DECAPEPTYL 3.75 MG/2 ML Порошок и раствор для инъекционной суспензии

Содержание инструкции

1. DECAPEPTYL 0.1 mg/ml powder and solvent for injectable solution
   1. What is Decapeptyl and what is it used for
   2. What you need to know before using Decapeptyl
   3. How to use Decapeptyl
   4. Possible side effects
   5. How to store Decapeptyl
   6. Package Contents and Other Information
   7. What is Decapeptyl and what is it used for
   8. What you need to know before using Decapeptyl
   9. How to use Decapeptyl
   10. Possible side effects
   11. How to store Decapeptyl
   12. Contents of the pack and other information
   13. What is Decapeptyl and what is it used for
   14. What you need to know before using Decapeptyl
   15. How to use Decapeptyl
   16. Possible side effects
   17. How to store Decapeptyl
   18. Contents of the pack and other information
   19. What is Decapeptyl and what is it used for
   20. What you need to know before using Decapeptyl
   21. How to use Decapeptyl
   22. Possible side effects
   23. How to store Decapeptyl
   24. Contents of the pack and other information

DECAPEPTYL 0.1 mg/ml powder and solvent for injectable solution

Triptorelin

Read this leaflet carefully before you use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Decapeptyl is and what it is used for
• 2. What you need to know before you use Decapeptyl
• 3. How to use Decapeptyl
• 4. Possible side effects
• 5. How to store Decapeptyl
• 6. Contents of the pack and other information

1. What is Decapeptyl and what is it used for

This medicine contains triptorelin. 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.
This medicine is used for the treatment of female infertility in association with
gonadotropins in ovulation induction protocols, within the scope of in vitro fertilization followed
by embryo transfer (IVF) and in other assisted reproductive technologies.

2. What you need to know before using Decapeptyl

Do not use Decapeptyl

• if you are allergic to triptorelin or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic (hypersensitive) to GnRH or other GnRH analogues (medicines similar to Decapeptyl).
• if you are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

If you have any doubts, it is essential to ask your doctor or pharmacist for advice.

Warnings and precautions
The use of GnRH agonists can cause a reduction in bone mineral density.
Pay particular attention if you are exposed to additional risk factors for osteoporosis (e.g. chronic alcohol abuse, smokers, long-term therapies with medicines that reduce bone mineral density, such as corticosteroids, medicines against epilepsy or adrenal gland hormones, family history of osteoporosis, malnutrition). If you experience bone problems, which may be due to osteoporosis, inform your doctor. This may affect how your doctor decides to treat you.
If you have a benign tumor of the pituitary gland, of which you are not aware, this could be revealed during treatment with triptorelin. Symptoms may include: sudden headache, vomiting, altered vision and paralysis of the eyes.
Cases of depression have been reported in patients taking Decapeptyl, which may be severe. If you are taking Decapeptyl and experience depressive symptoms, tell your doctor.
Consult your doctor if you have any of the following conditions: any heart or blood vessel disorders, including heart rhythm problems (arrhythmias), or if you are being treated with medicines for these disorders. The risk of heart rhythm problems may increase with the use of Decapeptyl 0.1 mg.
If you experience seizures, inform your doctor immediately. Cases of seizures have been reported in patients receiving triptorelin or similar medicines. These cases have occurred in patients with or without a history of epilepsy.
Before taking triptorelin, your doctor will perform a test to rule out an existing pregnancy.
Ovarian stimulation, induced by the use of GnRH analogues and gonadotropins, may be excessive for you, particularly if you suffer from Polycystic Ovary Syndrome. The response to stimulation, even if performed with the same dosage of medicines, may vary from patient to patient, but also, in the same patient, from cycle to cycle.
The doctor will closely monitor the occurrence of ovulation with regular checks such as :ultrasound and evaluation of plasma estrogens (female sex hormones in the blood). In case of ovarian hyper-response, the doctor will recommend stopping the administration of gonadotropins, while telling you to continue that of Decapeptyl 0.1 mg for a few days in order to avoid a possible spontaneous peak of natural hormone that stimulates the ovary.

Other medicines and Decapeptyl
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Decapeptyl 0.1 mg may interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, disopyramide, amiodarone and sotalol) or may increase the risk of heart rhythm problems when used with some other drugs, such as methadone (used to relieve pain and in detoxification programs from addiction), moxifloxacin (an antibiotic), antipsychotics (used for serious mental illnesses).
The doctor will check your hormonal status when Decapeptyl is administered together with other medicines that have effects on the pituitary secretion of gonadotropins.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not use this medicine during pregnancy or while breastfeeding.
Do not use Decapeptyl if you suspect you are pregnant. During treatment with Decapeptyl, you should use non-hormonal contraception, such as a condom or diaphragm.
Pregnancy must be ruled out by your doctor before using triptorelin for the treatment of infertility. When triptorelin is used for the treatment of infertility, there is no evidence of correlation between the use of the drug and abnormalities in the development of the oocyte, in pregnancy or in the outcome of pregnancy.

Driving and operating machinery
You may feel dizzy, tired or have vision problems such as blurred vision. These are possible side effects of the treatment or the underlying condition. If you experience any of these undesirable effects, you should not drive or operate machinery.

Decapeptyl contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially “sodium-free”.

For athletes
The use of the drug without therapeutic necessity constitutes doping and may still result in a positive doping test.

3. How to use Decapeptyl

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor.

The recommended dose is

• short protocol: administer 1 vial per day subcutaneously starting from the second day of the menstrual cycle (in conjunction with the start of ovarian stimulation) until the day before the administration of hCG, for an average duration of 10-12 days.
• long protocol: administer 1 vial per day subcutaneously, starting from the second day of the menstrual cycle. After achieving pituitary desensitization (plasma estrogen concentration less than 50 pg/ml, usually around the 15th day of treatment), start stimulation with gonadotropins simultaneously with Decapeptyl 0.1 mg/1 ml until the day before the administration of hCG.

The medicine is administered subcutaneously after extemporaneous preparation.

Method of use:
Withdraw the contents of the vial with the syringe and transfer all the liquid from the vial into the vial.
Gently shake the vial without inverting it to ensure a homogeneous solution.
Proceed immediately with the injection.

Important NoteIt is important that the injection is performed in strict accordance with the method of use.

If you use more Decapeptyl than you should
Although no adverse reactions resulting from overdose have been reported, if you accidentally take an
excessive dose of triptorelin, immediately inform your doctor or go to the nearest
hospital.

If you forget to use Decapeptyl
Do not use a double dose to compensate for a missed dose. Inform your doctor.

If you stop using Decapeptyl
Do not stop therapy with Decapeptyl on your own, but strictly follow the doctor's instructions.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In rare cases, a serious allergic reaction may occur. Tell your doctor immediately if you
experience symptoms such as difficulty swallowing or breathing, swelling of the lips, face, throat
or tongue, skin rash.

Experience in clinical studies
The adult population treated with triptorelina immediate release during clinical studies included 127
men with prostatic carcinoma, treated daily for 3 months, and approximately 1,000 women undergoing
in vitrofertilization. The safety of triptorelina was also evaluated during clinical studies conducted, in
men and women, with triptorelina 3.75 mg and 11.25 mg formulations.

General tolerability in women
Many of the side effects are expected due to the change in estrogen levels in the body.

Very common(affects more than 1 in 10 people)

• Weakness
• Headache
• Sleep disorders (including insomnia), mood alteration, decreased libido
• Breast disorders, pain during or after sexual intercourse, genital bleeding (including vaginal bleeding, withdrawal bleeding), ovarian hyperstimulation syndrome, ovarian hypertrophy, pelvic pain, vulvovaginal dryness
• Acne, excessive sweating, seborrhea, hot flushes

Common(affects more than 1 in 100 people)

• Nausea, abdominal pain or discomfort
• Swelling, inflammation, redness and/or pain at the injection site, peripheral edema
• Allergic reaction
• Weight gain
• Joint pain, muscle cramps, pain in the extremities
• Dizziness
• Nervousness, depression (long-term use. This frequency is based on the frequency of the class effect, common to all GnRH agonists)
• Breast pain

Uncommon(affects more than 1 in 1,000 people)

• Palpitations
• Dizziness
• Dry eyes, vision changes
• Abdominal distension, dry mouth, flatulence, mouth ulceration, vomiting
• Weight loss
• Decreased appetite, fluid retention
• Back pain, muscle pain
• Taste alteration, sensitivity alteration, syncope, memory impairment, attention disorders, tingling, tremor
• Emotional lability, anxiety, depression (short-term use. This frequency is based on the frequency of the class effect, common to all GnRH agonists), disorientation
• Bleeding during sexual intercourse, vaginal prolapse, menstrual cycle disorders (including painful cycles, genital bleeding, heavy menstrual bleeding), ovarian cyst, vaginal discharge
• Difficulty breathing, nosebleed
• Hair loss, dry skin, abnormal hair growth, brittle nails, itching and rash

Not known(frequency cannot be estimated from available data)

• Vision disorders
• Diarrhea
• Fever, malaise
• Anaphylactic shock
• Increased blood alkaline phosphatase, increased blood pressure
• Muscle weakness
• Convulsions
• Confusional state
• Absence of menstruation
• Angioedema, urticaria
• High blood pressure
• If a pituitary tumor is present, there is an increased risk of bleeding in the area.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not
listed in this leaflet. You can also report side effects directly through the
national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Decapeptyl

Store at a temperature below 25°C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Scad.. The expiry
date refers to the last day of that month.
Do not use this medicine if you notice visible signs of deterioration.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Decapeptyl Contains

• The active ingredient is triptorelin.
• The other component present in the powder vial is mannitol.
• The components of the solvent vial are sodium chloride, water for injections.

Description of the Appearance of Decapeptyl and Package Contents
The powder vial contains 0.1 mg of triptorelin.
The vial contains 1 ml of solvent solution.
The package contains 7 powder vials, 7 solvent vials of 1 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
IPSEN S.p.A. - Via Vittor Pisani n. 22 - 20124 Milan

Manufacturer
Ipsen Pharma Biotech S.A.S, Parc d'Activités du Plateau de Signes - Chemin Départemental n. 402 - 83870
Signes (France)

DECAPEPTYL 3.75 mg/2 ml powder and solvent for prolonged-release injectable suspension
triptorelin

Read this leaflet carefully before you use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your

doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Decapeptyl is and what it is used for
• 2. What you need to know before you use Decapeptyl
• 3. How to use Decapeptyl
• 4. Possible side effects
• 5. How to store Decapeptyl
• 6. Package Contents and Other Information

1. What is Decapeptyl and what is it used for

This medicine contains triptorelin. 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.

This medicine is used:
In men:

• with malignant (carcinoma) prostate tumor and metastases (spread to other organs), where suppression of male hormone (testosterone) production is indicated. In women:
• with malignant breast tumor (carcinoma) in the pre-menopausal period or in the early stages of menopause (perimenopause) where hormonal treatment is indicated;
• with genital and extra-genital endometriosis (stages I-IV);
• with benign (fibroid) uterine tumors.
• as treatment (for a duration of three months) before surgery to remove fibroids and the uterus in patients with significant genital bleeding;
• as treatment (for a duration of one month) before some surgical procedures such as endometrial ablation and resection of uterine septa via hysteroscopy.
• as treatment of female infertility in association with gonadotropins (HMG, HCG, FSH) in ovulation induction protocols.

In children:

• as treatment of Central Precocious Puberty (early puberty) before 8 years of age in girls and before 10 years of age in boys.

2. What you need to know before using Decapeptyl

Do not use Decapeptyl

• if you are allergic to triptorelin or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic (hypersensitive) to GnRH or other GnRH analogues (medicines similar to Decapeptyl).
• if you are pregnant or if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before using Decapeptyl.
Cases of depression have been reported in patients taking Decapeptyl which could be
severe. If you are taking Decapeptyl 3.75mg/ 2 ml and develop depression, tell your doctor.
If you experience convulsions, tell your doctor immediately. Cases of convulsions have been reported in
patients receiving triptorelin or similar medicines. These cases have occurred in patients with or without
a history of epilepsy.
Talk to your doctor if you have any of the following conditions: any heart or blood
vessel disorder, including heart rhythm problems (arrhythmias), or if you are being treated with medicines for these
disorders. The risk of heart rhythm problems may increase with the use of Decapeptyl.
If you have a benign tumor of the pituitary gland, of which you are not aware, this could
be revealed during treatment with triptorelin 3.75 mg. The symptoms are: sudden headache,
vomiting, changes in vision and paralysis of the eyes.

In men

• At the beginning of treatment there is an increase in testosterone circulating in the body. This could cause a worsening of the symptoms of the tumor. Contact your doctor if this should occur. Your doctor may prescribe you medicines (anti-androgens) to prevent the worsening of the symptoms. During the first weeks of treatment, Decapeptyl may, like other GnRH analogues, in isolated cases, cause compression of the spinal cord (paresthesias or a feeling of weakness in the lower limbs) or obstruction of the urethra (where urine passes). You will be monitored by your doctor and appropriate treatments will be prescribed to you if this should occur.
• After surgical castration, triptorelin does not produce any further reduction in testosterone.
• Diagnostic tests on the function of the pituitary gland performed during treatment or after discontinuation of therapy with Decapeptyl, may be misleading.
• In adults, if Decapeptyl or another GnRH analogue, is used for a long period of time, it may increase the risk of developing weakening of the bone structure which may be harmful especially if you abuse alcohol chronically, are a smoker, have a family history of osteoporosis (a condition that affects the strength of your bones), are malnourished or take anticonvulsant medicines (medicines for epilepsy) or corticosteroids (steroids). If you have any problems affecting your bones, such as osteoporosis, or any of the above risk factors, tell your doctor. This may affect how your doctor decides to treat you.
• If you are at risk of developing diabetes or if you suffer from heart problems, tell your doctor.
• Treatment with GnRH analogues, including DECAPEPTYL 3.75 mg, may increase the risk of anemia (defined as a decrease in the number of red blood cells).

In women

• In adults, if Decapeptyl or another GnRH analogue, is used for a long period of time, it may increase the risk of developing a weakening of the bone structure which may be harmful especially if you abuse alcohol chronically, are a smoker, have a family history of osteoporosis (a condition that affects the strength of your bones), are malnourished or take anticonvulsant medicines (medicines for epilepsy) or corticosteroids (steroids). If you have any problems affecting your bones, such as osteoporosis, or any of the above risk factors, tell your doctor. This may affect how your doctor decides to treat you.
• Vaginal bleeding may occur in the first month of treatment. After the first month, the menstrual cycle usually stops. Tell your doctor if you continue to have bleeding after the first month of treatment. The menstrual cycle resumes approximately 2-3 months after the last injection.
• You must use contraceptive methods other than the “pill” (non-hormonal) during treatment and for one month after the last injection, when triptorelin is not used for infertility.
• During the treatment of infertility, the gonadotropins associated with the product may induce an increase in the size of the ovaries or ovarian hyperstimulation which may cause pelvic and/or abdominal pain and difficulty breathing. If this should happen, consult your doctor immediately.

In children

• During the first month of treatment, girls may have episodes of vaginal bleeding from mild to moderate.
• When treatment is stopped, the signs of puberty will appear.
• In girls, menstruation will begin on average one year after stopping treatment.
• Central precocious puberty caused by other diseases should be excluded by the doctor.
• The amount of minerals in the bones decreases during treatment but after discontinuation the subsequent bone growth is preserved.
• if the patient experiences sudden hip pain after discontinuation of treatment the doctor must be informed
• 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).

If you have a brain tumor tell your doctor.
If you have any doubts about the use of this medicine, ask your doctor.
For possible side effects read section 4.

Other medicines and Decapeptyl
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Decapeptyl 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 with some other drugs, for example methadone (used to relieve
pain and in drug detoxification programs), moxifloxacin (an antibiotic),
antipsychotics (used for severe mental illnesses).
The doctor will check your hormonal status when Decapeptyl is administered together with other
drugs that have effects on the pituitary secretion of gonadotropins.

Pregnancy, breastfeeding and fertility
This medicine should not be used during pregnancy or while breastfeeding.
Do not use Decapeptyl if you are trying to become pregnant (unless Decapeptyl is used for
the treatment of infertility).

Driving and using machines
You may experience dizziness, drowsiness, or vision problems, such as blurred vision. These are possible
side effects of the treatment or your illness. If you experience any of these side effects,
do not drive or use machines.

Decapeptyl contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially
“sodium-free”.

For athletes
The use of the drug without therapeutic necessity constitutes doping and may still result in positive
anti-doping tests.

3. How to use Decapeptyl

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor. Do not interrupt the treatment without your doctor's advice.

The recommended dose is

• prostate cancer and breast cancer: one injection strictly every four weeks for a period established by the doctor.
• endometriosis and non-operable uterine fibroids: one injection every four weeks for six months, starting treatment within the first five days of the cycle.
• in pre-surgical therapy for myomectomy, hysterectomy, endometrial ablation and uterine septum resection, treatment should begin within the first 5 days of the cycle. The injection schedule is one every 4 weeks for 3 months.
• female infertility: it is recommended to administer a vial of Decapeptyl on the second day of the menstrual cycle; stimulation with gonadotropins can be started when the plasma concentration of estrogens is less than 50 pg/ml (usually around the 15th day

of the cycle).
In women, prolonged administration beyond 6 months should be carefully evaluated by the
specialist doctor, so that the expected benefit is greater than the possible undesirable effects resulting from
prolonged estrogen suppression, especially at the bone level.

Use in children
The dose depends on body weight.
Children weighing more than 30Kg: administer one intramuscular injection every 4 weeks (28
days).
Children weighing between 20Kg and 30Kg: administer two-thirds of the dose via intramuscular
injection every 4 weeks (28 days) (administer two-thirds of the volume of the reconstituted suspension
).
Children weighing less than 20Kg: administer half the dose via intramuscular injection every 4
weeks (28 days) (administer half the volume of the reconstituted suspension).

If you use more Decapeptyl than you should
Although no adverse reactions resulting from overdose have been reported, if you accidentally take an
excessive dose of triptorelin, immediately inform your doctor or go to the nearest
hospital.

If you forget to use Decapeptyl
Do not use a double dose to make up for a missed dose. Inform your doctor.

If you stop using Decapeptyl
Do not stop Decapeptyl therapy on your own, but strictly follow your doctor's instructions. If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In rare cases, a severe allergic reaction may occur. Tell your doctor immediately if you
experience symptoms such as problems swallowing or breathing, swelling of the lips, face, throat
or tongue, skin rash.
With other products containing triptorelin, unusual pressure-sensitive infiltrations have been reported after subcutaneous injection at the injection site.

Men
Many of the side effects are expected, due to changes in testosterone levels in the body.
These effects include: hot flashes and decreased libido.

Very common(may affect more than 1 in 10 people)

• Hot flashes
• Weakness
• Excessive sweating
• Back pain
• Tingling in the legs
• Decreased libido
• Impotence (including absent ejaculation and problems with ejaculation)

Common(may affect up to 1 in 10 people)

• Nausea, dry mouth
• Pain, redness, inflammation at the injection site, edema (fluid retention in the body's tissues)
• Muscle and bone pain, arm and leg pain
• Lower abdominal pain
• High blood pressure
• Allergic reaction
• Weight gain
• Dizziness, headache
• Loss of libido, depression*, mood changes* * This frequency is based on the frequency of the class effect, common to all GnRH agonists.Uncommon(may affect up to 1 in 1,000 people)
• Increased number of platelets
• Palpitations
• Tinnitus, dizziness
• Vision impairment
• Abdominal pain, constipation, diarrhea, vomiting
• Lethargy, muscle stiffness, drowsiness, pain, peripheral edema
• Changes in some blood tests (including increased liver and kidney function test results), increased blood pressure
• Weight loss
• Loss of appetite, increased lipids in the blood, gout (severe pain, swelling, and redness of the joints, frequently for example at the level of the big toe), diabetes
• Joint pain, muscle cramps, muscle weakness and pain, bone pain
• Tingling or numbness
• Insomnia, irritability
• Breast enlargement in men, breast pain, decreased testicular volume, testicular pain
• Difficulty breathing
• Acne, hair loss, itching, skin rash, skin redness, hives
• Excessive urination during nighttime rest, problems with urination
• Nosebleeds

Rare(may affect up to 1 in 10,000 people)

• Red or purplish discoloration of the skin, blisters
• Abnormal sensation in the eyes, visual disturbances
• Feeling of fullness in the abdomen, flatulence, altered sense of taste
• Chest pain
• Difficulty standing
• Flu-like symptoms, fever
• Anaphylactic reaction (a severe allergic reaction that can cause dizziness or difficulty breathing)
• Inflammation of the nose/throat
• Increased alkaline phosphatase in the blood
• Stiff, swollen joints, musculoskeletal stiffness, osteoarthritis
• Memory impairment
• Confusion, decreased activity, euphoria
• Shortness of breath when lying down
• Low blood pressure

Not known(frequency cannot be estimated from the available data)

• Anaphylactic shock (a severe allergic reaction that can cause dizziness or difficulty breathing)
• General feeling of being unwell
• Anxiety
• Angioedema
• Urinary incontinence
• Changes in ECG tracing (QT prolongation)
• If a pituitary tumor is present, there is an increased risk of bleeding in the area.
• Anemia (decrease in the number of red blood cells).

In patients treated with GnRH analogs, an increase in lymphocyte count has been reported.

Women
Many of the side effects are expected, due to changes in estrogen levels in the body.

Very common(may affect more than 1 in 10 people)

• Weakness
• Headache
• Sleep disorders (including insomnia), mood changes, decreased libido
• Breast disorders, pain during or after sexual intercourse, genital bleeding (including vaginal bleeding, breakthrough bleeding), ovarian hyperstimulation syndrome, ovarian hypertrophy, pelvic pain, vulvovaginal dryness
• Acne, excessive sweating, seborrhea
• Hot flashes

Common(may affect up to 1 in 10 people)

• Nausea, abdominal pain or discomfort
• Swelling, inflammation, redness and/or pain at the injection site, peripheral edema
• Allergic reaction
• Weight gain
• Joint pain, muscle cramps, pain in the extremities
• Dizziness
• Nervousness, depression (long-term use. This frequency is based on the frequency of the class effect, common to all GnRH agonists)
• Breast pain

Uncommon(may affect up to 1 in 1,000 people)

• Palpitations
• Dizziness
• Dry eyes, visual disturbances
• Abdominal distension, dry mouth, flatulence, mouth ulceration, vomiting
• Weight decrease
• Fluid retention, loss of appetite
• Back pain, muscle pain
• Altered taste, altered sensitivity, syncope, impaired memory, attention disorders, tingling, tremor
• Emotional lability, anxiety, depression (short-term use. This frequency is based on the frequency of the class effect, common to all GnRH agonists), disorientation
• Bleeding during sexual intercourse, vaginal prolapse, menstrual cycle disorders (including painful cycles, genital bleeding, heavy menstrual periods), ovarian cysts, vaginal discharge
• Difficulty breathing, nosebleeds
• Hair loss, dry skin, abnormal hair growth, brittle nails, itching and rash
Not known(frequency cannot be estimated from the available data)
• Visual disturbances
• Diarrhea
• Fever, malaise
• Anaphylactic shock
• Increased alkaline phosphatase in the blood, increased blood pressure
• Muscle weakness
• Convulsions
• Confusion
• Absence of menstrual cycle
• Angioedema, hives, high blood pressure
• If a pituitary tumor is present, there is an increased risk of bleeding in the area.

During treatment for infertility, the combination of triptorelin with gonadotropins can cause
ovarian hyperstimulation syndrome. Ovarian hypertrophy, pelvic and/or
abdominal pain may occur.

Children
Very common(may affect more than 1 in 10 people)

• Vaginal bleeding (including vaginal hemorrhage, breakthrough bleeding, uterine bleeding, vaginal discharge, vaginal spotting)

Common(may affect up to 1 in 10 people)

• Abdominal pain
• Injection site reactions (redness, inflammation and/or pain)
• Allergic reaction
• Weight gain
• Headache
• Acne
• Hot flashes
Uncommon(may affect up to 1 in 1,000 people)
• Visual impairment
• Vomiting, constipation, nausea
• Malaise
• Obesity
• Neck pain
• Mood changes
• Breast pain
• Nosebleeds
• Itching, rash, hives
Not known(frequency cannot be estimated from the available data)
• Visual disturbances
• Anaphylactic shock
• Convulsions
• Increased levels of prolactin in the blood, increased blood pressure
• Muscle pain
• Emotional lability, depression, nervousness
• Angioedema
• Increased blood pressure
• Idiopathic intracranial hypertension (increased pressure inside the brain 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, pharmacist or nurse. This includes any side effects not
listed in this leaflet. You can also report side effects directly through the
national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Decapeptyl

This medicine does not require any particular storage conditions.
Store in the original package to protect the medicine from light and humidity.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is reported on the package after Exp. The expiry
date refers to the last day of that month.
Do not use this medicine if you notice visible signs of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Decapeptyl contains

• The active ingredient is triptorelin.
• The other components present in the powder vial are d,l-lactide glycolic acid polymer, mannitol, sodium carboxymethylcellulose, polysorbate 80.
• The components of the solvent vial are mannitol, water for injections.

Description of the appearance of Decapeptyl and contents of the pack
The powder vial contains 3.75 mg of triptorelin.
The vial contains 2 ml of suspension solvent.
The pack contains 1 powder vial, 1 solvent vial of 2 ml, 2 needles, 1 syringe.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Ipsen S.p.A.
Via Vittor Pisani, n. 22
20124 Milan

Manufacturer
Ipsen Pharma Biotech S.A.S, Parc d'Activités du Plateau de Signes - Chemin Départemental n. 402 -
83870 Signes (France)

<------------------------------------------------------------------------------------------------------------------------>
The following information is intended exclusively for healthcare professionals (see section 3):
INSTRUCTIONS FOR USE
Read the leaflet carefully before injection
The suspension must be injected immediately after preparation using exclusively
the suspension solvent provided in the pack. The suspension obtained must not be mixed
with other medicinal products.

Important Note:It is important that the preparation of the injection is carried out strictly following the
instructions below. Any injection performed incorrectly that results in a loss of
medicinal product must be immediately reported to the doctor.

1 – PATIENT PREPARATION BEFORE RECONSTITUTION OF THE l SUSPENSION
e o Prepare the patient by disinfecting the buttock at the injection site. This operation must be performed before reconstitution, d as the suspension, once reconstituted, must be injected immediately.
a 2 – PREPARATION OF THE INJECTION
n Two needles are provided in the pack: a Needle 1: a 20G needle (38mm long) without a safety device to be used for reconstitution i Needle 2: a 20G needle (38mm long) with a safety device to a be used to perform the injection t Needle 1 – 38 mm Needle 2 – 38 mm I a i z n The presence of bubbles on the surface of the lyophilized powder is normal. The following steps must be completed in continuous sequence.
e g 2a o Take the vial containing the solvent. Allow any solution present at the top of the vial to descend into the body of the vial itself. o Attach Needle 1 (without the safety device) to the syringe. Do not

remove the needle protection yet. o Break the neck of the vial (point facing upwards). o Remove the protection from Needle 1. Insert the needle into the vial and draw all the solvent into the syringe. o Set aside the syringe containing the solvent.	r m a c o
a
F 2b Take the vial containing the powder. Allow any powder accumulated at the top of l the vial to descend to the bottom of the vial. e o Remove the plastic cap from the vial. o Take the syringe containing the solvent and insert the needle vertically d into the vial through the rubber stopper. Inject slowly the solvent so that, if possible, it can wash the entire upper part of the vial itself.
a 2c n Position Needle 1 above the level of the liquid. Do not remove the needle a from the vial. Reconstitute the suspension by gently oscillating from side to side. Do not invert the vial.
t Important: Check that there is no powder not suspended in the I vial (if there are clumps of powder, continue to agitate until they disappear).
a 2d i o When the suspension is homogeneous, lower the needle and without z inverting the vial, draw up all the suspension. A small amount will remain in the vial and must be discarded. An overfill is included to allow for this loss.

o Grip the colored part of the needle to detach it from the syringe. Remove Needle 1, used for reconstitution, from the syringe. Attach Needle 2 to the syringe. o Pull away the safety sheath from the needle in the direction of the syringe body. The safety sheath remains in the set position. o Remove the needle protection. o Load the needle to remove air from the syringe and inject immediately.	r m a c o
F 3 – INTRAMUSCULAR INJECTION
o To avoid sedimentation, inject immediately into the disinfected area as quickly as possible (within 1 minute of reconstitution). e d

4 – AFTER USE

o

o Activate the safety system using the one-hand technique Note: Keep your finger behind the tab at all times There are two alternative methods to activate the safety system. o Method A: push the tab forward with your finger F l o Method B: press the tab on a flat surface a n a o In both cases, push down with a firm, quick movement until you hear a click. i o Visually confirm the locking of the safety device. l a Used needles, any unused suspension and other waste materials must be disposed of in accordance with local regulations.

c a m r a Method A Method B

Inform your doctor if there is significant loss of medicinal product, resulting from an incorrectly performed injection, so that a second injection can be given shortly. Dispose of the material used for the injection by placing it back in the packaging and do not reuse.

Decapeptyl 11.25 mg/2 ml powder and solvent for prolonged-release injectable suspension
triptorelin

Read this leaflet carefully before you 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, pharmacist or nurse.
• This medicine has been prescribed only for you. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What is Decapeptyl and what is it used for
• 2. What you need to know before you use Decapeptyl
• 3. How to use Decapeptyl
• 4. Possible side effects
• 5. How to store Decapeptyl
• 6. Contents of the pack and other information

1. What is Decapeptyl and what is it used for

This medicine contains triptorelin. 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.

This medicine is used:
In men:

• with malignant (carcinoma) prostate tumor and metastases (spread to other organs), where suppression of male hormone (testosterone) production is indicated. In women:
• with malignant breast tumor (carcinoma) in the pre-menopausal period or in the early stages of menopause (perimenopause) where hormonal treatment is indicated;
• with genital and extra-genital endometriosis (stages I-IV);
• with benign (fibroid) uterine tumors.

In children:

• as treatment for Central Precocious Puberty (early puberty), before the age of 8 in girls and before the age of 10 in boys.

2. What you need to know before using Decapeptyl

Do not use Decapeptyl

• if you are allergic to triptorelin or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to GnRH or other GnRH analogues (medicines similar to Decapeptyl).
• if you are pregnant or if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”). Warnings and precautionsTalk to your doctor or pharmacist before using Decapeptyl.

In patients who were taking Decapeptyl, cases of depression have been reported which could be
severe. If you are taking Decapeptyl 11.25 mg/ 2 ml and develop depression, tell your doctor.
If you experience convulsions, tell your doctor immediately. Cases of convulsions have been reported in
patients receiving triptorelin or similar medicines. These cases have occurred in patients with or without
a history of epilepsy.

• Talk to your doctor if you have any of the following conditions: any heart or blood vessel disorder, including heart rhythm problems (arrhythmias), or if you are being treated with medicines for these disorders. The risk of heart rhythm problems may increase with the use of Decapeptyl.
• If you have a benign tumor of the pituitary gland, of which you are not aware, this could be revealed during treatment with triptorelin 11.25 mg. Symptoms may include: sudden headache, vomiting, changes in vision and paralysis of the eyes.

In men:

• At the beginning of treatment there is an increase in testosterone circulating in the body. This could cause a worsening of the symptoms of the tumor. Contact your doctor if this should occur. Your doctor may prescribe you medicines (anti-androgens) to prevent the worsening of symptoms. During the first weeks of treatment, Decapeptyl may, like other GnRH analogues, in isolated cases, cause compression of the spinal cord (paresthesia or feeling of weakness in the lower limbs) or obstruction of the urethra (where urine passes). You will be monitored by your doctor and appropriate treatments will be prescribed to you if this situation should occur.
• After surgical castration, triptorelin does not produce any further reduction in testosterone.
• Diagnostic tests on the function of the pituitary gland performed during or after discontinuation of therapy with Decapeptyl, may be misleading.
• In adults, if Decapeptyl or another GnRH analogue is used for a long period of time, it may increase the risk of developing weakening of the bone structure which can be harmful especially if you abuse alcohol chronically, are a smoker, have a family history of osteoporosis (a condition that affects the strength of your bones), are malnourished or take anticonvulsant medicines (medicines for epilepsy) or corticosteroids (steroids). If you have any problems affecting your bones, such as osteoporosis, or any of the above risk factors, tell your doctor. This may affect how your doctor decides to treat you.
• If you are at risk of developing diabetes or if you suffer from heart problems, tell your doctor.
• Treatment with GnRH analogues, including DECAPEPTYL 11.25 mg, may increase the risk of anemia (defined as a decrease in the number of red blood cells).

In women:

• In adults, if Decapeptyl or another GnRH analogue is used for a long period of time, it may increase the risk of developing a weakening of the bone structure which can be harmful especially if you abuse alcohol chronically, are a smoker, have a family history of osteoporosis (a condition that affects the strength of your bones), are malnourished or take anticonvulsant medicines (medicines for epilepsy) or corticosteroids (steroids). If you have any problems affecting your bones, such as osteoporosis, or any of the above risk factors, tell your doctor. This may affect how your doctor decides to treat you.
• It is possible that vaginal bleeding may occur in the first month of treatment. After the first month, the menstrual cycle usually stops. Tell your doctor if you continue to have bleeding after the first month of treatment. The menstrual cycle resumes approximately 5 months after the last injection.
• You must use contraceptive methods other than "the pill" (non-hormonal) during treatment and for 3 months after the last injection, when triptorelin is not used for infertility. In children
• During the first month of treatment, girls may have episodes of vaginal bleeding from mild to moderate.
• When treatment is stopped, the signs of puberty will appear.
• In girls, menstruation will begin on average one year after discontinuation of treatment.
• Central precocious puberty caused by other diseases should be ruled out by the doctor.
• The amount of minerals in the bones decreases during treatment, but after discontinuation the subsequent bone growth is preserved.
• If the patient experiences sudden hip pain after discontinuation of treatment, the doctor must be informed
• 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).

If you have a brain tumor tell your doctor.
If you have any doubts about the use of this medicine, ask your doctor.
For possible side effects, read section 4.

Other medicines and Decapeptyl
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Decapeptyl 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 with some other drugs, for example methadone (used to relieve
pain and in drug detoxification programs), moxifloxacin (an antibiotic),
antipsychotics (used for serious mental illnesses).
The doctor will check your hormonal status when Decapeptyl is administered together with other
drugs that have effects on pituitary secretion of gonadotropins.

Pregnancy, breastfeeding and fertility
This medicine should not be used during pregnancy or while breastfeeding.

Driving and operating machinery
You may experience dizziness, drowsiness, or vision problems, such as blurred vision. These are possible
side effects of the treatment or your illness. If you experience any of these side effects,
do not drive or operate machinery.

Decapeptyl contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially “sodium-free”.

For athletes
The use of the drug without therapeutic necessity constitutes doping and may still result in a positive
doping test.

3. How to use Decapeptyl

Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor. Do not interrupt the treatment without the advice of your doctor.

The recommended dose is:

• prostate cancer and breast cancer: perform an injection strictly every 3 months.
• endometriosis and uterine fibroids: one injection every three months, starting treatment within the first five days of the cycle. In women, prolonged administration beyond 6 months must be carefully evaluated by the specialist doctor, so that the expected benefit is greater than the possible undesirable effects resulting from prolonged estrogen suppression, especially at the bone level. Use in childrenIn central precocious puberty, treatment with triptorelin must be carried out under the general supervision of a pediatric endocrinologist or pediatrician or an endocrinologist experienced in the treatment of central precocious puberty. Children weighing more than 20 Kg: administer an intramuscular injection of Decapeptyl 11.25 mg/ 2 ml every 3 months. Treatment should be discontinued upon reaching the physiological age of puberty in children and girls and it is recommended not to continue treatment in girls with a bone age greater than 12 years. Limited data are available in children regarding the optimal age for stopping treatment based on bone age, however, it is advisable to discontinue treatment in children with a bone age of 13-14 years.

The suspension must be injected immediately after preparation using exclusively
the suspension solvent provided in the package. The obtained suspension must not be mixed
with other medicines.

If you use more Decapeptyl than you should
Although no adverse reactions have been reported as a result of overdose, if you accidentally take
an excessive dose of triptorelin, immediately inform your doctor or go to the nearest
hospital.

If you forget to use Decapeptyl
Do not use a double dose to make up for a missed dose. Inform your doctor.

If you stop using Decapeptyl
Do not stop therapy with Decapeptyl on your own, but strictly follow the instructions
of your doctor. If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In rare cases, a severe allergic reaction may occur. Tell your doctor immediately if you
experience symptoms such as difficulty swallowing or breathing, swelling of the lips, face, throat
or tongue, skin rash.
With other triptorelin products, unusual pressure-sensitive infiltrations have been reported
after subcutaneous injection at the injection site.

Men
Many of the side effects are expected, due to changes in testosterone levels in the body.
These effects include: hot flushes and decreased libido.

Very common(may affect more than 1 in 10 people):

• Weakness
• Back pain
• Tingling in the legs
• Decreased libido
• Impotence (including absent ejaculation and problems with ejaculation)
• Excessive sweating
• Hot flushes

Common(may affect up to 1 in 10 people):

• Dry mouth, nausea
• Pain, inflammation and redness at the injection site, edema (fluid retention in the body’s tissues)
• Lower abdominal pain
• Muscle and bone pain, arm and leg pain
• High blood pressure
• Allergic reaction
• Weight gain
• Dizziness, headache
• Loss of libido, depression*, mood changes* * This frequency is based on the frequency of the class effect, common to all GnRH agonists.

Uncommon(may affect up to 1 in 100 people):

• Increased number of platelets
• Palpitations
• Tinnitus, dizziness
• Vision impairment
• Abdominal pain, constipation, diarrhea, vomiting
• Lethargy, muscle stiffness, drowsiness, pain, peripheral edema
• Changes in some blood tests (including increased liver and kidney function test results), increased blood pressure, weight loss
• Loss of appetite, increased lipids in the blood, gout (severe pain, swelling and redness of the joints, frequently for example at the level of the big toe), diabetes
• Joint pain, muscle cramps, muscle weakness and pain, bone pain
• Tingling or numbness
• Insomnia, irritability
• Enlargement of the breasts in men, breast pain, reduced testicular volume, testicular pain
• Difficulty breathing, nosebleeds
• Acne, hair loss, itching, skin rash, skin redness, hives
• Excessive urination during the night, problems with urination

Rare(may affect up to 1 in 10,000 people):

• Red or purplish discoloration of the skin, blisters
• Abnormal sensation in the eyes, visual disturbances
• Feeling of fullness in the abdomen, flatulence, altered taste sensation
• Chest pain
• Difficulty standing
• Flu-like symptoms, fever
• Anaphylactic reaction (a severe allergic reaction that can cause dizziness or difficulty breathing)
• Inflammation of the nose/throat
• Increased alkaline phosphatase in the blood
• Stiff, swollen joints, musculoskeletal stiffness, osteoarthritis
• Memory impairment
• Confusion, decreased activity, euphoria
• Shortness of breath when lying down
• Low blood pressure

Not known(frequency cannot be estimated from the available data):

• Anaphylactic shock (a severe allergic reaction that can cause dizziness or difficulty breathing)
• General feeling of being unwell
• Anxiety
• Angioedema
• Changes in ECG tracing (QT prolongation)
• Urinary incontinence
• If there is a pituitary tumor, there is an increased risk of bleeding in the area.
• Anemia (decreased number of red blood cells).

In patients treated with GnRH analogues, an increase in lymphocyte count has been reported.

Women
Many of the side effects are expected, due to changes in estrogen levels in the body.

Very common(may affect more than 1 in 10 people):

• Weakness
• Headache
• Sleep disorders (including insomnia), mood changes, decreased libido
• Breast disorders, pain during or after sexual intercourse, genital bleeding (including vaginal bleeding, breakthrough bleeding), ovarian hyperstimulation syndrome, ovarian hypertrophy, pelvic pain, vulvovaginal dryness
• Acne, excessive sweating, seborrhea
• Hot flushes

Common(may affect up to 1 in 10 people):

• Nausea, pain or discomfort in the abdomen
• Redness, swelling, inflammation and/or pain at the injection site, peripheral edema
• Allergic reaction
• Weight gain
• Joint pain, muscle cramps, pain in the extremities
• Dizziness
• Depression (long-term use. This frequency is based on the frequency of the class effect, common to all GnRH agonists), nervousness
• Breast pain

Uncommon(may affect up to 1 in 100 people):

• Palpitations
• Dizziness
• Dry eyes, vision impairment
• Abdominal distension, dry mouth, flatulence, mouth ulceration, vomiting
• Weight decrease
• Fluid retention, loss of appetite
• Back pain, muscle pain
• Alteration of taste, altered sensitivity, syncope, memory impairment, attention disorders, tingling, tremor
• Emotional lability, anxiety, depression (Short-term use. This frequency is based on the frequency of the class effect, common to all GnRH agonists), disorientation
• Bleeding after sexual intercourse, vaginal prolapse, menstrual cycle disorders (including painful cycles, genital bleeding, heavy menstrual bleeding), ovarian cysts, vaginal discharge
• Difficulty breathing, nosebleeds
• Hair loss, dry skin, abnormal hair growth, brittle nails, itching, skin rash

Not known(frequency cannot be estimated from the available data)

• Visual disturbances
• Diarrhea
• Fever, malaise
• Anaphylactic shock
• Increased alkaline phosphatase in the blood, increased blood pressure
• Muscle weakness
• Convulsions
• Confusion
• Absence of menstrual cycle
• Angioedema, hives
• High blood pressure
• If there is a pituitary tumor, there is an increased risk of bleeding in the area.

Children
Very common(may affect more than 1 in 10 people):

• Vaginal bleeding (including vaginal hemorrhage, breakthrough bleeding, uterine bleeding, vaginal discharge, vaginal bleeding including spotting)

Common(may affect up to 1 in 10 people):

• Abdominal pain
• Injection site reaction (redness, inflammation and/or pain)
• Allergic reaction
• Weight gain
• Headache
• Acne
• Hot flushes

Uncommon(may affect up to 1 in 100 people):

• Vision impairment
• Vomiting, constipation, nausea
• Malaise
• Obesity
• Neck pain
• Mood changes
• Breast pain
• Nosebleeds
• Itching, hives, skin rash

Long-term follow-up (up to 4 years) has not revealed any new and significant safety concerns.

Not known(frequency cannot be estimated from the available data)

• Visual disturbance
• Anaphylactic shock
• Convulsions
• Increased blood pressure, increased prolactin levels in the blood
• Muscle pain
• Emotional lability, nervousness, depression
• Angioedema
• High blood pressure
• Idiopathic intracranial hypertension (increased pressure inside the skull around the brain characterized by headache, blurred 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, pharmacist or nurse. This includes any side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Decapeptyl

Store at a temperature below 25°C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is reported on the package after Expiry. The expiry
date refers to the last day of that month.
Do not use this medicine if you notice visible signs of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Decapeptyl contains

• The active ingredient is triptorelin.
• The other components present in the vial of powder are d,l-lactide coglycolide polymer, mannitol, sodium carboxymethylcellulose, polysorbate 80.
• The components of the solvent vial are mannitol, water for injections.

Description of the appearance of Decapeptyl and contents of the pack
The powder vial contains 11.25 mg of triptorelin.
The vial contains 2 ml of suspension solvent.
The pack contains 1 vial of powder, 1 solvent vial of 2 ml, 2 needles, 1 syringe.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
IPSEN S.p.A.
Via Vittor Pisani n. 22
20124 Milan

Manufacturer
Ipsen Pharma Biotech S.A.S, Parc d'Activités du Plateau de Signes - Chemin Departemental n. 402 -
83870 Signes (France)
<------------------------------------------------------------------------------------------------------------------------>
The following information is intended exclusively for healthcare professionals:
INSTRUCTIONS FOR USE
Read the leaflet carefully before injection

Note:It is important that the preparation of the injection is carried out strictly following the
instructions below. Any injection performed incorrectly that results in a loss of
medicinal product must be immediately reported to the doctor.

n 1 – PATIENT PREPARATION BEFORE RECONSTITUTION OF THE SUSPENSION
a o Prepare the patient by disinfecting the buttock at the injection site. This operation must be performed before the i reconstitution, as the suspension, once reconstituted, must be injected immediately. l
2 – PREPARATION OF THE INJECTION
a In the pack there are two needles: t Needle 1: a 20G needle (38mm long) without the safety device to be used for reconstitution Needle 2: a 20G needle (38mm long) with the safety device to be used to administer the injection a
Ago 1 – 38 mm Ago 2 – 38 mm i z n e g A The presence of bubbles on the surface of the lyophilised product is normal. The following steps must be completed in continuous sequence.

	r m a c o
2a o Take the vial containing the solvent. Allow any solution present at the top of the vial to descend into the body of the vial itself. o Attach Needle 1 (without the safety device) to the syringe. l Do not remove the needle protection yet. e o Break the neck of the vial (point facing upwards). o Remove the protection from Needle 1. Insert the needle into the vial and d draw all the solvent into the syringe. o Set aside the syringe containing the solvent.	F a
a 2b n Take the vial containing the powder. Allow any powder accumulated at the top of the vial to descend to the bottom. a o Remove the plastic cap from the vial. o Take the syringe containing the solvent and insert i vertically the needle into the vial through the rubber stopper. Inject the solvent slowly so that, if a possible, it can wash the entire upper part of the vial itself.
t
I 2c a Position Needle 1 above the level of the liquid. Do not remove the needle from the vial. Reconstitute the suspension by gently shaking i from side to side. Do not invert the z vial. Make sure that the shaking is long enough (at least 30 n seconds) to obtain a homogeneous and milky suspension.
e Important: Check that there is no powder not suspended in the vial (if there are clumps of powder, continue shaking until they disappear).

2d o When the suspension is homogeneous, lower the needle and without inverting the vial, aspirate all the suspension. A small amount will remain in the vial and must be discarded. An overfill is included to allow this loss.	a c o
o Grip the coloured part of the needle to detach it from the syringe. Remove Needle 1, used for reconstitution, from the syringe. Attach Needle 2 to the syringe. o Remove the safety sheath from the needle by directing it away from the body of the syringe. The safety sheath remains in the set position. l o Remove the needle protection. o Load the needle to remove air from the syringe and inject e immediately.	F a r m
d 3 – INTRAMUSCULAR INJECTION
o To avoid sedimentation, inject immediately into the disinfected area as quickly as possible (within 1 minute of reconstitution). n
4 – AFTER USE
a i o Activate the safety system using the one-handed technique. Note: Keep your finger behind the tab at all times. l a There are two alternative methods to activate the safety system. o Method A: push the tab forward with your finger t I o a i z o Method B: press the tab on a flat surface. n o In both cases, push down with a firm, quick movement until you hear a click. e o Visually confirm that the safety device is locked. g Used needles, any unused suspension and other waste materials must be disposed of in accordance with local regulations.	Method A Method B

Inform your doctor if there is significant loss of medication, as a result of an incorrectly performed injection, so that a second injection can be given shortly.
Dispose of the material used for the injection by placing it back in the packaging and do not reuse.

Decapeptyl 22.5 mg/2 ml powder and solvent for prolonged-release injectable suspension
triptorelin

Read this leaflet carefully before you 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, pharmacist or nurse.
• This medicine has been prescribed only for you. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1.What Decapeptyl is and what it is used for
• 2.What you need to know before you use Decapeptyl
• 3.How to use Decapeptyl
• 4.Possible side effects
• 5.How to store Decapeptyl
• 6.Contents of the pack and other information

1. What is Decapeptyl and what is it used for

This medicine contains triptorelin. 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.
In men, triptorelin reduces the levels of the hormone testosterone, in women it reduces the levels of
estrogens.

This medicine is used:

• In adult men with malignant (carcinoma) prostate cancer and metastases (spread to other organs), where suppression of male hormone (testosterone) production is indicated.

a c o

• In children aged 2 years and over, Decapeptyl 22.5 mg/ 2ml is used to treat puberty that occurs at a very young age, i.e. before the age of 8 in girls and before the age of 10 in boys.

2. What you need to know before using Decapeptyl

Do not use Decapeptyl
if you are allergic to triptorelin or any of the other ingredients of this medicine
(listed in section 6).
if you are allergic (hypersensitive) to GnRH or other GnRH analogues (medicines similar to Decapeptyl).
if you are pregnant or if you are breastfeeding (see section “Pregnancy,
breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before using Decapeptyl.
Cases of depression have been reported in patients taking Decapeptyl 22.5 mg/ 2 ml which
may be serious. If you are taking Decapeptyl 22.5 mg/ 2 ml and develop depression, tell your
doctor.
If you are using medicines to prevent blood clotting, as you may experience, in addition to
burning, the appearance of bruises at the injection site.
Talk to your doctor if you have any of the following conditions: any heart or
blood vessel disorder, including heart rhythm problems (arrhythmias), or if you are being treated with medicines for
these disorders. The risk of heart rhythm problems may increase with the use of Decapeptyl.
If you experience seizures, tell your doctor immediately. Cases of seizures have been reported
in patients receiving triptorelin or similar medicines. These cases have occurred in patients with
or without a history of epilepsy.
The product must be injected only into the muscle
Men
At the beginning of treatment there is an increase in testosterone circulating in the body. This
may worsen the symptoms of the tumor. Contact your doctor if this should
occur. The doctor may prescribe you medicines (anti-androgens) to prevent the
worsening of symptoms. During the first weeks of treatment, Decapeptyl may, like
other GnRH analogues, in isolated cases, cause compression of the spinal cord (paresthesia or
weakness in the lower limbs) or obstruction of the urethra (where urine passes). You will be monitored
by the doctor and appropriate treatments will be prescribed to you if this should occur.
After surgical castration, triptorelin does not produce any further reduction in testosterone.
If Decapeptyl or another GnRH analogue is used for a long period of time, it may increase the
risk of developing weakening of the bone structure which may be harmful especially if
you chronically abuse alcohol, are a smoker, have a family history of osteoporosis (a condition
affecting the strength of your bones), are malnourished or take anticonvulsant medicines
(medicines for epilepsy) or corticosteroids (steroids). If you have any problems affecting your bones,
such as osteoporosis, or any of the aforementioned risk factors, tell your doctor. This may
affect how your doctor decides to treat you.
If you are at risk of developing diabetes or if you suffer from heart problems, tell your doctor.
If you have a benign tumor of the pituitary gland, of which you are not aware, this may
be revealed during treatment with triptorelin 22.5mg. Symptoms are: sudden headache,
vomiting, altered vision and paralysis of the eyes.
Treatment with GnRH analogues, including DECAPEPTYL 22.5 mg, may increase the risk of
anemia (defined as a decrease in the number of red blood cells).
Children:
Girls with Central Precocious Puberty (early puberty) may have vaginal bleeding
in the first month of treatment.
When treatment is stopped, the signs of puberty will appear.
In girls, menstruation will start on average one year after stopping treatment.
Central precocious puberty caused by other diseases should be excluded by the doctor.
The amount of minerals in the bones decreases during treatment, but after stopping the
subsequent growth of the bones is preserved.
If the patient experiences sudden hip pain after stopping treatment, the doctor must
be informed
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).
If you have a brain tumor that is progressing, inform your doctor. This may affect how your doctor
decides to treat you.
If you have any doubts about using this medicine, ask your doctor.
For possible side effects, read section 4.

Other medicines and Decapeptyl
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Decapeptyl 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 with some other drugs (e.g. methadone (used to relieve
pain and in detoxification programs from drug addiction), moxifloxacin (an antibiotic),
antipsychotics (used for severe mental illnesses)).
The doctor will check your hormonal status when Decapeptyl is administered together with other
drugs that have effects on pituitary secretion of gonadotropins.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not use this medicine if you are pregnant.
Do not use this medicine if you are breastfeeding.

Driving and using machines
You may experience dizziness, drowsiness, or vision problems, such as blurred vision. These are possible
side effects of the treatment or your illness. If you experience any of these side effects,
do not drive or use machines.

For athletes
The use of the drug without therapeutic necessity constitutes doping and may still result in positive
doping tests.

Decapeptyl contains sodium
This medicine contains less than 1 mmol (23mg) of sodium per dose, i.e. it is essentially “sodium-free”.

3. How to use Decapeptyl

Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor. Do not interrupt the treatment without the advice of your doctor.
Men
The recommended dose is
one intramuscular injection every 6 months (24 weeks). Decapeptyl 22.5mg/ 2ml must be
injected only into the muscle.
Children
one intramuscular injection every 6 months (24 weeks). Decapeptyl 22.5mg/ 2ml must be
injected only into the muscle. The doctor will decide when to interrupt the treatment
(normally at 12-13 years for girls and 13-14 for boys).
As with all medicines administered by injection, the injection site must be changed
periodically.
Since Decapeptyl is a suspension of microgranules, inadvertent
intravascular injection must be strictly avoided.
No dosage adjustment is necessary in patients with impaired renal or hepatic function.
Strictly adhere to the doctor's prescription; do not interrupt the treatment without the advice of
your doctor.

If you use more Decapeptyl than you should
Although no adverse reactions resulting from overdose have been reported, if you accidentally
take an excessive dose of triptorelin, immediately inform your doctor or go to the nearest hospital.
In case of overdose, symptomatic treatment is indicated.

If you forget to use Decapeptyl
Do not use a double dose to make up for a missed dose. Inform your doctor.

If you stop using Decapeptyl
Do not stop therapy with Decapeptyl on your own, but strictly follow the instructions of
your doctor. If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Many of the side effects are expected, due to the change in testosterone levels in the body.
These effects include: hot flushes and decreased libido.
In rare cases, a serious allergic reaction may occur. Tell your doctor immediately if you
experience symptoms such as difficulty swallowing or breathing, swelling of the lips, face, throat
or tongue, skin rash.
Men
With other products containing triptorelin, unusual pressure-sensitive infiltrations at the injection site have been reported after subcutaneous injection.

Very common(affects more than 1 in 10 people):
Hot flushes
Weakness
Excessive sweating
Back pain
Tingling in the legs
Decreased libido
Impotence (including absent ejaculation and problems with ejaculation)

Common(affects more than 1 in 100 people):
Nausea, dry mouth
Pain, redness and inflammation at the injection site, edema (fluid retention in the body’s tissues)
Muscle and bone pain, arm and leg pain
Lower abdominal pain
High blood pressure
Allergic reaction
Weight gain
Dizziness, headache
Loss of libido, depression*, mood changes*
* This frequency is based on the frequency of the class effect, common to all GnRH agonists

GnRH

Uncommon(affects more than 1 in 1,000 people):
Increased number of platelets
Palpitations
Tinnitus, dizziness
Vision impairment
Abdominal pain, constipation, diarrhea, vomiting
Lethargy, muscle stiffness, drowsiness, pain, peripheral edema
Changes in some blood tests (including increased liver and kidney function test results), increased blood pressure
Weight loss
Loss of appetite, increased appetite, gout (severe pain, swelling and redness in the joints, for example at the level of the big toe), diabetes, excessive lipids in the blood
Joint pain, muscle cramps, muscle weakness and pain, bone pain
Tingling or numbness
Insomnia, irritability
Breast enlargement in men, breast pain, decreased testicular volume, testicular pain
Difficulty breathing, nosebleeds
Acne, hair loss, itching, skin rash, skin redness, hives
Excessive urination during nighttime rest, problems with urination

Rare(affects more than 1 in 10,000 people):
Red or purplish discoloration of the skin, blisters
Abnormal sensation in the eyes, visual disturbances
Feeling of fullness in the abdomen, flatulence, altered taste sensation
Chest pain
Difficulty standing
Flu-like symptoms, fever
Anaphylactic reaction (a serious allergic reaction that can cause dizziness or difficulty breathing)
Inflammation of the nose/throat
Increased alkaline phosphatase in the blood
Stiff, swollen joints, musculoskeletal stiffness, osteoarthritis
Memory impairment
Confusion, decreased activity, euphoria
Shortness of breath when lying down
Low blood pressure

Not known(frequency cannot be estimated from available data):
Anaphylactic shock (a serious allergic reaction that can cause dizziness or difficulty breathing)

• General malaise
• Anxiety
• Angioedema
• Urinary incontinence
• Changes in ECG tracing (QT prolongation)
• If there is a pituitary tumor, there is an increased risk of bleeding in the area
• Anemia (decrease in the number of red blood cells).

Children
Very common(affects more than 1 in 10 people)

• Vaginal bleeding which may occur in the first month of treatment in girls Common(affects more than 1 in 100 people)
• Abdominal pain
• Injection site pain
• Redness and swelling at the injection site
• Headache
• Hot flushes
• Weight gain
• Acne
• Allergic reaction Uncommon(affects more than 1 in 1,000 people)
• Vision impairment
• Vomiting
• Constipation
• Nausea
• General malaise
• Obesity
• Neck pain
• Mood changes
• Breast pain
• Nosebleeds
• Itching
• Skin rash or hives Not known(frequency cannot be estimated from available data)
• High blood pressure
• Visual disturbances
• Severe allergic reaction causing difficulty swallowing, breathing problems, swelling of the lips, face, throat and tongue, or hives
• Convulsions
• Changes in some blood tests, including hormone levels
• Rapid formation of wheals due to swelling of the skin or mucous membranes
• Muscle pain
• Emotional lability
• Depression
• Nervousness
• 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)

If you have a benign tumor of the pituitary gland, of which you are not aware, this may
be revealed during treatment with triptorelin 22.5 mg. The symptoms are: sudden headache,
vomiting, visual impairment and paralysis of the eyes.
In patients treated with GnRH analogues, an increase in lymphocyte count has been reported.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not
listed in this leaflet. You can also report side effects directly through
the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Decapeptyl

Store in the original package to protect the medicine from light and moisture.
The reconstituted suspension must be used immediately.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after Exp. The expiry date
refers to the last day of that month.
Do not use this medicine if you notice visible signs of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Decapeptyl contains
The active ingredient is triptorelin
The other components present in the vial of powder are polymer Poly(DL-lactide co-glycolide)
75/25 (“PLG 75/25”), Poly(DL-lactide co-glycolide) 85/15 lauryl ester (“PLG85/15”), mannitol,
sodium carboxymethylcellulose, polysorbate 80
The component of the solvent vial is water for injections

Description of the appearance of Decapeptyl and contents of the pack
The powder vial contains 22.5 mg of triptorelin.
The vial contains 2 ml of solvent suspension.
The pack contains 1 vial of powder, 1 solvent vial of 2 ml, 2 needles, 1 syringe.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
IPSEN S.p.A.
Via Vittor Pisani n. 22
20124 Milan

Manufacturer
Ipsen Pharma Biotech, Parc d'Activités du Plateau de Signes - Chemin Départemental N° 402 - 83870
Signes (France)
<------------------------------------------------------------------------------------------------------------------------>
The following information is intended exclusively for healthcare professionals (see section 3):
INSTRUCTIONS FOR USE
Read the leaflet carefully before injection
The suspension must be injected immediately after preparation using exclusively
the solvent provided in the pack. The suspension obtained must not be mixed
with other medicinal products.

Important Note:It is important that the preparation of the injection is carried out strictly
following the instructions below. Any injection carried out incorrectly that results
in a loss of medicinal product must be immediately reported to the doctor.

1 – PATIENT PREPARATION BEFORE RECONSTITUTION OF THE SUSPENSION	c
o Prepare the patient by disinfecting the buttock at the injection site. This operation must be performed before reconstitution, as the suspension, once reconstituted, must be injected immediately.	m a
2 – PREPARATION OF THE INJECTION	r
a F Two needles are provided in the pack: Needle 1: a 20G needle (length 38mm) without a safety device to be used for reconstitution l Needle 2: a 20G needle (length 38mm) with a safety device to e be used to perform the injection d Needle 1 – 38 mm Needle 2 – 38 mm a n a i l The presence of bubbles on the surface of the lyophilized powder is normal. a The following steps must be completed in continuous sequence.
t 2a I o Take the vial containing the solvent. Allow any solution present at the top of the vial to descend into the body of the vial a itself. o Attach Needle 1 (without the safety device) to the syringe. Do not remove the needle protection yet. z o Break the neck of the vial (point facing upwards). o Remove the protection from Needle 1. Insert the needle into the vial and n draw all the solvent into the syringe. o Set aside the syringe containing the solvent.

2b o Take the vial containing the powder. Allow any powder accumulated at the top of the vial to descend to the bottom of the vial. o Remove the plastic cap from the vial. o Take the syringe containing the solvent and insert the needle vertically into the vial through the rubber stopper. Inject slowly the solvent in such a way that, if possible, it can wash the entire upper part of the vial itself.	m a c o
	r
a 2c F Position Needle 1 above the level of the liquid. Do not remove the needle from the vial. Reconstitute the suspension by gently rocking from side to side. Do not invert the vial. l e Make sure that the shaking is long enough (at least 30 seconds) to obtain a homogeneous and milky suspension.
d Important: Check that there is no powder that has not dissolved in the vial (if there are clumps of powder, continue to shake until they disappear).
n 2d a o When the suspension is homogeneous, lower the needle and without inverting the vial, draw up all the suspension. A small quantity will remain in the vial and must be discarded. A slight overfill is included to allow for this loss.
a t o Grasp the coloured part of the needle to detach it from the syringe. Remove Needle 1, used for reconstitution, from the syringe. Attach Needle 2 to the syringe. o Remove the safety sheath from the needle by directing it away from the body of the syringe. The safety sheath remains in the set position. o Remove the needle protection. o Load the needle to remove air from the syringe and inject immediately. g
3 – INTRAMUSCULAR INJECTION

o To prevent sedimentation, inject immediately into the disinfected area as quickly as possible (within 1 minute of reconstitution).	a c o
4 – AFTER USE
o Activate the safety system using the one-handed technique Note: Keep your finger behind the tab at all times. There are two alternative methods to activate the safety system. o Method A: push the tab forward with your finger o Method B: press the tab on a flat surface. o In both cases, push down with a firm and quick movement until you hear a click. o Visually confirm that the safety device is locked.	m r Method A Method B

The doctor must be informed in case of significant loss of medicine, resulting from an incorrectly performed injection, so that he can provide a second injection at short notice.
Dispose of the material used for the injection by placing it back in the packaging and do not reuse.