PROSTAP 3 DCS 11.25MG POWDER FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Active substance: LEUPRORELIN ACETATE

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DCS
Leuprorelin acetate depot injection 11.25 mg
PROSTAP® 3 DCS
11.25 mg Powder and Solvent for Prolonged-release Suspension for
Injection in Prefilled Syringe
Leuprorelin acetate
Read all of this leaflet carefully before you start using this
medicine.
• 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 symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What PROSTAP 3 is and what it is used for
2. Before having this medicine
3. How to take PROSTAP 3
4. Possible side effects
5. How to store PROSTAP 3
6. Further information

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

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. BEFORE HAVING THIS MEDICINE
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.
• 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.
Take special care with PROSTAP 3:
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 are at an increased risk of thinning of the bones (osteoporosis)
you should tell your doctor before taking PROSTAP 3. Risk factors
include:
o If you or any of your close family have thinning of the bones.
o If you drink excessive amounts of alcohol, and/or smoke heavily.
o 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.

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.

FRONTE

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• 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.

PROSTAP 3 Sterile Solvent is made by:
Takeda Pharmaceutical Company Limited
Hikari Plant, 4720, Takeda, Mitsui,
Hikari, Yamaguchi 743-8502, JAPAN
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 3.
This leaflet was last approved in February 2013
* Registered Trademark of Takeda

This leaflet can be made available in large print, audio or Braille on
request. Contact 0800 198 5000 to request this, quoting the following
number: 16189/0013

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.
5. HOW TO STORE PROSTAP 3
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the
packaging. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not refrigerate or freeze.
Store in the original container in order to protect from light.
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. FURTHER INFORMATION
What PROSTAP 3 contains:
• The active ingredient in PROSTAP 3 powder is leuprorelin acetate
(11.25 mg).
• The other ingredients in PROSTAP 3 are: poly (DL-lactic acid),
which controls the release of the active ingredient into the body, and
mannitol (E421).
• The Sterile Solvent contains carmellose sodium, mannitol (E421),
polysorbate 80, glacial acetic acid and Water for injections.
What PROSTAP 3 looks like and contents of the pack:
PROSTAP 3 is a prolonged release powder for use in an injection.
The Sterile Solvent is a clear liquid, which is mixed with the
PROSTAP 3 Powder before injection.
Each pack contains a pre-filled dual chamber syringe containing
11.25 mg leuprorelin acetate powder in the front chamber and 1 ml of
Sterile Solvent in the rear chamber.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
Takeda UK Limited
Takeda House, Mercury Park
Wooburn Green, High Wycombe
Bucks., HP10 0HH, UK
PROSTAP 3 Powder is made by:
Takeda Pharmaceutical Company Limited
Osaka Plant, 17-85, Jusohonmachi 2-Chome,
Yodogawa-Ku, Osaka 532-8686, JAPAN
Or
Takeda Pharmaceutical Company Limited
Hikari Plant
4720, Takeda, Mitsui, Hikari,
Yamaguchi743-8502, JAPAN



RETRO

ZTAK019

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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.

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