2583 12.01.15[6]

Prostap® 3 DCS 11.25 mg Powder and Solvent for Prolonged-release Suspension for Injection in Pre-filled Syringe

(leuprorelin acetate)

PATIENT INFORMATION LEAFLET

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.

-    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    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.

Your medicine will be referred to as PROSTAP 3 throughout the following leaflet.

In this leaflet:

1.    What PROSTAP 3 is and what it is used for

2.    What you need to know before you use PROSTAP 3

3.    How to take PROSTAP 3

4.    Possible side effects

5.    How to store PROSTAP 3

6.    Contents of the pack and other information

1.    WHAT PROSTAP 3 IS AND WHAT IT IS USED FOR

PROSTAP 3 is a synthetic hormone which can be used to reduce the levels of testosterone and estrogen circulating in the body.

PROSTAP 3 is used to treat prostate cancer in men and endometriosis in women.

The safety and efficacy of PROSTAP 3 in children has not yet been established.

2.    WHAT YOU NEED TO KNOW BEFORE YOU USE PROSTAP 3

PROSTAP 3 is not recommended for use in children under the age of 18 years.

Do not take PROSTAP 3:

-    If you are allergic (hypersensitive) to leuprorelin acetate (PROSTAP SR or PROSTAP 3) or any of the other ingredients of PROSTAP 3 (listed in section 6).

-    If you are pregnant, planning to become pregnant or are breastfeeding.

-    If you have abnormal vaginal bleeding which you have not discussed with your doctor.

Warnings and Precautions:

Both men and women:

-    If you are diabetic PROSTAP 3 can aggravate existing diabetes therefore diabetes patients may need more frequent monitoring of the blood glucose levels.

-    If you have diabetes or suffer from heart problems you should tell your doctor.

-    If you are at an increased risk of thinning of the bones (osteoporosis) you should tell your doctor before taking PROSTAP 3. Risk factors include:

-    If you or any of your close family have thinning of the bones.

-    If you drink excessive amounts of alcohol, and/or smoke heavily.

-    If you take drugs for epilepsy or have taken steroids such as hydrocortisone or prednisolone for a long time.

-    There have been reports of depression in patients taking PROSTAP 3 which may be severe. If you are taking PROSTAP 3 and develop depressed mood, inform your doctor.

Women only:

-    If you are a woman with submucous fibroids (benign tumours in the muscle underneath the lining of the womb), PROSTAP 3 can cause severe bleeding when the fibroids break-down.

Contact your doctor immediately if you experience severe or unusual bleeding or pain.

-    If you are a woman and continue to have periods (menstruate) after starting treatment with PROSTAP 3 you should tell your doctor.

-    If you are a woman of child-bearing age, you should use non hormonal contraception whilst receiving PROSTAP 3. Although PROSTAP 3 causes periods to stop, it is not itself a contraceptive. If you are unsure about this talk to your doctor.

Men only:

-    In the rare event of an abscess occurring at the injection site your doctor may measure your testosterone levels as there could be reduced absorption of leuprorelin from the injection site.

-    If you are a man with urinary obstruction or spinal cord compression.

Your doctor will supervise you closely for the first few weeks of treatment.

-    If you are a man with prostate cancer, and have had injections of a synthetic hormone in the past that has not worked, or you have had an operation to remove your testicles you should tell your doctor.

-    Please tell your doctor if you have any of the following: 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 PROSTAP 3.

Other medicines and PROSTAP 3

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

PROSTAP 3 might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or might increase the risk of heart rhythm problems when used with some other drugs (e.g. methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics used for serious mental illnesses).

PROSTAP 3 with food and drink

PROSTAP 3 can be taken with or without food.

Pregnancy and breastfeeding

You should not take PROSTAP 3 if you are pregnant, planning to become pregnant or are breastfeeding.

Driving and using machines

Do not drive or operate machinery if you experience drowsiness, dizziness or visual disturbances whilst being treated with PROSTAP 3.

3.    HOW TO TAKE PROSTAP 3

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.

If you have endometriosis you will be given an injection of PROSTAP 3 for a period of 6 months only and treatment will be initiated during the first five days of the menstrual cycle.

If you miss an injection

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

Women only:

If a PROSTAP 3 injection is missed, breakthrough bleeding or ovulation may occur with the potential for conception. If you think you may be pregnant you should stop using PROSTAP 3 and contact your doctor immediately.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, PROSTAP 3 can cause side effects, although not everybody gets them.

Contact your doctor immediately or go to hospital:

-    If you develop a severe rash, itching or shortness of breath or difficulty breathing. These could be symptoms of a severe allergic reaction.

Tell your doctor:

-    If you get a severe headache which does not get better when you take painkillers.

-    If you suffer from any unexplained bruising or bleeding or feel generally unwell whilst taking PROSTAP 3. Although rare, these could be symptoms of changes in the number of red or white blood cells.

If any of the following side effects get serious, or if you notice any side effects not listed in this leaflet, speak to your doctor or pharmacist:

Both men and women:

-    PROSTAP 3 can sometimes cause swelling in your ankles, tiredness, nausea or headaches. The treatment may cause pain in the joints, anaemia, fever or chills, dizziness, vomiting, loss of appetite, diarrhoea, pounding heartbeats, tingling in the hands or feet, muscle aching or weakness, mood changes, depression, altered vision, changes in weight, jaundice, abnormalities in liver function, thinning of bones, increase in blood pressure, difficulty sleeping, blood clots in the lungs, spinal fracture, paralysis or low blood pressure. Skin reactions at the injection site have been reported rarely following injection of leuprorelin. These include: skin hardening, redness, pain, abscesses, swelling, nodules, ulcers and skin damage.

-    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 an existing pituitary lesion, there may be an increased risk of loss of blood to the area, which may cause permanent damage.

-    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.

Men only:

-    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, weakness or loss of feeling in your legs or difficulty passing urine, contact your doctor immediately.

-    PROSTAP 3 can cause a loss of interest in sexual intercourse, hot flushes and occasionally it may cause a reduction in size and function of the testes or swelling of the breasts.

-    Frequency unknown: changes in ECG (QT prolongation).

MANUFACTURER AND PRODUCT LICENCE HOLDER

Manufactured by

Abbott Laboratories S.A., Apartado De Correos, 967, Avenida De Burgos, 91, Madrid, E-28050, Spain.

AbbVie Logistics B.V., Meeuwenlaan 4, 8011 BZ Zwolle, The Netherlands.

Procured from within EU by Product Licence holder: Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.

Leaflet revision and issue date (Ref): 12.01.15[6]

Prostap is a trademark of Takeda Pharmaceutical Company Limited.

Women only:

- In women PROSTAP 3 may cause hot flushes and vaginal dryness. 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.

Additional Effects in Children:

- In children PROSTAP 3 may cause abdominal pain/abdominal cramps, acne, vaginal bleeding, spotting, discharge or injection site reactions. Very rarely general allergic reactions (fever, rash, itching or a serious allergic reaction which causes difficulty in breathing or dizziness) may occur.

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects, you can help provide more information on the safety of this medicine.

5.    HOW TO STORE PROSTAP 3

Keep out of the sight and reach of children Do not store above 25^oC.

Do not refrigerate or freeze.

Store in the original container in order to protect from light.

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

Once mixed with the Sterile Solvent, the suspension must be used immediately.

If the pack has been opened or damaged, return it to your pharmacist. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION What PROSTAP 3 contains:

The active ingredient in PROSTAP 3 Powder is leuprorelin acetate (11.25 mg)

Leuprorelin acetate 11.25 mg equivalent to 10.72 mg leuprorelin base. When reconstituted with the solvent, the solution contains 11.25 mg/ml of leuprorelin acetate.

The other ingredients are:

Powder- polylactic acid, mannitol

Sterile solvent- carboxymethylcellulose sodium, mannitol, polysorbate 80, glacial acetic acid (for pH adjustment) and water for injections.

What PROSTAP 3 looks like and contents of the pack:

One dual chamber pre-filled syringe with a needle and needle cap containing a white powder in the front chamber and 1 ml of sterile solvent (clear liquid) in the rear chamber, with a red end stopper.

The pack also contains 1 x syringe plunger and 1 x alcohol swab.