Suprefact Depot

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Package leaflet: Information for the user

Suprefact Depot9.45 mg Implant

Buserelin

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Suprefact Depot is and what it is used for

What you need to know before you use Suprefact Depot

How to use Suprefact Depot

Possible side effects

How to store Suprefact Depot

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 a medicine called buserelin. Buserelin is similar to a natural hormone released by the brain. It belongs to a group of medicines called ‘luteinizing-hormone-releasing hormones analogues’ (LHRH analogues).

How Suprefact Depot works

It works by lowering the amount of hormones which promote prostate tumour growth. Prostate is a gland that lies underneath the bladder of men.

What Suprefact Depot is used for

Suprefact Depot is used to treat advanced prostate cancer.

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

Do not use Suprefact Depot :

If you are allergic to buserelin, to other LHRH analogues (e.g. leuprolide, goserelin, triptorelin) or any of the other ingredients of this medicine (listed in section 6).

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

Do not have this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before starting treatment with Suprefact Depot.

Warnings and precautions

Talk to your doctor or pharmacist before using Suprefact Depot:

If you have had your testicles removed.
If your cancer has spread (metastatic cancer). At first, it is important for you to use another medicine to lower certain hormones. However, this can cause tumour pain, if this happens ask your doctor or pharmacist.
If you are having problems passing water (urine).
If you have risk factors for cardiovascular disease or diabetes.
If you have any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions. The risk of heart rhythm problems may be increased when using Suprefact Depot.
If you have diabetes. Check your blood sugar levels regularly. This is because Suprefact Depot can affect your metabolism and therefore your blood sugar levels.
If you have high blood pressure. You should get your doctor or nurse to regularly check your blood pressure. This is because it can be affected by Suprefact Depot.
If you have ever had depression. You should closely monitor your mental condition because there is a risk that your depression may recur or worsen.
If you have a decrease in the number of red blood cells or experience increased tiredness (anaemia).

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Suprefact Depot.

Your physician should require that your bone density be monitored and may prescribe appropriate treatment. This is because the use of LHRH analogues can cause a decrease in bone density, osteoporosis (weakening of the bones) and an increased risk of bone fractures, particularly if you have risk factors for osteoporosis such as chronic alcohol abuse, smoking, a family history of osteoporosis, or are on long term therapy with anticonvulsants or corticosteroids.

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

Other medicines and Suprefact Depot

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This is because Suprefact Depot can affect the way some medicines work. Also some other medicines can affect the way Suprefact Depot works.

In particular, talk to your doctor:

If you are taking medicines for diabetes. This is because Suprefact Depot can affect the way these medicines work, which can lead to worsening of your diabetes.
If you are using medicines to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol).

If you are using some other medicines that might increase the risk of heart rhythm problems when used with Suprefact Depot (e.g. methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics used for serious mental illnesses).
Pregnancy and breast-feeding

Suprefact Depot is a medicine that is only used in men. It must not be used in women.

Driving and using machines

You may experience side effects after taking this medicine. Some of these side effects (such as dizziness) can affect you being able to concentrate and your reaction speed. If this happens, be careful while driving, using any tools or machines or during any work that requires a high level of attention.

3. How to use Suprefact Depot

The content of one pre-filled syringe (three rod-shaped implants to give a dose of 9.45 mg of buserelin) is injected under the skin (subcutaneous) in the stomach area, every 3-months. This can be extended to an additional three weeks.
The site of the injection will be cleaned. The injection would normally be given by a doctor or a nurse. A local anaesthetic may then be given to ease the pain of the implant injection.
Follow your doctor's advice on when you should have Suprefact Depot and the time between each injection.

Blood tests

Your doctor will need to give you regular blood tests to check whether this medicine is working.

If you are given more Suprefact Depot than you should

It is unlikely that your doctor or nurse will give you too much medicine. Having too much of this medicine can make you feel weak, nervous, dizzy or sick (nausea). You may also experience headaches, hot flushes, stomach pain, swelling (oedema) of the ankles and lower legs, and pain in your breasts, or reactions at the injection site.

Your doctor may give you appropriate treatment for these side effects.

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

4. Possible side effects

Like all medicines, this medicinecan cause side effects, although not everybody gets them.

If you experience any side effect it is important that you inform your doctor before your next treatment.

If you experience severe allergic reaction such as shortness of breath or shock, please contact your doctor immediately as it may become necessary to have your implant removed.

Side effects that may occur at the start of your treatment

At the beginning of treatment the amount of sex hormones that your body produces may increase and you may notice a temporary worsening of symptoms. For example, you may suffer from bone pain, muscle weakness in the legs, trouble in passing urine, fluid retention or blood clotting disorders in the lungs. Usually you will be given another medicine, for example cyproterone acetate, to prevent this. This additional medicine must be continued for 3-4 weeks after receiving Suprefact Depot. After this time the testosterone levels have usually fallen into the desired range in response to Suprefact Depot.

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a

few days:

Common (may affect up to 1 in 10 people):

Loss of sexual drive (libido)
Inability to sustain an erection
Headache
Hot flushes
Shrinking of your testicles (called ‘testicular atrophy’)
Pain or other local reactions at the injection site (such as reddening or swelling)
Mood changes, depression (long term use)

Uncommon (may affect up to 1 in 100 people):

Allergic reactions such as skin rash which may be red and itchy (including urticaria)
Feeling drowsy or tired
Feeling dizzy
Constipation
Enlargement of your breasts
Build up of fluid (oedema) around your ankles and the lower parts of your legs
An increase in the enzymes produced in your liver shown up in the results of some blood tests
Weight change
Mood changes, depression (short term use)

Rare (may affect up to1 in 1,000 people):

Severe allergic reactions such as shortness of breath
Feeling nervous, stressed and emotionally unstable. Also, difficulty sleeping and memory or concentration problems
Fast or uneven heartbeats (palpitations), rise in blood pressure in people who already have high blood pressure (hypertension)
Feeling sick (nausea), being sick (vomiting) or diarrhoea
Change in the amount of hair on your body or head
Changes in blood lipids and increase in bilirubin shown up in the results of some blood tests

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

Severe allergic reactions with shock
Increased thirst, changes in appetite, lowering of your glucose tolerance levels (in diabetic patients it may lead to a loss of diabetic control)
Ringing in your ear (tinnitus), changes in your hearing
Changes to your eyesight such as blurred vision and a feeling of pressure behind your eyes
Discomfort or pain in the muscles or skeletal system
Deterioration of general well-being
Lowering in the number of blood cells which may lead to blood test abnormality and/or bruising

Increase in size of ‘benign’ tumours in the pituitary gland or temporary increase in tumour pain
Not known (frequency cannot be estimated from the available data):

Changes in ECG (QT prolongation).

Abnormal skin sensations like tingling has been observed with other buserelin formulations.

This group of medicines (called LH-RH analogues) can cause a lowering in bone density, osteoporosis and an increased risk of bone fractures. The chance of you getting bone fractures increases with the length of treatment. LH-RH analoguesmay increase the risk of cardiovascular disease (such as heart attack and stroke), diabetes or anaemia (decrease in the number of red blood cells that makes you feel tired).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Suprefact Depot

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 pack after EXP.
The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Suprefact Depot contains

The active ingredient of Suprefact Depot is buserelin. Each pre-filled syringe contains three rod‑shaped implants to give a dose of 9.9 mg buserelin acetate. This is equivalent to 9.45 mg buserelin.

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

What Suprefact Depot looks like and contents of the pack

One pack contains 1 or 2 sterile pre-filled syringes.
Each syringe contains three creamy-coloured rod-shaped implants.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

[To be completed nationally]

Manufacturer

Sanofi-Aventis Deutschland GmbH,

Industriepark Höchst, (Bruningstrasse 50),

65926 Frankfurt am Main, Germany

This medicinal product is authorised in the Member States of the EEA 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 pour voie sous-cutanée

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

Spain: Suprefact Depot 9.45 mg Implante Subcutaneo

Sweden: Suprefact Depot 9.45 mg implantat

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

This leaflet was last revised in 25 June 2015

Other sources of information

Detailed information on this medicine is available on the web site of: {name of MS/Agency}

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The following information is intended for healthcare professionals only:

1 NAME OF THE MEDICINAL PRODUCT

Suprefact Depot 9.45 mg implant, for subcutaneous route

2 POSOLOGY AND METHOD OF ADMINISTRATION

A syringe contains 3 implant-rods, are injected beneath the skin of the abdomen every three month. It is important to maintain a three-month dosage interval, however, injection interval may be occasionally extended by up to three weeks. A local anaesthetic can be given before the injection.

N.B. In order to prevent the implants rods from falling out of the injection needle (A), hold the applicator vertically with the injection needle pointing upwards until immediately before the injection.

A Injection needle

B Protective cap of needle

C Plunger

D Implant

E Protective cover of plunger

After opening the packaging and removing the applicator from the wrapping, check that the implant rods are visible in the window in the handle. If necessary, tap the protective cap over the injection needle lightly with the finger to reposition them in the window. The applicator should be used immediately after opening the wrapping.

Disinfect the injection site in the area of the lateral abdominal wall. First remove the protective cover (E) from the plunger then remove the protective cap (B) from the injection needle.

Lift a fold of skin and insert the injection needle approximately 3 cm (somewhat more than 1 inch) into the subcutaneous tissue. Keep the applicator in a horizontal position or with the injection needle pointing upwards until just before the injection. Remove the applicator 1-2 cm prior to injecting the implant rods.

Inject the implant rods into the subcutaneous tissue by fully pushing the plunger. Compress the injection channel whilst withdrawing the injection needle so that the implant rods are retained in the tissue.

To ensure that the three implant rods have been injected, check that the tip of the plunger is visible at the tip of the injection needle.

It is recommended that administration of an anti-androgen is started as adjunctive therapy about 5 days before starting Suprefact Depot.

3 PHARMACEUTICAL PARTICULARS

3.1 List of excipients

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

3.2 Incompatibilities

Not applicable as product is presented in a special applicator.

3.3 Shelf‑life

3 years

3.4 Special precautions for storage

Do not store above 30°C.

3.5 Nature and content of container

Pre-filled syringe containing a rod-shaped implant consisting of three rods in a disposable applicator made of cellulose propionate and stainless steel sealed in a bag made of a polyethylene terephthalate, aluminium, low density polyethylene composite foil.

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

Not all pack sizes may be marketed.