Prospect: information for the user

Eligard semestral 45 mg

powder and solvent for injectable solution

Leuprorelin, acetate.

1. What is Eligard semestral and for what it is used

2. What you need to know before starting to use Eligard semestral

3. How to use Eligard semestralEligard semestral

4. Possible adverse effects

5. Storage of Eligard semestral

6. Contents of the package and additional information

The active ingredient of Eligard semestral belongs to the group of gonadotropin-releasing hormone analogs. These medications are used to reduce the production of certain sex hormones (testosterone).

Eligard semestral is used to treatmetastatic hormone-dependent prostate cancerin adult males and hormone-dependent non-metastatic high-risk prostate cancer in combination with radiation therapy.

No use Eligard semestral

• If you are awoman or a child.
• If you areallergic to the active ingredient leuprorelin, or to other medicines with a similar mechanism of action to Eligard semestral (see section 6).
• After surgical removal of your testicles, as Eligard semestral will not lead to a further decrease in serum testosterone levels.
• As a single treatment if you experience symptoms related to spinal cord compression or a spinal tumor. In this case, Eligard semestral may only be used in combination with other medicines for prostate cancer.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting Eligard semestral

• If you have: any heart or blood vessel disorder, including heart rhythm problems (arrhythmias), or if you are being treated with medicines to correct these disorders. The risk of heart rhythm problems may be increased with the use of Eligard semestral.
• If you havedifficulty urinating. You should be closely monitored during the first weeks of treatment.

• Ifyou experience spinal cord compression or difficulty urinating. As severe cases (related to other medicines with a similar mechanism of action to Eligard semestral) of spinal cord compression and narrowing of the urethra have been reported, which may contribute to the development of symptoms similar to paralysis. If these complications occur, standard treatment should be initiated.
• If you experience, within two weeks of taking Eligard semestral, sudden headache, vomiting, altered mental state, and sometimes heart collapse, inform your doctor or medical team. Rarely, these cases have been reported with OTHER MEDICINES that have a similar mechanism to Eligard semestral, and are known as pituitary apoplexy.

• If you suffer fromdiabetes mellitus(high blood glucose levels). You should be closely monitored during treatment.
• The treatment with Eligard semestral may increase the risk of fractures due to osteoporosis (bone density decrease).
• Cases of depression have been reported in patients using Eligard semestral. If you are using Eligard semestral and start to experience a depressive mood, inform your doctor.
• Cases of cardiovascular effects have been reported in patients using similar medicines to Eligard semestral, it is unknown if they are related to these medicines. If you are using Eligard semestral and start to experience signs or symptoms of cardiovascular effects, inform your doctor.
• Cases of epileptic seizures have been reported in patients after the administration of Eligard semestral. If you are using Eligard semestral and start to experience epileptic seizures, inform your doctor.
• Contact your doctor immediately if you experience intense or recurrent headaches, visual problems, and tinnitus or buzzing.
• You have fatty liver.

Cases of severe skin eruptions, including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/NET) have been reported in association with leuprorelin. Discontinue the use of leuprorelin and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Complications at the start of treatment

During the first week of treatment, a brief increase in blood testosterone levels is usually observed. This may lead to a temporary worsening of symptoms related to the disease and the appearance of new symptoms that had not been experienced until then. These symptoms include, in particular, bone pain, urinary disorders, spinal cord compression, or presence of blood in the urine. These symptoms usually resolve as treatment continues. If symptoms do not resolve, contact your doctor.

If Eligard semestral does not improve

A proportion of patients will have tumors that are not sensitive to the decrease in serum testosterone levels. If you feel that the effect of Eligard semestral is not as expected, inform your doctor.

Use of Eligard semestral with other medicines

This medicine may interfere with some medicines used to treat heart rhythm disorders (e.g. quinidine, procainamide, amiodarone and sotalol) or may increase the risk of heart rhythm disorders when used with certain medicines (e.g. methadone (used for pain relief and as part of drug detoxification), moxifloxacino (an antibiotic), antipsychotics used for severe mental illnesses).

Inform your doctor or pharmacist if you are using or have recently used any other medicine, including those purchased without a prescription.

Pregnancy and breastfeeding

This medicine is contraindicated in women.

Driving and operating machinery

Drowsiness, dizziness, and visual disturbances are possible side effects of treatment with Eligard semestral or may occur due to the disease. If you experience these adverse effects, exercise caution when driving or operating machinery.

Dosage

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Unless your doctor prescribes otherwise, this medication is administeredonceeverysix months.

The injected solution forms a depot of active principle from which a continuous release of the active principle, leuprorelin acetate, occurs over a period of six months.

Additional tests

The response to treatment with this medication should be reviewed by your doctor by checking specific clinical values and determining the blood concentrations of the so-called prostate-specific antigen (PSA).

Administration form

This medicationshould only beadministered by yourdoctorornurse.They will be responsible for its preparation.

After preparation, Eligard semestral is administered as a subcutaneous injection (injection into the tissue under the skin). The intraarterial (into an artery) or intravenous (into a vein) injection should be avoided entirely. As with other active principles injected subcutaneously, the injection site should be changed periodically.

If you receive more Eligard semestral than you should

Since your doctor or qualified personnel will usually administer the injection, it is not expected that an overdose will occur.

If an amount greater than expected has been administered, contact your doctor for special monitoring and administration of additional treatment if necessary, or consult the Toxicological Information Service. Phone 91 562 04 20.

If you forget to administer Eligard semestral

Talk to your doctor if you think you have forgotten your semestral medication administration.

Effects when treatment with Eligard semestral is interrupted

As a general rule, treatment of prostate cancer with this medication is prolonged. Therefore, treatment should not be interrupted even if symptoms improve or disappear completely.

If treatment with this medication is interrupted prematurely, an aggravation of symptoms related to the disease may occur.

Do not interrupt treatment prematurely without consulting your doctor first.

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

Like all medications, Eligard semestral may cause side effects, although not everyone will experience them.

The side effects observed during treatment with Eligard semestral are mainly attributed to the specific effect of the active ingredient, leuprorelina acetate, specifically the increase and decrease of certain hormones. The most frequently described side effects are hot flashes (approximately 58% of patients), nausea, general discomfort, and fatigue, as well as temporary local irritation at the injection site.

Side effects at the beginning of treatment

During the first weeks of treatment with Eligard semestral, specific symptoms of the disease may worsen because there is a brief increase in male sex hormone, testosterone, in the blood at the beginning. Therefore, your doctor may administer an appropriate antiandrogen (a substance that inhibits the effect of testosterone) in the initial phase of treatment to reduce any undesirable effects.(See also Section 2 Before using Eligard semestral, Complications at the beginning of treatment).

Local side effects

The local side effects described after the injection of Eligard semestral are typically those that are often associated with similar preparations that are injected subcutaneously (preparations that are injected into the tissue under the skin). Mild burning immediately after injection is very frequent. Itching and pain after injection, as well as redness at the injection site are frequent. Redness of the skin at the injection site has been frequently reported. Hardening of tissues and ulceration are infrequent.

These local side effects after subcutaneous injection are mild and have been described as having a brief duration. They do not recur between individual injections.

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

• Hot flashes
• Spontaneous bleeding in the skin or mucous membrane, skin redness
• Fatigue, injection-related side effects(See also local side effects above)

Common side effects (may affect up to 1 in 10 people)

• Nasopharyngitis (common cold symptoms)
• Nausea, general discomfort, diarrhea, stomach and intestinal inflammation (gastroenteritis/colitis)
• Itching, night sweats
• Joint pain
• Irregular urination, difficulty starting to urinate, pain while urinating, reduced urine volume
• Breast tenderness, breast inflammation, testicular size reduction, testicular pain, infertility, erectile dysfunction, penile size reduction
• Rigidity (exaggerated tremors with high fever), weakness
• Prolonged bleeding time, changes in blood values, low red blood cell count

Rare side effects (may affect up to 1 in 100 people)

• Urinary tract infection, local skin infection
• Worsening of diabetes mellitus
• Abnormal dreams, depression, decreased libido
• Dizziness, headache, skin sensitivity disorders, insomnia, taste disorder, smell disorder
• Hypertension (increased blood pressure), hypotension (decreased blood pressure)
• Shortness of breath
• Constipation, dry mouth, indigestion (bad digestion, stomach fullness, stomach pain, belching, nausea, vomiting, burning sensation in the stomach), vomiting
• Heat sensation, increased sweating
• Lower back pain, muscle cramps
• Blood in urine
• Urinary spasms, frequent urination, inability to urinate
• Male breast enlargement, impotence
• Somnolence, pain, fever
• Weight gain
• Loss of balance, dizziness
• Loss of muscle mass/loss of muscle tissue after prolonged use

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

• Abnormal involuntary movements
• Sudden loss of consciousness, fainting
• Flatulence, belching
• Hair loss, skin rash (grains on the skin)
• Chest pain
• Ulceration at the injection site

Very rare side effects (may affect up to 1 in 10,000 people)

• Necrosis at the injection site

Not known (frequency cannot be estimated from available data)

• Changes in the electrocardiogram (prolongation of the QT interval)
• Pulmonary inflammation, lung disease
• Idiopathic intracranial hypertension (increased intracranial pressure around the brain characterized by headaches, double vision, and other visual symptoms, tinnitus or ringing in one or both ears)
• If you notice circular or target-shaped red patches on your trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• Skin redness and rash with itching (toxic skin eruption)
• A skin reaction that causes red spots or patches on the skin, which may resemble a target, with a dark red center surrounded by lighter red rings (erythema multiforme)

Other side effects

Other side effects reported in relation to treatment with leuprorelina, the active ingredient of Eligard semestral, are edema (accumulation of fluid in the tissue, appearing as swelling of hands and feet), pulmonary embolism (produces symptoms such as shortness of breath, difficulty breathing, and chest pain), palpitations (perception of heartbeats), muscle weakness, chills, skin rash, memory loss, and vision deterioration. It can be expected that there will be an increase in bone tissue loss (osteoporosis) after prolonged treatment with Eligard semestral. Due to osteoporosis, the risk of fractures increases.

Rarely, severe allergic reactions have been reported that cause difficulty breathing or dizziness after administration of products of the same class as Eligard semestral.

Seizures have been reported after administration of products of the same class as Eligard semestral.

Reporting of side effects

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

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Conservation Instructions

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

Store in original packaging to protect it from humidity.

This product must be at room temperature before injection. Remove from refrigerator approximately 30 minutes before use. Once out of the refrigerator, this product can be stored in its original packaging at room temperature (below 25°C) for up to 4 weeks.

Once the tray has been opened, the product must be prepared immediately and used immediately. Single use only.

Instructions for the disposal of unused or expired Eligard semestral packaging

Unused or expired medications should not be disposed of through drains or trash. Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Eligard Semiannual

The active ingredient is leuprorelin acetate.

A preloaded syringe (syringe B) contains 45 mg of leuprorelin acetate.

The other components are poly (DL-lactide-co-glycolide) (85:15) and N-methyl-2-pyrrolidone in the preloaded syringe with injectable solution (syringe A).

Appearance of Eligard Semiannual and packaging contents

Powder and injectable solution solvent.

It is available in the following packaging:

• A thermoformed tray-type packaging and a sterile 18-gauge needle inserted into a cardboard support. The tray containsa desiccant bag and a preconnected syringe system that consists of:

• syringe A preloaded with the solvent
• syringe B preloaded with the powder with a connector with a button for attaching syringe A and B

• A multiple packaging that contains 2 kits of the preconnected syringe system.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Recordati Industria Chimica e Farmaceutica S.p.A.

Via Matteo Civitali, 1

20148 Milan

Italy

Responsible for Manufacturing

Recordati Industria Chimica e Farmaceutica S.p.A.

Via Matteo Civitali, 1

20148 Milan

Italy

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Casen Recordati, S.L.

Autovía de Logroño, km 13,300

50180 Utebo - Zaragoza

Spain

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Austria:Eligard Depot 45 mg

Belgium:Depo-Eligard 45 mg

Bulgaria:Eligard 45 mg

Cyprus:Eligard

Czech Republic:Eligard

Denmark:Eligard

Estonia:Eligard

Finland:Eligard

France:Eligard 45 mg

Germany:Eligard 45 mg

Hungary:Eligard 45 mg

Iceland:Eligard

Ireland:Eligard 45 mg

Italy:Eligard

Latvia:Eligard 45 mg

Lithuania:Eligard 45 mg

Luxembourg:Depo-Eligard 45 mg

Netherlands:Eligard 45 mg

Norway:Eligard

Poland:Eligard 45 mg

Portugal:Eligard 45 mg

Romania:Eligard 45 mg

Slovakia:Eligard 45 mg

Slovenia:Eligard 45 mg

Spain:Eligard semiannual 45 mg

Sweden:Eligard

Last update of this leaflet: 10/2024

For detailed and updated information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/

This information is intended for healthcare professionals only:

Wait for the medicinal product to reach room temperature by removing it from the refrigerator approximately 30 minutes before use.

Please prepare the patient for the injection first, then prepare the medicinal product following the instructions below. If the medicinal product is not prepared using the correct technique, it should not be administered, as it may result in clinical ineffectiveness due to incorrect reconstitution.

Step 1

In a clean area, open the tray by removing the aluminum by the corner to remove the contents. Discard the desiccant bag. Remove the preconnected syringe system (Figure 1.1) from the tray. Open the safety needle package (Figure 1.2) by removing the paper tab. Note:thesyringe A and syringe Bshould not be aligned yet.

Step 2

Hold the button of the connector with your index and thumb and press (Figure 2) until you hear a click. The two syringes will be aligned. No particular orientation of the syringe system is required to activate the connector. Do not twist the syringe system (please note that some of the medicinal product may be lost if the syringes are partially disengaged).

Step 3

Hold the syringes in a horizontal position, transfer the liquid content of syringe A to the leuprorelin acetate powder contained in syringe B. Mix the product well for 60 cycles by pressing the content of both syringes forward and backward between the two syringes (one cycle is a stroke of the plunger for syringe A and a stroke of the plunger for syringe B) in a horizontal position to obtain a homogeneous and viscous solution (Figure 3). Do not twist the syringe system (please note that some of the medicinal product may be lost if the syringes are partially disengaged).

When well mixed, the viscous solution will have a color within the range of colorless to white-yellowish (which may include shades from white to yellowish).

Important: after mixing, proceed to the next step immediately as the viscosity of the product increases over time. Do not refrigerate the medicinal product once reconstituted.

Please note: The medicinal product must be mixed as described; shaking will not obtain an adequate mix.

Step 4

After mixing, hold the syringes vertically with syringe B at the bottom. The syringes must remain well engaged. Transfer all the content to syringe B (wide syringe) by pressing the plunger of syringe A and slightly retracting the plunger of syringe B (Figure 4).

Step 5

While ensuring that the plunger of syringe A is completely pressed down, hold the connector and disengage it from syringe B. Syringe A will remain attached to the connector (Figure 5). Ensure that no content is lost as the needle will not fit properly when attached.

Please note: In the preparation, a large air bubble or several small ones may remain - this is acceptable.Please do not purge the air bubbles from syringe B at this time, as some medicinal product will be lost!

Step 6

• Hold syringe B in a vertical position and keep the white plunger back to prevent medicinal product loss.

• Attach the safety needle to syringe B by holding the syringe and turning the needle clockwise, approximately three-quarters of a turn, until the needle is securely attached (Figure 6).

Do not over-tighten, as the needle cone may crack and some medicinal product may be lost during injection. The safety needle cap may also be damaged if the needle is screwed on too tightly.

The damaged needle should not be replaced or substituted, and the medicinal product should not be injected. All elements of the administration device should be disposed of safely.

If the needle cone is damaged, a new medicinal product should be used.

Step 7

Immediately beforeadministration, remove the safety needle cover and remove the protective cap from the needle (Figure 7).

Important: Do not manipulate the safety needle mechanism before administration. If the needle appears damaged or has leaks, the product should not be used. The damaged needle should not be replaced, and the medicinal product should not be injected. In case of needle damage, use another ELIGARD kit.

Step 8

Before administration, purge any largeair bubblefrom syringe B. Administer the medicinal product subcutaneously while keeping the safety needle cover away from the needle.

Administration procedure:

• Choose an injection site in the abdomen, the upper part of the buttocks, or another area with sufficient subcutaneous tissue that is not excessively pigmented, has no nodules, lesions, or hair, and has not been used recently.
• Clean the area around the injection site with an alcohol wipe (not included).
• Using your thumb and index finger, pinch and gather the skin around the injection site.
• Using your dominant hand, insert the needle quickly at a 90° angle to the skin surface. The depth of penetration will depend on the amount and thickness of the subcutaneous tissue and the length of the needle. After inserting the needle, release the skin.
• Inject the medicinal product slowly and steadily by pressing the plunger until the syringe is empty. Ensure that the entire medicinal product is injected before removing the needle.
• Remove the needle quickly at the same 90° angle used for insertion while maintaining pressure on the plunger.

Figure 8

Step 9

After injection, block the safety mechanism using one of the activation methods mentioned below.

1. Close over a flat surface

Press the safety cover down with the slider against a flat surface (Figure 9a) to cover the needle and block the cover.

Verify the blocking position by an audible and tactile "click". The blocking position will completely cover the needle tip.

1. Close with your thumb

By placing your thumb over the safety cover (Figure 9b), cover the needle tip and block the cover.

Verify the blocking position by an audible and tactile "click". The blocking position will completely cover the needle tip.

Once the safety cover is blocked, immediately dispose of the needle and syringe in an authorized sharp container.