Suprefact Depot 9.45 mg implant

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Suprefact Depot 9.45 mg implant

Buserelin

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

Contents of the leaflet

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

1. What Suprefact Depot is and what it is used for

What Suprefact Depot is

Suprefact Depot contains an active substance called buserelin. Buserelin is similar to a hormone naturally produced in the brain. It belongs to a group of medicines known as "gonadotropin-releasing hormone analogues" (GnRH analogues).

How Suprefact Depot works

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

What Suprefact Depot is used for

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

2. What you need to know before starting Suprefact Depot

Do not use Suprefact Depot:

• if you are allergic to buserelin, to other LHRH analogues (for example leuprorelin, goserelin, triptorelin) or to any of the other ingredients of this medicine (listed in section 6).

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 medicine if any of the above apply to you. If you are unsure, consult 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 has spread (metastatic cancer). Initially, it is important for you to use another medicine to reduce levels of certain hormones. However, this may cause tumour pain; if this occurs, consult your doctor or pharmacist
• you have difficulty urinating
• you have risk factors for cardiovascular disease or diabetes
• you have a condition affecting the heart or blood vessels, or are being treated for such a condition, including medicines to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when using Suprefact Depot
• you have diabetes. Monitor your blood sugar levels regularly, because Suprefact Depot affects metabolism and therefore your blood sugar levels
• you have high blood pressure. Your doctor or nurse should monitor your blood pressure regularly, because Suprefact Depot affects blood pressure
• you have ever had depression. You should carefully monitor your mental state, as there is a risk that depression may reappear or worsen
• you have a reduced number of red blood cells or feel increased fatigue (anaemia).

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 analogues may cause a decrease in bone density, osteoporosis (weakening of the bones), and an increased risk of bone fractures, especially if you have risk factors such as chronic alcoholism, smoking, a family history of osteoporosis, or long-term treatment with anticonvulsants or corticosteroids.

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

Other Suprefact Depot medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines purchased without a prescription and herbal remedies. This is because Suprefact Depot may affect how these medicines work. Other medicines may also affect how Suprefact Depot works.

In particular, consult your doctor:

• if you are taking medicines for diabetes. This is because Suprefact Depot may affect how these medicines work, which could lead to worsening of diabetes.
• if you are taking medicines used to treat heart rhythm problems (for example: quinidine, procainamide, amiodarone, and sotalol). This is because Suprefact Depot may interfere with these medicines.
• if you are taking other medicines (for example: methadone (used for pain relief and detoxification from other drugs), moxifloxacin (an antibiotic), antipsychotics (used for serious mental illnesses)). This is because Suprefact Depot may increase the risk of heart rhythm problems when used together with these medicines.

Pregnancy, lactation and fertility

Suprefact Depot is a medication intended for use only by men. It must not be used by women.

Driving and using machines

After taking this medicinal product, you may experience adverse effects. Some of these adverse effects (such as, for example, dizziness) may affect your ability to concentrate and your reaction time. If this occurs, exercise caution when driving, operating tools or machinery, or performing any task requiring a high level of attention.

3. How to use Suprefact Depot

The contents of a pre-filled syringe (containing 3 cylindrical implants with a total dose of 9.45 mg of buserelin) are injected under the skin (subcutaneously) in the abdominal area every 3 months. This interval may be extended by up to 3 additional weeks.

The injection site should be disinfected. Normally, the injection should be administered by a doctor or nurse. Before use, the implant should be at room temperature. A local anesthetic may be applied to relieve injection discomfort. 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 whether this medicine 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 required. If an excessive dose is used, you may experience weakness, nervousness, dizziness, or nausea. You may also experience headache, hot flushes, stomach pain, swelling (edema) in the ankles and legs, breast enlargement, or reactions at the injection site.

Your doctor will provide appropriate treatment for these adverse effects.

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

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

4. Possible adverse effects

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

If you experience any adverse effects, it is important that you inform your doctor before your next treatment with Suprefact Depot.

If you experience a severe allergic reaction such as difficulty breathing or shock, please contact your doctor immediately, as removal of the implant may be necessary.

Adverse effects that may occur at the beginning of your treatment

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

Tell your doctor or pharmacist if any of the following adverse effects are severe or last for more than a few days:

Frequent (may affect up to 1 in 10 patients)

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

Uncommon (may affect up to 1 in 100 patients)

• Allergic reactions such as skin rashes which may be red and itchy (including urticaria)
• Feeling of drowsiness and fatigue
• Dizziness
• Constipation
• Breast enlargement
• Fluid accumulation (edema) around the ankles and legs
• Increase in liver enzymes, evident in certain blood test results
• Changes in body weight
• Mood changes, depression (with short-term treatment)

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

• Severe allergic reactions such as shortness of breath
• Feelings of nervousness, stress, and emotional instability. In addition, difficulty sleeping and problems with memory or concentration
• Rapid or irregular heartbeat (palpitations), increased blood pressure in people who already have high blood pressure (hypertension)
• Dizziness (nausea and vomiting) or diarrhea
• Increase or decrease in body hair and hair growth
• Changes in blood lipids and increased bilirubin, evident in certain blood test results

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

• Severe allergic reactions with shock
• Increased thirst, changes in appetite, reduced glucose tolerance (in diabetic patients, this may lead to loss of diabetic control)
• Ringing in the ears (tinnitus) and hearing disorders
• Vision disturbances such as blurred vision and sensation of pressure in the eye
• Discomfort or pain in muscles and bones
• Deterioration of general well-being
• Decrease in blood cells, which could lead to abnormalities in blood test results and/or bruising (contusions)
• Increase in 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 electrocardiogram (ECG) (prolongation of QT interval)

With other formulations containing buserelin, abnormal skin sensations 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 likelihood 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 (reduction in red blood cells causing fatigue).

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Suprefact Depot

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicine and its packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Suprefact Depot

The active substance in Suprefact Depot is buserelin. Each pre-filled syringe contains 1 implant composed of 3 cylinders, with a final dose of 9.9 mg of buserelin acetate. This corresponds to 9.45 mg of buserelin.

The other component is Poly (D, L-lactic-co-glycolic acid) with a 75:25 ratio of lactic to glycolic acid.

Appearance of the product and contents of the pack

One pack contains 1 or 2 sterile, pre-filled syringes.

Each syringe contains 3 cream-colored cylindrical implants.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer

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

Austria: Suprefact Depot - Implantat Für 3 Monate
Belgium: Suprefact Depot 9.45 mg Implant
Denmark: Suprefact Depot
Finland: Suprefact Depot 9.45 mg implantaatti
France: Trigonist 9.45 mg implant for subcutaneous use
Germany: Profact Depot 9,45 mg 3-Monatsimplantat
Italy: Suprefact depot 3 Mesi
Luxembourg: Suprefact Depot 9.45 mg Implant
Netherlands: Suprefact Depot 3 Maanden, implantatiestift 9.45 mg
Portugal: Suprefact Depot 3 Meses
Sweden: Suprefact Depot 9.45 mg implantat
United Kingdom: Suprefact Depot 9.45 mg implant, for subcutaneous route

Date of the most recent review of this leaflet: June 2015

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

This information is intended for healthcare professionals only.

1 NAME OF THE MEDICINAL PRODUCT

Suprefact Depot 9.45 mg implant, for subcutaneous use

2DOSAGE AND METHOD OF ADMINISTRATION

A pre-filled syringe with 1 implant contains 3 cylinders, which are injected under the skin of the abdomen every three months. It is important to maintain a regular administration schedule every three months; however, the injection interval may occasionally be extended up to 3 weeks. Prior to injection, a local anesthetic may be administered.

Before use, the implant must be at room temperature.

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

A: Needle
B: Needle protective cap
C: Plunger
D: Implant
E: Plunger protective sheath

1. After opening the case and removing the applicator from its packaging, check that the 3 implant cylinders are positioned in the viewing window of the applicator. If necessary, gently tap the syringe's protective cap with your finger to reposition them into the viewing window. Once the packaging is opened, the applicator must be used immediately.

1. Disinfect the injection site located on one side of the abdominal wall. First remove the plunger protective sheath (E), then remove the injection needle protective cap (B).

1. Pinch a skin fold and insert the needle approximately 3 cm (a little over one inch) into the subcutaneous tissue. Hold the applicator horizontally just before puncture, or with the needle tip slightly oriented upwards. Retract the applicator approximately 1–2 cm before injecting the cylinders.

1. Inject the three implant cylinders into the subcutaneous tissue by fully depressing the plunger. Compress the puncture site while withdrawing the needle so that the 3 implant cylinders remain in place within the tissue.

1. To ensure that all three implant cylinders have been injected, verify that the end of the plunger is visible at the tip of the needle.

Administration of an antiandrogen is recommended 5 days prior to starting treatment with Suprefact Depot.

3PHARMACEUTICAL DATA

3.1 List of excipients

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

3.2 Incompatibilities

Not applicable, as the product is supplied in a special applicator.

3.3 Shelf life

3 years.

3.4 Special storage precautions

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

3.5 Nature and contents of the container

Pre-filled syringe containing a cylindrical implant composed of three cylinders, housed in a disposable applicator made of cellulose propionate and stainless steel, sealed in a laminate pouch composed of polyethylene terephthalate, aluminum, and low-density polyethylene.

Pack sizes: 1 or 2 pre-filled syringes per package.

Only certain pack sizes may be commercially available.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/