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Active substance(s): LEUPRORELIN ACETATE

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ProstapĀ® 3 DCS 11.25 mg Powder and
Solvent for Prolonged-release
Suspension for Injection in Pre-filled
(leuprorelin acetate)
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
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
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
The safety and efficacy of PROSTAP 3 in children has not yet been
PROSTAP 3 is not recommended for use in children under the age of 18
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
- 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
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
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.
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
- 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
- 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
- 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).
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
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
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:
By reporting side effects, you can help provide more information on the
safety of this medicine.
Keep out of the sight and reach of children
Do not store above 25oC.
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
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.
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.

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.

PL 20636/2583

Leaflet revision and issue date (Ref): 12.01.15[6]
Prostap is a trademark of Takeda Pharmaceutical Company Limited.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.