Document: leaflet MAH BRAND_PL 16189-0012 change

• leaflet MAH BRAND HEALTH PROFESSIONAL_PL 16189-0012
• leaflet MAH BRAND_PL 16189-0012

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PACKAGE LEAFLET: INFORMATION FOR THE USER

PROSTAP® SR DCS

3.75 mg Powder and Solvent for Prolonged-release Suspension for Injection in Pre-filled Syringe 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.

In this leaflet:

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

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

3.    How to take PROSTAP SR

4.    Possible side effects

5.    How to store PROSTAP SR

6.    Contents of the pack and other information

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

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

PROSTAP SR is used to treat prostate cancer in men and endometriosis and uterine fibroids in women. It can also be used to reduce the thickness of the lining (endometrium) of the womb (uterus) in preparation for surgery.

Use in children:

PROSTAP SR is a synthetic hormone which can be used to reduce the levels of testosterone and estrogen circulating in the body. Leuprorelin 1 Month Depot is used to treat premature puberty which is caused by a release of certain hormones from the pituitary gland (central precocious puberty) in girls under 9 years of age and boys under 10 years of age.

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

Use in children: Your doctor will make a precise diagnosis of central precocious puberty.

Do not take PROSTAP SR:

•    If you are allergic (hypersensitive) to leuprorelin acetate (PROSTAP SR or PROSTAP 3) or any of the other ingredients of PROSTAP SR (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.

•    In girls with central precocious puberty

-    if the girl to be treated is pregnant or breast-feeding.

-    if the girl has undiagnosed vaginal bleeding.

Warnings and precautions:

Both men and women:

•    If you are diabetic PROSTAP SR 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 SR. 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 SR which may be severe. If you are taking PROSTAP SR 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 SR 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 SR you should tell your doctor.

•    If you are a woman of child-bearing age, you should use non hormonal contraception whilst receiving PROSTAP SR. Although PROSTAP SR 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 SR.

In children:

•    In the event of a sterile abscess at the injection site (mostly reported after injection into the muscle) your doctor will monitor your hormone levels as there could be reduced absorption of leuprorelin from the injection site.

•    If the child has progressive brain tumour your doctor will decide if treatment with leuprorelin is appropriate.

In girls with central precocious puberty:

•    After the first injection vaginal bleeding (spotting) and discharge may occur as a sign of hormone withdrawal. Vaginal bleeding beyond the first/second month of treatment needs to be investigated.

•    Bone density may decrease during treatment of central precocious puberty with Leuprorelin 1 Month Depot. However, after treatment is stopped, subsequent bone mass growth is preserved and peak bone mass in late adolescence does not seem to be affected by treatment.

•    Often sterile abscesses at the injection site occurred when Leuprorelin 1 Month Depot is administered in higher dosages than recommended and when it is administered into the muscle. Your doctor will therefore administer the medicinal product under the skin of e.g. abdomen, bottom or thigh.

•    Discontinuation of treatment may lead to a slipping of the growth plate of the thigh bone. A possible cause could be a weakness of the growth plate due to a lower concentration of female sexual hormones during treatment.

Other medicines and PROSTAP SR

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. PROSTAP SR 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 SR with food and drink

PROSTAP SR can be taken with or without food.

Pregnancy and breastfeeding

PROSTAP SR must not be administered in pregnant or breast-feeding women or girls (see also section “Do not use Prostap SR”).

Driving and using machines

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

3. HOW TO TAKE PROSTAP SR

The doctor or nurse will give you an injection of PROSTAP SR. 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 a month. If you are to be given PROSTAP SR prior to intrauterine surgery you will receive a single injection 5-6 weeks before your surgery.

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

If you have uterine fibroids you will be given an injection of PROSTAP SR once a month usually for 3-4 months before surgery.

Use in children

Treatment of children should be under the overall supervision of the paediatric endocrinologist.

The dosing scheme needs to be adapted individually.

The recommended starting dose is dependent on the body weight:

a)    Children with a body weight 20 kg or more

Unless prescribed otherwise, 1 ml PROSTAP SR (3.75 mg leuprorelin acetate) is administered once a month under the skin of e.g. abdomen, bottom or thigh as a single injection.

b)    Children with a body weight less than 20 kg

Taking into account the clinical activity of the central precocious puberty in these rare cases, the following applies:

Unless prescribed otherwise, 0.5 ml PROSTAP SR (1.88 mg leuprorelin acetate) is administered once a month under the skin of e.g. abdomen, bottom or thigh as a single injection. The remainder of the suspension should be discarded. Your doctor will monitor the child's weight gain.

Depending on the central precocious puberty activity, your doctor may increase the dosage in the presence of inadequate suppression (e.g. vaginal bleeding). Your doctor will determine the minimal effective dose with the help of a blood test.

The duration of treatment depends on the clinical signs at the start of treatment or during the course of treatment and is decided by your doctor together with the legal guardian and, if appropriate, the treated child. Your doctor will determine the bone age of the child in regular intervals.

In girls with bone maturation of older than 12 years and boys with bone maturation of older than 13 years your doctor will consider discontinuing the treatment, depending on the clinical effects in your child.

In girls, pregnancy should be excluded before the start of treatment. The occurrence of pregnancy during treatment cannot be generally excluded. In such cases, please talk to your doctor.

FRONTE

THIS ARTWORK IS PROPERTY OF:

TAKEDA

PRODUCT NAME:

I-PROSTAP 3,75mg DCS SD (GB)

PRODUCT CODE:

6100681.07

EURPACK Gratifarma Grafiflex - Aprilia (LT) tel. +39 06 92732420 produzione@gratifarma.it - Robecco s/N (MI) tel. +39 02 94974002 milano@grafifarma.it/

Ricordiamo che il risultato cromatico delle stampe potra essere diverso in funzione del supporto e della tecnica utilizzata. We remind you that prints chromatic results could be different depending on support and used technique. - La responsabilita della EURPACK GRAFIFARMA GRAFIFLEX Srl, termina con I’approvazione del seguente documento. EURPACK GRAFIFARMA GRAFIFLEX’s responsability ends with the approval of the present document. - Vietato I’utilizzo del presente tassello di informazioni se non espressamente autorizzato dalla EURPACK GRAFIFARMA GRAFIFLEX Srl. It is forbidden the use of the present information if not officially allowed from EURPACK GRAFIFARMA GRAFIFLEX Srl.___v 01-2013/

The therapy is a long-term treatment, adjusted individually. Please arrange with your doctor that PROSTAP SR is administered as precisely as possible in regular monthly periods. An exceptional delay of the injection date for a few days (30 ± 2 days) does not influence the result of the therapy.

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 SR 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 SR and contact your doctor immediately.

4. POSSIBLE SIDE EFFECTS

Like all medicines, PROSTAP SR 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 SR. 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:

Men:

•    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. 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 SR injection. If you do get worsening pain, weakness or loss of feeling in your legs or difficulty passing urine, contact your doctor immediately.

•    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. This is very rare (may affect more than 1 in 10,000 people).

•    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.

Very common (may affect more than 1 in 10 people)

Weight changes, hot flushes, sweating, muscle weakness, bone pain, loss of interest in sexual intercourse, inability to have an erection, a reduction in size and function of the testes, tiredness or skin reactions at the injection site (these include skin hardening, redness, pain, abscesses, swelling, nodules, ulcers and skin damage).

Common (may affect up to 1 in 10 people)

Loss of appetite, difficulty sleeping, depression, mood changes (with long-term use), headache, nausea, abnormalities in liver function or liver blood tests, joint pain, swelling of the breast tissue or swelling in your ankles.

Uncommon (may affect more than 1 in 100 people)

Mood changes (with short-term use), dizziness, tingling in the hands or feet, diarrhoea, vomiting, muscle ache or weakness in the legs.

Not known (frequency cannot be estimated from the available data) Blood tests may show anaemia (low red cell counts), low counts in white cells or platelets, allergic reactions (may include symptoms of rash, itching, wheals or a serious allergic reaction which causes difficulty breathing or dizziness), changes in blood lipids (cholesterol) or blood sugar, paralysis, seizure, altered vision, pounding heartbeats, changes in ECG (QT prolongation), blood clots in lungs, high or low blood pressure, jaundice, fracture of the spine, thinning of bone, difficulty passing urine, fever or chills.

Women:

• Many of the side effects of PROSTAP SR are related to the decrease in oestrogen level. Oestrogen level returns to normal after treatment is stopped. Common side effects include hot flushes, mood swings, depression and vaginal dryness. As can happen naturally when women reach the menopause, PROSTAP SR can cause a small amount of bone thinning. Vaginal bleeding may occur during treatment.

•    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. This is very rare (may affect more than 1 in 10,000 people).

•    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.

Very common (may affect more than 1 in 10 people)

Difficulty sleeping, headaches or hot flushes Common (may affect up to 1 in 10 people)

Weight changes, mood changes, depression, tingling in hands or feet, dizziness, nausea, joint pain, muscle weakness, breast tenderness, changes in breast size, vaginal dryness, swelling in ankles or skin reactions at the injection site (these include skin hardening, redness, pain, abscesses, swelling, nodules, ulcers and skin damage)

Uncommon (may affect more than 1 in 100 people)

Loss of appetite, changes in blood lipids (cholesterol), altered vision, pounding heartbeats, diarrhoea, vomiting, abnormalities in liver blood tests, hair loss, muscle aches, fever, chills or tiredness

Not known (frequency cannot be estimated from the available data)

Blood tests may show anaemia (low red cell counts), low counts in white cells i or platelets, allergic reactions (may include symptoms of rash, itching, wheals | or a serious allergic reaction causing difficulty breathing or dizziness), changes i in blood sugar, paralysis, blood clots in the lungs, high or low blood pressure, i jaundice, abnormalities in liver function, fracture of the spine, seizure, thinning of bone or vaginal bleeding.

Children

In the initial phase of treatment, a short-term rise in the sex hormone levels occurs, followed by a fall to values within the prepuberty range. Due to this effect, side effects may occur particularly at the start of treatment.

Common (may affect up to 1 in 10 people):

•    mood swings

•    headache

•    abdominal pain / abdominal cramps

•    feeling sick / vomiting

•    acne

•    vaginal bleeding

•    spotting

•    discharge

•    injection site reactions

Very rare (may affect less than 1 in 10,000 people):

•    general allergic reactions (fever, rash, itching)

•    serious allergic reaction which causes difficulty in breathing or dizziness

•    As with other medicinal products of this class: 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.

Not known (frequency cannot be estimated from the available data)

•    Seizure Notes:

In general, if vaginal bleeding (spotting) occurs with continued treatment (after possible withdrawal bleeding in the first month of treatment), this may be a sign of potential underdosage. Please tell your doctor if vaginal bleeding occurs. 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 SR

Keep out of the sight and reach 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.

Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

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

•    The active ingredient in PROSTAP SR powder is leuprorelin acetate (3.75 mg).

•    The other ingredients in PROSTAP SR are: gelatin, copoly (DL-lactic acid/ glycolic 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, water for injections and acetic acid, glacial.

What PROSTAP SR looks like and contents of the pack:

PROSTAP SR is a prolonged release powder for use in an injection.

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

Each pack contains a pre-filled dual chamber syringe containing 3.75 mg leuprorelin acetate powder in the front chamber and 1 ml of Sterile Solvent in the rear chamber.

Marketing Authorisation Holder:

Takeda UK Limited Building 3, Glory Park,

Glory Park Avenue, Wooburn Green,

BUCKS, HP10 0DF, UK Manufacturer:

Delpharm Novara S.r.l.,

Via Crosa 86 28065 Cerano Italy

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.

This leaflet was last revised in October 2016.

•    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: 16189/0012

6100681.07

RETRO

THIS ARTWORK IS PROPERTY OF:

TAKEDA

PRODUCT NAME:

I-PROSTAP 3,75mg DCS SD (GB)

PRODUCT CODE:

6100681.07

EURPACK Gratifarma Gratitlex - Aprilia (LT) tel. +39 06 92732420 produzione@gratifarma.it - Robecco s/N (MI) tel. +39 02 94974002 milano@grafifarma.it/

Ricordiamo che il risultato cromatico delle stampe potra essere diverso in funzione del supporto e della tecnica utilizzata. We remind you that prints chromatic results could be different depending on support and used technique. - La responsabilita della EURPACK GRAFIFARMA GRAFIFLEX Srl, termina con I’approvazione del seguente documento. EURPACK GRAFIFARMA GRAFIFLEX’s responsability ends with the approval of the present document. - Vietato I’utilizzo del presente tassello di informazioni se non espressamente autorizzato dalla EURPACK GRAFIFARMA GRAFIFLEX Srl. It is forbidden the use of the present information if not officially allowed from EURPACK GRAFIFARMA GRAFIFLEX Srl.___v 01-2013/