Prospect: information for the user

Eligard trimestral 22.5 mg

powder and solvent for injectable solution

Leuprorelin, acetate.

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

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

3. How to use Eligard trimestral

4. Possible adverse effects

5. Storage of Eligard trimestral

6. Contents of the package and additional information

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

Eligard trimestralis used to treatmetastatic hormone-dependent prostate cancerin adult males and for the treatment of high-risk non-metastatic hormone-dependent prostate cancer in combination with radiation therapy.

No use Eligard trimestral

• If you are a woman or a child.
• If you are hypersensitive (allergic) to the active ingredient leuprolide acetate, to drugs with a comparable activity to the natural gonadotropin-releasing hormone or to any of the other components of Eligard trimestral (listed in section 6).
• After surgical removal of your testicles, since in that case Eligard trimestral does not lead to an additional decrease in serum testosterone concentrations.
• As a single treatment if you suffer from symptoms related to spinal cord pressure or a spinal column tumor. In this case, Eligard trimestral may only be used in combination with other drugs for prostate cancer.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Eligard trimestraltrimestral

• Si padece: cualquier alteración cardiaca o de los vasos sanguíneos, incluidos los problemas de ritmo cardiaco (arritmias), o si está siendo tratado con medicamentos para corregir estas alteraciones. El riesgo de problemas de ritmo cardiaco puede verse aumentado con la utilización deEligard trimestral.
• If you have difficulty urinating. You must be closely monitored during the first weeks of treatment.
• If you start to experience spinal cord pressure or difficulty urinating. Since severe cases (related to other drugs with a similar mechanism of action to Eligard trimestral) of spinal cord pressure and narrowing of the channels between the kidneys and the urinary bladder have been reported, which may contribute to the appearance of symptoms similar to paralysis. If these complications occur, standard treatment should be initiated.
• If you experience, within two weeks of taking Eligard trimestral, sudden headache, vomiting, alteration of mental state and sometimes heart collapse, inform your doctor or medical team. Rarely, these cases have been reported with OTHER MEDICATIONS that have a similar mechanism to Eligard trimestral, and are known as pituitary apoplexy.
• If you suffer from diabetes mellitus (high blood glucose levels). You should be controlled frequently during treatment.
• The treatment with Eligard trimestral may increase the risk of fractures due to osteoporosis (bone density decrease).
• Cases of depression have been reported in patients using Eligard trimestral. If you are using Eligard trimestral and start to feel a depressive mood, inform your doctor.
• Cases of cardiovascular effects have been reported in patients using similar drugs to Eligard trimestral, which is unknown if they are related to these drugs. If you are using Eligard trimestral and start to experience signs or symptoms of cardiovascular effects, inform your doctor.
• Cases of epileptic seizures have been reported in patients after administration of Eligard trimestral. If you are using Eligard trimestral 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 leuprolide. Discontinue the use of leuprolide 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 beginning 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 also to the appearance of new symptoms that had not been experienced until then. These symptoms include especially bone pain, urinary disorders, spinal cord pressure or presence of blood in the urine. These symptoms usually subside as treatment continues. If symptoms do not subside, you should contact your doctor.

If you do not improve with Eligard trimestral

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

Use of Eligard trimestral with other medications

This medication may interfere with some medications 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 certain medications (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 medication, including those acquired without a prescription.

Pregnancy and lactation

This medication is contraindicated in women.

Driving and operating machines

Drowsiness, dizziness and visual disturbances are possible side effects of treatment with Eligard trimestral or may appear due to the disease. If you experience these adverse effects, be careful when driving or operating machines.

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 administered onceevery three 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 three months.

Additional tests

Your doctor should review the response to treatment with this medication by checking specific clinical values and determining the blood concentrations of the called prostate-specific antigen (PSA).

Administration form

This medication must only be administered by yourdoctorornurse. They will be responsible for its preparation.

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

If you receive more Eligard quarterly than you should

Since your doctor or qualified personnel will normally 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 as necessary or consult the Toxicological Information Service. Phone 91 562 04 20.

If you forget to administer Eligard quarterly

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

Effects when treatment with Eligard quarterly 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, a worsening 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 medicines, Eligard quarterly may cause side effects, although not everyone will experience them.

The side effects observed during treatment with Eligard quarterly are mainly attributed to the specific effect of the active ingredient, leuprorelin 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 quarterly, specific symptoms of the disease may worsen because there is a brief increase in male sex hormone, testosterone, in the blood. 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 quarterly, Complications at the beginning of treatment).

Local side effects

The local side effects described after the injection of Eligard quarterly 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, redness of the skin
• 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 (also at night), difficulty starting to urinate, pain while urinating, reduced urine volume
• Breast tenderness, breast inflammation, decreased testicular size, testicular pain, infertility, erectile dysfunction, reduced penis size
• Rigidity (exaggerated tremors with high fever), weakness
• Prolonged bleeding time, changes in blood values, decreased 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
• Loss of hair, 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 electrocardiogram (prolongation of QT interval)
• Pneumonitis, pulmonary 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).
• Redness of the skin 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 leuprorelin, the active ingredient of Eligard quarterly, 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, loss of memory, and vision deterioration. It can be expected that there will be an increase in bone tissue loss (osteoporosis) after prolonged treatment with Eligard quarterly. 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 quarterly.

Cerebral seizures have been reported after administration of products of the same class as Eligard quarterly.

Reporting of side effects

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

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 the original packaging to protect it from moisture.

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 Trimestral packaging

Unused or expired medications should not be flushed down the drain or thrown away. Dispose of 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. This will help protect the environment.

Composition of Eligard Trimestral

The active ingredient is leuprorelin acetate.

A preloaded syringe (syringe B) contains 22.5 mg of leuprorelin acetate.

The other components are polylactic-co-glycolic acid (75:25) and N-methyl-2-pyrrolidone in the preloaded syringe with injectable solution (syringe A).

Appearance of Eligard Trimestral and packaging contents

Powder and solvent for injectable solution.

It is available in the following packaging:

• A thermoformed tray-type packaging and a sterile 20-gauge needle inserted in a cardboard support. The tray contains a desiccant bag and a preconnected syringe system consisting of:
• syringe A preloaded with the solvent
• syringe B preloaded with the powder

a connector with a latch button for syringe A and B.

• A multiple packaging containing 2 kits with 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 more information about this medication, 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 medication is authorized in the member states of the European Economic Area with the following names:

Austria:Eligard Depot 22.5 mg

Belgium:Depo-Eligard 22.5 mg

Cyprus:Eligard

Czech Republic:Eligard

Denmark:Eligard

Estonia:Eligard

Finland:Eligard

France:Eligard 22.5 mg

Germany:Eligard 22.5 mg

Hungary:Eligard 22.5 mg

Iceland:Eligard

Ireland:Eligard 22.5 mg

Italy:Eligard

Latvia:Eligard 22.5 mg

Lithuania:Eligard 22.5 mg

Luxembourg:Depo-Eligard 22.5 mg

Netherlands:Eligard 22.5 mg

Norway:Eligard

Poland:Eligard 22.5 mg

Portugal:Eligard 22.5 mg

Slovakia:Eligard 22.5 mg

Slovenia:Eligard 22.5 mg

Spain:Eligard Trimestral 22.5 mg

Sweden:Eligard

Last review date of this leaflet: 10/2024

For detailed and updated information about this medication, 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 medication 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 medication following the instructions below. If the medication 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 latch 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 medication 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 by pressing the contents 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 medication 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 medication once reconstituted.

Please note: The medication 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, short 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 if it is.

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 medication will be lost!

Step 6

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

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

Do not overtighten, as the cone of the needle may crack and medication 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 used, and the medication should not be injected. All components of the administration device should be disposed of safely.

If the cone of the needle is damaged, a new medication should be replaced.

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 to be damaged or has leaks, the product should not be used. The damaged needle should not be replaced, and the medication should not be injected. In case of needle damage, use another ELIGARD kit.

Step 8

Before administration, purge any large air bubbles from syringe B. Administer the medication 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, nodular, or damaged, 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-degree 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 medication slowly and steadily, pressing the plunger until the syringe is empty. Ensure that the entire amount of medication from syringe B is injected before removing the needle.
• Remove the needle quickly at the same 90-degree angle used for insertion while maintaining pressure on the plunger.

Figure 8

Step 9

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

1. Closure on 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 tip of the needle.

1. Closure with your thumb

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

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

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