Active ingredient
- leuprorelin acetate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL16189/0012.
Prostap SR DCS
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.
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 to treat hormone responsive early stage breast cancer in pre and perimenopausal women at higher risk of recurrence and hormone responsive advanced breast cancer in pre and perimenopausal women. It can also be used in women to reduce the thickness of the lining (endometrium) of the womb (uterus) in preparation for surgery and to treat endometriosis and uterine fibroids. PROSTAP SR can additionally be used to preserve ovarian function in pre-menopausal women with cancer who are having chemotherapy.
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. PROSTAP SR 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:
Warnings and precautions:
Both men and women:
Women only:
Men only:
In children:
In girls with central precocious puberty:
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
PROSTAP SR should only be administered by your doctor or a nurse who will also take care of the preparation of the product.
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 early breast cancer, you will be given PROSTAP SR once a month in combination with tamoxifen or an aromatase inhibitor. A minimum of two injections of PROSTAP SR with one month between each injection should be given before you start treatment with an aromatase inhibitor or tamoxifen.
If you have advanced breast cancer, you will be given PROSTAP SR once a month as an add-on to your other breast cancer treatment.
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.
If you are being given PROSTAP SR to preserve ovarian function whilst receiving chemotherapy, you will normally be given one injection of PROSTAP SR two weeks before starting chemotherapy and then every month for the duration of your chemotherapy treatment.
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) are 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.
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.
If you stop using PROSTAP SR
If you are being given PROSTAP SR for the treatment of advanced or early breast cancer, you must not stop your treatment with PROSTAP SR whilst you are taking an aromatase inhibitor. If you are going to discontinue treatment with PROSTAP SR, your aromatase inhibitor treatment must also be discontinued within 1 month of your last PROSTAP SR injection.
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:
Tell your doctor:
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:
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 up to 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, chills, inflammation of lungs or lung disease.
Women:
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 up to 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 or platelets, allergic reactions (may include symptoms of rash, itching, wheals or a serious allergic reaction causing difficulty breathing or dizziness), changes in blood sugar, paralysis, blood clots in the lungs, high or low blood pressure, jaundice, abnormalities in liver function, fracture of the spine, seizure, thinning of bone or vaginal bleeding, inflammation of lungs or lung disease.
Side effects when used for breast cancer in combination with either tamoxifen or an aromatase inhibitor
The following side effects have been seen when a similar class of medicine called GnRH analogues (Gonadotrophin Releasing Hormone analogues) has been used for breast cancer in combination with either tamoxifen or an aromatase inhibitor:
Very common (may affect more than 1 in 10 people)
Nausea, feeling very tired, joint and muscle pain, osteoporosis, hot flushes, excessive sweating, difficulty in sleeping, depression, decreased libido, dryness of the vagina, pain during or after sexual intercourse, urinary incontinence, increased blood pressure.
Common (may affect up to 1 in 10 people)
Diabetes, high blood sugar (hyperglycaemia), pain, bruising, redness and swelling at injection site, allergic reaction, bone fractures, blood clot in a blood vessel.
Uncommon (may affect up to 1 in 100 people)
Bleed in the brain, lack of blood supply to the brain or the heart.
Rare (may affect up to 1 in 1000 people)
Change in ECG (QT prolongation)
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):
Very rare (may affect up to 1 in 10,000 people):
Not known (frequency cannot be estimated from the available data):
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. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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:
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:
Manufacturer:
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 August 2020.
* Registered Trademark of Takeda
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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
1 Kingdom Street, London, W2 6BD, UK
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