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POLITRATE DEPOT 22.5 MG POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION

Active substance(s): LEUPRORELIN ACETATE

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Package leaflet: Information for the user

Politrate Depot 22.5 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. See section 4.

What is in this leaflet
1.

What Politrate Depot is and what it is used for

2.

What you need to know before you use Politrate Depot

3.

How to use Politrate Depot

4.

Possible side effects

5.

How to store Politrate Depot

6.

Contents of the pack and other information

1.

What Politrate Depot is and what it is used for

Politrate Depot is a vial containing a white powder, which is made into a suspension for
injection into a muscle. Politrate 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 Politrate Depot for palliative treatment of advanced prostate
cancer.

2.

What you need to know before you use Politrate Depot

Do not use Politrate 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.

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if you have had an orchiectomy (removal of the testicles).

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if you are female or a child.

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Politrate 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 Politrate 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 Politrate Depot which may be
severe. If you are taking Politrate 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
Politrate 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 Politrate 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 Politrate 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 Politrate Depot treatment is stopped.



Politrate Depot may interfere with certain laboratory tests so make sure your doctor
knows you are using Politrate Depot



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.


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 Politrate Depot.

Other medicines and Politrate 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 Politrate Depot and your doctor will be
able to decide what is suitable for you.
Politrate Depot 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).
Pregnancy and breast-feeding
Politrate 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
No specific studies on the effects of Politrate Depot on the ability to drive and use machines
have been performed.
Disturbance of vision and dizziness can occur during treatment. If affected you should not
drive or operate machinery.
Politrate Depot contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially
‘sodium- free’.

3. How to use Politrate Depot

Dose
Politrate Depot must be given under the supervision of a doctor or a qualified health
practitioner.

Adults including the elderly:
The recommended dose of Politrate Depot is an injection once every three months. The
powder is made up into a suspension and given as a single injection intramuscularly (into a
muscle) once every three months
The injection site should be varied at regular intervals.
Politrate Depot must be administered via the intramuscular route only. Do not administer by
another route.
Use in children: Politrate Depot is not indicated for use in children.
The strength of your treatment is decided by your doctor.
If you use more Politrate Depot than you should
This is unlikely as your doctor or nurse will 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 Politrate Depot
It is important not to miss a dose of Politrate 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 Politrate Depot
Since the medical treatment involves administration of Politrate 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

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):
Cold sweats, hyperhidrosis (increased sweating), pruritus (itching), fatigue, insomnia (not
sleeping), decreased sex drive, spinning sensation

(dizziness), flushing, feeling sick

(nausea), diarrhoea, , decreased appetite, erectile dysfunction, asthenia (lack or loss of
strength), bone pain, pain in the joints and injection site reactions such as pain, induration,
erythema (redness of the skin). Urinary tract pain, urine flow decreased, frequent need to
urinate, mood changes and depression in long term use of leuprorelin, changes in liver
enzymes and, blood triglyceride increased (high levels of blood lipids), blood suggar
increased.
Uncommon (These may affect up to 1 in 100 people):
High cholesterol, sleep disorders, feeling jittery, taste disturbance, formication (alteration in
the skin sensation), headache, lethargy (sleepiness), vision blurred, pleurisy, ringing in the
ears (tinnitus), tummy pain upper, constipation, papule, rash, pruritus generalised (itching),
night sweats, back pain, muscle aching, neck pain, nipple pain, pelvic pain, testicular
atrophy, testicular disorder, feeling hot, mood changes depression in short term use of
leuprorelin. Changes in blood values and changes in ECG (QT prolongation). And injection
site reactions such as: urticaria, warmth and hemorrhage.
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 Yellow
Card Scheme website: 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 Politrate Depot

Your doctor or pharmacist will know how to store Politrate Depot.
Keep this medicine out of sight and reach of children.
Do not store above 25o C. Do not freeze.
Do not use this medicine after the expiry date which is stated on 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.

6.

Contents of the pack and other information

What Politrate Depot contains
The active substance is leuprorelin acetate. Each vial contains 22.5 mg of leuprorelin
acetate.
The concentration of the reconstituted product is 11.25 mg/ml.

The other ingredients are: Polysorbate 80, Mannitol (E-421), Carmellose sodium (E-466),
Triethyl citrate and Poly(lactic acid) (PLA).
The solvent contains (pre-filled syringe): mannitol, water for injection, sodium hydroxide (for
pH adjustment) and hydrochloric acid (for pH adjustment).
What Politrate Depot looks like and contents of the pack
Each pack contains a vial with 22.5 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:
Spain: Lutrate Depot Trimestral 22.5 mg polvo y disolvente para suspensión de liberación
prolongada inyectable
Germany: Lutrate Depot 22.5 mg pulver und lösungsmittel zur Herstellung einer DepotInjektionssuspension
Portugal: Lutrate Depot 22.5 mg / 2 ml pó e veículo para suspensão injectável de libertação
prolongada
Greece: Lutrate Depot 22.5 mg Κόνις και διαλύηης για παραζκεσή ενεζίμοσ εναιωρήμαηος
παραηεηαμένης αποδέζμεσζης
Italy: Politrate
Sweden: Politrate 22.5 mg pulver och vätska till injektionväska, suspension
Hungary: Politrate Depot 22.5 mg
Denmark: Lutrate Depot
Finland: Lutrate 22.5 mg
Ireland: Leuprorelin 3-month Depot 22.5 mg powder and solvent for prolonged-release
suspension for injection
United Kingdom: Politrate Depot 22.5 mg powder and solvent for prolonged-release
suspension for injection
Belgium: Lutrate Depot 22.5 mg poeder en oplosmiddel voor suspensie voor injectie met
verlengde afgifte
The Netherlands: Leuproreline Lutrate Depot 22,5 mg poeder en oplosmiddel voor suspensie
voor injectie met verlengde afgifte
Norway: Lutrate Depot
Austria: Lutrate Depot 22.5 mg pulver und lösungsmittel zur herstellung einer Depotinjektionssuspension
Estonia: Lutrate Depot 22.5 mg
Lithuania: Lutrate Depot 22.5 mg milteliai ir tirpiklis pailginto atpalaidavimo injekcinei

Uk-Lut(3)-pil-v01-clean

Latvia: Lutrate Depot 22.5 mg pulveris un šķīdinātājs ilgstošas darbības injekciju suspensijas
pagatavošanai
Czech Republic: Lutrate Depot 22.5 mg
Poland: Lutrate Depot
Slovak Republic: Lutrate Depot 22.5 mg
Romania: Lutrate Depot 22.5 mg pulbere şi solvent pentru suspensie injectabilă cu eliberare
prelungită
Bulgaria: Lutrate Depot

This leaflet was last revised in 05/2015.

The following information is intended for healthcare professionals only:

How to prepare the injection?
Follow these instructions carefully.
An aseptic technique should be observed during the reconstitution procedure.

Important:
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.

The pack contains:
1 (one) vial of Politrate Depot 22.5 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 containing 1 (one) single-use sterile needle.
1

2

3

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

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

4

5

6

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 drawup the resuspended drug
from the vial into the
syringe

Remove cap from the vial

7

8

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

Some product may cake or clump at the vial wall. This is considered normal. During the
manufacture of the product the vial is filled with excess product in order to make sure that a
final dose of 22.5 mg of leuprorelin acetate is administered.

Uk-Lut(3)-pil-v01-clean

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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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