7.5 mg powder and solvent for injection, solution 
leuprorelin

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor, pharmacist, or nurse.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In 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 ingredients information

1. What Eligard is and what it is used for

The active substance in Eligard belongs to the group of drugs gonadotropin-releasing hormones. These drugs are used to inhibit the production of certain sex hormones ( testosterone ).

Eligard is used for the treatment of metastatic hormone-dependent prostate cancer in adult men and the treatment of non-metastatic hormone-dependent prostate cancer of the high-risk type in combination with radiation therapy.

2. What you need to know before using Eligard

Do not use Eligard:

  • If you are a woman or a child
  • If you are allergic (hypersensitive) to the active substance leuprorelin acetate, to substances affecting comparable to the naturally occurring hormone et gonadotropin or any of the other ingredients of Eligard (listed in section 6).
  • If your testicles have been surgically removed, as Eligard does not affect in these cases.
  • If you have Eligard as the only treatment and you get pressure on the spinal cord or a tumor in the spinal cord. In these cases, Eligard must be supplemented with other drugs in the treatment of prostate cancer.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Eligard

  • If you have any of the following: Cardiovascular disease, including heart rhythm ( arrhythmia ), or if you take medicine for that. The risk of heart rhythm disorders may be increased when using Eligard.
  • If you have urination problems. You should be checked more often during the first weeks of treatment.
  • If pressure on the spinal cord occurs or if you have difficulty urinating. When other medicines that work in a similar way to Eligard have been taken at the same time, there are reports of severe cases of pressure on the spinal cord and narrowing of the ureter between the kidney and bladder, which can contribute to paralysis symptoms. If these complications occur, standard treatment must be instituted.
  • If you experience sudden headache, vomiting, altered mood, and sometimes heart collapse within two weeks of starting treatment with Eligard, contact your doctor or healthcare professional. These are rare cases of so-called pituitary- stroke, which have been seen with OTHER MEDICINES with similar effects to Eligard.
  • If you have diabetes mellitus (high blood sugar). You should be checked regularly during treatment.
  • Treatment with Eligard may increase the risk of bone fractures due to osteoporosis.
  • Depression has been reported in patients taking Eligard. Tell your doctor if you become depressed while taking Eligard.
  • Cardiovascular disease has been reported in patients taking drugs similar to Eligard. It is unknown if it is related to these drugs. Tell your doctor if you develop symptoms or signs of cardiovascular disease while taking Eligard.
  • Convulsions have been reported in patients following the administration of Eligard. If you are taking Eligard and develop seizures, tell your doctor.

Complications when starting treatment

During the first few weeks of treatment, the levels of testosterone in the blood usually increase temporarily. This can lead to the temporary worsening of disease-related symptoms and also the emergence of new symptoms that have not been experienced before. Symptoms that can especially occur are skeletal pain, urination problems, pressure on the bone marrow, and blood in the urine. These symptoms usually disappear with continued treatment. If the symptoms do not go away, contact your doctor.

If Eligard has no effect

Some patients have tumors that are not susceptible to decreased testosterone levels. Tell your doctor if you feel that Eligard is not having enough effect.

Other drugs and Eligard

Eligard may affect some other medicines used to treat heart rhythm disorders (eg quinidine, procainamide, amiodarone,e, and sotalol) or may increase the risk of heart rhythm disorders when used with other medicines (eg methadone (used for pain and in case of treatment of drug dependence), moxifloxacin (an antibiotic ), antipsychotics (used for severe mental illness)).

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

Pregnancy and breastfeeding

Eligard is not for women.

Driving and using machines

Fatigue, dizziness, and visual disturbances are possible side effects of treatment with Eligard or may be a consequence of the disease. If you are bothered by these side effects, be careful when driving or using machines.

3. How to use Eligard

Dosage

Always use Eligard exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Unless your doctor prescribes otherwise, Eligard 7.5 mg is given once a month.

The injected solution forms a depot with an active substance under the skin from which a continuous release of the active substance leuprorelin acetate takes place for one month.

Additional tests

Eligard treatment should be monitored by your doctor by measuring specific clinical values ​​and by measuring the levels in the blood of so-called prostate-specific antigen(PSA).

Method of administration

Eligard should only be given by your doctor or nurse who is also prescribing the medicine.

After preparation should ELIGARD is administered as a subcutaneous injection ( injection just under the skin). Intraarterial- (in an artery ) or intravenous (into a vein) injection should be carefully avoided. As with other subcutaneous injections, the injection site should be varied over time.

If you use more Eligard than you should

As the injection is usually administered by your doctor or appropriately trained healthcare professional, no overdose is expected.

If a larger amount than intended is still administered, your doctor will monitor you specifically and give you additional treatment as needed.

If you forget to use Eligard

Ask your doctor if you think your injection has been forgotten.

If you stop using Eligard

As a rule, long-term treatment with Eligard is required for prostate cancer. Therefore, treatment should not be stopped even if the symptoms improve or disappear completely.

If treatment with Eligard is stopped prematurely, a worsening of disease-related symptoms may occur.

You should not stop treatment too early without first consulting your doctor.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Eligard can cause side effects, although not everybody gets them.

Side effects that have been experienced during treatment with Eligard are mainly caused by the specific effects of the active substance leuprorelin acetate, such as raising and lowering certain hormones. The most commonly described side effects are hot flashes (approximately 58% of patients), nausea, malaise, and fatigue as well as transient local irritation at the injection site.

A side effect when depositing

During the first few weeks of treatment with Eligard, disease-related symptoms may increase, as there is usually a transient increase in testosterone levels in the blood at the beginning of treatment. Your doctor may therefore want to give you a suitable anti-androgen (a substance that inhibits the effect of testosterone) at the beginning of treatment to reduce any side effects (see also section 2. What you need to know before using Eligard, Complications when starting treatment ).

Local side effect ar

The local side effects described after injection with Eligard are typically those commonly seen with similar subcutaneously injected medicines (medicines injected just under the skin). A slight burning sensation shortly after injection is very common. Tingling and pain at the injection site after injection are common, as are bruising and redness of the skin. Hardening of tissues and wounds is uncommon.

The local side effects after a subcutaneous injection are mild and are described as transient. The side effects do not occur between injections.

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

  • Hot flashes
  • Spontaneous bleeding in the skin and mucous membranes, redness
  • Fatigue, injection site reactions (see also Local side effects above)

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

  • Inflammation of the nose and throat (cold symptoms)
  • Nausea, malaise, diarrhea, gastrointestinal inflammation (gastroenteritis/colitis)
  • Itching, night sweats
  • Joint pain
  • Irregular urination (even at night), difficulty urinating, pain when urinating, decreased urine output
  • Sore breasts, swollen breasts, reduced testicles (loss), testicular pain, infertility, erection problems, decreased penis size
  • Stiffness (periods of excessive shaking and high fever), weakness
  • Prolonged bleeding time, altered blood values, low number of red blood cells

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

  • Urinary tract infections, local skin infections
  • Exacerbation of diabetes
  • Abnormal dreams, depression, decreased sex drive
  • Dizziness, headache, altered sensitivity to touch, insomnia, effects on the sense of taste and smell
  • High blood pressure, low blood pressure
  • Respiratory distress
  • Constipation, dry mouth, indigestion, vomiting
  • Stickiness, increased sweating
  • Back pain, muscle cramps
  • Blood in the urine
  • Bladder cramps may go to the toilet more often than usual, inability to urinate
  • Enlargement of male breast tissue, impotence
  • Drowsiness, pain, fever
  • Weight gain
  • Balance disturbance, fraud
  • Muscle loss/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
  • Gases in the stomach, belching
  • Hair loss, skin rash
  • Chest pain
  • Sores at the injection site

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

  • Tissue death at the injection site

Has been reported (occurs in an unknown number of users)

  • Changes ( QT prolongation) in ECG ( electrocardiogram )
  • Inflammation of the lungs, lung disease

Other side effects ar

Other side effects that have been described in the literature in connection with leuprorelin, the active substance in Eligard, are edema (accumulation of fluid, which leads to swollen hands and feet), pulmonary embolism (causes symptoms such as shortness of breath, difficulty breathing, and chest pain), palpitations, muscle weakness, chills, rash, impaired memory, and impaired vision. Increased signs of decreased bone tissue (osteoporosis) can be expected after long-term treatment with Eligard. Due to osteoporosis, the risk of fractures increases.

Severe allergic reactions, which cause difficulty breathing or dizziness, have been reported in rare cases after administration with drugs in the same class of drugs as Eligard.

Seizures have been reported after the administration of drugs in the same drug class as Eligard.

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 expiration date is the last day of the specified month.

Storage

Store in a refrigerator (2 ° C – 8 ° C).

Store in the original package. Moisture sensitive.

The product should reach room temperature before injection. Remove from the refrigerator about 30 minutes before use. Once removed from the refrigerator, the product can be stored in its original packaging at room temperature for up to 4 weeks (below 25 ° C).

Once any of the tray packages have been opened, the product must be prepared immediately. After reconstitution, the product should be used immediately. For single use only.

Instructions for disposal of unused or expired packaging by Eligard

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is leuprorelin acetate. One pre-filled syringe ( syringe B) contains 7.5 mg leuprorelin acetate.
  • The other ingredients are DL-lactide-glycolide copolymer (50:50) and N-methyl pyrrolidone in a pre-filled syringe with liquid for solution for injection ( syringe A).

What the medicine looks like and the contents of the pack

Eligard is a powder and solvent for solution for injection.

Eligard 7.5 mg is supplied in the following packs:

  • Tray packaging consisting of two molded trays in a cardboard box. One tray contains a pre-filled syringe A, a longer piston rod for syringe B, and a desiccant bag. The second tray contains a pre-filled syringe B, a sterile 20-gauge needle, and a desiccant bag.
  • Multi-pack containing sets of 3 x 2 pre-filled syringes (1 x syringe A, 1 x syringe B).

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Astellas Pharma a / s

Kajakvej 2

2770 Kastrup

Denmark

Manufacturer:

Astellas Pharma Europe BV

Sylviusweg 62

2333 BE Leiden

Netherlands

This medicinal product is authorized under the European Economic Area under the names:

Austria: Eligard Depot 7.5 mg

Belgium: Depo-Eligard 7.5 mg

Bulgaria: Eligard 7.5 mg

Cyprus: Eligard

Czech Republic: Eligard

Denmark: Eligard

Estonia: Eligard

Finland: Eligard

France: Eligard 7.5 mg

Germany: Eligard 7.5 mg

Hungary: Eligard 7.5 mg

Iceland: Eligard

Ireland: Eligard 7.5 mg

Italy: Eligard

Latvia: Eligard 7.5 mg

Lithuania: Eligard 7.5 mg

Luxembourg: Depo-Eligard 7.5 mg

Netherlands: Eligard 7.5 mg

Norway: Eligard

Poland: Eligard 7.5 mg

Portugal: Eligard 7.5 mg

Romania: Eligard 7.5 mg

Slovakia: Eligard 7.5 mg

Slovenia: Eligard 7.5 mg

Spain: Eligard Mensual 7.5 mg


Muhammad Nadeem

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