NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
LUCRIN® CMI – VERSION 13 – 27 MAY 2020
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
Why am I using Lucrin?
Lucrin contains the active ingredient leuprorelin acetate.Lucrin is used to treat prostate cancer in men and precocious (unusually early) puberty in children.
For more information, see Section 1. Why am I using Lucrin? in the full CMI.
What should I know before I use Lucrin?
Check the list of ingredients at the end of the CMI.Do not use Lucrin if you have ever had an allergic reaction to any of them.
Talk to your doctor before you use this medicine if he/she is not aware that you have any other medical conditions, take any other medicines or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Lucrin? in the full CMI.
What if I am using other medicines?
Some medicines may interfere with Lucrin and affect how it works or Lucrin may interfere with other medicines and affect how they work.
A list of these medicines is in Section 3. What if I am using other medicines? in the full CMI.
How do I use Lucrin?
Lucrin Injection is given by your doctor or nurse.
The Lucrin dose and how frequently it is given is based on your doctor’s assessment.
More instructions can be found in Section 4. How do I use Lucrin? in the full CMI.
What should I know while using Lucrin?
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Things you should do
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Keep all your appointments, including those for blood tests
Remind any doctor or dentist you visit that you are using Lucrin.
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Things you should not do
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Do not miss a scheduled injection.
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Driving or using machines
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It is unlikely that Lucrin will affect your ability to drive or use machines.
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Drinking alcohol
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There is no information on the use of Lucrin with alcohol.
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Looking after your medicine
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Store Lucrin in a cool dry place away from sunlight.
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For more information, see Section 5. What should I know while using Lucrin? in the full CMI.
Are there any side effects?
Swelling of face, lips, throat; chest pain; tingling/numbness in arms or legs; headache; vision problems; unconsciousness.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
Active ingredient:leuprorelin acetate (loop-ror-el-lin ass-set-tayt)
Consumer Medicine Information (CMI)
This leaflet provides important information about using Lucrin.You should also speak to your doctor or pharmacist if you would like further informationor if you have any concerns or questions about using it.
Where to find information in this leaflet:
1. Why am I using Lucrin?
2. What should I know before I use Lucrin?
3. What if I am taking other medicines?
4. How do I use Lucrin?
5. What should I know while using Lucrin?
6. Are there any side effects?
7. Product details
Why am I using Lucrin?
Lucrin contains the active ingredient leuprorelin acetate.
Lucrin is used to treat prostate cancer in men, and unusually early puberty in children (central precocious puberty).
What should I know before I use Lucrin?
Warnings
Do not use Lucrin if:
1. you are allergic to leuprorelin acetate, or any of the ingredients listed at the end of this CMI.
2. you are pregnant or breastfeeding, although unlikely unless your doctor has prescribed Lucrin for another condition.
Check with your doctor if:
you have or have had convulsions or seizures
you have diabetes
you have had a heart attack or stroke
you have high blood pressure or cholesterol
you have or have had depression (low mood, anxiety, feeling of worthlessness)
your cancer has spread to the spine (when being treated for prostate cancer)
you have any other medical conditions not already discussed with your doctor
you take any medicines for any other condition.
During treatment, you may be at risk of developing certain side effects.It is important you understand these risks and how to monitor for them.See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Although not expected to be applicable, make sure your doctor is aware you are pregnant or are breastfeeding.
Hormonal Flare
Symptoms may increase at the beginning of treatment.This is applicable to patients being treated for prostate cancer (also known as tumour flare) and precocious puberty. Refer to Section 6 Are there any side effects? for advice on symptoms of hormonal flare and what to do if you experience any of them.
Pituitary apoplexy (in children)
The pituitary gland is a small gland in your brain that plays a major role in regulating body functions and general wellbeing.Pituitary apoplexy is a condition where blood flow is restricted into the pituitary gland.If your child experiences symptoms including sudden headache, vomiting, changes to vision, unconsciousness, then urgent medical attention is required.
What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with Lucrin and affect how it works, while Lucrin mayaffect how other medicines work.
Medicines that may increase the risk of developing irregular heart rhythms:
quinidine, a medicine used to treat certain heart conditions
disopyramide, a medicine used to treat marked changes in heart rhythms
procainamide, a medicine used to treat changes in heart rate, whether fast slow or irregular
amiodarone, a medicine used to treat marked changes in heart rhythm
sotalol, a medicine used to treat certain heart conditions
dofetilide and ibutilide, medicines used to maintain normal heart rhythm
methadone, a medicine used to treat strong pain and to help with addiction to drugs like heroin
certain medicines used to treat infections caused by bacteria, antibiotics, e.g.moxifloxacin
medicines used to treat certain mental and emotional conditions (e.g. risperidone, olanzapine, clozapine).
Check with your doctor or pharmacist if you are not sure about what medicines, vitaminsor supplements you are taking and if these affect Lucrin.
How do I use Lucrin?
How much to use
The Lucrin dose and how often it is to be injected is determined by your doctor
Lucrin is given as an injection into the muscle by your doctor or nurse.
Please look for the QR code on the medicine pack. Scan this code with your smart phone for more information on Lucrin.
If you use too much Lucrin
As Lucrin is injected by your doctor or nurse, it is unlikely that you will receive too much.If you have any concerns about having received too much Lucrin, medical attention may be required.
You should immediately:
phone the Poisons Information Centre
(by calling13 11 26), or
(by calling13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
What should I know while using Lucrin?
Things you should do
Keep all doctor’s appointments to ensure you receive Lucrin regularly and your progress can be checked
Keep all blood test appointments to keep track of progress and to monitor for side effects.
Call your doctor straight away if:
you notice an increase in symptoms
you experience an increase in pain, difficulty passing urine feeling weak or numb in your legs (when being treated for prostate cancer)
your child feels unwell (when being treated for precocious puberty).
Remind any doctor or dentist you visit that you are using Lucrin.
Things you should not do
Do not miss a scheduled injection.
Driving or using machines
It is unlikely that Lucrin will affect your ability to drive or use machines.
Looking after your medicine
Follow the instructions on the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight, for example:
do not store it in the bathroom or near a sink, or
do not store it in the car or on window sills.
Do not use this medicine after the expiry date.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary.However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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Prostate cancer:
pain, swelling or redness at the injection site
cough
unusual tiredness or weakness, feeling drowsy
dizziness or light-headedness
difficulty sleeping
headache
mild muscle, back or joint pain
changes in testicular size
change in sex drive or inability to get or maintain an erection
hot flushes, sweating, body odour
nausea/vomiting
diarrhoea
constipation
ringing in the ear
rash, itching, hives, dry skin or acne
Precocious puberty:
pain, swelling, redness at the injection site
general pain
hot flushes, sweating
dizziness, light-headedness
rash, itching, hives, dry skin, acne
vaginal irritation, bleeding or discharge
blood in the urine
increased weight
changes in mood, irritability, restlessness, aggression
tearfulness, crying
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Speak to your doctor if you have any of these less serious side effects and they worryyou.
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Serious side effects
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Serious side effects
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What to do
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Prostate cancer:
swelling in arms or legs
changes to breasts
problems with vision
difficulty breathing
thirst
frequent passing of urine
difficulty or pain when passing urine
blood in your urine
numbness or tingling of hands or feet
chest pain
problems with speech.
Precocious puberty:
swelling in arms or legs
problems with your vision
difficulty breathing
numbness or tingling of hands or feet
changes in breast size
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Call your doctor straight away, if you notice any of these serious side effects.
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Very serious side effects
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Very serious side effects
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What to do
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Prostate cancer:
swelling of the face, lips, mouth, throat which may cause difficulty in swallowing or breathing
feeling of weakness in arms or legs
unsteadiness when walking
chest pain
sudden collapse.
Precocious puberty:
swelling of the face, lips, mouth, throat which may cause difficulty in swallowing or breathing
unsteadiness when walking
sudden headache
vomiting
changes to vision
unconsciousness.
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Go straight to the Emergency Department at your nearest hospital if you notice anyof these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making youfeel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems .By reporting side effects, you can help provide more information on the safety of this medicine.
Product details
This medicine is only available with a doctor’s prescription for injection by a doctor or nurse.
What Lucrin contains
Lucrin 1-month 7.5 mg Depot Injection
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Active ingredient
(main ingredient)
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Leuprorelin acetate
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|---|---|
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Other ingredients
(inactive ingredients)
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polyglactin
mannitol
carmellose sodium
gelatin
polysorbate 80
glacial acetic acid
water for injections
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Lucrin 3-month 22.5 mg Depot Injection
Lucrin 4-month 30 mg Depot Injection
Lucrin Paediatric 30 mg Depot Injection
Lucrin 4-month 30 mg Depot Injection
Lucrin Paediatric 30 mg Depot Injection
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Active ingredient
(main ingredient)
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Leuprorelin acetate
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|---|---|
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Other ingredients
(inactive ingredients)
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polylactic acid
mannitol
carmellose sodium
polysorbate 80
glacial acetic acid
water for injections
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Lucrin 6-Month 45 mg Depot Injection
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Active ingredient
(main ingredient)
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Leuprorelin acetate
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|---|---|
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Other ingredients
(inactive ingredients)
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polylactic acid
mannitol
stearic acid
carmellose sodium
polysorbate 80
glacial acetic acid
water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
What Lucrin looks like
Lucrin is available in prefilled dual chamber syringes containing white powder in the front chamber and liquid in the rear chamber.Before injecting, the liquid is pushed into the front chamber to be mixed with the powder.
Lucrin 1-month 7.5 mg Depot Injection
(AUST R 114302)
(AUST R 114302)
Lucrin 3-month 22.5 mg Depot Injection
(AUST R 114303)
(AUST R 114303)
Lucrin 4-month 30 mg Depot Injection
(AUST R 114304)
(AUST R 114304)
Lucrin 6-month 45 mg Depot Injection
(AUST R 222375)
(AUST R 222375)
Lucrin Paediatric 30 mg Depot Injection
(AUST R 218936).
(AUST R 218936).
Who distributes Lucrin?
Lucrin is distributed in Australia by:
AbbVie Pty Ltd
ABN 48 156 384 262
241 O’Riordan Street
Mascot NSW 2020
This leaflet was prepared in 27 May 2020.
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