Label: information for the user

Suprefact Depot 9.45 mg implant

Buserelin

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
  If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is Suprefact Depot and how is it used

2. What you need to know before starting to use Suprefact Depot

3. How to use Suprefact Depot

4. Possible adverse effects

5. Storage of Suprefact Depot

6. Contents of the package and additional information

What is Suprefact Depot

Suprefact Depot contains an active ingredient called buserelin. Buserelin is similar to a hormone that is produced naturally in the brain. It belongs to a group of medicines called “gonadotropin-releasing hormone analogues” (LHRH analogues).

How Suprefact Depot works

It works by reducing the amount of hormones that stimulate the growth of prostate tumor. The prostate is a gland that is located below the bladder in men.

What Suprefact Depot is used for

Suprefact Depot is used for the treatment of advanced prostate cancer.

No use Suprefact Depot:

• If you are allergic to buserelin, other LHRH analogs (for example leuprolide, goserelin, triptorelin), or any of the other components of this medication (listed in section 6).

The symptoms of an allergic reaction may include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.

Do not take this medication if any of the above occurs. If you are unsure, ask your doctor or pharmacist before starting treatment with Suprefact Depot.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Suprefact Depot if:

- you have had your testicles removed

- you have cancer and it is widespread (metastatic cancer). Initially, it is important for you to use another medication to reduce the levels of certain hormones. However, this may cause tumor pain; if this happens, ask your doctor or pharmacist

- you have difficulty urinating

- you have risk factors for cardiovascular disease or diabetes

- you have any heart or blood vessel disease or are being treated for it, including medications to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when using Suprefact Depot

- you have diabetes. Regularly monitor your blood sugar levels. This is because Suprefact Depot affects metabolism and therefore your blood sugar levels

- you have high blood pressure. Your doctor or nurse should regularly monitor your blood pressure. This is because Suprefact Depot affects blood pressure

- you have ever had depression. You should closely monitor your mental state because there is a risk that depression may recur or worsen

- you have reduced red blood cell count or feel an increase in fatigue (anemia).

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before using Suprefact Depot.

Your doctor will monitor your bone density and may prescribe appropriate treatment. This is because the use of LHRH analogs may cause a decrease in bone density, osteoporosis (bone weakening), and an increased risk of bone fractures, especially if you have risk factors such as chronic alcoholism, smoking, or if family members have had osteoporosis, or if you have been on anticonvulsant or corticosteroid medications for a long time.

There have been reports of depression in patients using Suprefact Depot, which may be severe. If you are using Suprefact Depot and develop a depressive mood, inform your doctor.

Other Medications Suprefact Depot

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes over-the-counter medications and herbal remedies. This is because Suprefact Depot may affect how these medications work. Other medications may also affect how Suprefact Depot works.

Particularly, consult your doctor:

- if you are taking medications for diabetes. This is because Suprefact Depot may affect how these medications work, which may lead to worsening of diabetes.

- if you are using medications used to treat heart rhythm problems (for example: quinidine, procainamide, amiodarone, and sotalol). This is because Suprefact Depot may interfere with these medications.

- if you are using other medications (for example: methadone (used for pain relief and detoxification of other medications), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses). This is because Suprefact Depot may increase the risk of heart rhythm problems when used with these medications.

Pregnancy, Breastfeeding, and Fertility

Suprefact Depot is a medication that only men should use. It should not be used by women.

Driving and Operating Machines

After taking this medication, you may experience some adverse effects. Some of these adverse effects (such as dizziness) may affect your ability to concentrate and your reaction time. If this happens, be careful while driving, using tools or machines, or performing any work that requires a high level of attention.

The contents of a preloaded syringe (which contains 3 cylindrical implants with a final dose of 9.45 mg of buserelin) are injected subcutaneously into the abdominal area, every 3 months. This time may be increased by up to 3 weeks.

The injection site must be disinfected. The injection is usually administered by a doctor or nurse. Before use, the implant must be at room temperature. An anesthetic may be applied to alleviate the pain of the implant injection. Follow your doctor's instructions regarding when to use Suprefact Depot and the time interval between each injection.

Blood Tests

• Your doctor will perform blood tests to check if this medication is working properly.

If You Use More Suprefact Depot Than You Should

It is unlikely that your doctor or nurse will administer more medication than you should. If more than the recommended amount is used, you may feel weakness, nervousness, dizziness, or nausea. You may also experience headaches, hot flashes, stomach pain, swelling (edema) in the ankles and legs, breast enlargement, or reactions at the injection site.

Your doctor will provide the necessary treatment for these adverse effects.

In case of overdose, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the side effects, it is essential to inform your doctor before the next treatment with Suprefact Depot.

If you experience any severe allergic reaction such as shortness of breath or shock, please contact your doctor immediately, as it may be necessary to remove the implant.

Side effects that may occur at the beginning of your treatment

At the start of your treatment, you may notice an increase in the amount of sex hormones your body produces, and you may experience a temporary worsening of symptoms. For example, you may experience bone pain, muscle weakness in your legs, urinary problems, fluid retention, or blood clotting problems in the lungs. To prevent this, other medications, such as ciproterone acetate, are usually administered. Treatment with ciproterone should continue for 3-4 weeks after receiving Suprefact Depot.After this time, testosterone levels usually decrease to the desired values in response to Suprefact Depot.

Inform your doctor or pharmacist if any of the following side effects are severe or last more than a few days:

Frequent (may affect up to 1 in 10 patients)

• Loss of sexual desire (libido)
• Difficulty achieving an erection
• Headache
• Hot flashes
• Decreased testicle size (known as testicular atrophy)
• Pain or other reactions at the injection site (such as redness or swelling)
• Mood changes, depression (long-term treatment).

Rare (may affect up to 1 in 100 patients)

• Allergic reactions such as skin rashes that may be red and itchy (including urticaria)
• Sensation of sleepiness and fatigue
• Sensation of dizziness
• Constipation
• Enlargement of the breasts
• Fluid accumulation (edema) around the ankles and legs
• Increased liver enzymes that are evident in some blood test results
• Weight changes
• Mood changes, depression (short-term treatment).

Rare (may affect up to 1 in 1,000 patients)

• Severe allergic reactions such as shortness of breath
• Sensation of nervousness, stress, and emotional instability. Additionally, difficulty sleeping and problems with memory or concentration
• Fast or irregular heartbeats (palpitations), increased blood pressure in people who already have high blood pressure
• Sensation of dizziness (nausea and vomiting) or diarrhea
• Increased or decreased hair and body hair
• Changes in blood lipids and increased bilirubin evident in some blood test results.

Very rare (may affect up to 1 in 10,000 patients)

• Severe allergic reactions with shock
• Increased thirst, changes in appetite, decreased glucose tolerance (in diabetic patients, it may lead to loss of blood sugar control)
• Tinnitus and hearing disorders
• Visual disturbances such as blurred vision and a sensation of pressure in the eye
• Muscle and bone pain
• General feeling of unwellness
• Decreased blood cell count that may cause abnormalities in blood test results and/or hematomas (bruises)
• Increased size of benign tumors in the pituitary gland or temporary increase in tumor pain.

Frequency not known (cannot be estimated from available data)

• Changes in the electrocardiogram ECG (prolongation of the QT interval).

With other presentations containing buserelin, abnormal sensations in the skin, such as tingling, have also been observed.

This group of medicines (known as LHRH analogues) may cause a decrease in bone density, osteoporosis, and an increased risk of bone fractures. The risk of bone fractures increases over the course of treatment. LHRH analogues may increase the risk of cardiovascular disease (such as heart attack and stroke), diabetes, or anemia (decreased red blood cell count causing fatigue).

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, 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:https://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.

Store in refrigerator (between 2°C and 8°C). It can be stored at a maximum temperature of 25 °C for a maximum of 7 days.

Medicines should not be thrown down the drains or in the trash.Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

Composition of Suprefact Depot

The active ingredient of Suprefact Depot is buserelin. Each syringe is preloaded with 1 implant composed of 3 cylinders, with a final dose of 9.9 mg of buserelin acetate. This is equivalent to 9.45 mg of buserelin.

The other component is Poli (D, L-lactide-co-glycolide) with a ratio of 75:25 of lactide-glycolide.

Appearance of the product and contents of the package

A package contains 1 or 2 sterile preloaded syringes.

Each syringe contains 3 cylindrical implants of cream color.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Responsible for manufacturing

Sanofi Aventis Deutschland GmbH

Brüningstraße 50 – Frankfurt am Main

65926 Germany

Local Representative

Laboratorios Rubió, S.A.

Industria, 29

Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria: Suprefact Depot - Implant for 3 months

Belgium: Suprefact Depot 9.45 mg Implant

Denmark: Suprefact Depot

Finland: Suprefact Depot 9.45 mg implant

France: Trigonist 9.45 mg implant for subcutaneous route

Germany: Profact Depot 9.45 mg 3-Months implant

Italy: Suprefact depot 3 Months

Luxembourg: Suprefact Depot 9.45 mg Implant

Netherlands: Suprefact Depot 3 Months, implant 9.45 mg

Portugal: Suprefact Depot 3 Months

Sweden: Suprefact Depot 9.45 mg implant

United Kingdom: Suprefact Depot 9.45 mg implant, for subcutaneous route

Last review date of this leaflet:June 2015

Other sources of information

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

This information is intended solely for healthcare professionals.

1NAME OF THE MEDICINE

Suprefact Depot 9.45 mg implant, for subcutaneous route

2POSOLGY AND ADMINISTRATION ROUTE

One preloaded syringe with 1 implant contains 3 cylinders, which are injected under the skin of the abdomen every 3 months. It is essential to maintain the administration rhythm every 3 months regularly, however, the injection interval may occasionally be prolonged up to 3 weeks. Before injection, a local anesthetic may be administered.

Before use, the implant must be at room temperature.

Warning. To avoid the 3 cylinders of the implant falling from the injection needle (A), keep the applicator in a vertical position until immediately before puncture, with the needle pointing upwards.

A: Needle

B: Protective cap of the needle

C: Plunger

D: Implant

E: Protective cover of the plunger

1. After opening the package and removing the applicator from its container, check that the 3 cylinders of the implant are located in the window of the applicator. If necessary, gently tap the protective cap of the syringe with your finger to relocate them in the window. Once the container is opened, the applicator must be used immediately.

2.Disinfect the injection area located on one side of the abdominal wall. First, remove the protective cover of the plunger (E), and then remove the protective cap of the injection needle (B).

3.Pinch a fold of skin and insert the needle approximately 3 cm (about 1 inch) into the subcutaneous tissue. Keep the applicator in a horizontal position at the moment before puncture or with the tip of the needle slightly oriented upwards. Remove the applicator 1-2 cm approximately, before injecting the cylinders.

4.Inject the 3 cylinders of the implant into the subcutaneous tissue by pushing the plunger completely. Compress the puncture channel while removing the needle so that the 3 cylinders of the implant remain retained in the tissue.

1. To ensure that the 3 cylinders of the implant have been injected, check that the end of the plunger is visible at the end of the needle.

It is recommended to administer an anti-androgen 5 days before starting treatment with Suprefact Depot.

3PHARMACEUTICAL DATA

3.1Excipients list

Poli (D, L-lactide-co-glycolide)

3.2Incompatibilities

Not applicable since the product is presented in a special applicator.

3.3Shelf life

3 years.

3.4Special precautions for storage

Store in the refrigerator (between 2°C and 8°C). It can be stored at a maximum temperature of 25°C for a maximum of 7 days.

3.5Nature and contents of the package

Preloaded syringe with a cylindrical implant composed of 3 cylinders, housed in a disposable applicator made of cellulose propionate and stainless steel sealed in a laminate composed of polyethylene terephthalate, aluminum, and low-density polyethylene.

Presentation: 1 or 2 preloaded syringes per package.

Only some package sizes may be marketed.

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/