Label: information for the user

GONAPEPTYL DEPOT 3.75 milligrams

Powder and solvent for injectable suspension

Triptorelin

Read this label carefully before starting to use the medication

• Keep this label, as you may need to read it again.
  If you have any doubts, consult your doctor or pharmacist.
• If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this label, inform your doctor or pharmacist.

1. What isGONAPEPTYL DEPOTand for what it is used

2. Precautions before starting touseGONAPEPTYL DEPOT

3. How to useGONAPEPTYL DEPOT

4. Possible adverse effects

5. Storage ofGONAPEPTYL DEPOT

6. Additional information

GONAPEPTYL Depot contains triptorelin (as 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.

It is used:

In men:

- Treatment of locally advanced or metastatic hormone-dependent prostate cancer.

In women:

To suppress ovarian hormone levels for:

- Reducing the size of uterine fibroids (commonly known as fibromas), which are non-cancerous tumors arising from the myometrium (smooth muscle layer) of the uterus.

- Treating endometriosis (presence of uterine tissue outside the uterus).

In children:

- Treatment of central precocious puberty (premature puberty but with normal physical and hormonal changes of puberty).

Do not use GONAPEPTYL Depot:

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

In women:

• If you are pregnant or breastfeeding.

Be especially careful with GONAPEPTYL Depot

In men and women:

• Cases of depression have been reported in patients treated with Gonapeptyl, which can be severe. If you are taking Gonapeptyl and develop depressive mood, inform your doctor.
• GONAPEPTYL Depot may cause mood changes.
• Treatment with GONAPEPTYL Depot may cause cerebral hemorrhage (pituitary apoplexy) in rare cases. Inform your doctor immediately if you experience sudden headache, vomiting, or vision disturbances.
• Treatment with GONAPEPTYL Depot may cause bone loss, increasing the risk of bone fractures.
• If you have an additional risk of bone loss (osteoporosis), inform your doctor before using GONAPEPTYL Depot. Risk factors include:
• If any of your close relatives have bone loss.
• If you consume excessive amounts of alcohol, have a poor diet, and/or smoke heavily.
• If you are being treated with certain medications that may affect bone resistance.

In men::

Inform your doctor:

- if you experience bone pain or difficulty urinating.

- if you have spinal cord tumors or urinary tract tumors.

- if you are castrated.

- if you have diabetes.

- if you have a high risk of heart disease, such as diagnosed high blood pressure or arrhythmia.

- if you have any cardiac or vascular problems, including arrhythmia, or if you are being treated with medications for these conditions. Gonapeptyl may increase the risk of arrhythmia when used.

During treatment:

During the start of treatment with GONAPEPTYL Depot, you may experience worsening of your disease symptoms.

Consult your doctor if any of your disease symptoms worsen.

In women:

Inform your doctor

- if you experience mid-cycle bleeding during treatment (except during the first month).

During treatment:

Non-hormonal contraceptives, such as condoms or diaphragms, should be used during the first month after the first injection. They should also be used from week 4 after the last injection until your period (menstruation) resumes.

Your period (menstruation) will stop during treatment. Once treatment is completed, your periods (menstruation) will resume 7-12 weeks after the final injection.

If your periods (menstruation) persist during treatment, please inform your doctor.

In children::

- Treatment should only be started in girls under 9 years old and in boys under 10 years old.

Inform your doctor:

• If your child experiences intense or recurrent headaches, vision problems, and ringing or buzzing in the ears, contact a doctor immediately (see section 4).

During treatment:

During the first month of treatment, girls may experience mild to moderate vaginal bleeding.

Once treatment is completed, puberty characteristics will develop. In most cases, menstruation will occur 1 year after treatment completion, and in most cases, it will be regular.

For any possible side effect, please see section 4.

Use of other medications

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including those purchased without a prescription.

GONAPEPTYL Depot may interact with medications used to treat arrhythmia (e.g., quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of arrhythmia when used with other medications (e.g., methadone (used for pain relief and addiction treatment), moxifloxacino (an antibiotic), and antipsychotics used for severe mental illnesses.

Driving and operating machines

No effects on the ability to drive and operate machines are known.

However, it cannot be ruled out that the ability to drive or operate machines may be affected during treatment due to some side effects (dizziness, sleep disturbances/insomnia, and eye vision disturbances). Take extra precautions if you experience these side effects.Driving and operating machines

Pregnancy and breastfeedingNo effects on the ability to drive and operate machines are known.

However, it cannot be ruled out that the ability to drive or operate machines may be affected during treatment due to some side effects (dizziness, sleep disturbances/insomnia, and eye vision disturbances). Take extra precautions if you experience these side effects.

Gonapeptyl should not be used during pregnancy and lactation (see section “Do not use GONAPEPTYL Depot”). If you suspect you are pregnant, your doctor should rule out pregnancy before using Gonapeptyl Depot.

Fertile women should use effective non-hormonal contraceptives, such as condoms or diaphragms, during treatment with Gonapeptyl Depot until menstruation resumes.

Driving and operating machines

No effects on the ability to drive and operate machines are known.

However, it cannot be ruled out that the ability to drive or operate machines may be affected during treatment due to some side effects (dizziness, sleep disturbances/insomnia, and eye vision disturbances). Take extra precautions if you experience these side effects.

Gonapeptyl should not be used during pregnancy and lactation (see section “Do not use GONAPEPTYL Depot”). If you suspect you are pregnant, your doctor should rule out pregnancy before using Gonapeptyl Depot.

Fertile women should use effective non-hormonal contraceptives, such as condoms or diaphragms, during treatment with Gonapeptyl Depot until menstruation resumes.

Driving and operating machines

No effects on the ability to drive and operate machines are known.

However, it cannot be ruled out that the ability to drive or operate machines may be affected during treatment due to some side effects (dizziness, sleep disturbances/insomnia, and eye vision disturbances). Take extra precautions if you experience these side effects.

Gonapeptyl should not be used during pregnancy and lactation (see section “Do not use GONAPEPTYL Depot”). If you suspect you are pregnant, your doctor should rule out pregnancy before using Gonapeptyl Depot.

Fertile women should use effective non-hormonal contraceptives, such as condoms or diaphragms, during treatment with Gonapeptyl Depot until menstruation resumes.

Gonapeptyl should not be used during pregnancy and lactation (see section “Do not use GONAPEPTYL Depot”). If you suspect you are pregnant, your doctor should rule out pregnancy before using Gonapeptyl Depot.

Fertile women should use effective non-hormonal contraceptives, such as condoms or diaphragms, during treatment with Gonapeptyl Depot until menstruation resumes.

Driving and operating machines

No effects on the ability to drive and operate machines are known.

However, it cannot be ruled out that the ability to drive or operate machines may be affected during treatment due to some side effects (dizziness, sleep disturbances/insomnia, and eye vision disturbances). Take extra precautions if you experience these side effects.

The powder and solvent are mixed and injected normally by healthcare professionals.

Depending on your treatment indication, the appropriate dose will be administered via intramuscular injection (into the muscle) or subcutaneous injection (only under the skin).

In men:

- GONAPEPTYL Depot is usually administered as a single injection every 4 weeks as long-term treatment.

In women:

• GONAPEPTYL Depot is usually administered as a single injection every 4 weeks for a maximum of 6 months.
• Treatment should be initiated during the first 5 days of the menstrual cycle.

In children:

- At the start of treatment, a triptorelin injection should be administered on days 0, 14, and 28.

- The dose is adjusted according to the child's weight. Children weighing less than 20 kilograms receive 1.875 milligrams (1/2 dose), children weighing 20-30 kilograms receive 2.5 milligrams (2/3 dose), and children weighing more than 30 kilograms receive 3.75 milligrams.

- Subsequent injections are administered every 3-4 weeks, depending on their effect.

The duration of treatment should be monitored by your doctor.

If you use more GONAPEPTYL Depot than you should:

It is unlikely that you will receive more GONAPEPTYL Depot than you should have. If you have received more GONAPEPTYL Depot than you should have, inform your doctor or pharmacist immediately.

If you interrupt treatment with GONAPEPTYL Depot:

Treatment with GONAPEPTYL Depot should only be discontinued under the advice of your doctor.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications,GONAPEPTYL Depotmay cause side effects, although not everyone will experience them.

General (all patients):

If you experience swelling of the face, lips, mouth, or throat that may cause difficulty swallowing or breathing, consult your doctor or visit the nearest health service.

Cases of existing pituitary tumor enlargement have been reported during treatment with LH-RH agonists, however these have not been observed with triptorelin treatment.

Men:

Due to the initial increase in testosterone levels, symptoms may worsen at the start of treatment (e.g. urinary obstruction, back pain, spinal cord compression, muscle fatigue, and leg edema and weakness and tingling in the feet and hands).

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

Common, occurring in 1 to 10 patients in every 100 treated:allergic reaction, depressive mood, mood changes, depression, sleep disorders, nausea, muscle and joint pain, fatigue, reaction at the injection site, pain at the injection site, irritability, excessive sweating, headache, and breast enlargement in men.

Rare, occurring in 1 to 10 patients in every 1000 treated:some liver enzyme elevations, anaphylactic reaction, testicular atrophy, high blood pressure, decreased appetite, dry mouth, upper abdominal pain, worsening of asthma, weight changes, embolism, hair loss, and reduced hair growth.

Frequency not known, cannot be estimated from available data:

Women:

Very common, occurring in more than 1 in 10 patients treated:decreased libido, mood changes, sleep disorders, hot flashes, abdominal pain, bone pain, excessive sweating, vaginal bleeding or spotting, vaginal dryness, painful intercourse, painful menstruation, ovarian enlargement, pelvic pain, weakness, and headache.

Common, occurring in 1 to 10 patients in every 100 treated:allergic reaction, depressive mood, depression, nausea, muscle and joint pain, fatigue, reaction at the injection site, pain at the injection site, irritability.

Rare, occurring in 1 to 10 patients in every 1000 treated:anaphylactic reaction, visual disturbances, tingling, numbness, or prickling sensation, back pain, elevated cholesterol levels, some liver enzyme elevations.

Frequency not known, cannot be estimated from available data:

Children:

Common, occurring in 1 to 10 patients in every 100 treated:mood changes, depression.

Rare, occurring in 1 to 10 patients in every 1000 treated:in girls, vaginal bleeding or discharge may occur. Nausea, vomiting, and anaphylactic reaction have been seen.

Frequency not known, cannot be estimated from available data:

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Do not use GONAPEPTYL Depot after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Store in refrigerator(between 2°C and 8°C). Store in the original packaging.

Do not dispose of medications through drains or trash. Dispose of unused packaging and medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. This will help protect the environment.

Composition of GONAPEPTYL DEPOT

• In each preloaded syringe, the powder contains 4.12 milligrams of triptorelin acetate equivalent to 3.75 milligrams of active principle, triptorelin.
• The other components are: Poly-(D,L-lactide coglycolide), dicaprilocaprato of propylene glycol.

The solvent contains:

• Dextran 70, polisorbate 80, sodium chloride, dihydrogen sodium phosphate dihydrate, sodium hydroxide, and injection water.

This product contains less than 1 millimole of sodium (3.69 milligrams/milliliter or 0.160 millimoles/milliliter) per dose, that is, it is essentially "sodium-free".

Appearance of Gonapeptyl Depot and contents of the package

It is presented in packages of 1 set of: 1 or 3 pairs of preloaded syringes (powder and solvent).

All presentations are not available in Spain.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

FERRING S.A.U.

C/ del Arquitecto Sánchez Arcas 3, 1st

28040 Madrid.- Spain

Responsible for manufacturing:

FERRING GmbH

Wittland 11,

D-24109 Kiel

Germany.

This medicine is authorized in the member states of the European Economic Area with the following names:

GONAPEPTYL DEPOT (Belgium, Greece, Italy, Luxembourg, Netherlands, Sweden, Spain, Portugal, United Kingdom), GONAPEPTYL 3.75 mg (France), GONAPEPTYL DEPOT 3.75 mg (Ireland), DECAPEPTYL DEPOT (Czech Republic, Denmark, Iceland, Estonia, Germany, Latvia, Lithuania, Norway, Poland, Slovakia), DECAPEPTYL DEPOT 3.75 (Finland), DECAPEPTYL N (Germany), UROPEPTYL DEPOT (Germany), DECAPEPTYL GYN (Germany), GYNOPEPTYL (Germany), 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).

This leaflet has been approved in March 2023.

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

The following information is intended only for healthcare professionals:

INSTRUCTIONS FOR USE

Important information:

1. Store Gonapeptyl Depot in the packaging in the refrigerator.

2. Ensure that Gonapeptyl Depot is injected within 3 minutes after reconstitution.

Description of the general components of Gonapeptyl Depot:

1. Preparation

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

1. Reconstitution

To mix the suspension:

• Inject all the liquid into the syringe with powder.
• Pull the suspension forward and backward in the two syringes until the suspension is a homogeneous white creamy color to slightly yellow.Take care to keep the syringes straight; do not tilt them.

3.Injection

• Twist the syringe with the ready-to-inject suspension off the connector.
• Twist the injection needle onto the syringe.
• Inject the suspension within 3 minutes.

Gonapeptyl Depot is only for single use and any unused suspension should be discarded.