LEPTOPROL 3.6 MG Implant

Treść ulotki

1. LEPTOPROL 5 mg/3 months implant
   1. What is Leptoprol 5 mg/3 months implant and what is it used for
   2. What you need to know before using Leptoprol 5 mg/3 months implant
   3. How to use Leptoprol 5 mg/3 months implant
   4. Possible side effects
   5. How to store Leptoprol 5 mg/3 months implant
   6. Content of the pack and other information
2. LEPTOPROL 3,6 mg/1 month implant
   1. What is Leptoprol 3.6 mg/1 month implant and what is it used for
   2. What you need to know before using Leptoprol 3,6 mg/1 month implant
   3. How to use Leptoprol 3.6 mg/1 month implant
   4. Possible side effects
   5. How to store Leptoprol 3,6 mg/1 month implant
   6. Contents of the pack and other information

LEPTOPROL 5 mg/3 months implant

leuprorelin

Read this leaflet carefully before you start to use this medicine as it contains important
information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:
1 What LEPTOPROL 5 mg/3 months implant is and what it is used for
2 What you need to know before you use LEPTOPROL 5 mg/3 months implant
3 How to use LEPTOPROL 5 mg/3 months implant
4 Possible side effects
5 How to store LEPTOPROL 5 mg/3 months implant
6 Contents of the pack and other information

1. What is Leptoprol 5 mg/3 months implant and what is it used for

The active substance of LEPTOPROL 5 mg/3 months implant (leuprorelin acetate) belongs to the group of
inhibitors of certain sex hormones.
LEPTOPROL 5 mg/3 months implant acts on the pituitary gland, stimulating it for a short time
and then reducing the production of hormones that control the release of sex hormones in the testicles.
This means that subsequently the concentrations of sex hormones decrease markedly and, with
continuous administration, remain at this level. After discontinuation of LEPTOPROL 5 mg/3 months
implant, the concentrations of pituitary and sex hormones return to normal values.
LEPTOPROL 5 mg/3 months implant is used for the symptomatic treatment of advanced hormone-dependent
tumors of the prostate (prostate cancer).

2. What you need to know before using Leptoprol 5 mg/3 months implant

Do not use LEPTOPROL 5 mg/3 months implant

• if you are allergic to leuprorelin or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to substances similar to leuprorelin, such as goserelin or buserelin
• if the tumour is not affected by hormonal factors
• if you are a woman or a child.

Warnings and precautions
Talk to your doctor or nurse before taking LEPTOPROL 5 mg/3 months implant:

• in case of known high blood pressure. In this case your doctor will monitor you closely;

1/18

• if both testicles have been surgically removed. In this case LEPTOPROL 5 mg/3 months implant will not produce any further decrease in the concentration of male sex hormone in the blood;
• if, before starting treatment, you already suffer from symptoms affecting the nervous system (pressure on the spinal cord, metastases in the spine) or discomfort when urinating due to displacement of the urinary tract. In this case you should immediately inform your doctor: they will monitor you particularly closely in the first few weeks, if possible by admitting you to hospital;
• if, with prolonged use of LEPTOPROL 5 mg/3 months implant, the symptoms of the disease reappear (for example pain, difficulty urinating or weakness in the legs). In this case your doctor will regularly check the success of the treatment using clinical examinations (digital rectal examination of the prostate, imagingtests) and by checking blood values (phosphatase and specific prostate antigen [PSA] and male sex hormone [testosterone]);
• if you have a risk of developing osteoporosis. If possible, your doctor will prescribe you an additional medicine, to prevent bone loss;
• if you suffer from diabetes. In this case, your doctor will monitor you very carefully.

Cases of depression have been reported in patients taking Leptoprol 5 mg/3 months implant, which
can be serious. If you are taking Leptoprol 5 mg/3 months implant and develop a depressed mood, inform
your doctor.
Talk to your doctor if you have any of the following conditions: any heart or blood vessel disorder,
including heart rhythm problems (arrhythmias), or if you are being treated with medicines for these disorders. The
risk of heart rhythm problems may increase with the use of Leptoprol 5 mg/3 months implant.
For athletes: the use of the medicine without therapeutic need constitutes doping and may
still result in a positive doping test.

Other medicines and Leptoprol 5 mg/3 months implant
If you are taking, have recently taken or might take other medicines, tell your doctor, pharmacist
or nurse.
Leptoprol 5 mg/3 months implant may interfere with some medicines used to treat heart rhythm problems (for example quinidine, procainamide, amiodarone and sotalol) or may increase the risk
of heart rhythm problems when used with some other medicines (for example methadone
(used to relieve pain and in detoxification programmes),
moxifloxacin (an antibiotic), antipsychotics (used for serious mental illnesses).

Children and adolescents
LEPTOPROL 5 mg/3 months implant is intended exclusively for adult patients.

Pregnancy and breastfeeding
LEPTOPROL 5 mg/3 months implant is intended exclusively for male patients.

Driving and using machines
This medicine, as well as the underlying cancer, can cause fatigue, which is
more likely to occur with the consumption of alcoholic beverages.
Therefore, if this is the case, do not drive or use machineswithout your doctor's permission.
2/18

3. How to use Leptoprol 5 mg/3 months implant

Administration of LEPTOPROL 5 mg/3 months implant

• The injection site must be cleaned.
• A local anesthetic may be used to relieve the pain caused by the implant injection.
• LEPTOPROL 5 mg/3 months implant must be administered by injection under the skin (subcutaneously) in the abdominal area.
• LEPTOPROL 5 mg/1 month implant must be administered by your doctor or a nurse who will also be responsible for preparing the medication

Dosage
The recommended dose is: one implantwith 5 mg of leuprorelin every 3 months.

• Follow your doctor's advice regarding the day you should receive LEPTOPROL 5 mg/3 months implant and the time interval that should elapse between two injections.
• The injection of LEPTOPROL 5 mg/3 months implant should be administered every 3 months. If, in exceptional cases, the next injection is delayed by a maximum of 4 weeks, the therapeutic effect is generally not compromised.
• Inject the contents of a prefilled syringe.
• The syringe contains an implant designed to deliver a dose of 5 mg of leuprorelin.

Blood tests
Your doctor will need to prescribe you periodic blood tests to verify whether the drug is
working.
After 3 months of treatment, your doctor is usually able to establish whether the prostate cancer is treatable with
LEPTOPROL 5 mg/3 months implant and must therefore monitor prostate-specific antigen (PSA) and
testosterone levels.

Duration of treatment
The duration of therapy will be established by your doctor. Treatment should be continued even if the symptoms
related to the cancer have decreased or if the cancer itself has improved.
Prostate cancer can be treated with LEPTOPROL 5 mg/3 months implant for several years. Therefore,
if it proves effective and tolerable, the medication can be used continuously. Your doctor will
prescribe you a series of tests at regular intervals in order to evaluate the therapy, especially if
symptoms such as:

• pain
• difficulty urinating
• leg weakness.

If you use more LEPTOPROL 5 mg/3 months implant than you should
It is unlikely that a doctor or nurse will administer an excessive amount of this medication to you.
However, if you are accidentally administered an excessive amount, your doctor will monitor you and,
if necessary, administer appropriate treatment.

If you forget to use LEPTOPROL 5 mg/3 months implant
3/18
If you believe that the quarterly administration of your dose of LEPTOPROL 5 mg/3 months implant has been
forgotten, inform your doctor.

If you stop using LEPTOPROL 5 mg/3 months implant
If you stop treatment without your doctor's approval, the symptoms associated with your illness may
worsen.
Therefore, therapy should not be discontinued prematurely without your doctor's permission.
If you have any doubts about the use of this medication, please consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

If you experience the following serious side effects, contact your doctor immediately or go to the
nearest emergency room:

• Allergic reactions(anaphylactic reactions). Symptoms may include the sudden onset of: o feeling of warmth, rash, itching or hives on the skin and/or mucous membranes; o swelling of the face, lips or tongue or other parts of the body; o shortness of breath, wheezing or difficulty breathing; o drop in blood pressure, rapid heartbeat, convulsions and, in the most severe cases, potentially fatal cardiovascular system failure.
• Swelling and pain in a part of the body, due to a blood clot in a vein.
• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin anddiscoloration, due to a blood clot in the lungs.

These side effects are rare (may affect up to 1 in 1000 people)
Generally, at the beginning of therapy, there is a short-term increase in the level of the male sex hormone
(testosterone) in the blood. As a result, the following symptoms related to the disease may
be temporarily aggravated:

• Onset or increase of bone pain
• Difficulty urinating due to displacement of the urinary tract
• Pressure on the spinal cord
• Muscle weakness in the legs
• Swelling due to the inability of fluids to drain from the tissues (lymphatic edema).

This increase in symptoms usually subsides without LEPTOPROL 5 mg/3 months implant having to be
interrupted.
When starting treatment, the administration of an appropriate
antagonist of the male sex hormone (antiandrogen) should be considered, in order to reduce the possible consequences
of the initial increase in the level of the male sex hormone.
During treatment, the male sex hormone reaches a very low level. As a result, in
some patients the following side effects occur:
4/18

Very common,may affect more than 1 in 10 people

• hot flashes
• increased sweating
• bone pain
• decreased or loss of sexual desire and potency
• reduction in testicle size
• weight gain
• local skin reactions, such as redness or hardening, pain, swelling and itching at the injection site, which normally subside even with continued treatment; in isolated cases, an abscess has appeared.

Common,may affect up to 1 in 10 people

• enlargement of the breasts in men
• decreased appetite
• increased appetite
• depression, mood swings
• sleep disorders
• headache
• abnormal sensations, such as a tingling and/or numbness
• nausea/vomiting
• joint or back pain
• muscle weakness
• increased need to urinate during the night
• excessively frequent need to urinate during the day
• difficulty and pain when urinating
• fatigue
• swelling of ankles, feet or fingers (peripheral edema)
• weight loss
• increased plasma levels of liver enzymes (ALT, AST, gamma-GT) and other enzymes (LDH, alkaline phosphatase).

Uncommon,may affect up to 1 in 100 people

• general allergic reactions, such as fever, itching, increased eosinophilic blood cells, skin rashes
• diarrhea
• dryness of the skin or mucous membranes
• testicular pain
• inability to completely empty the bladder spontaneously
• increased night sweats.

Rare,may affect up to 1 in 1000 people

• decreased or increased blood sugar levels
• dizziness
• transient taste changes
• decreased or increased blood pressure
• hair loss

5/18

Veryrare,may affect up to 1 in 10,000 people

• as with other medicines of this class of substances: pituitary infarction after the first administration to patients with a pituitary tumor.

Not known, the frequency cannot be estimated on the basis of the available data

• non-infectious lung disease (pneumonia, reported predominantly in Japan)
• inflammation of the lungs, lung disease
• in isolated cases, an abscess has manifested at the injection site
• changes in the ECG tracing (QT prolongation)
• convulsions

Special information
The effect of treatment with LEPTOPROL 5 mg/3 months implant can be monitored by measuring
blood concentrations of the male sex hormone (testosterone) and performing other blood tests
(acid phosphatase, PSA = prostate-specific antigen). Testosterone levels increase at the beginning of treatment,
then decrease over two weeks. After 2-4 weeks, the concentrations of
testosterone reached are similar to those observed after surgical removal of both
testicles and remain constant throughout the treatment period.
In the early phase of treatment, a temporary increase in blood levels of acid
phosphatase may occur. After a few weeks, normal or near-normal levels are reached again.
The decrease in the level of the male sex hormone testosterone, as occurs after removal
of the testicles or with treatment with drugs that inhibit sex hormones (such as LEPTOPROL 5 mg/3
months implant), can cause a reduction in bone density, with an increased risk of bone fractures
(see section Warnings and precautions). The reduction in bone density after removal of the
testicles is, however, more pronounced than that caused by the administration of LEPTOPROL 5 mg/3 months
implant. The doctor will consider the additional administration of a medicine (called
a bisphosphonate) to regulate calcium metabolism.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Leptoprol 5 mg/3 months implant

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the outer packaging, on the sterile
sachet and on the syringe label, after the words ‘Expiry Date’. The expiry date refers to the last day
of that month.
Do not store at a temperature above 30°C.
6/18
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What LEPTOPROL 5 mg/3 months implant contains

• The activesubstanceis leuprorelin(as leuprorelin acetate). Each implant contains 5 mg of leuprorelin (as leuprorelin acetate)
• The excipient is polylactic acid.

Description of the appearance of LEPTOPROL 5 mg/3 months implant and content of the pack
Prefilled polycarbonate syringe with a plunger made of acrylonitrile-butadiene-styrene copolymer and a needle,
sealed in a composite laminate pouch made of polyethylene terephthalate/aluminum/PE.
Packs containing:

• 1 prefilled syringe with one implant
• 2 prefilled syringes with one implant each
• 3 prefilled syringes with one implant each
• 5 prefilled syringes with one implant each

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz Spa
Largo U. Boccioni 1
21040 Origgio (VA)
Italy

Manufacturer:
EVER Pharma Jena GmbH - Otto-Schott-Straße 15, 07745 Jena – Germany
EBEWE Pharma Ges.m.b.H. Nfg. KG, Mondseestrasse 11, 4866 Unterach – Austria
Sandoz GmbH, Biochemiestraße 10, 6250 Kundl, Austria

This medicinal product is authorised in the member states of the EEA with the following denominations:
Austria: Leuprorelin Sandoz 5 mg Implantat für 3 Monate
Denmark: Leuprorelin Sandoz
Germany: Leuprorelin Hexal 5 mg
Greece: PROSTAPLANT 5 mg εμφύτευμα
Hungary: LEUPRORELIN Sandoz 5 mg implantátum
Ireland: Leuprex 3, 5 mg Implant
Italy: LEPTOPROL
Norway: Leuprorelin Sandoz 5 mg implantat
Poland: Leuprostin
Sweden: Leuprorelin Sandoz 5 mg implantat
Slovakia: Leuprorelin Sandoz 5 mg implantát
7/18

The following information is intended exclusively for healthcare professionals
Read the instructions carefully, as the applicator supplied with this medicinal product may be
different from others you have used.

Instructions for use
1 Disinfect the injection site on the anterior abdominal wall, below the navel.
2 Remove the applicator from the sterile pouch and verify that the implant is visible in its housing
(see the framed area). To verify, observe the applicator against the light or shake it gently.

3 Pull the applicator plunger completely back until you see the complete line
in the second window.
Note: the plunger can only be pushed forward to inject the implant if it has previously been

pulled completely back into the stop position!

• 4. Remove the protective cap from the needle
• 5. Hold the applicator body with one hand. With the other hand, pinch the skin of the anterior abdominal wall of the patient, below the navel. See illustration. With the openingof the needle facing upwards, insert the entire needle. Do this at a slight angle, keeping it almost parallel to the skin into the subcutaneous tissue.

8/18

6 Pullthe applicator back gently by about 1 cm. This creates the insertion channel for
the implant.
7 Inject the implant into the insertion channel, pushing the plunger completelyforward until
it clicks into place and you hear a click.

• 8. Remove the needle. To ensure that the implant has been inserted correctly, check that the terminal of the plunger (blue) is visible at the end of the needle.

For information relating to dosage, refer to section 3, “How to use Leptoprol 5
mg/3 months implant”
9/18

LEPTOPROL 3,6 mg/1 month implant

leuprorelin

Read this leaflet carefully before using this medicine because it contains important
information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:
1 What LEPTOPROL 3,6 mg/1 month implant is and what it is used for
2 What you need to know before using LEPTOPROL 3,6 mg/1 month implant
3 How to use LEPTOPROL 3,6 mg/1 month implant
4 Possible side effects
5 How to store LEPTOPROL 3,6 mg/1 month implant
6 Contents of the pack and other information

1. What is Leptoprol 3.6 mg/1 month implant and what is it used for

The active substance of LEPTOPROL 3,6 mg/1 month implant (leuprorelin acetate) belongs to the group of
inhibitors of certain sex hormones.
LEPTOPROL 3,6 mg/1 month implant acts on the pituitary gland, stimulating it for a short
time and then reducing the production of hormones that control the release of sex hormones in the
testicles.
This means that subsequently the concentrations of sex hormones decrease markedly and, with continuous
administration, remain at this level. After discontinuation of LEPTOPROL 3,6 mg/1
month implant, the concentrations of pituitary and sex hormones return to normal values.
LEPTOPROL 3,6 mg/1 month implant is used for the symptomatic treatment of advanced hormone-dependent
tumors of the prostate (prostate cancer).

2. What you need to know before using Leptoprol 3,6 mg/1 month implant

Do not use LEPTOPROL 3,6 mg/1 month implant

• if you are allergic to leuprorelin or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to substances similar to leuprorelin, such as goserelin or buserelin
• if the tumor is not influenced by hormonal factors
• if you are a woman or a child.

10/18

Warnings and precautions
Consult your doctor or nurse before taking Leptoprol 3,6 mg/1 month implant:

• in case of known hypertension. In this case, your doctor will monitor you closely;
• if both testicles have been surgically removed. In this case, LEPTOPROL 3,6 mg/1 month implant does not produce any further decrease in the concentration of male sex hormone in the blood;
• if, before starting treatment, you already suffer from symptoms affecting the nervous system (pressure on the spinal cord, metastases in the spine) or discomfort when urinating due to displacement of the urinary tract. In this case, you should immediately inform your doctor: they will monitor you with particular attention in the first few weeks, if possible in hospital;
• if, with prolonged use of LEPTOPROL 3,6 mg/1 month implant, the symptoms of the disease reappear (for example pain, difficulty urinating or weakness in the legs). In this case, the doctor will regularly check the success of the treatment using clinical examinations (digital rectal examination of the prostate, imaging tests) and by checking blood values (phosphatase and specific prostate antigen [PSA] and male sex hormone [testosterone]);
• if you are at risk of developing osteoporosis. If possible, your doctor will prescribe you an additional medicine to prevent bone loss;
• if you suffer from diabetes. In this case, your doctor will monitor you very carefully.

Cases of depression have been reported in patients taking Leptoprol 3,6 mg/1 month implant, which
can be severe. If you are undergoing therapy with Leptoprol 3,6 mg/1 month implant and develop a depressed mood,
inform your doctor.
Consult your doctor if you have any of the following conditions: any heart or blood vessel disorder,
including heart rhythm problems (arrhythmias), or if you are being treated with medications for these disorders. The
risk of heart rhythm problems may increase with the use of Leptoprol 3,6 mg/1 month implant.
For those who engage in sports: the use of the drug without a therapeutic need constitutes doping and may
still result in a positive doping test.

Other medicines and Leptoprol 3,6 mg/1 month implant
If you are taking, have recently taken or might take other medicines, inform your doctor, pharmacist
or nurse.
Leptoprol 3,6 mg/1 month implant may interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or may increase the risk
of heart rhythm problems when used with some other drugs (e.g. methadone
(used to relieve pain and in drug detoxification programs),
moxifloxacin (an antibiotic), antipsychotics used for severe mental illnesses).

Children and adolescents
LEPTOPROL 3,6 mg/1 month implant is intended exclusively for adult patients.

Pregnancy and breastfeeding
LEPTOPROL 3,6 mg/1 month implant is intended exclusively for male patients.

Driving and operating machinery
11/18
This medicine, as well as the underlying cancer, can cause fatigue, which is even more likely with
the consumption of alcoholic beverages.
Therefore, if this is the case, do not drive or operate machinerywithout your doctor's permission.

3. How to use Leptoprol 3.6 mg/1 month implant

Administration of LEPTOPROL 3.6 mg/1 month implant

• The injection site should be cleaned.
• A local anesthetic may be used to relieve the pain caused by the implant injection.
• LEPTOPROL 3.6 mg/1 month implant should be administered by subcutaneous injection in the abdominal area.
• LEPTOPROL 3.6 mg/1 month implant must be administered by your doctor or a nurse who will also be responsible for preparing the medicine

Dosage
The recommended dose isone implantwith 3.6 mg of leuprorelin per month.

• Follow your doctor's advice regarding the day you should receive LEPTOPROL 3.6 mg/1 month implant and the time interval that should elapse between two injections.
• The injection of LEPTOPROL 3.6 mg/1 month implant should be administered every month. After the second application, in exceptional cases the next injection may be postponed for a maximum of 2 weeks. Generally, the therapeutic effect in most patients is not compromised.
• Inject the contents of a prefilled syringe.
• The syringe contains an implant designed to deliver a dose of 3.6 mg of leuprorelin.

Blood tests
The doctor will periodically prescribe blood tests to verify whether the drug is
working.
After 3 months of treatment, the doctor is usually able to establish whether the prostate cancer is treatable with
LEPTOPROL 3.6 mg/1 month implant and must therefore check the prostate-specific antigen (PSA) and
testosterone levels.

Duration of treatment
The duration of therapy will be established by the doctor. Treatment should be continued even if the symptoms
related to the cancer have decreased or if the cancer itself has improved.
Prostate cancer can be treated with LEPTOPROL 3.6 mg/1 month implant for several years.
Therefore, if it proves effective and tolerable, the medicine can be used continuously. The doctor will
prescribe you a series of tests at regular intervals to evaluate the therapy, especially if
symptoms such as:

• pain
• difficulty urinating
• weakness in the legs.

If you use more LEPTOPROL 3.6 mg/1 month implant than you should
It is unlikely that a doctor or nurse will administer an excessive amount of this medicine to you.
12/18
However, if an excessive amount were accidentally administered, the doctor will monitor you and, if
necessary, administer appropriate treatment.

If you forget to use LEPTOPROL 3.6 mg/1 month implant
If you believe that the monthly administration of your dose of LEPTOPROL 3.6 mg/1 month implant has been
forgotten, inform your doctor.

If you stop using LEPTOPROL 3.6 mg/1 month implant
If you stop treatment without your doctor's approval, the symptoms associated with your illness may
worsen.
Therefore, therapy should not be discontinued prematurely without the doctor's permission.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest them.

If you experience the following serious side effects, contact your doctor immediately or go to the
nearest emergency room:

• Allergic reactions(anaphylactic reactions). Symptoms may include the sudden onset of: o feeling of warmth, rash, itching or hives on the skin and/or mucous membranes; o swelling of the face, lips or tongue or other parts of the body; o shortness of breath, wheezing or difficulty breathing; o drop in blood pressure, rapid heartbeat, convulsions and, in the most severe cases, potentially fatal cardiovascular system failure.
• Swelling and pain in a part of the body, due to a blood clot in a vein.
• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin anddiscoloration, due to a blood clot in the lungs.

These side effects are rare (may affect up to 1 in 1000 people)
Generally, at the beginning of therapy, there is a short-term increase in the level of the male sex hormone
(testosterone) in the blood. Consequently, the following symptoms related to the disease may
be temporarily aggravated:

• Onset or increase of bone pain
• Difficulty urinating, due to displacement of the urinary tract
• Pressure on the spinal cord
• Muscle weakness in the legs
• Swelling due to the inability of fluids to drain from the tissues (lymphatic edema).

This increase in symptoms usually resolves without LEPTOPROL 3.6 mg/1 month implant having to be
interrupted.
When starting treatment, the administration of an appropriate
antagonist of the male sex hormone (antiandrogen) should be considered, in order to reduce the possible consequences
of the initial increase in the level of the male sex hormone.
13/18
During treatment, the male sex hormone reaches a very low level. Consequently, in
some patients the following side effects occur:

Very common,may affect more than 1 in 10 people

• bone pain
• hot flashes, with episodes of sweating
• decreased desire and sexual potency
• increased sweating

Common, may affect up to 1 in 10 people

• depression, mood swings
• abnormal sensations, such as tingling and/or numbness
• increased need to urinate during the night
• excessively frequent need to urinate during the day
• difficulty and pain during urination
• increased appetite
• sleep disorders

Uncommon,may affect up to 1 in 100 people

• decreased appetite
• decreased or increased blood sugar levels
• headache
• dizziness
• changes in blood pressure (decrease or increase in pressure)
• difficulty breathing
• diarrhea
• hair loss
• dryness of the skin and mucous membranes
• increased night sweats
• inability to completely empty the bladder spontaneously
• reduction in the size of the testicles
• testicular pain
• breast enlargement in men
• weight gain
• weight loss
• increased plasma levels of liver enzymes (ALT, AST, gamma-GT) and other enzymes (LDH, alkaline phosphatase)

Very rare,may affect up to 1 in 10,000 people

• general allergic reactions (fever, rash, itching, increased count of certain white blood cells [eosinophilia])
• transient changes in taste
• nausea/vomiting
• joint and/or back pain and muscle disorders
• edema
• fatigue

14/18

• local skin reactions, such as redness or hardening, pain, swelling and itching at the injection site, which normally subside even with continued treatment; in isolated cases, an abscess has appeared
• as with other medicines of this class of substances: pituitary infarction after the first administration to patients with a pituitary tumor.

Not known, the frequency cannot be estimated on the basis of the available data

• non-infectious lung disease (pneumonia, reported predominantly in Japan) inflammation of the lungs, lung disease
• in isolated cases, an abscess has manifested at the injection site
• changes in the ECG tracing (QT prolongation)
• convulsions

Special information
The effect of treatment with LEPTOPROL 3.6 mg/1 month implant can be monitored by measuring
the concentrations in the blood of the male sex hormone (testosterone) and performing other blood tests
(acid phosphatase, PSA = prostate-specific antigen). Testosterone levels increase at the beginning of treatment
then decrease over two weeks. After 2-4 weeks, the concentrations of
testosterone reached are similar to those observed after surgical removal of both
testicles and remain constant throughout the treatment period.
In the early stages of treatment, a temporary increase in blood levels of acid
phosphatase may occur. After a few weeks, normal or near-normal levels are reached again.
The decrease in the level of the sex hormone testosterone, as occurs after removal
of the testicles or with treatment with drugs that inhibit sex hormones (such as LEPTOPROL 3.6
mg/1 month implant), can cause a reduction in bone density, with an increased risk of bone fractures
(see the section Warnings and precautions). The reduction in bone density after removal of
the testicles is, however, more marked than that caused by the administration of LEPTOPROL 3.6 mg/1
month implant. The doctor will consider the additional administration of a medicine
(called a bisphosphonate) to regulate calcium metabolism.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting
side effects you can help provide more information on the safety of this medicine.

5. How to store Leptoprol 3,6 mg/1 month implant

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 30°C.
Do not use this medicine after the expiry date, which is stated on the outer packaging, on the sterile
sachet and on the syringe label, after the wording Exp.. The expiry date refers to the last day
of that month.
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Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What LEPTOPROL 3.6 mg/1 month implant contains

• The active substanceis leuprorelin(as leuprorelin acetate). Each implant contains 3.6 mg of leuprorelin (as leuprorelin acetate)
• The excipient is poly(lactic-co-glycolic) acid 1:1

Description of the appearance of LEPTOPROL 3.6 mg/1 month implant and contents of the pack
Prefilled polycarbonate syringe with a plunger made of acrylonitrile-butadiene-styrene copolymer and a needle,
sealed in a composite laminate pouch made of polyethylene terephthalate/aluminum/PE. The pouch also contains a
desiccant based on sodium aluminum silicate.
Packs containing:

• 1 prefilled syringe with one implant
• 2 prefilled syringes with one implant each
• 3 prefilled syringes with one implant each
• 5 prefilled syringes with one implant each

It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder
Sandoz Spa
Largo U. Boccioni 1
21040 Origgio (VA)
Italy

Manufacturer responsible for batch release:
EVER Pharma Jena GmbH - Otto-Schott-Straße 15 - 07745 Jena – Germany
EBEWE Pharma Ges.m.b.H. Nfg. KG, Mondseestrasse 11, 4866 Unterach – Austria
Sandoz GmbH, Biochemiestraße 10, 6250 Kundl, Austria

This medicinal product is authorised in the member states of the EEA under the following designations:
Austria: Leuprorelin Sandoz 3.6 mg Implantat für 1 Monat
Denmark: Leuprorelin Sandoz
Germany: Leuprorelin Hexal 3.6 mg
Italy: LEPTOPROL
Hungary: Leuprorelin Sandoz 3.6mg/ implantátum
Norway: Leuprorelin Sandoz 3.6 mg implantat
Poland: LEUPROSTIN
Sweden: Leuprorelin Sandoz 3.6 mg implantat
Slovakia: Leuprorelin Sandoz 3.6 mg implantát
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The following information is intended exclusively for healthcare professionals
Read the instructions carefully, as the applicator supplied with this medicinal product may be
different from others you have used.

Instructions for use
1 Disinfect the injection site on the anterior abdominal wall, below the navel.
2 Remove the applicator from the sterile pouch and check that the implant is visible in its housing
(see the framed area). To verify, observe the applicator against the light or shake it gently.
3 Pull the applicator plunger completely back until you see the complete line in the

second window.
Note: the plunger can only be pushed forward to inject the implant if it has previously been

pulled completely back into the stop position!

• 5. Remove the protective cap from the needle
• 6. Hold the body of the applicator with one hand. With the other hand, pinch the skin of the anterior abdominal wall of the patient, below the navel. See illustration. With the openingof the needle facing upwards, insert the entire needle. Do this at a slight angle, keeping it almost parallel to the skin, into the subcutaneous tissue.

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• 6. Pullthe applicator back carefully by about 1 cm. This creates the insertion channel for the implant.
• 7. Inject the implant into the insertion channel, pushing completelythe plunger forward until it clicks into place and you hear a click.

• 8. Remove the needle. To ensure that the implant has been inserted correctly, check that the plunger tip (white) is visible at the end of the needle.

For information relating to dosage, refer to section 3, “How to use Leptoprol 3.6
mg/1 month implant”
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