vomiting or visual disturbances occur.
• Because treatment with GONAPEPTYL Depot may cause thinning of the bones (osteoporosis), increasing the risk of fractures.
• If you have additional risk factors for bone thinning (osteoporosis), inform your doctor before using GONAPEPTYL Depot. Risk factors include:
• If a close family member has osteoporosis.
• If you consume excessive amounts of alcohol, follow a poor diet and/or smoke heavily.
• If you are also being treated with certain medications that may affect bone strength.

In men:
Inform your doctor:

• If you have bone pain or urinary difficulties.
• If you have spinal or urinary tract metastases.
• If you have been castrated.
• If you have been diagnosed with diabetes.
• If you are at high risk of heart disease, such as high blood pressure or heart rhythm disorders (arrhythmia).
• If you have heart or vascular disorders, including heart rhythm problems (arrhythmia), or if you are being treated with medications for these conditions. The risk of heart rhythm problems may increase when using GONAPEPTYL.

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

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

During treatment:

• During the first month after the first injection, non-hormonal contraceptive methods such as condoms or diaphragm must be used. The same methods must also be used for 4 weeks after the last injection, until the return of menstruation.
• During treatment, your menstrual cycle will stop. After completing treatment, your cycle (menstruation) will resume 7–12 weeks after the last injection.
• If your menstrual cycle continues during treatment, inform your doctor.

In children:
Inform your doctor:

• If your child experiences severe or recurrent headaches, vision problems, or ringing or buzzing in the ears, contact a doctor immediately (see section 4).
• Treatment should only be initiated 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 mild to moderate episodes of vaginal bleeding.
After treatment ends, pubertal development will resume. In many girls, menstruation occurs on average one year after treatment ends, and in most cases, periods are regular.
For possible side effects, see section 4.

Other medicines and GONAPEPTYL Depot
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
GONAPEPTYL Depot may interfere with certain medications 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 drug detoxification), moxifloxacin (an antibiotic), antipsychotics used for severe mental illnesses).

Pregnancy and Breastfeeding
GONAPEPTYL Depot must not be used during pregnancy or breastfeeding (see section "Do not use GONAPEPTYL Depot"). If there is any possibility you may be pregnant, pregnancy must be ruled out by your doctor before starting treatment with GONAPEPTYL Depot.
Women of childbearing potential must use an effective non-hormonal contraceptive method, such as condoms or diaphragm, during treatment with GONAPEPTYL Depot until menstruation resumes.

Driving and using machines
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 machines may be impaired during treatment due to certain side effects such as dizziness, sleep disturbances/insomnia, and visual disturbances. Be very cautious if you experience these side effects.
For athletes: using the drug without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to use GONAPEPTYL Depot

The powder and solvent are normally mixed and administered by a healthcare professional.
Depending on the reason for treatment, the appropriate dose will be given as an intramuscular injection
(into the muscle) or subcutaneous injection (just under the skin).

In men

• For long-term treatment, a GONAPEPTYL Depot injection is normally administered every 4 weeks.

In women

• A GONAPEPTYL Depot injection 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 determined 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 should receive a dose of 2.5 mg (two-thirds dose); children weighing more than 30 kg should receive a dose of 3.75 mg (full dose).
• Subsequently, an injection every 3–4 weeks, depending on the response.

The duration of treatment should be monitored and controlled by your doctor.

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

If you stop treatment with GONAPEPTYL Depot
Treatment with GONAPEPTYL Depot should only be discontinued if instructed by your doctor. For any questions regarding the use of this product, consult your doctor or pharmacist.

4. Possible side effects

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

In men:
Due to the initial rise in testosterone levels at the beginning of treatment, worsening of various symptoms and conditions may occur (e.g. urinary obstruction, skeletal pain, spinal cord compression, muscle fatigue and leg oedema, weakness and tingling in hands and feet).
Very common, more than 1 in 10 patients treated: most side effects of GONAPEPTYL Depot in men are due to reduced testosterone levels. These include impotence, decreased libido, hot flushes, bone pain, and difficulty or pain when urinating.
Common, between 1 and 10 in 100 patients treated: allergic reactions, depressed mood, mood changes, depression, sleep disturbances, nausea, muscle and joint pain, fatigue, injection site reactions, pain at injection site, irritability, excessive sweating, headache, and breast enlargement in men.
Uncommon, between 1 and 10 in 1,000 patients treated: elevated levels of certain 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 reduced hair growth.
Not known: frequency cannot be estimated from the available data:

• Common cold - Diabetes mellitus
• Gout - Abdominal swelling
• Dizziness - Constipation
• Diarrhoea - Shortness of breath
• Redness at injection site - Influenza-like symptoms
• Drowsiness - Blurred vision
• Tingling, prickling or numbness sensation - Memory impairment
• Taste disturbances - Visual disturbances
• Abnormal eye sensitivity - Tinnitus
• Increased appetite - General malaise
• Anxiety - Loss of libido
• Dizziness - Insomnia
• Chest pain - Confusional state
• Chills - Decreased activity
• Breast pain - Fever
• Testicular pain - Weakness
• Joint swelling - Absence of ejaculation
• Musculoskeletal rigidity - Osteoarthritis
• Back pain - Shortness of breath when lying down
• Purple skin discolouration - Joint stiffness
• Musculoskeletal pain - Limb pain
• Flatulence - Muscle weakness
• Blisters - Hives
• Angioedema (swelling under the skin) - Muscle spasms
• Vomiting - Itching
• Abdominal pain - Acne
• Decrease in blood pressure - Skin rash
• Euphoria - Nosebleeds
• Increased body temperature - Difficulty maintaining upright posture
• Oedema - Elevated levels of certain liver and kidney enzymes
• Increased blood pressure - Inflammation at injection site
• Changes in ECG trace (prolongation of QT interval)
• Pain

In women:
Very common, more than 1 in 10 patients treated: decreased libido, mood changes, sleep disturbances, hot flushes, abdominal pain, bone pain, excessive sweating, vaginal bleeding/spotting, vulvovaginal dryness, pain during sexual intercourse, painful menstruation, ovarian enlargement, pelvic pain, weakness and headache.
Common, between 1 and 10 in 100 patients treated: allergic reactions, depressed mood, depression, nausea, muscle and joint pain, fatigue, injection site reactions, pain at injection site, irritability.
Uncommon, between 1 and 10 in 1,000 patients treated: anaphylactic reactions, visual disturbances, sensations of tingling, prickling or numbness, back pain, increased blood cholesterol, elevated levels of certain liver enzymes.
Not known: frequency cannot be estimated from the available data:

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

In children:
Common, between 1 and 10 in 100 patients treated: mood changes, depression.
Uncommon, between 1 and 10 in 1,000 patients treated: in girls, vaginal bleeding or discharge may occur. Nausea, vomiting and anaphylactic reactions have also been observed.
Not known: frequency cannot be estimated from the available data:

• Allergic reactions - Pain
• Nervousness - Headache
• Abdominal pain - Blurred vision
• Visual disturbances - Abdominal discomfort
• Nosebleeds - Genital haemorrhage
• Hot flushes - Increased blood pressure
• Skin rash - Weight gain
• Hives - Pain, inflammation and redness at injection site
• Hair loss - General malaise
• Loosening or separation of growth plates - Muscular pain in long bones
• Angioedema (swelling under the skin) - Emotional lability
• Redness - Idiopathic intracranial hypertension (increased intracranial pressure around the brain, characterized by headache, double vision and other visual symptoms, ringing or buzzing in the ears)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website [insert address]. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GONAPEPYL Depot

Keep out of sight and reach of children.
Do not use GONAPEPTYL Depot after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store in the refrigerator (2°C-8°C). Store the primary container in the outer carton.
Medicines must not be disposed of via the sink or with household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures are taken to protect the environment.

6. Package contents and other information

What GONAPEPTYL Depot contains

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

The solvent contains:

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

This medicinal product 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 contents of the pack
Available in packs consisting of the following set: 1 or 3 pairs of pre-filled syringes (powder and solvent).

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Ferring S.p.A. - via C. Imbonati, 18 - 20159 Milan, Italy
Manufacturer
Ferring GmbH - Wittland 11 - D-24109 Kiel, Germany

This medicinal product is authorized in the European Union Member States under 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 package in the refrigerator.
Ensure that GONAPEPTYL Depot is injected within 3 minutes after reconstitution.
Overview of the components of GONAPEPTYL Depot:

1. Preparation

To ensure correct preparation of the suspension, the following instructions must be followed carefully:

The following information is intended for healthcare professionals only:
Reconstitution
To mix the suspension:
Inject all the liquid from the syringe into the syringe containing the powder.
Slowly push the suspension back and forth between the two syringes until the mixture becomes homogeneous, ranging from milky white to slightly yellow. Take care to keep the syringes straight; do not bend them.

Injection
Unscrew the syringe containing the reconstituted suspension from the connector.
Screw the injection needle onto the syringe.
Inject the suspension within 3 minutes.
GONAPEPTYL Depot is for single use only, and any unused suspension must be discarded.