Takeda UK Ltd

PATIENT INFORMATION LEAFLET

Prostap 3* 11.25mg

Powder and solvent for prolonged release suspension for injection

Leuprorelin Acetate 3 Month Depot Injection

This leaflet provides information about your medicine. Please read it carefully. If you have any questions or there is anything you do not understand you should ask your doctor or pharmacist (chemist).

WHAT IS IN PROSTAP 3 INJECTION?

Each pack contains a vial of PROSTAP 3 Powder containing 11.25mg of the active ingredient, leuprorelin acetate (equivalent to 10.72mg base), and a separate syringe containing 2ml of Sterile solvent.

The Sterile solvent is a clear liquid which is mixed with the PROSTAP 3 Powder before injection.

The other ingredients in PROSTAP 3 are: poly (D,L-lactic acid), which controls the release of the active ingredient into the body, and mannitol. The Sterile solvent contains carmellose sodium, mannitol, polysorbate 80 and water for injections.

PRODUCT AUTHORISATION HOLDER AND MANUFACTURER

The authorisation holder is:

PROSTAP 3 is made by:

The Sterile solvent is made by:

WHAT CAN PROSTAP 3 BE USED TO TREAT?

PROSTAP 3 is a synthetic hormone analogue which can be used to reduce the levels of testosterone and oestrogen circulating in the body. PROSTAP 3 is used to treat prostate cancer in men and endometriosis and uterine fibroids in women.

BEFORE HAVING THIS MEDICINE

If the answer to any of the following questions is “yes” you should tell your doctor as this medicine may not be suitable for you.

For women:

• Are you pregnant, planning to become pregnant or breastfeeding? Although PROSTAP 3 causes periods to stop, it is not in itself a contraceptive. You should use contraception, other than the ‘pill’, while you are receiving PROSTAP 3. If you are unsure about this talk to your doctor.
• Do you have unusual vaginal bleeding which you have not discussed with your doctor?

For men:

• If you have prostate cancer, have you had injections of a synthetic hormone in the past that has not worked or have you had an operation to remove your testicles?

Both:

• Do you or any of your close family have thinning of the bones (osteoporosis)?
• Do you take any drugs for epilepsy or have you taken steroids such as hydrocortisone or prednisolone for a long time?
• Have you had an allergic reaction to leuprorelin acetate (PROSTAP 3) in the past?
• Are you taking any other medicines including those that you have bought without a prescription?
• Are you diabetic?
• Do you suffer from urinary obstruction or spinal cord compression?

When men with prostate cancer first start treatment with PROSTAP 3, they may experience a temporary “tumour flare” which can make the present symptoms of prostate cancer worse. In some men this may cause a temporary increase in local pain and they can experience difficulty in passing urine. These symptoms usually subside on continuation of therapy.

As PROSTAP 3 may make you feel drowsy, your ability to drive or operate machinery may be affected.

HOW IS THE MEDICINE GIVEN?

The doctor or nurse will give you an injection of PROSTAP 3. The injection will normally be given in your arm, thigh or abdomen. The injection site should be varied at regular intervals. You will normally be given an injection once every 3 months.

As soon as you realise you have missed an injection, contact your doctor who will be able to give you your next injection.

If you suspect that you have injected too much PROSTAP 3, it is important that you contact your doctor immediately.

AFTER BEING GIVEN THIS MEDICINE

If you develop a severe rash, itching, shortness of breath or difficulty breathing, speak to your doctor immediately.

As with all medicines, as well as helping with your illness, PROSTAP 3 can cause unwanted effects (side effects).

If you develop any side effects that bother you, speak to your doctor or pharmacist.

PROSTAP 3 can sometimes cause swelling in your ankles, tiredness, nausea or headaches. If you get a severe headache which does not get better when you take painkillers you should speak to your doctor. The treatment may cause pain in the joints, fever or chills, dizziness, vomiting, loss of appetite, diarrhoea, pounding heartbeats, tingling in the hands or feet, muscle aching or weakness, altered vision, changes in weight, increase in blood pressure, or difficulty sleeping. Sometimes PROSTAP 3 causes redness or discomfort at the place where the injection is given.

Blood sugar levels may be altered during treatment with PROSTAP 3 which may affect control in diabetic patients and require more frequent monitoring. If you have a blood test, your doctor may notice a change in blood lipid (cholesterol) levels or in values for tests on how the liver is working. These changes do not usually cause any symptoms.

If you suffer from depression, this may become worse when receiving PROSTAP 3.

Rarely changes in the number of red or white blood cells have been reported. You should therefore inform your doctor if you suffer from any unexplained bruising or bleeding or feel generally unwell whilst taking PROSTAP 3.

If you have an existing pituitary lesion, there may be an increased risk of local bleeding or loss of blood supply to the area, which may cause permanent damage.

When men with prostate cancer first start treatment with PROSTAP 3, levels of testosterone can increase and in some people this may cause a temporary increase in local pain. In some cases, to prevent this from happening, your doctor may give you another type of drug such as cyproterone acetate or flutamide before and just after your first PROSTAP 3 injection. If you do get worsening pain, loss of feeling in your legs or difficulty passing urine, contact your doctor. PROSTAP 3 can cause hot flushes and a loss of interest in sexual intercourse. Occasionally it may cause testicular atrophy or swelling of the breasts.

In women PROSTAP 3 may cause hot flushes, mood changes, vaginal dryness, and spotting/breakthrough bleeding may occur. It may cause a change in breast size or breast tenderness and can occasionally cause hair loss. As can happen naturally when women reach the menopause, PROSTAP 3 can cause a small amount of bone thinning.

In some women with fibroids, PROSTAP 3 may cause bleeding or pain when the fibroids break down. Contact your doctor immediately if you experience severe or unusual bleeding or pain.

OTHER INFORMATION

Keep out of reach and sight of children.

Do not use this medicine after the date stated on the packaging.

PROSTAP 3 should be stored below 25°C (room temperature) and stored in the original package in order to protect from light.

PROSTAP 3 is for single use only and is to be used immediately after reconstitution, shaking before use. When PROSTAP 3 is reconstituted with the Sterile solvent, it produces a cloudy suspension. Do not use PROSTAP 3 if it does not match this description.