Eligard

PACKAGE LEAFLET: INFORMATION FOR THE USER

ELIGARD 7.5 mg

powder and solvent for injectable solution
Leuprorelin acetate
Please read this leaflet carefully before using this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet

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

1. WHAT ELIGARD IS AND WHAT IT IS USED FOR

The active substance of ELIGARD belongs to the group of so-called gonadotropin-releasing hormones.
These medicines are used to reduce the production of certain sex hormones (testosterone).
ELIGARD is used for the treatment of hormone-dependent metastatic prostate cancer in adult men and for the treatment of high-risk, non-metastatic hormone-dependent prostate cancer in combination with radiotherapy.

2. WHAT YOU SHOULD KNOW BEFORE USING ELIGARD

Do not use ELIGARD

• If you are a woman or a child
• If you are hypersensitive (allergic) to the active substance leuprorelin acetate, to medicines with activity similar to that of the natural gonadotropin-releasing hormone, or to any of the excipients of ELIGARD (listed in section 6).
• Following surgical removal of the testicles, since in this case ELIGARD does not cause any further reduction in serum testosterone levels.
• As the sole treatment if you have symptoms related to spinal cord compression or spinal column tumors. In such cases, ELIGARD should only be used in combination with other medications for the treatment of prostate cancer.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using ELIGARD

• If you are in any of the following situations: any heart or circulatory condition, including heart rhythm problems (arrhythmia), or if you are about to be treated with medicines for these conditions. The risk of heart rhythm problems may increase when ELIGARD is used.
• If you have difficulty urinating. You should be closely monitored during the first weeks of treatment.
• If spinal cord compression or difficulty urinating occurs. In cases with other medicines having a mechanism of action similar to ELIGARD, severe cases of spinal cord compression and narrowing of the tubes between the kidneys and the urinary bladder have been reported, which may lead to paralysis as a symptom. If these complications occur, standard therapy must be initiated.
• If you experience sudden headache, vomiting, altered mental status, and sometimes cardiac collapse, within two weeks after taking ELIGARD, contact your doctor or medical personnel immediately. Rare cases described as pituitary apoplexy have been reported with OTHER MEDICINES having a mechanism of action similar to ELIGARD.
• If you have diabetes mellitus (high blood sugar levels). You should be monitored regularly during treatment.
• Treatment with ELIGARD may increase the risk of fractures due to osteoporosis (reduced bone density).
• Cases of depression have been reported in patients taking ELIGARD. If you are taking ELIGARD and feel depressed, inform your doctor.
• Cardiovascular events have been reported in patients taking products similar to ELIGARD, and it is not known whether these are related to the use of such products. If you are taking ELIGARD and develop signs or symptoms of cardiovascular problems, inform your doctor.
• Seizures have been reported in patients taking ELIGARD. If you are taking ELIGARD and experience seizures, inform your doctor.
• If you suffer from severe or recurrent headaches, have vision problems, or hear ringing or buzzing in your ears, seek medical advice immediately.
• For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Complications occurring at the beginning of treatment
During the first week of treatment, there is generally a transient increase in blood levels of the male sex hormone testosterone. This may cause a temporary worsening of disease-related symptoms and even the onset of new symptoms not previously experienced. These symptoms include mainly bone pain, urinary disturbances, spinal cord compression, or blood in the urine. Usually, these symptoms tend to subside with continued treatment. If symptoms persist, you must contact your doctor.

If ELIGARD does not provide improvement
Some patients have tumors that are not sensitive to reductions in serum testosterone levels. If you feel that the effect of ELIGARD is too weak, talk to your doctor.

Other medicines and ELIGARD
ELIGARD may interfere with certain medicines used to treat heart rhythm disorders (e.g., quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm problems when used together with other medicines (e.g., methadone (used to relieve pain and for detoxification from substance abuse), moxifloxacin (an antibiotic), antipsychotics used for severe mental illnesses).
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Pregnancy and breastfeeding
ELIGARD is not intended for use in women.

Driving and operating machinery
Fatigue, dizziness, or visual disturbances are possible side effects of treatment with ELIGARD or could be consequences of the disease. If you experience these side effects, exercise caution when driving or operating machinery.

3. HOW TO USE ELIGARD

Dosage
Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
ELIGARD 7.5 mg is administered once a month, unless otherwise prescribed by your doctor.
The injected solution forms a depot that allows prolonged release of the active substance, leuprorelin acetate, over one month.

Additional tests
Your doctor must monitor your response to ELIGARD therapy by evaluating specific clinical parameters and measuring blood levels of prostate-specific antigen (PSA).

Method of administration
ELIGARD must be administered only by your doctor or a nurse.
They will also handle the preparation of the medicine.
After preparation, ELIGARD is administered by subcutaneous injection (injection into the tissue beneath the skin). Intra-arterial (into an artery) or intravenous (into a vein) injection must be strictly avoided.
As with other active substances administered by subcutaneous injection, the injection site should be rotated periodically.

If you use more ELIGARD than you should
Since the injection is generally given by your doctor or by appropriately trained personnel, overdose is unlikely.
However, if a higher than prescribed amount is administered, your doctor will carry out specific monitoring and provide any additional treatment as required.

If you forget to use ELIGARD
If you think you have missed your monthly ELIGARD dose, you should contact your doctor.

If you stop using ELIGARD
As a general rule, treatment of prostate cancer with ELIGARD requires long-term therapy. Therefore, treatment must not be stopped, even if your symptoms improve or disappear completely.
Premature discontinuation of ELIGARD treatment may result in worsening of disease-related symptoms.
Do not stop treatment earlier than planned without first consulting your doctor.

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, ELIGARD can cause adverse reactions, although not everyone experiences them.
The adverse reactions observed during treatment with ELIGARD are mostly due to the specific effect of the active substance leuprorelin acetate, namely an increase followed by a decrease in certain hormones. The most commonly reported adverse reactions are hot flushes (in 58% of patients), nausea, malaise and fatigue, as well as temporary local irritation at the injection site.

Initial adverse reactions
During the first weeks of treatment with ELIGARD, disease-specific symptoms may worsen, since initially there is generally a brief increase in the male sex hormone testosterone in the blood. Therefore, your doctor may administer an appropriate anti-androgen (a substance that inhibits the effects of testosterone) during the initial phase of treatment to reduce these possible effects (see also Section 2. Before using ELIGARD, Complications occurring at the beginning of treatment).

Local adverse reactions
Local adverse reactions reported after ELIGARD injection are typically those often associated with similar preparations administered subcutaneously (preparations injected into the tissue beneath the skin). Mild burning immediately after injection is a very common effect. Acute pain and pain after injection are common, as is the occurrence of bruising at the injection site. Cases of skin redness at the injection site have been reported as rare events. Tissue hardening and ulceration are uncommon.
These local adverse reactions following subcutaneous injection are mild and generally short-lived. These adverse reactions do not recur during the interval between individual injections.

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

• Hot flushes
• Spontaneous bleeding of the skin or mucous membranes, skin redness
• Fatigue, injection-related adverse reactions (see also above, Local adverse reactions)

Common adverse reactions (may affect up to 1 in 10 people)

• Rhinopharyngitis (cold-like symptoms)
• Nausea, malaise, diarrhoea, inflammation of the stomach and intestine (gastroenteritis/colitis)
• Itching, night sweats
• Joint pain
• Irregular urges to urinate (including at night), difficulty starting to urinate, pain during urination, reduced volume of urine passed
• Breast tenderness, breast swelling, testicular atrophy, testicular pain, infertility, erectile dysfunction, reduced penis size
• Chills (episodes of severe shivering with high fever), weakness
• Prolonged bleeding time, changes in blood parameters, decreased red blood cells/low red blood cell count

Uncommon adverse reactions (may affect up to 1 in 100 people)

• Urinary tract infections, local skin infections
• Worsening of diabetes mellitus
• Abnormal dreams, depression, reduced libido
• Dizziness, headache, altered skin sensation, insomnia, taste disturbances, smell disturbances
• Hypertension (increased blood pressure), hypotension (decreased blood pressure)
• Shortness of breath
• Constipation, dry mouth, dyspepsia (digestive disturbances with symptoms such as feeling of fullness in the stomach, stomach pain, belching, nausea, vomiting, heartburn sensation), vomiting
• Cold sweating, increased sweating
• Back pain, muscle cramps
• Haematuria (blood in urine)
• Bladder spasms, increased urge to urinate, inability to urinate
• Enlargement of male breast tissue, impotence
• Lethargy (drowsiness), pain, fever
• Weight gain
• Loss of balance, mental confusion
• Muscle wasting/muscle tissue loss after prolonged use

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

• Abnormal involuntary movements
• Sudden loss of consciousness, fainting
• Flatulence, belching
• Hair loss, skin eruptions (boils on the skin)
• Breast pain
• Ulceration at injection site

Very rare adverse reactions (may affect up to 1 in 10,000 people)

• Necrosis at injection site

Not known (frequency cannot be estimated from available data)

• Changes in electrocardiogram (QT interval prolongation)
• Lung inflammation, lung disease
• Idiopathic intracranial hypertension (increased intracranial pressure around the brain, characterized by headache, double vision and other visual disturbances, and ringing or buzzing in one or both ears)

Other adverse reactions
Other adverse reactions described in the literature related to treatment with leuprorelin, the active substance in ELIGARD, include oedema (fluid accumulation in tissues, manifesting as swelling of the hands and feet), pulmonary embolism (manifesting with symptoms such as shortness of breath, breathing difficulties, and chest pain), palpitations (awareness of one's own heartbeat), muscle weakness, chills, skin rash, memory and vision impairment. After long-term treatment with ELIGARD, symptoms related to reduced bone tissue (osteoporosis) may be expected. Due to the development of osteoporosis, the risk of fractures increases.
After administration of medicines belonging to the same class as ELIGARD, severe allergic reactions causing difficulty in breathing or dizziness have been reported rarely.
Seizures have been reported after administration of medicines belonging to the same class as ELIGARD.

Reporting of adverse reactions
If any of the adverse reactions worsens, or if you notice any adverse reaction not listed in this leaflet, inform your doctor.
You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ELIGARD

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp".
The expiry date refers to the last day of that month.
Storage instructions
Store in the refrigerator (2°C-8°C).
Keep in the original packaging to protect the medicine from moisture.
Before injection, this medicine should be brought to room temperature. Remove from the refrigerator
approximately 30 minutes before use. After removal from the refrigerator, this medicine may be stored
in the original packaging at room temperature (below 25°C) for up to four weeks.
Once the tray has been opened, the medicine must be prepared and used immediately. Single-use package.
Disposal instructions for unused or expired ELIGARD packages
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What ELIGARD contains
The active substance is leuprorelin acetate.
One pre-filled syringe (Syringe B) contains 7.5 mg of leuprorelin acetate.
The excipients are copolymer of DL-lactic and glycolic acids (50:50) and N-methyl-2-pyrrolidone in a
pre-filled syringe with injectable solution (Syringe A).

Description of the appearance of ELIGARD and pack contents
ELIGARD contains a powder and a solvent for injectable solution.
ELIGARD 7.5 mg is available in the following pack sizes:

• One thermoformed blister and one sterile 20-gauge needle in a cardboard box. The blister contains a desiccant bag and a pre-connected syringe system consisting of:
  • pre-filled Syringe A containing the solvent
  • pre-filled Syringe B containing the powder
  • connector with alignment button for Syringes A and B.
• A multiple pack containing 3 pre-connected syringe systems.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali, 1
20148 Milan
Italy

Manufacturer
Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali, 1
20148 Milan
Italy

This medicinal product is authorized in the EEA Member States under the following names:
Austria: Eligard Depot 7.5 mg
Belgium: Depot-Eligard 7.5 mg
Bulgaria: Eligard 7.5 mg
Cyprus: Eligard
Denmark: Eligard
Estonia: Eligard
Finland: Eligard
France: Eligard 7.5 mg
Germany: Eligard 7.5 mg
Ireland: Eligard 7.5 mg
Iceland: Eligard
Italy: Eligard
Latvia: Eligard 7.5 mg
Lithuania: Eligard 7.5 mg
Luxembourg: Depot-Eligard 7.5 mg
Norway: Eligard
Netherlands: Eligard 7.5 mg
Poland: Eligard 7.5 mg
Portugal: Eligard 7.5 mg
Czech Republic: Eligard
Romania: Eligard 7.5 mg
Slovakia: Eligard 7.5 mg
Slovenia: Eligard 7.5 mg
Spain: Eligard Mensual 7.5 mg
Sweden: Eligard
Hungary: Eligard 7.5 mg

The following information is intended for healthcare professionals only:
Remove the medicine from the refrigerator approximately 30 minutes before use to bring it to room temperature.
First prepare the patient for injection, then prepare the medicine according to the instructions below. If the medicine is not prepared using the correct technique, it must not be administered, as improper reconstitution may result in lack of clinical efficacy.

Step 1
On a clean working surface, open the blister by tearing the foil from the corners to remove the contents. Discard the desiccant bag.
Remove the pre-connected syringe system (Figure 1.1) from the blister. Open the safety needle package (Figure 1.2) by peeling off the paper tab. Note: Syringe A and Syringe B must not yet be aligned.

Figure 1.1 Figure 1.2
Contents of the blister: pre-connected syringe system Under the blister: safety needle and cap

Step 2
Using index finger and thumb, press the alignment button on the connector (Figure 2) until a click is heard. The two syringes will now be aligned. No specific orientation of the pre-connected syringe system is required to activate the connector. Do not bend the syringe system (note that this could cause leakage, as the syringes could partially unscrew).

Step 3
Holding the syringes horizontally, transfer the liquid content of Syringe A into the leuprorelin acetate powder contained in Syringe B. Mix the product thoroughly for 60 cycles by gently pushing the contents back and forth between the two syringes (one cycle consists of one push of the plunger of Syringe A and one push of the plunger of Syringe B), keeping the syringes horizontal, to obtain a homogeneous, viscous solution (Figure 3). Do not bend the syringe system (note that this could cause leakage, as the syringes could partially unscrew).

When properly mixed, the viscous solution will appear colorless to white to light brown (may have tints ranging from white to pale yellow).
Important: After mixing, proceed immediately to the next steps, as the product becomes more viscous over time. Do not refrigerate the product after mixing.
Caution: The product must be mixed as described; shaking will NOT achieve adequate mixing.

Step 4
After mixing, hold the syringes vertically with Syringe B at the bottom. The syringes must remain firmly connected. Transfer the entire mixed product into Syringe B (short, wide syringe) by fully depressing the plunger of Syringe A while slightly withdrawing the plunger of Syringe B (Figure 4).

Figure 4

Step 5
Ensure the plunger of Syringe A is fully depressed. Hold the connector and unscrew it from Syringe B. Syringe A will remain attached to the connector (Figure 5). Ensure no product leaks out, as this would prevent secure attachment of the needle.
Caution: Small air bubbles or one larger bubble may remain in the formulation – this is acceptable.
Avoid removing air bubbles from Syringe B at this stage, as product loss may occur!

Figure 5

Step 6

• Hold Syringe B vertically and hold back the white plunger to prevent product from leaking out.
• Attach the safety needle to Syringe B by holding the syringe steady and gently rotating the needle clockwise approximately three-quarters of a turn until securely fastened (Figure 6).

Do not force, as cracks may form at the needle base, resulting in product leakage during injection. The safety shield may also be damaged if the needle is screwed on too tightly.
Do not use the product if the needle base appears damaged, leaks, or is cracked. Do not replace the damaged needle and do not inject the product. Immediately dispose of the entire product safely.
If the needle base is damaged, use a new ELIGARD pack.

Step 7
Remove the safety shield from the needle and remove the protective cap before administration (Figure 7).
Important: Do not manipulate the safety needle mechanism before administration. If the needle hub appears damaged or leaking, the product MUST NOT be used. The damaged needle MUST NOT be replaced and the product MUST NOT be injected. In case of damage to the needle hub, use another ELIGARD kit.
Figure 7

Step 8
Before administration, remove any large air bubbles from Syringe B. Administer the product by subcutaneous injection, keeping the safety shield away from the needle.

Administration procedure:

• Select an injection site on the abdomen,

upper part of the buttocks, or another area with adequate subcutaneous tissue that shows no excessive pigmentation, nodules, lesions, or hair, and has not been recently used.

• Clean the injection site area with an alcohol swab (not included). Using thumb and index finger, pinch and lift the skin around the injection site.
• Using the dominant hand, quickly insert

the needle at a 90° angle to the skin surface. The depth of penetration will depend on the amount and fullness of subcutaneous tissue and the needle length. After inserting the needle, release the skin.

• Inject the medication by applying slow, steady pressure and depress the plunger until the syringe is empty. Ensure the entire content of Syringe B is injected before removing the needle. Quickly withdraw the needle at the same 90° angle used for insertion, maintaining pressure on the plunger.

Step 9
After injection, activate the safety shield using one of the activation methods described below.

1. Closing on a flat surface

Press the safety shield, levering downward, onto a flat surface (Figure 9a)
to cover the needle and lock the shield in place.
Check for the locking position by listening for a "click" sound or feeling it with your fingers.
Once locked, the shield will completely cover the needle tip.

2. Closing with your thumb

Place your thumb on the safety shield (Figure 9b), covering the needle tip and locking the shield in place.
Verify that the shield is securely locked by checking for a "click" sound and sensation felt with your fingers. Once locked, the shield will completely cover the needle tip.
Figure 9a Figure 9b
Closing on a flat surface Closing with your thumb

Once the needle shield is locked, immediately dispose of the needle and syringe in an appropriate sharps container.

PACKAGE LEAFLET: INFORMATION FOR THE USER

ELIGARD 22.5 mg

powder and solvent for injectable solution
Leuprorelin acetate
Please read this leaflet carefully before using this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be dangerous.
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet

7. What ELIGARD is and what it is used for
8. What you need to know before using ELIGARD
9. How to use ELIGARD
10. Possible side effects
11. How to store ELIGARD
12. Contents of the pack and other information

1. WHAT ELIGARD IS AND WHAT IT IS USED FOR

The active substance of ELIGARD belongs to the group of so-called gonadotropin-releasing hormones.
These medicines are used to reduce the production of certain sex hormones (testosterone).
ELIGARD is used for the treatment of hormone-dependent metastatic prostate cancer in adult men and for the treatment of high-risk, non-metastatic hormone-dependent prostate cancer in combination with radiotherapy.

2. WHAT YOU SHOULD KNOW BEFORE USING ELIGARD

Do not use ELIGARD

• If you are a woman or a child
• If you are hypersensitive (allergic) to the active substance leuprorelin acetate, to medicines with activity similar to that of the natural gonadotropin hormone, or to any of the excipients of ELIGARD (listed in section 6).
• Following surgical removal of the testicles, since in this case ELIGARD does not cause any further reduction in serum testosterone levels.
• As the sole treatment if you have symptoms related to spinal cord compression or spinal tumours. In these cases, ELIGARD should only be used in combination with other medicines for the treatment of prostate cancer.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using ELIGARD

• If you have any of the following conditions: any heart or circulatory condition, including heart rhythm problems (arrhythmia), or if you are about to be treated with medicines for these conditions. The risk of heart rhythm problems may increase when ELIGARD is used.
• If you have difficulty urinating. You should be closely monitored during the first weeks of treatment.
• If spinal cord compression or difficulty urinating occurs. As with other medicines having a mechanism of action similar to ELIGARD, severe cases of spinal cord compression and narrowing of the tubes between the kidneys and the urinary bladder have been reported, which may lead to paralysis as a symptom. If these complications occur, standard therapy must be initiated.
• If you experience sudden headache, vomiting, altered mental status, and sometimes cardiac collapse, within two weeks after taking ELIGARD, contact your doctor or medical personnel immediately. Rare cases described as pituitary apoplexy have been reported with OTHER MEDICINES having a mechanism of action similar to ELIGARD.
• If you have diabetes mellitus (high blood sugar levels). You should be monitored regularly during treatment.
• Treatment with ELIGARD may increase the risk of fractures due to osteoporosis (reduced bone density).
• Cases of depression have been reported in patients taking ELIGARD. If you are taking ELIGARD and feel depressed, inform your doctor.
• Cardiovascular events have been reported in patients taking products similar to ELIGARD, and it is not known whether these are related to the use of such products. If you are taking ELIGARD and develop signs or symptoms of cardiovascular disease, inform your doctor.
• Seizures have been reported in patients taking ELIGARD. If you are taking ELIGARD and experience seizures, inform your doctor.
• If you suffer from severe or recurrent headaches, have vision problems, or hear ringing or buzzing in your ears, seek medical advice immediately.
• For athletes: using the medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Complications occurring at the beginning of treatment
During the first week of treatment, there is generally a transient increase in blood levels of the male sex hormone testosterone. This may cause a temporary worsening of disease-related symptoms and may also lead to the appearance of new symptoms not previously experienced. These symptoms mainly include bone pain, urinary disturbances, spinal cord compression, or blood in the urine. Usually, these symptoms tend to subside as treatment continues. If symptoms persist, you should contact your doctor.

If ELIGARD does not provide improvement
Some patients have tumours that are not sensitive to reductions in serum testosterone levels. If you feel that the effect of ELIGARD is too weak, talk to your doctor.

Other medicines and ELIGARD
ELIGARD may interfere with certain medicines used to treat heart rhythm disorders (e.g. quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm problems when used together with other medicines (e.g. methadone (used to relieve pain and in detoxification from substance abuse), moxifloxacin (an antibiotic), antipsychotics used for severe mental illnesses).
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Pregnancy and breastfeeding
ELIGARD is not indicated for use in women.

Driving and operating machinery
Fatigue, dizziness, or visual disturbances are possible side effects of treatment with ELIGARD or may be consequences of the disease. If you experience these side effects, take care when driving or operating machinery.

3. HOW TO USE ELIGARD

Dosage
Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
ELIGARD 22.5 mg is administered once every three months, unless otherwise prescribed by your doctor.
The injected solution forms a depot that allows prolonged release of the active substance, leuprorelin acetate, over three months.

Additional tests
Your doctor must monitor your response to ELIGARD therapy by evaluating specific clinical parameters and measuring blood levels of prostate-specific antigen (PSA).

Method of administration
ELIGARD must be administered only by your doctor or by a nurse.
They will also handle the preparation of the medicine.
After preparation, ELIGARD is administered as a subcutaneous injection (an injection into the tissue beneath the skin). Intra-arterial (into an artery) or intravenous (into a vein) injection must be strictly avoided.
As with other active substances administered by subcutaneous injection, the injection site should be rotated periodically.

If you take more ELIGARD than you should
Since the injection is generally given by your doctor or by appropriately trained personnel, overdose cases are not expected.
However, if a higher than intended dose is administered, your doctor will carry out specific monitoring and provide any additional treatment as required.

If you forget to take ELIGARD
If you think you have missed your scheduled quarterly ELIGARD injection, contact your doctor.

If you stop using ELIGARD
As a general rule, prostate cancer treatment with ELIGARD requires long-term therapy. Therefore, treatment must not be stopped, even if symptoms improve or disappear completely.
Premature discontinuation of ELIGARD treatment may result in worsening of disease-related symptoms.
Do not stop therapy earlier than planned without first consulting your doctor.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, ELIGARD can cause adverse reactions, although not everyone experiences them.
The adverse reactions observed during treatment with ELIGARD are mostly due to the specific effect of the active substance, leuprorelin acetate, namely an increase followed by a decrease in certain hormones. The most commonly reported adverse reactions include hot flushes (in 58% of patients), nausea, malaise and fatigue, as well as temporary local irritation at the injection site.

Initial adverse reactions
During the first few weeks of treatment with ELIGARD, disease-specific symptoms may worsen, because initially there is generally a brief increase in the male sex hormone testosterone in the blood. Therefore, your doctor may administer an appropriate anti-androgen (a substance that inhibits the effects of testosterone) at the beginning of treatment to reduce these possible effects (see also Section 2. Before using ELIGARD, Complications occurring at the start of treatment).

Local adverse reactions
Local adverse reactions reported after ELIGARD injection are typically those often associated with similar preparations administered subcutaneously (preparations injected into the tissue beneath the skin). A mild burning sensation immediately after injection is a very common effect. Acute pain and pain after injection are common, as are bruising at the injection site. Cases of skin redness at the injection site have been reported as rare reactions. Tissue hardening and ulceration are uncommon.
These local adverse reactions following subcutaneous injection are generally mild and of short duration. These adverse reactions do not recur during the interval between individual injections.

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

• Hot flushes
• Spontaneous bleeding of the skin or mucous membranes, skin redness
• Fatigue, injection-related adverse reactions (see also above, Local adverse reactions)

Common adverse reactions (may affect up to 1 in 10 people)

• Nasopharyngitis (cold-like symptoms)
• Nausea, malaise, diarrhoea, inflammation of the stomach and intestine (gastroenteritis/colitis)
• Itching, night sweats
• Joint pain
• Irregular urges to urinate (also at night), difficulty starting to urinate, pain during urination, reduced urine output
• Breast tenderness, breast swelling, testicular atrophy, testicular pain, infertility, erectile dysfunction, reduced penis size
• Chills (episodes of violent shivering with high fever), weakness
• Prolonged bleeding time, changes in blood parameters, decreased red blood cells/low red blood cell count

Uncommon adverse reactions (may affect up to 1 in 100 people)

• Urinary tract infections, local skin infections
• Worsening of diabetes mellitus
• Abnormal dreams, depression, reduced libido
• Dizziness, headache, changes in skin sensation, insomnia, taste disturbances, smell disturbances
• Hypertension (increased blood pressure), hypotension (decreased blood pressure)
• Shortness of breath
• Constipation, dry mouth, dyspepsia (digestive disturbances with symptoms such as feeling of fullness in the stomach, stomach pain, belching, nausea, vomiting, heartburn sensation), vomiting
• Cold sweating, increased sweating
• Back pain, muscle cramps
• Haematuria (blood in urine)
• Bladder spasms, increased urge to urinate, inability to urinate
• Increase in male breast tissue, impotence
• Lethargy (drowsiness), pain, fever
• Weight gain
• Loss of balance, mental confusion
• Muscle wasting/muscle tissue loss after prolonged use

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

• Abnormal involuntary movements
• Sudden loss of consciousness, fainting
• Flatulence, belching
• Hair loss, skin eruptions (boils on the skin)
• Breast pain
• Ulceration at the injection site

Very rare adverse reactions (may affect up to 1 in 10,000 people)

• Necrosis at the injection site

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

• Changes in electrocardiogram (QT interval prolongation)
• Lung inflammation, lung disease
• Idiopathic intracranial hypertension (increased intracranial pressure around the brain, characterized by headache, double vision and other visual disturbances, and ringing or buzzing in one or both ears)

Other adverse reactions
Other adverse reactions described in the literature related to treatment with leuprorelin, the active substance in ELIGARD, include oedema (fluid accumulation in tissues, manifesting as swelling of the hands and feet), pulmonary embolism (manifesting with symptoms such as shortness of breath, breathing difficulties and chest pain), palpitations (awareness of your own heartbeat), muscle weakness, chills, skin rash, memory and vision impairment. With long-term treatment with ELIGARD, symptoms related to reduced bone tissue (osteoporosis) may be expected. Due to the development of osteoporosis, the risk of fractures increases.
After administration of medicines belonging to the same class as ELIGARD, serious allergic reactions causing breathing difficulties or dizziness have been reported rarely.
After administration of medicines belonging to the same class as ELIGARD, seizures have been reported.

Reporting of adverse reactions
If any of the adverse reactions worsens, or if you notice any adverse reaction not listed in this leaflet, inform your doctor.
You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ELIGARD

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after "Exp."
The expiry date refers to the last day of that month.
Storage instructions
Store in a refrigerator (2°C–8°C).
Keep in the original packaging to protect the medicine from moisture.
Before injection, this medicine should be brought to room temperature. Remove from the refrigerator
approximately 30 minutes before use. After removal from the refrigerator, this medicine may be stored
in the original packaging at room temperature (below 25°C) for up to four weeks.
Once the tray has been opened, the medicine must be prepared and used immediately. Single-use
packaging.
Disposal instructions for unused or expired ELIGARD packs
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What ELIGARD contains
The active substance is leuprorelin acetate.
One pre-filled syringe (Syringe B) contains 22.5 mg of leuprorelin acetate.
The excipients are copolymer of DL-lactic and glycolic acids (75:25) and N-methyl-2-pyrrolidone in a
pre-filled syringe with injectable solution (Syringe A).

Description of the appearance of ELIGARD and contents of the package
ELIGARD contains a powder and a solvent for injectable solution.
ELIGARD 22.5 mg is available in the following pack sizes:

• One thermoformed blister and one sterile 20-gauge needle in a cardboard box. The blister contains a desiccant bag and a pre-connected syringe system consisting of:
  • Syringe A pre-filled with solvent
  • Syringe B pre-filled with powder
  • Connector with alignment button for Syringes A and B.
• A multiple pack containing 2 pre-connected syringe systems.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali, 1
20148 Milan
Italy

Manufacturer
Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali, 1
20148 Milan
Italy

This medicinal product is authorized in EEA Member States under the following
names:
Austria: Eligard Depot 22.5 mg
Belgium: Depot-Eligard 22.5 mg
Bulgaria: Eligard 22.5 mg
Cyprus: Eligard
Denmark: Eligard
Estonia: Eligard
Finland: Eligard
France: Eligard 22.5 mg
Germany: Eligard 22.5 mg
Ireland: Eligard 22.5 mg
Iceland: Eligard
Italy: Eligard
Latvia: Eligard 22.5 mg
Lithuania: Eligard 22.5 mg
Luxembourg: Depot-Eligard 22.5 mg
Norway: Eligard
Netherlands: Eligard 22.5 mg
Poland: Eligard 22.5 mg
Portugal: Eligard 22.5 mg
Czech Republic: Eligard
Romania: Eligard 22.5 mg
Slovakia: Eligard 22.5 mg
Slovenia: Eligard 22.5 mg
Spain: Eligard Trimestral 22.5 mg
Sweden: Eligard
Hungary: Eligard 22.5 mg

The following information is intended for healthcare professionals only:
Remove the medicine from the refrigerator and allow it to reach room temperature approximately 30 minutes before use.
First prepare the patient for injection, then prepare the medicine according to the instructions below. If the medicine is not prepared using the proper technique, it must not be administered, as incorrect reconstitution may result in lack of clinical efficacy.

Step 1
On a clean working surface, open the blister by tearing the foil from the corners to remove the contents. Discard the desiccant bag.
Remove the pre-connected syringe system (Figure 1.1) from the blister. Open the safety needle package (Figure 1.2) by removing the paper tab. Note: Syringe A and Syringe B must not be aligned yet.

Figure 1.1 Figure 1.2
Contents of the blister: pre-connected syringe system Under the blister: safety needle and cap

Step 2
Using index finger and thumb, press the alignment button on the connector (Figure 2) until a click is heard. The two syringes will now be aligned. No specific orientation of the pre-connected syringe system is required to activate the connector. Do not bend the syringe system (note that this could cause leakage as the syringes could partially unscrew).

Step 3
Holding the syringes horizontally, transfer the liquid content of Syringe A into the leuprorelin acetate powder contained in Syringe B. Mix the product thoroughly for 60 cycles by gently pushing the contents back and forth between the two syringes (one cycle equals one push of the plunger of Syringe A and one push of the plunger of Syringe B), while keeping the syringes horizontal, to obtain a homogeneous viscous solution (Figure 3). Do not bend the syringe system (note that this could cause leakage as the syringes could partially unscrew).

When properly mixed, the viscous solution will appear colorless to white to light brown (may have tints ranging from white to pale yellow).
Important: After mixing, proceed immediately to the next steps, as the product becomes more viscous over time. Do not refrigerate the product after mixing.
Caution: The product must be mixed as described; shaking will not achieve adequate mixing.

Step 4
After mixing, hold the syringes vertically with Syringe B at the bottom. The syringes must remain firmly connected. Transfer the entire mixed product into Syringe B (short, wide syringe) by pushing the plunger of Syringe A and slightly pulling the plunger of Syringe B (Figure 4).

Figure 4

Step 5
Ensure the plunger of Syringe A is fully depressed. Hold the connector and unscrew it from Syringe B. Syringe A will remain attached to the connector (Figure 5). Ensure no product leaks out, as this would prevent secure attachment of the needle.
Caution: Small air bubbles or one larger bubble may remain in the formulation – this is acceptable.
Avoid removing air bubbles from Syringe B at this stage, as product loss may occur!

Figure 5

Step 6

• Hold Syringe B vertically and hold back the white plunger to prevent product from leaking out.
• Attach the safety needle to Syringe B by holding the syringe steady and gently rotating the needle clockwise approximately three-quarters of a turn until securely fastened (Figure 6).

Do not force, as cracks may form at the base of the needle, leading to product leakage during injection. The safety shield may also be damaged if the needle is over-tightened.
Do not use the product if the needle base appears damaged, is leaking, or cracked. Do not replace the damaged needle and do not inject the product. Immediately dispose of the entire product safely.
If the needle base is damaged, use a new ELIGARD kit.

Step 7
Remove the safety shield from the needle and remove the protective cap before administration (Figure 7).
Important: Do not manipulate the safety needle mechanism before administration. If the needle hub appears damaged or leaking, the product must NOT be used. The damaged needle must NOT be replaced and the product must NOT be injected. In case of damage to the needle hub, use another ELIGARD kit.
Figure 7

Step 8: Before administration, remove large air bubbles from Syringe B. Administer the product subcutaneously, keeping the safety shield away from the needle.
Administration procedure:

• Select an injection site on the abdomen, upper part of the buttocks, or another area with adequate subcutaneous tissue that does not show excessive pigmentation, nodules, lesions, or hair, and has not been recently used.

• Clean the injection site area with an alcohol swab (not included). Using thumb and index finger, pinch and lift the skin around the injection site.

• Using the dominant hand, rapidly insert the needle at a 90° angle to the skin surface. The depth of penetration will depend on the amount and fullness of subcutaneous tissue and the length of the needle. After inserting the needle, release the skin.

• Inject the medication by applying slow, steady pressure and push the plunger until the syringe is empty. Ensure that the entire amount of product in Syringe B is injected before removing the needle. Rapidly withdraw the needle at the same 90° angle used for insertion, maintaining pressure on the plunger.

Step 9
After injection, lock the safety shield using one of the activation methods described below.

3. Closing on a flat surface

Press the safety shield downward, using leverage on a flat surface (Figure 9a),
to cover the needle and lock the shield in place.
Check the locking position by paying attention to an audible or tactile "click" signal perceived with the fingers.
Once locked, the shield will completely cover the needle tip.

4. Closing with your thumb

Place your thumb on the safety shield (Figure 9b), covering the needle tip and locking the shield in place.
Check that the shield is securely locked by paying attention to an audible and tactile signal (“click”) that can be both heard and felt with your fingers. When locked, the shield will completely cover the needle tip.
Figure 9a Figure 9b
Closing on a flat surface Closing with your thumb

Once the needle shield is locked, immediately dispose of the needle and syringe in the appropriate sharps container.

INSTRUCTION LEAFLET: INFORMATION FOR THE USER

ELIGARD 45 mg

powder and solvent for injectable solution
Leuprorelin acetate
Please read this leaflet carefully before using this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet

13. What ELIGARD is and what it is used for
14. What you need to know before using ELIGARD
15. How to use ELIGARD
16. Possible side effects
17. How to store ELIGARD
18. Contents of the pack and other information

1. WHAT ELIGARD IS AND WHAT IT IS USED FOR

The active substance of ELIGARD belongs to the group of so-called gonadotropin-releasing hormones.
These medicines are used to reduce the production of certain sex hormones (testosterone).
ELIGARD is used to treat hormone-dependent metastatic prostate cancer in adult men and for the treatment of high-risk, non-metastatic hormone-dependent prostate cancer in combination with radiotherapy.

2. WHAT YOU SHOULD KNOW BEFORE USING ELIGARD

Do not use ELIGARD

• If you are a woman or a child
• If you are hypersensitive (allergic) to the active substance leuprorelin acetate, to medicines with activity similar to that of the natural hormone gonadotropin-releasing hormone, or to any of the excipients of ELIGARD (listed in section 6).
• Following surgical removal of the testicles, as in this case ELIGARD does not cause any further reduction in serum testosterone levels.
• As the sole treatment if you have symptoms related to spinal cord compression or spinal column tumors. In these cases, ELIGARD should only be used in combination with other medications for the treatment of prostate cancer.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using ELIGARD

• If you have any of the following conditions: any heart or circulatory condition, including heart rhythm problems (arrhythmia), or if you are about to be treated with medicines for these conditions. The risk of heart rhythm problems may increase when ELIGARD is used.
• If you have difficulty urinating. You should be closely monitored during the first weeks of treatment.
• If spinal cord compression or difficulty urinating occurs. In analogy with other medicines having a mechanism of action similar to ELIGARD, severe cases of spinal cord compression and narrowing of the tubes connecting the kidneys to the bladder have been reported, which may contribute to paralysis as a symptom. If these complications occur, standard therapy must be initiated.
• If you experience sudden headache, vomiting, altered mental status, and sometimes cardiac collapse within two weeks after starting ELIGARD, contact your doctor or medical personnel immediately. Rare cases described as pituitary apoplexy have occurred with other drugs having a mechanism of action similar to ELIGARD.
• If you have diabetes mellitus (high blood sugar levels). You should be monitored regularly during treatment.
• Treatment with ELIGARD may increase the risk of fractures due to osteoporosis (reduction in bone density).
• There have been reports of depression in patients taking ELIGARD. If you are taking ELIGARD and feel depressed, inform your doctor.
• In patients taking products similar to ELIGARD, cardiovascular events have been reported, and it is not known whether these are related to taking these products. If you are taking ELIGARD and develop signs or symptoms of cardiovascular disease, inform your doctor.
• Seizures have been reported in patients taking ELIGARD. If you are taking ELIGARD and experience seizures, inform your doctor.
• If you suffer from severe or recurrent headaches, vision problems, or hear ringing or buzzing in your ears, contact your doctor immediately.
• For athletes: using the medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

Complications occurring at the beginning of treatment
During the first week of treatment, there is generally a transient increase in blood levels of the male sex hormone testosterone. This may cause a temporary worsening of disease-related symptoms and may even lead to the onset of new symptoms not previously experienced. These symptoms include mainly bone pain, urinary disorders, spinal cord compression, or blood in the urine. Usually, these symptoms tend to subside as treatment continues. If symptoms persist, you should contact your doctor.

If ELIGARD does not provide improvement
Some patients have tumors that are not sensitive to reductions in serum testosterone levels. If you feel that the effect of ELIGARD is too weak, talk to your doctor.

Other medicines and ELIGARD
ELIGARD may interfere with certain medicines used to treat heart rhythm disorders (e.g., quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm problems when used together with other medicines (e.g., methadone (used to relieve pain and in detoxification from substance abuse), moxifloxacin (an antibiotic), antipsychotics used for severe mental illnesses).
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Pregnancy and breastfeeding
ELIGARD is not indicated for use in women.

Driving and using machines
Fatigue, dizziness, or visual disturbances are possible side effects of treatment with ELIGARD or may be consequences of the disease. If you experience these side effects, take care when driving or operating machinery.

3. HOW TO USE ELIGARD

Dosage
Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
ELIGARD is administered once every six months, unless otherwise prescribed by your doctor.
The injected solution forms a depot that allows prolonged release of the active substance, leuprorelin acetate, over six months.

Additional tests
Your doctor must monitor the response to ELIGARD therapy by assessing specific clinical parameters and measuring blood levels of prostate-specific antigen (PSA).

Method of administration
ELIGARD must be administered only by your doctor or a nurse.
They will also handle the preparation of the medicine.
After preparation, ELIGARD is administered by subcutaneous injection (injection into the tissue beneath the skin). Arterial (into an artery) or intravenous (into a vein) injection must be strictly avoided.
As with other active substances administered by subcutaneous injection, the injection site should be rotated periodically.

If you take more ELIGARD than you should
Since the injection is generally given by your doctor or other properly trained personnel, overdose is not expected.
However, if a higher than prescribed amount is administered, your doctor will carry out specific monitoring and provide any additional treatment as needed.

If you forget to take ELIGARD
If you think you have missed the scheduled six-monthly administration of ELIGARD, contact your doctor.

If you stop using ELIGARD
As a general rule, treatment of prostate cancer with ELIGARD requires long-term therapy. Therefore, treatment should not be stopped, even if symptoms improve or disappear completely.
Premature discontinuation of ELIGARD treatment may result in worsening of symptoms related to the disease.
Do not stop therapy earlier than planned without first consulting your doctor.

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, ELIGARD can cause adverse reactions, although not everyone experiences them.
The adverse reactions observed during treatment with ELIGARD are mostly due to the specific effect of the active substance leuprorelin acetate, namely an increase followed by a decrease in certain hormones. The most commonly reported adverse reactions are hot flushes (in 58% of patients), nausea, malaise and fatigue, as well as temporary local irritation at the injection site.

Initial adverse reactions
During the first few weeks of treatment with ELIGARD, disease-specific symptoms may worsen, because initially there is generally a brief increase in the male sex hormone testosterone in the blood. Therefore, your doctor may administer an appropriate anti-androgen (a substance that inhibits the effects of testosterone) during the initial phase of treatment to reduce these possible effects (see also Section 2. Before using ELIGARD, Complications occurring at the beginning of treatment).

Local adverse reactions
Local adverse reactions reported after ELIGARD injection are typically those often associated with similar preparations administered subcutaneously (preparations injected into the tissue beneath the skin). Mild burning immediately after injection is a very common effect. Acute pain and pain after injection are common, as is the occurrence of bruising at the injection site. Cases of skin redness at the injection site have been reported as rare events. Tissue hardening and ulceration are uncommon.

Such local adverse reactions following subcutaneous injection are mild and generally of short duration. These adverse reactions do not recur during the time interval between individual injections.

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

• Hot flushes
• Spontaneous bleeding of the skin or mucous membranes, skin redness
• Fatigue, injection-related adverse reactions (see also above, Local adverse reactions)

Common adverse reactions (may affect up to 1 in 10 people)

• Rhinopharyngitis (cold-like symptoms)
• Nausea, malaise, diarrhoea, inflammation of the stomach and intestine (gastroenteritis/colitis)
• Itching, night sweats
• Joint pain
• Irregular urges to urinate (including at night), difficulty initiating urination, pain during urination, reduced urine volume
• Breast tenderness, breast swelling, testicular atrophy, testicular pain, infertility, erectile dysfunction, reduced penis size
• Chills (episodes of intense shivering with high fever), weakness
• Prolonged bleeding time, changes in blood parameters, reduction in red blood cells/low red blood cell count

Uncommon adverse reactions (may affect up to 1 in 100 people)

• Urinary tract infections, local skin infections
• Worsening of diabetes mellitus
• Abnormal dreams, depression, reduced libido
• Dizziness, headache, altered skin sensation, insomnia, taste disturbances, smell disturbances
• Hypertension (increased blood pressure), hypotension (decreased blood pressure)
• Shortness of breath
• Constipation, dry mouth, dyspepsia (digestive disturbances with symptoms such as feeling of fullness, stomach pain, belching, nausea, vomiting, heartburn), vomiting
• Cold sweating, increased sweating
• Back pain, muscle cramps
• Haematuria (blood in urine)
• Bladder spasms, increased urge to urinate, inability to urinate
• Gynaecomastia (enlargement of male breast tissue), impotence
• Lethargy (drowsiness), pain, fever
• Weight gain
• Loss of balance, mental confusion
• Muscular wasting/muscle tissue loss after prolonged use

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

• Abnormal involuntary movements
• Sudden loss of consciousness, fainting
• Flatulence, belching
• Hair loss, skin eruptions (boils on the skin)
• Breast pain
• Ulceration at the injection site

Very rare adverse reactions (may affect up to 1 in 10,000 people)

• Necrosis at the injection site

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

• Changes in electrocardiogram (QT interval prolongation)
• Inflammation of the lungs, lung disease
• Idiopathic intracranial hypertension (increased intracranial pressure around the brain, characterized by headache, double vision and other visual disturbances, and ringing or buzzing in one or both ears)

Other adverse reactions
Other adverse reactions described in the literature in relation to treatment with leuprorelin, the active substance of ELIGARD, include oedema (fluid accumulation in tissues, manifesting as swelling of the hands and feet), pulmonary embolism (manifesting with symptoms such as shortness of breath, difficulty breathing and chest pain), palpitations (awareness of one's heartbeat), muscle weakness, chills, skin rash, memory and vision impairment.
With long-term treatment with ELIGARD, symptoms related to reduced bone tissue (osteoporosis) may be expected. Due to the development of osteoporosis, the risk of fractures increases.
After administration of medicines belonging to the same class as ELIGARD, serious allergic reactions causing breathing difficulties or dizziness have been reported rarely.
After administration of medicines belonging to the same class as ELIGARD, seizures have been reported.

Reporting of adverse reactions
If any of the adverse reactions worsens, or if you notice any adverse reaction not listed in this leaflet, inform your doctor.
You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ELIGARD

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp".
The expiry date refers to the last day of that month.
Storage instructions
Store in a refrigerator (2°C–8°C).
Keep in the original packaging to protect the medicine from moisture.
Before injection, this medicine should be brought to room temperature. Remove from the refrigerator
approximately 30 minutes before use. After removal from the refrigerator, this medicine may be stored in
the original packaging at room temperature (below 25°C) for up to four weeks.
Once the tray has been opened, the medicine must be prepared and used immediately. Single-use package.
Instructions for disposal of unused or expired ELIGARD packages
Do not dispose of any medicine via 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 PACKAGE AND OTHER INFORMATION

What ELIGARD contains
The active substance is leuprorelin acetate.
One pre-filled syringe (Syringe B) contains 45 mg of leuprorelin acetate.
The excipients are copolymer of DL-lactic and glycolic acids (85:15) and N-methyl-2-pyrrolidone in a
pre-filled syringe with injectable solution (Syringe A).

Description of the appearance of ELIGARD and contents of the package
ELIGARD contains a powder and a solvent for injectable solution.
ELIGARD 45 mg is available in the following pack sizes:

• One thermoformed tray and one sterile 18-gauge needle in a cardboard box. The tray contains a desiccant bag and a pre-connected syringe system consisting of:
  • pre-filled Syringe A containing the solvent
  • pre-filled Syringe B containing the powder
  • connector with alignment button for Syringes A and B.
• A multiple pack containing 2 pre-connected syringe kits.

It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali, 1
20148 Milan
Italy

Manufacturer
Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali, 1
20148 Milan
Italy

This medicinal product is authorized in the EEA Member States under the following
names:
Austria: Eligard Depot 45 mg
Belgium: Depot-Eligard 45 mg
Bulgaria: Eligard 45 mg
Cyprus: Eligard
Denmark: Eligard
Estonia: Eligard
Finland: Eligard
France: Eligard 45 mg
Germany: Eligard 45 mg
Ireland: Eligard 45 mg
Iceland: Eligard
Italy: Eligard
Latvia: Eligard 45 mg
Lithuania: Eligard 45 mg
Luxembourg: Depot-Eligard 45 mg
Norway: Eligard
Netherlands: Eligard 45 mg
Poland: Eligard 45 mg
Portugal: Eligard 45 mg
Czech Republic: Eligard
Romania: Eligard 45 mg
Slovakia: Eligard 45 mg
Slovenia: Eligard 45 mg
Spain: Eligard Semestral 45 mg
Sweden: Eligard
Hungary: Eligard 45 mg

The following information is intended for healthcare professionals only:
Remove the medicine from the refrigerator and allow it to reach room temperature approximately 30 minutes before use.
First prepare the patient for injection, then prepare the medicine according to the instructions below. If the medicine is not prepared using the correct technique, it must not be administered, as improper reconstitution may result in lack of clinical efficacy.

Step 1
On a clean work surface, open the tray by peeling off the foil starting from the corners to remove the contents. Discard the desiccant bag.
Remove the pre-connected syringe system (Figure 1.1) from the tray. Open the safety needle packaging (Figure 1.2) by pulling off the paper tab. Note: Syringe A and Syringe B must not yet be aligned.

Figure 1.1 Figure 1.2
Tray contents: pre-connected syringe system Below the tray: safety needle and cap

Step 2
Using index finger and thumb, press the alignment button on the connector (Figure 2) until a click is heard. The two syringes will become aligned. No specific orientation of the pre-connected syringe system is required to activate the connector. Do not bend the syringe system (note that this could cause leakage, as the syringes might partially unscrew).

Step 3
Holding the syringes horizontally, transfer the liquid content of Syringe A into the powder of leuprorelin acetate contained in Syringe B. Mix the product thoroughly for 60 cycles by gently pushing the contents back and forth between the two syringes (one cycle equals one push of the plunger of Syringe A and one push of the plunger of Syringe B), keeping the syringes horizontal, to obtain a homogeneous, viscous solution (Figure 3). Do not bend the syringe system (note that this could cause leakage due to partial unscrewing of the syringes).

When properly mixed, the viscous solution will appear colorless to white to light brown (may have tints ranging from white to pale yellow).
Important: After mixing, proceed immediately to the next steps, as the product becomes increasingly viscous over time. Do not refrigerate the product after mixing.
Caution: The product must be mixed as described; shaking will NOT achieve adequate mixing.

Step 4
After mixing, hold the syringes vertically with Syringe B at the bottom. The syringes must remain firmly connected. Transfer the entire mixed product into Syringe B (the larger syringe) by pushing the plunger of Syringe A while slightly withdrawing the plunger of Syringe B (Figure 4).
Figure 4

Step 5
Ensure the plunger of Syringe A is fully depressed. Hold the connector and unscrew it from Syringe B. Syringe A will remain attached to the connector (Figure 5). Make sure no product leaks out, as this would prevent secure needle attachment.
Caution: Small air bubbles or one larger bubble may remain in the formulation – this is acceptable.
Avoid removing air bubbles from Syringe B at this stage, as product loss may occur!
Figure 5

Step 6

• Hold Syringe B vertically and hold back the white plunger to prevent product from leaking out.
• Attach the safety needle to Syringe B by holding the syringe steady and gently rotating the needle clockwise by approximately three-quarters of a turn until securely fastened (Figure 6). Do not force, as cracks may form at the needle hub, leading to product leakage during injection. The safety shield may also be damaged if the needle is over-tightened.

Do not use the product if the needle hub appears damaged, leaks, or shows cracks. Do not replace the damaged needle and do not inject the product. Immediately dispose of the entire product safely.
If the needle hub is damaged, use a new ELIGARD kit.

Step 7
Remove the safety shield from the needle and remove the protective cap before administration (Figure 7).
Important: Do not manipulate the safety needle mechanism before administration. If the needle hub appears damaged or leaking, the product must NOT be used. The damaged needle must NOT be replaced and the product must NOT be injected. In case of damage to the needle hub, use another ELIGARD kit.
Figure 7

Step 8
Before administration, remove large air bubbles from Syringe B. Administer the product subcutaneously, keeping the safety shield away from the needle.
Administration procedure:

• Select an injection site on the abdomen, upper buttocks, or another area with adequate subcutaneous tissue that is free from excessive pigmentation, nodules, lesions, or hair, and has not been recently used.

• Clean the injection site area with an alcohol swab (not included). Using thumb and index finger, pinch and lift the skin around the injection site.
• Using the dominant hand, quickly insert the needle at a 90° angle to the skin surface. The depth of penetration will depend on the amount and fullness of subcutaneous tissue and the needle length. After inserting the needle, release the skin.

• Inject the medication by applying slow, steady pressure and push the plunger until the syringe is empty. Ensure that the entire amount of product in Syringe B is injected before removing the needle. Withdraw the needle rapidly at the same 90° angle used for insertion, maintaining pressure on the plunger.

Step 9
After injection, lock the safety shield using one of the activation methods described below.

5. Closing on a flat surface

Press the safety shield, levering downwards, onto a flat surface (Figure 9a)
to cover the needle and lock the shield in place.
Check that it has locked by listening for a click sound and/or feeling it with your fingers.
Once locked, the shield will completely cover the needle tip.

6. Closing with your thumb

Place your thumb on the safety shield (Figure 9b), cover the needle tip and lock the shield in place.
Check that the shield is securely locked by listening for and feeling a "click" with your fingers. Once locked, the shield will completely cover the needle tip.
Figure 9a Figure 9b
Closing on a flat surface Closing with your thumb

Once the needle shield is locked, immediately dispose of the needle and syringe in the appropriate sharps container.