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LUTRATE DEPOT 3.75 MG POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Lutrate Depot 3.75 mg powder and solvent for prolonged-release suspension for injection
leuprorelin acetate
Read all of this leaflet carefully before you start taking
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 only. 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.
What is in this leaflet
1. What Lutrate Depot is and what it is used for
2. What you need to know before you use Lutrate Depot
3. How to use Lutrate Depot
4. Possible side effects
5. How to store Lutrate Depot
6. Contents of the pack and other information
1. What Lutrate Depot is and what it is used for
Lutrate Depot is a vial containing a white powder, which is
made into a suspension for injection into a muscle. Lutrate
Depot contains the active ingredient leuprorelin (also called
leuprolide), which belongs to a group of medicines called
luteinizing hormone releasing hormone (LHRH) agonists
(medicines that reduce testosterone – a sex hormone).
Your doctor has prescribed Lutrate Depot for palliative
treatment of advanced prostate cancer.
2. What you need to know before you use Lutrate
Depot
Do not use Lutrate Depot:
- if you are allergic (hypersensitive) to LHRH, LHRH agonists
or any of the other ingredients of this medicine (listed in
section 6). An allergic reaction may include rash, itching,
difficulty of breathing or swelling of the face, lips, throat or
tongue.
- if you have had an orchiectomy (removal of the testicles).
- if you are female or a child.
- Lutrate Depot must not be used alone for the treatment of
prostate cancer when the spinal cord is compressed or the
cancer has spread to the spine.
Warnings and precautions
• Talk to your doctor or pharmacist before you are given
Lutrate Depot
• Your condition may get worse at first during the first weeks
of the treatment, but should improve with continued
treatment. Such signs and symptoms include: temporary
increase of testosterone (a male hormone), hot flushes,
bone pain, nervous system disorders (including depression)
or urinary obstruction.
• If you feel you have experienced an allergic reaction
(shortness of breath, asthma, rhinitis, swelling of the face,
urticaria, skin eruption), stop using this medicine and inform
your doctor.
• Tell your doctor if you might be at risk or if you have any of
the following as you may need more frequent check ups:
• you suffer from any unexplained bruising or bleeding or
if you feel generally unwell. Although rare, these could
be symptoms of changes in the number of red or white
cells
• you have metabolic disease
• you have heart problems, or a pounding heart beat
• you have diabetes
• Your doctor should be aware of any previous personal
clinical history of pituitary adenoma (non-cancerous tumor
of pituitary). Cases of pituitary apoplexy (partial tissue loss of
pituitary gland) have been described after initial administration of this type of drug to patients with pituitary adenoma.
Pituitary apoplexy may be manifested by sudden headache,
meningismus, visual disturbances or altered vision, even
blindness, and occasionally, decrease in the level of

consciousness.
• Your doctor should be aware if you suffer from a bleeding
disorder, thrombocytopenia or if you are on treatment with
anticoagulants. Your liver function may need to be monitored as changes to the liver and jaundice (yellow eyes and
skin) have been reported with leuprorelin treatment.
• A fractured spine, paralysis, low blood pressure and high
blood pressure have been reported with leuprorelin
treatment.
• There have been reports of depression in patients taking
Lutrate Depot which may be severe. If you are taking Lutrate
Depot and develop depressed mood, inform your doctor.
• A decreased bone density (brittleness or thinning of the
bones) has been reported with leuproreline. Your doctor
may consider adding an antiandrogen to the treatment with
Lutrate Depot. Your doctor will be on the alert for inflamed
veins (thrombophlebitis) and other signs of clotting
disorders and oedema (swelling of hands, feet or ankles).
There is an increased risk of these occurring in the case that
an antiandrogen treatment is added to Lutrate Depot.
• Tell your doctor, if you feel pressure on the spinal cord
and/or experience urinary disorders and/or haematuria
(blood in the urine). In this case your doctor will be take if
necessary, additional precautions to avoid neurological
complications (e.g. tingling in hands and feet, paralysis) or
obstruction of the urethra (the tube that connects the
bladder to the outside of the body). You will be closely
supervised during the first weeks of treatment.
• Patients may experience metabolic changes (e.g. glucose
intolerance or worsening of existing diabetes), weight
changes and cardiovascular disorders.
• Patients with metabolic or cardiovascular disease and
especially patients with history of congestive heart failure
(condition in which the heart can no longer pump enough
blood to the rest of the body) should be monitored during
treatment with leuprorelin.
• You will need some blood tests during treatment, to check
that Lutrate Depot is being efficacious.
• You may experience a loss of interest in sexual intercourse,
hot flushes and occasionally there may be a reduction in
size and function of the testes.
• You may become fertile again when Lutrate Depot treatment
is stopped.
• Lutrate Depot may interfere with certain laboratory tests so
make sure your doctor knows you are using Lutrate Depot
• Lutrate Depot contains an ingredient which may give a
positive test result in doping controls
• Convulsions can occur in predisposed patients (those with
a history of seizures, epilepsy, cerebrovascular disorders,
anomalies or central nervous system tumors), in patients
receiving drugs that can cause seizures and, to a lesser
extent, in other patients who do not have these characteristics.
Other medicines and Lutrate Depot
Tell your doctor or pharmacist if you are taking, have recently
taken, or might take any other medicines. It may still be all
right for you to be given Lutrate Depot and your doctor will be
able to decide what is suitable for you.
Pregnancy and breast-feeding
Lutrate Depot is not indicated for use in women.
This medicine is contraindicated during pregnancy. Spontaneous abortions may occur if this medicine is administered
during pregnancy.
Driving and using machines
Disturbance of vision and dizziness can occur during treatment.
If affected you should not drive or operate machinery.
Lutrate Depot contains less than 1 mmol sodium (23 mg)
per dose, i.e. essentially ‘sodium- free’.
3. How to use Lutrate Depot
Dose
Lutrate Depot must be given under the supervision of a
doctor or a qualified health practitioner.

The following information is intended for healthcare professionals only:
How to prepare the injection?

The pack contains:

Follow these instructions carefully.

1 (one) vial of Lutrate Depot 3.75 mg (leuprorelin acetate)
powder for suspension for injection
1 (one) pre-filled syringe containing the suspension solvent
(mannitol 0.8% solution for injection);
1 (one) device for reconstitution;
1 (one) single-use sterile needle.

An aseptic technique should be observed during the
reconstitution procedure.
Important:
Allow the product to reach room temperature before
administration. Once mixed, the product must be administered immediately.
This product is for single use only.
Verify the contents of the kit and make sure it includes
everything that’s mentioned in the leaflet.

Remove blue cap from the vial.

Attach the adaptor system (in
purple) to vial until a ‘clicking’
sound is heard.

Adults including the elderly:
The recommended dose of Lutrate Depot is an injection once
a month. The powder is made up into a suspension and given
as a single injection intramuscularly (into a muscle) once a
month (approximately every 28 to 33 days).
The injection site should be varied at regular intervals.
Lutrate Depot must be administered via the intramuscular
route only. Do not administer by another route.

the box, vial and pre-filled syringe after "EXP". The syringe has
the same expiry date to that of the vial. The expiry date refers
to the last day of that month.
Do not throw away any medicines via wastewater. Ask your
pharmacist how to throw away medicines you no longer use.
These measures will help to protect the environment.

Use in children: Lutrate Depot is not indicated for use in
children.
The strength of your treatment is decided by your doctor.

What Lutrate Depot contains
The active substance is leuprorelin acetate. Each vial contains
3.75 mg of leuprorelin acetate.
The other ingredients are: Polysorbate 80, Mannitol (E-421),
Carmellose sodium (E-466), Triethyl citrate and Poly(DLlactide-co-glycolide) (PLGA).
The solvent contains (pre-filled syringe): mannitol, water for
injection, sodium hydroxide (for pH adjustment) and hydrochloric acid (for pH adjustment).
The concentration of the reconstituted product is 1.8 75
mg/ml.

If you use more Lutrate Depot than you should
This is unlikely as your doctor or nurse will not know the
correct dosage. However, if you suspect you have received
more than you should, let your doctor know about it immediately so appropriate measures can be taken.
If you forget a dose of Lutrate Depot
It is important not to miss a dose of Lutrate Depot. As soon
as you realise you have missed an injection contact your
doctor who will be able to give you your next injection.
If you stop using Lutrate Depot
Since the medical treatment involves administration of Lutrate
Depot for a long period, when the treatment is interrupted you
may experience a worsening of the symptoms related to the
disease. Therefore you must not interrupt the treatment
prematurely without your doctor’s permission.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.
4. Possible side effects

6. Contents of the pack and other information

What Lutrate Depot looks like and contents of the pack
Each pack contains a vial with 3.75 mg of leuprorelin acetate,
one prefilled syringe with 2 ml of solvent, one adaptor system
and one sterile 20 gauge needle.
Marketing Authorisation Holder and Manufacturer
GP-PHARM, S.A.
Pol ind Els Vinyets –els Fogars. Sector 2
Carretera comarcal 244, km22
08777 Sant Quintí de Mediona.
Spain
This medicinal product is authorised in the Member
States of the EEA under the following names:

If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

Spain: Lutrate Depot 3.75 mg polvo y disolvente para
suspensión de liberación prolongada inyectable
Germany: Lutrate Depot 3.75 mg pulver und lösungsmittel
zur Herstellung einer Depot-Injektionssuspension
Portugal: Lutrate Depot 3.75 mg / 2 ml pó e veículo para
suspensão injectável de libertação prolongada
Greece: Lutrate Depot 3.75 mg Κόνις και διαλύτης για
παρασκευή
ενεσίμου
εναιωρήματος
παρατεταμένης
αποδέσμευσης
Italy: Politrate 3.75 mg Polvere e solvente per sospensione
iniettabile a rilascio prolungato.
Sweden: Politrate 3.75 mg pulver och vätska till injektionväska, suspension
Hungary: Politrate Depot 3.75 mg
Denmark: Lutrate Depot
Finland: Lutrate 3.75 mg
Ireland: Lutrate Depot 3.75 mg
United Kingdom: Lutrate Depot 3.75 mg
Belgium: Lutrate Depot 3.75 mg poeder en oplosmiddel voor
suspensie voor injectie met verlengde afgifte
The Netherlands: Leuproreline Lutrate Depot 3.75 mg poeder
en oplosmiddel voor suspensie voor injectie met verlengde
afgifte
Norway: Lutrate Depot
Austria: Lutrate Depot 3.75 mg pulver und lösungsmittel zur
herstellung einer Depot-injektionssuspension
Estonia: Lutrate Depot 3.75 mg
Lithuania: Lutrate Depot 3.75 mg milteliai ir tirpiklis pailginto
atpalaidavimo injekcinei
Latvia: Lutrate Depot 3.75 mg pulveris un šķīdinātājs ilgstošas
darbības injekciju suspensijas pagatavošanai
Czech Republic: Lutrate Depot 3.75 mg
Poland: Lutrate Depot
Slovak Republic: Lutrate Depot 3.75 mg
Romania: Lutrate Depot 3.75 mg pulbere şi solvent pentru
suspensie injectabilă cu eliberare prelungită
Bulgaria: Lutrate Depot

5. How to store Lutrate Depot

This leaflet was last revised in June 2013.

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Tell your doctor straight away if you get any sudden
wheeziness, difficulty in breathing, swelling of the
eyelids, face or lips, rash or itching (especially affecting
your whole body).
The following side effects have been reported:
Very common (These may affect more than 1 in 10 people):
Hot flushes and injection site reactions.
Common (These may affect up to 1 in 10 people):
Night sweats, cold sweats, fatigue, headache, pyrexia (rise in
body temperature), increased appetite, erectile dysfunction,
hyperhidrosis (increased sweating), asthenia (lack or loss of
strength), back pain and injection site reactions such as pain,
irritation, discomfort, erythema (redness of the skin), swelling
(increment in size or inflation) bruising (contusion), mood
changes and depression in long term use of leuprorelin.
Uncommon (These may affect up to 1 in 100 people):
Breast swelling, breast tenderness, spinning sensation
(vertigo), weakness, sleep disorders, somnolence
(sleepiness), insomnia ( not sleeping), low tummy pain,
diarrhea, feeling sick (nausea), vomiting, feeling hot and cold,
feeling jittery, fever, yellow eyes and skin (jaundice), changes
in liver enzymes, anorexia (not eating), high cholesterol, joint
pain, muscle spasms, pain in the hands and feet, decreased
sex drive, mood alterations, urine retention, frequent need to
urinate, uncontrolled urine (incontinence), swelling around the
eyes, ejaculation failure, hyperlipidemia (high levels of blood
lipids, pruritus (itching), urticaria (nettle rash), mood changes
depression in short term use of leuprorelin, and injection site
reactions such as: swelling, injury and hemorrhage.

Your doctor or pharmacist will know how to store Lutrate
Depot.
Keep this medicine out of sight and reach and sight of
children.
Do not store above 25º C. Do not freeze.
Store in the original package, in order to protect from light
Do not use this medicine after the expiry date as indicated on

eringa todavía acoplada al
ite suavemente el vial
un minuto aproximadaasta obtener una suspenhosa uniforme.

PR-LP1M601-UK-01

Affix the white finger-grip to the
diluents-containing syringe.
Remove the rubber cap from the
syringe and attach it to the
adaptor system.

While keeping the syringe and vial
securely coupled in an upright
position, slowly push the plunger
in order to transfer all the diluent
into the vial.

With the syringe still coupled to
the vial, shake the vial gently for
approximately one minute until a
uniform milky-white suspension
is obtained.

Turn the system upside down,
and carefully pull out the plunger
to draw-up the resuspended drug
from the vial into the syringe.

Detach the syringe and needle
from the adaptor system by
twisting the upper piece of the
adaptor counter-clockwise. The
drug is ready to be used.

Clean the injection area with an
alcohol swab and let the skin dry.
Inject the suspension intramuscularly into the upper outer
quadrant of the gluteus.

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