Takeda UK Ltd

PATIENT INFORMATION LEAFLET

Prostap* SR 3.75mg

Powder and solvent for prolonged-release suspension for injection

Leuprorelin Acetate

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 INJECTION?

Each pack contains a vial of PROSTAP SR powder containing 3.75mg of leuprorelin acetate and a separate syringe containing 1ml of Sterile Solvent. When reconstituted, the vial contains 3.75mg/ml leuprorelin acetate.

The Sterile Solvent is a clear liquid which is mixed with the PROSTAP SR powder before injection.

The active ingredient in PROSTAP SR powder is leuprorelin acetate. The other ingredients in PROSTAP SR are: gelatin, Copoly (DL-lactic acid/glycolic acid), which control the release of the active ingredient into the body, and mannitol (E421). The Sterile Solvent contains carmellose sodium, mannitol (E421), Polysorbate 80 and Water for Injection.

MARKETING AUTHORISATION HOLDER AND MANUFACTURER

The authorisation holder is:

PROSTAP SR is made by:

The Sterile Solvent is made by

WHAT CAN PROSTAP BE USED TO TREAT?

Leuprorelin is a synthetic hormone which can be used to reduce the levels of testosterone and oestrogen circulating in the body. It is used to treat prostate cancer in men and endometriosis and uterine fibroids in women. It can also be used to prepare the endometrium prior to intrauterine surgical procedures such as endometrial ablation or resection.

BEFORE GIVING 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:

• Are you pregnant, planning to become pregnant or breastfeeding? Although PROSTAP SR causes periods to stop, it is not in itself a contraceptive. You should use contraception, other than the ‘pill’, while you are receiving PROSTAP SR. If you are unsure about this talk to your doctor.
• Do you have unusual vaginal bleeding which you have not discussed with your doctor?
• 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?
• 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?
• Have you had an allergic reaction to leuprorelin acetate (PROSTAP SR) 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, 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 may make you feel drowsy, your ability to drive or operate machinery may be affected.

This medicinal product contains 0.54mg of sodium per dose, i.e. essentially ‘sodium free’.

HOW IS THE MEDICINE GIVEN?

The doctor or nurse will give you an injection of PROSTAP SR. The injection will normally be given in your arm, thigh or abdomen. You will normally be given an injection once a month. The injection site should be varied at regular intervals. If you are to be given PROSTAP SR prior to intrauterine surgery you will receive a single injection 5-6 weeks before your surgery.

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, 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, PROSTAP SR may cause unwanted effects (side effects) in some people. Most people do not have side effects but if you develop any unusual side effects or any side effects that bother you, speak to your doctor or pharmacist.

PROSTAP SR 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. It can also 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

Takeda UK Limited. 30 June 2009

blood pressure, or difficulty sleeping. Sometimes PROSTAP SR causes redness or discomfort at the place where the injection is given.

Blood sugar levels may be altered during treatment with PROSTAP SR 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 SR.

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 SR.

PROSTAP SR can infrequently cause blood clots in the lungs.

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.

As can happen naturally when women reach the menopause, PROSTAP SR can cause osteoporosis, or thinning of the bones, which in women can be irreversible. This can lead to an increased risk of fractures, including the spine.

When men with prostate cancer first start treatment with PROSTAP SR, levels of testosterone can increase and in some people this may cause a temporary increase in local pain. To prevent this from happening, your doctor may give you another drug such as cyproterone acetate or flutamide for three days before and a few weeks after you have your first PROSTAP SR injection. If you do get a worsening pain, loss of feeling in your legs or difficulty passing urine, speak to your doctor. PROSTAP SR may cause hot flushes and a loss of libido. Occasionally it may cause testicular atrophy or tenderness of the breasts.

In women PROSTAP SR may cause hot flushes, mood changes or vaginal dryness. It may cause a change in breast size or breast tenderness and can occasionally cause hair loss.

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

OTHER INFORMATION

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

PROSTAP SR and PROSTAP Sterile Solvent should not be used after the expiry date printed on the vial label, syringe label and carton.

PROSTAP SR should be stored below 25°C in the original container in order to protect from light. Keep out of reach and sight of children.

This leaflet does not contain the complete information about your medicine. If you have any questions or you are not sure about anything you should ask your doctor or pharmacist who can give you more information. The information in this leaflet applies only to PROSTAP SR.

The Product Authorisation number in Ireland is: PA 1547/3/1 (Packs containing 1ml Sterile Solvent).