Gonapeptyl Depot 3.75 mg powder and solvent for injectable suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

GONAPEPTYL DEPOT 3.75 milligrams

Powder and solvent for injectable suspension

Triptorelin

Read the entire leaflet carefully before you start using this medicine

• Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet

1. What GONAPEPTYL DEPOT is and what it is used for
2. Before you use GONAPEPTYL DEPOT
3. How to use GONAPEPTYL DEPOT
4. Possible side effects
5. How to store GONAPEPTYL DEPOT
6. Further information

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

GONAPEPTYL DEPOT is a medication containing the active substance triptorelin, which belongs to a group of medicines called gonadotropin-releasing hormone (GnRH) agonists. It works by initially stimulating and then suppressing the production of certain hormones in the body, particularly those involved in reproductive function.

It is used for the treatment of:

• Prostate cancer in men
• Endometriosis in women
• Central precocious puberty (early onset of puberty) in children

The medicine is administered as an injection, usually once every 1, 3, or 6 months, depending on the formulation and the condition being treated.

GONAPEPTYL Depot contains triptorelin (as triptorelin acetate). Triptorelin belongs to the group of medicines known as GnRH analogues. One of its actions is to reduce 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 fibroids), which are non-cancerous tumours 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 (puberty occurring prematurely but with the physical and hormonal changes of normal puberty).

2. Before using GONAPEPTYL DEPOT

Do not use GONAPEPTYL Depot:

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

In women:

• If you are pregnant or breastfeeding your child.

Take special care with GONAPEPTYL Depot

In men and women:

• Cases of depression have been reported in patients treated with Gonapeptyl, which may become severe. If you are taking Gonapeptyl and develop depressive mood, inform your doctor.
• GONAPEPTYL Depot may cause changes in mood.
• Treatment with GONAPEPTYL Depot may rarely lead to cerebral haemorrhage (pituitary apoplexy). Inform your doctor immediately if you experience sudden headache, vomiting or visual disturbances.
• Treatment with GONAPEPTYL Depot may result in loss of bone mass, increasing the risk of bone injury.
• If you have an increased risk of bone mass loss (osteoporosis), you should inform your doctor before using GONAPEPTYL Depot. Risk factors include:
  • If any of your close family members have bone mass loss.
  • If you drink excessive amounts of alcohol, have 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 difficulty urinating.
• If you have spinal tumour or urinary tract tumour.
• If you are castrated.
• If you have been diagnosed with diabetes.
• If you have a high risk of heart disease, such as diagnosed high blood pressure or heart rhythm problems (arrhythmia).
• If you have any cardiac or vascular problems, including heart rhythm disorders (arrhythmia), or if you are being treated with medications for these conditions. Use of Gonapeptyl may increase the risk of heart rhythm problems.

During treatment:

At the beginning of treatment with GONAPEPTYL Depot, you may experience a worsening of your disease symptoms.

Consult your doctor if any of your disease symptoms worsen.

In women:

Inform your doctor:

• If you experience bleeding in the middle of your cycle during treatment (except during the first month).

During treatment:

Non-hormonal contraceptive methods, such as condoms or diaphragm, must be used during the first month after the first injection. These should also be used starting from week 4 after the last injection until your period (menstruation) returns.

Your menstruation will stop during treatment. After treatment ends, your periods (menstruation) will return 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 of age and in boys under 10 years of age.

Inform your doctor:

• If your child experiences severe or recurrent headache, vision problems, or 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 episodes of vaginal bleeding.

After treatment ends, the development of puberty characteristics will occur. In most girls, menstruation will occur within one year after treatment ends, and in most cases it will be regular.

For any possible adverse effects, please see section 4.

Use of other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

GONAPEPTYL Depot may interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone, and sotalol), or may increase the risk of heart rhythm problems when used together with other medicines (e.g. methadone (used for pain relief and drug addiction detoxification), moxifloxacin (an antibiotic), and antipsychotics used for severe mental illnesses).

Driving and using machines

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

However, it cannot be excluded that the ability to drive or use machines may be affected during treatment due to some of the adverse effects (dizziness, sleep disturbances/insomnia, and eye vision disturbances). Take extra caution if you experience these adverse effects.

Pregnancy and breastfeeding

Gonapeptyl must not be used during pregnancy and breastfeeding (see section “Do not use GONAPEPTYL Depot”). If you think you may be pregnant, your doctor must rule out pregnancy before administering Gonapeptyl Depot.

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

Driving and using machines

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

However, it cannot be excluded that the ability to drive or use machines may be affected during treatment due to some of the adverse effects (dizziness, sleep disturbances/insomnia, and eye vision disturbances). Take extra caution if you experience these adverse effects.

Gonapeptyl must not be used during pregnancy and breastfeeding (see section “Do not use GONAPEPTYL Depot”). If you think you may be pregnant, your doctor must rule out pregnancy before administering Gonapeptyl Depot.

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

Driving and using machines

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

However, it cannot be excluded that the ability to drive or use machines may be affected during treatment due to some of the adverse effects (dizziness, sleep disturbances/insomnia, and eye vision disturbances). Take extra caution if you experience these adverse effects.

Gonapeptyl must not be used during pregnancy and breastfeeding (see section “Do not use GONAPEPTYL Depot”). If you think you may be pregnant, your doctor must rule out pregnancy before administering Gonapeptyl Depot.

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

Gonapeptyl must not be used during pregnancy and breastfeeding (see section “Do not use GONAPEPTYL Depot”). If you think you may be pregnant, your doctor must rule out pregnancy before administering Gonapeptyl Depot.

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

Driving and using machines

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

However, it cannot be excluded that the ability to drive or use machines may be affected during treatment due to some of the adverse effects (dizziness, sleep disturbances/insomnia, and eye vision disturbances). Take extra caution if you experience these adverse effects.

3. How to use GONAPEPTYL DEPOT

The powder and solvent are mixed and usually administered by healthcare professionals.

Depending on the indication for your treatment, the appropriate dose will be given as an intramuscular injection (into the muscle) or subcutaneous injection (just under the skin).

In men:

• GONAPEPTYL Depot is usually administered as one injection every 4 weeks as long-term treatment.

In women:

• GONAPEPTYL Depot is usually administered as one injection every 4 weeks for up to 6 months.
• Treatment should be started within the first five days of the menstrual cycle.

In children:

• At the beginning of treatment, one injection of triptorelin 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 between 20-30 kilograms receive 2.5 milligrams (2/3 dose), and children weighing more than 30 kilograms receive 3.75 milligrams.
• Afterwards, injections are administered every 3-4 weeks, depending on their effect.

The duration of treatment must be supervised by your doctor.

If you use more GONAPEPTYL DEPOT than you should:

It is unlikely that more GONAPEPTYL DEPOT will be administered than you should receive. If you have been given more GONAPEPTYL DEPOT than recommended, inform your doctor or pharmacist immediately.

If you interrupt treatment with GONAPEPTYL DEPOT

Treatment with GONAPEPTYL DEPOT should only be stopped on the advice of your doctor. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, GONAPEPTYL Depot may cause adverse effects, although not everyone experiences them.

General (all patients):

If you experience swelling of the face, lips, mouth or throat which may cause difficulty swallowing or breathing, consult your doctor or go to the nearest healthcare facility.

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

In men:

Due to the increase in testosterone levels at the beginning of treatment, symptoms for which you are being treated may initially worsen (i.e. urinary obstruction, vertebral pain, spinal cord compression, muscle fatigue, leg edema, and weakness and tingling in the feet and hands).

Very common, more than 1 in every 10 patients treated: most adverse effects of GONAPEPTYL Depot in men occur due to decreased testosterone levels. These may include impotence, decreased libido, hot flushes, bone pain, difficulty and pain when urinating.

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

Uncommon, between 1 and 10 in every 1,000 patients treated: elevation of certain liver enzymes, 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:

common cold	diabetes mellitus
gout	abdominal distension
dizziness	constipation
diarrhea	difficulty breathing
redness at injection site	flu-like symptoms
sleepiness	blurred vision
tingling, numbness, or prickling sensation	memory impairment
taste disturbance	vision disturbance
abnormal sensation in the eye	ringing in the ears
increased appetite	malaise
anxiety	loss of libido
	insomnia
dizziness	confusion
chest pain	decreased activity
chills	fever
breast pain	weakness
testicular pain	absence of ejaculation
joint inflammation	osteoarthritis
musculoskeletal rigidity	difficulty breathing when lying down
back pain	joint stiffness
purple discoloration of the skin	limb pain
musculoskeletal pain	muscle weakness
flatulence	urticaria
blistering	muscle spasms
angioedema (swelling beneath the skin)	itching
vomiting	acne
abdominal pain	rash
low blood pressure	nosebleed
euphoria	difficulty maintaining balance
increased body temperature	elevated levels of certain liver and kidney enzymes
edema	injection site swelling
high blood pressure ECG changes (QT prolongation)	pain

In women:

Very common, more than 1 in 10 treated patients: decreased libido, mood changes, sleep disorders, 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 every 100 treated patients: allergic reaction, depressed mood, depression, nausea, muscle and joint pain, fatigue, injection site reaction, injection site pain, irritability.

Uncommon, between 1 and 10 in every 1,000 treated patients: anaphylactic reaction, visual disorders, sensation of tingling, numbness or prickling, back pain, increased blood cholesterol, elevation of some liver enzymes.

Frequency not known, cannot be estimated from available data:

abdominal discomfort	fever
heavy, prolonged, and/or irregular menstruation	dizziness
angioedema (swelling beneath the skin)	high blood pressure
withdrawal of menstruation	breast pain
loss of bone mineral that increases bone fragility	redness at injection site
itching	skin rash
anxiety	general malaise
diarrhea	vomiting
vertigo	muscle weakness
blurred vision	hives
confusion	difficulty breathing
weight changes	muscle spasms
swelling at injection site

In children:

Frequent, between 1 and 10 patients out of every 100 treated patients: mood changes, depression.

Uncommon, between 1 and 10 patients out of every 1,000 treated patients: in girls, vaginal bleeding or discharge may occur. Nausea, vomiting, and anaphylactic reaction have been observed.

Frequency not known, cannot be estimated from available data:

allergic reactions	pain
nervousness	headache
abdominal pain	blurred vision
vision disturbances	abdominal discomfort
nosebleeds	genital bleeding
hot flushes	increased blood pressure
skin rash	weight gain
urticaria	pain, swelling, and redness at the injection site
hair loss	general malaise
loosening or separation at the growth area of long bones	muscle pain
angioedema (swelling beneath the skin)	emotional instability
redness	Idiopathic intracranial hypertension (increased intracranial pressure around the brain characterized by headache, double vision and other visual symptoms, and ringing or buzzing in the ears).

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of GONAPEPTYL DEPOT

Keep out of the reach and sight of children.

Do not use GONAPEPTYL DEPOT after the expiry date stated on the container. The expiry date is the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE Point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Information for the user

Composition of GONAPEPTYL DEPOT

• Each pre-filled syringe contains a powder with 4.12 milligrams of triptorelin acetate, equivalent to 3.75 milligrams of the active substance triptorelin.
• Other components: Poly-(d,l-lactide-co-glycolide), propylene glycol dicaprylocaprate.

The solvent contains:

• Dextran 70, polysorbate 80, sodium chloride, disodium hydrogen phosphate dihydrate, sodium hydroxide and water for injection.

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

Appearance of Gonapeptyl Depot and contents of the pack

It is supplied in packs of 1 set: 1 or 3 pairs of pre-filled syringes (powder and solvent).

Not all presentations are available in Spain.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

FERRING S.A.U.

C/ del Arquitecto Sánchez Arcas 3, 1º

28040 Madrid, Spain

Manufacturer:

FERRING GmbH

Wittland 11,

D-24109 Kiel

Germany

This medicinal product is authorised in the European Economic Area member states under 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 summary of product characteristics was approved in March 2023.

Detailed and up-to-date information on this medicinal product 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 for healthcare professionals only:

DIRECTIONS FOR USE

Important information:

1. Store Gonapeptyl Depot in its packaging inside the refrigerator.
2. Ensure that Gonapeptyl Depot is injected within 3 minutes after reconstitution.

Overview of the components of Gonapeptyl Depot:

1. Preparation

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

A	B	C
Remove the GONAPEPTYL Depot container from the refrigerator. Open the connector package and remove the connector.	Unscrew the cap of the syringe containing powder. Hold the syringe with the tip pointing upwards to avoid spilling the powder.	Screw the syringe containing powder onto one of the threads of the connector until it stops.
	Make sure not to touch the threads of the connector		Do not push the injection plunger.		Always connect the syringe with powder to the connector before connecting the syringe with liquid.

D	E
Twist off the cap from the syringe containing the liquid. Hold the syringe with the tip pointing upwards to avoid spilling any liquid.	Screw the syringe with the liquid onto the other thread of the connector until it stops.	CONTINUE ON THE NEXT PAGE TURN PAGE
	Make sure not to push the injection plunger.

1. Reconstitution

To mix the suspension:

• Inject all the liquid into the syringe containing the powder.
• Slowly push the suspension back and forth between the two syringes until the suspension becomes a uniform milky white to slightly yellow color. Be careful to keep the syringes upright; do not tilt them.

1/2 or 2/3 dose for children: Use the dose indicators on the connector to measure 1/2 or 2/3 of a dose: • Ensure the suspension is in the syringe attached to the side of the connector without dose indicators. • Rotate the syringes into a vertical position with the syringe containing the suspension on top. • Wait a few seconds to allow the foam to separate. • Slowly pull down the plunger of the empty syringe until the suspension reaches the 1/2 or 2/3 dose indicator.

1/2 DOSIS

2/3 DOSIS

3. Injection

• Unscrew the syringe containing the ready-to-inject 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.