TESTOGEL 25 mg Гель

Содержание инструкции

1. TESTOGEL 25 mg transdermal gel in sachet
   1. What this medicine is and what it is used for
   2. What you need to know before using this medicine
   3. How to use this medicine
   4. Possible side effects
   5. How to store this medicine
   6. Contents of the pack and other information
2. TESTOGEL 50 mg transdermal gel in sachet
   1. What this medicine is and what it is used for
   2. What you need to know before using this medicine
   3. How to use this medicine
   4. Possible side effects
   5. How to store this medicine
   6. Contents of the pack and other information

TESTOGEL 25 mg transdermal gel in sachet

Testosterone

Read this leaflet carefully before you start using 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 or pharmacist.
• 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 may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

TESTOGEL 25 mg transdermal gel in sachetwill be referred to as “this medicine” in this
leaflet.

Contents of this leaflet:

• 1. What this medicine is and what it is used for
• 2. What you need to know before you use this medicine
• 3. How to use this medicine
• 4. Possible side effects
• 5. How to store this medicine
• 6. Contents of the pack and other information.

1. What this medicine is and what it is used for

This medicine contains testosterone, a male hormone produced naturally by the body.
This medicine is used to replace testosterone in adult men, for the treatment of various
health problems due to testosterone deficiency (male hypogonadism). This condition
must be confirmed with two distinct testosterone measurements in the blood and must include
clinical symptoms such as:

• Impotence
• Infertility
• Low libido
• Fatigue
• Depressed mood
• Loss of bone tissue due to low hormone levels
• Regression of male sexual characteristics
• Reduction of lean body mass
• Inability to achieve/maintain an erection.

2. What you need to know before using this medicine

Who can use this medicine

• Only men can use this medicine.
• Boys under the age of 18 should not use this medicine.
• This medicine should not be used by women of any age.
• Do not allow women (especially those who are pregnant or breastfeeding) or children to come into contact with this medicine or with the areas of skin where it has been applied.

Do not use this medicine

• If you are allergic to testosterone or any of the other ingredients of this medicine (listed in section 6),
• In case of prostate cancer,
• In case of breast cancer.

Warnings and precautions
Consult your doctor or pharmacist before using this medicine:
Before starting treatment with this medicine, testosterone deficiency must be
clearly demonstrated by clinical signs (regression of male characteristics, reduction in
lean body mass, weakness or fatigue, decreased sexual desire, inability to
achieve/maintain an erection, etc.) and confirmed by laboratory tests. The doctor will perform the necessary
tests before you can use this medicine and will perform follow-up checks by periodically performing
blood tests.
If any of the following conditions apply to you (or if you are not sure), talk to your
doctor before
using this medicine, because the use of this medicine may worsen these
conditions.

• you have difficulty urinating due to an enlarged prostate gland
• you suffer from bone cancer - the doctor will check your calcium levels
• you suffer from high blood pressure or are being treated for high blood pressure, as this medicine can cause an increase in blood pressure
• you suffer from severe heart, liver or kidney disease, as treatment with this medicine can cause serious complications in the form of fluid retention in the body, sometimes accompanied by congestive heart failure (fluid overload in the heart)
• you suffer from ischemic heart disease (affecting blood supply to the heart)
• you have blood clotting problems:
• (thrombophilia, an abnormality of blood coagulation that increases the risk of thrombosis, blood clots in blood vessels)
• factors that increase your risk of blood clots in a vein:
• previous blood clots in a vein; smoking; obesity; cancer; immobility; if one of your close relatives has had a blood clot in the leg, lung or another organ at a young age (e.g. under the age of 50); or advancing age.
• How to recognize a blood clot: painful swelling of a leg or sudden change in skin color, such as pallor, redness or blue, sudden shortness of breath, sudden unexplained cough that may bring up blood; or sudden chest pain, severe dizziness or vertigo, severe stomach pain, sudden loss of vision. Seek urgent medical attention if you experience any of these symptoms.
• you suffer from epilepsy
• you suffer from migraine
• you have difficulty breathing during sleep - this is more likely to happen if you are overweight or have long-standing lung problems

Androgens can increase the risk of increased prostate volume (benign prostatic hyperplasia) or prostate cancer. Regular prostate examinations should therefore be performed, before and during therapy, in accordance with the doctor's instructions.
If you suffer from diabetes and use insulin to control your blood sugar levels, treatment with
testosterone may affect your response to insulin and you may need to adjust the dosage
of antidiabetic medicines.
In case of severe skin reactions, treatment should be reconsidered and possibly discontinued.
This medicine should not be used by women due to possible virilizing effects (such as
growth of facial or body hair, lowering of the voice or changes in the menstrual cycle).

Information about additional checks
The following blood tests must be performed by the doctor before and during treatment: blood testosterone level, complete blood count.
During treatment, you will need to undergo regular check-ups (at least once a year and twice
a year if you are elderly or if your doctor considers you a high-risk patient).
If you receive long-term testosterone replacement therapy, you may develop an
abnormal increase in the number of red blood cells in your blood (polycythemia). You will need to have regular
blood tests to check that this does not happen.

Children and adolescents
This medicine is not recommended for children, as there is no clinical information
available for subjects under the age of 18.

Potential transfer of testosterone
In case of repeated or prolonged physical contact, the medicine may be transferred to another person.
This can cause unwanted effects such as the growth of hair on the face or body, a lowering of
the voice or changes in the menstrual cycle in women, or accelerated height growth,
enlargement of the genitals and early puberty (including the development of pubic hair) in children.
The following precautions are recommended to protect against transfer:

• wash your hands thoroughly with water and soap after applying the gel,
• Once the gel has dried, cover the application area with clothing. Wait at least 1 hour after applying the medicine before showering or bathing.
• shower and wash the application area or areas thoroughly with water and soap to remove any testosterone residue before any situation involving close contact, or, if this is not possible, wear clothing such as a shirt or t-shirt covering the application site during the period of contact.

Patients using this product who may be in close physical contact with children
should take extra care, as testosterone can pass through clothing.
when in physical contact with children, also covering the application site with clean clothing
once the gel has dried. Also, wash the application site with water and soap once
the recommended time has elapsed (at least 1 hour) and cover again with clean clothing
before physical contact with children.
If you believe that testosterone has been transferred to another person (man, woman or child) that
person should:

• immediately wash the affected skin surface with water and soap
• contact a doctor if symptoms such as acne, changes in hair growth or pattern on the body or face, lowering of the voice, changes in the menstrual cycle appear.
• For children, also observe the signs of early puberty and enlargement of the genitals.

It is preferable for patients to wait at least 1 hour after applying this medicine
before bathing or showering.

Other medicines and this medicine
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, in particular the following:

• oral anticoagulants (medicines used to thin the blood),
• corticosteroids (medicines used to reduce inflammation)
• insulin (medicine used to control blood sugar levels in people with diabetes). You may need to reduce the dose of insulin when using this medicine.

If any of the above cases apply to you (or if you are not sure), talk to your
doctor or pharmacist before using this medicine. These particular medicines may require an
adjustment of the dose of this medicine.

Pregnancy and breastfeeding
This medicine should not be used by women.
Sperm production can be reversibly suppressed with this medicine.
This medicine should not be used by pregnant or breastfeeding women.
If your partner becomes pregnant, she should follow the advice to avoid transfer of the testosterone gel.
Pregnant women should avoid any contact with this medicine because this
medicine can have negative virilizing effects on the fetus. In case of accidental skin-to-skin contact, the partner should wash the area thoroughly with water and soap as soon as possible.

Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

Warnings for athletes
For those who play sports: the use of the drug without a therapeutic need constitutes doping and may
still result in a positive doping test.

This medicine contains alcohol (ethanol)
This medicine contains 1.8 g of alcohol (ethanol) in each sachet.
It can cause a burning sensation on damaged skin.
When administering the medicine for the first time, avoid sources of heat or open flames
until the gel has dried on the skin, as ethanol is flammable.

3. How to use this medicine

This medicine is for transdermal use in adult men only.
Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor.
The recommended dose is 5 g of gel (50 mg of testosterone) applied once a day, more or less
at the same time, preferably in the morning.
The daily dose will possibly be adjusted by the doctor depending on the individual patient, without
exceeding 10 g of gel per day.

How to apply the gel:

• The gel should be distributed by the patient himself on clean, dry and healthy skin on both shoulders, or on both arms
• Once the sachet is opened, all of the contents must be removed and applied immediately to the skin.
• The gel must be gently distributed on clean, dry and healthy skin.
• Apply a thin layer to the upper part of the left and right arm and on the shoulders. Do not rub the medicine into the skin.
• Allow the gel to dry for at least 3-5 minutes before getting dressed.
• Wash your hands with water and soap after application. Do not apply to the genitals (penis and testicles), as the high alcohol content may cause local irritation.

Patients must be informed that other people (adults or children) should not come into contact
with the area of the body where the testosterone gel has been applied.
Once the gel is dry, cover the application site with clean clothes (e.g. a
t-shirt).
Before close physical contact with another person (adult or child), wash the site of
application with water and soap once the recommended time has elapsed (at least 1 hour) and
cover again with clean clothes.

If you use more of this medicine than you should
Seek the advice of your doctor or pharmacist. They may advise you to wash the application site immediately
and your doctor may advise you to stop treatment.
The following signs may indicate that you are taking too much product and that it is
necessary to contact your doctor:

• irritability
• nervousness
• weight gain
• frequent or prolonged erections

These symptoms may indicate that the dose of this medicine is too high and your doctor may
need to adjust the dose (see Warnings and precautions, paragraph 2)

If you forget to use this medicine
Do not use a double dose to make up for a missed dose. Apply the next dose at the
usual time.

If you stop using this medicine
You should not stop treatment with this medicine unless your doctor tells you to.
If you have any questions about using 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.

Common side effects (may affect up to 1 in 10 people)

• mood disturbances
• emotional symptoms (mood swings, affective disorders, anger, aggression, impatience, insomnia, abnormal dreams, increased libido
• dizziness
• paresthesia
• amnesia
• hyperesthesia
• headache
• hypertension
• diarrhea
• alopecia
• urticaria
• gynecomastia
• reaction at the application site
• laboratory test alterations (polycythemia, lipids)
• increased hematocrit
• increased hemoglobin
• increased red blood cell count

Uncommon side effects (may affect up to 1 in 100 people)
This medicine can cause

• malignant hypertension
• hot flushes
• phlebitis
• oral pain
• abdominal distension
• acne
• hirsutism
• skin rash
• dry skin
• seborrhea
• skin lesions
• contact dermatitis
• hair color changes
• hypersensitivity at the application site
• pruritus at the application site
• nipple disorders
• prostate abnormalities
• testicular pain
• increased frequency of erections
• edema
• increased PSA

Rare (may affect up to 1 in 1,000)
This medicine can cause

• priapism
• hepatic neoplasia

Very rare (may affect up to 1 in 10,000)
This medicine can cause

• jaundice
• urinary obstruction

Frequency not known (cannot be estimated from the available data)
This medicine can cause:

• prostate cancer
• asthenia
• nervousness
• depression
• hostility
• sleep apnea
• urinary obstruction
• muscle cramps
• libido alterations
• therapy with high-dose testosterone preparations commonly interrupts or reversibly reduces spermatogenesis, thus reducing testicular size
• malaise
• edema
• hypersensitivity reactions
• weight gain
• electrolyte alterations (retention of sodium, chlorine, potassium, calcium, inorganic phosphate and water) during high-dose and/or prolonged treatment
• skin reactions (due to the alcohol contained in the product, frequent applications to the skin can cause irritation and dryness)
• increases water retention and edema

Due to the alcohol contained in this medicine, frequent applications to the skin can cause
irritation and dryness.

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 through the national reporting system at the website: 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 this medicine

This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the pack. The expiry date refers to the last day of that month.
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 this medicine contains

• The active ingredient is testosterone. Each 2.5 g sachet contains 25 mg of testosterone.
• The other ingredients are Carbomer 980, isopropyl myristate, 96% ethanol, sodium hydroxide, purified water.

Description of the appearance of this medicine and contents of the pack
This 25 mg medicine is a colorless gel presented in 2.5 g sachets.
This medicine is available in packs of 1, 2, 7, 10, 14, 28, 30, 50, 60, 90 or 100 sachets (not all pack sizes may be marketed).

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratoires Besins International
3, rue du Bourg l’Abbé
75003 Paris
France
Manufacturers
Laboratoires Besins International or Besins Manufacturing Belgium
13, rue Périer Groot Bijgaardenstraat, 128
92120 Montrouge 1620 Drogenbos
France Belgium

This medicine is authorised in the Member States of the European Economic Area under the
following denominations:
Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,
Luxembourg, Norway, Portugal, Spain, Sweden, Netherlands, United Kingdom: TESTOGEL

TESTOGEL 50 mg transdermal gel in sachet

Testosterone

Read this leaflet carefully before you start using 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

TESTOGEL 50 mg transdermal gel in sachetwill be referred to as “this medicine” in this
leaflet.

Contents of this leaflet:

• 1. What this medicine is and what it is used for
• 2. What you need to know before you use this medicine
• 3. How to use this medicine
• 4. Possible side effects
• 6. How to store this medicine
• 6. Contents of the pack and other information.

1. What this medicine is and what it is used for

This medicine contains testosterone, a male hormone produced naturally by the body.
This medicine is used to replace testosterone in adult men, for the treatment of various
health problems due to testosterone deficiency (male hypogonadism). This condition
must be confirmed with two distinct measurements of testosterone in the blood and must include
clinical symptoms such as:

• Impotence
• Infertility
• Low libido
• Fatigue
• Depressed mood
• Loss of bone tissue due to low hormone levels
• Regression of male sexual characteristics
• Reduction of lean body mass
• Inability to achieve/maintain an erection.

2. What you need to know before using this medicine

Who can use this medicine

• Only men can use this medicine.
• Boys under the age of 18 should not use this medicine.
• This medicine should not be used by women of any age.
• Do not allow women (especially those who are pregnant or breastfeeding) or children to come into contact with this medicine or with the areas of skin where it has been applied.

Do not use this medicine

• If you are allergic to testosterone or any of the other ingredients of this medicine (listed in section 6),
• In case of prostate cancer,
• In case of breast cancer.

Warnings and precautions
Talk to your doctor or pharmacist before using this medicine:
Before starting treatment with this medicine, testosterone deficiency must be
clearly demonstrated by clinical signs (regression of male characteristics, reduction of
lean body mass, weakness or fatigue, reduced sexual desire, inability to
achieve/maintain an erection, etc.) and confirmed by laboratory tests. The doctor will perform the necessary
tests before you can use this medicine and will perform follow-up checks by periodically performing
blood tests.
If any of the following conditions apply to you (or if you are not sure), talk to your
doctor before
using this medicine, because the use of this medicine could worsen these
conditions.

• have difficulty urinating due to an enlarged prostate gland
• have bone cancer - the doctor will check calcium levels
• suffer from high blood pressure or are being treated for high blood pressure, as this medicine can cause an increase in blood pressure
• suffer from severe heart, liver or kidney disease, as treatment with this medicine can cause serious complications in the form of fluid retention in the body, sometimes accompanied by congestive heart failure (fluid overload in the heart)
• suffer from ischemic heart disease (affecting blood supply to the heart)
• have blood clotting problems
• (thrombophilia, an abnormality of blood coagulation that increases the risk of thrombosis, blood clots in blood vessels)
• factors that increase the risk of blood clots in a vein: previous blood clots in a vein; smoking; obesity; cancer; immobility; if one of your close relatives has had a blood clot in the leg, lung or another organ at a young age (e.g. under about 50 years old); or with age.
• How to recognize a blood clot: painful swelling of a leg or sudden change in skin color, such as paleness, redness or blueness, sudden shortness of breath, sudden unexplained cough that may bring up blood; or sudden chest pain, severe dizziness or lightheadedness, severe stomach pain, sudden loss of vision. Seek urgent medical attention if you experience any of these symptoms.
• suffer from epilepsy
• suffer from migraine
• have difficulty breathing during sleep - this is more likely to happen if you are overweight or have long-term lung problems

Androgens can increase the risk of an enlarged prostate (benign prostatic hyperplasia) or prostate cancer. Regular prostate examinations should therefore be performed, before and during therapy, in accordance with the doctor's prescriptions.
If you suffer from diabetes and use insulin to control your blood sugar levels, treatment with
testosterone may affect your response to insulin and you may need to adjust the dosage
of your antidiabetic medications.
In case of severe skin reactions, treatment should be reconsidered and possibly discontinued.

Information about additional checks
The following blood tests must be performed by the doctor before and during treatment: blood testosterone level, complete blood count.
During treatment, you will need to undergo regular check-ups (at least once a year and twice
a year if you are elderly or if your doctor considers you a high-risk patient).
If you receive testosterone replacement therapy for long periods of time, you may develop an
abnormal increase in the number of red blood cells in your blood (polycythemia). You will need to have regular
blood tests to check that this does not happen.

Children and adolescents
This medicine is not recommended for children, as there is no clinical information available
for boys under the age of 18.

Potential transfer of testosterone
In case of repeated or prolonged physical contact, the medicine may be transferred to another person.
This may cause undesirable effects such as growth of hair on the face or body, a lowering of
the tone of the voice or changes in the menstrual cycle in women, or accelerated height growth,
enlargement of the genitals and precocious puberty (including the development of pubic hair) in children.
The following precautions are recommended to protect against transfer:

• wash your hands thoroughly with soap and water after applying the gel,
• Once the gel has dried, cover the application area with clothing. Wait at least 1 hour after applying the medicine before showering or bathing.
• shower and wash the application area or areas thoroughly with soap and water to remove any testosterone residue before any situation where close contact is expected, or, if this is not possible, wear clothing such as a shirt or t-shirt covering the application site during the period of contact.

Patients who use this product and who may be in close physical contact with children
should take extra care, as testosterone can pass through clothing.
when in contact with children, also covering the application site with clean clothing
once the gel has dried. Also, wash the application site with soap once the
recommended time has elapsed (at least 1 hour) and cover again with clean clothing before
physical contact with children.
If you believe that testosterone has been transferred to another person (man, woman or child) that
person should:

• immediately wash the skin surface on which testosterone transfer may have occurred with soap and water,
• contact a doctor if symptoms such as acne, changes in growth or hair pattern on the body or face, lowering of the voice, changes in the menstrual cycle appear.
• For children, also observe signs of precocious puberty and enlargement of the genitals.

It is preferable for patients to allow at least 1 hour after applying this medicine
before bathing or showering.

Other medicines and this medicine
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, in particular:

• oral anticoagulants (medicines used to thin the blood),
• corticosteroids (medicines used to reduce inflammation)
• insulin (medicine used to control blood sugar levels in people with diabetes) You may need to reduce your dose of insulin when using this medicine.

If any of the above cases apply to you (or if you are not sure), talk to your doctor or
pharmacist before using this medicine. These particular medicines may require an
adjustment of the dose of this medicine.

Pregnancy and breastfeeding
This medicine should not be used by women.
Sperm production may be reversibly suppressed with this medicine.
If your partner is or becomes pregnant or is planning to have a baby, she must follow the advice on
avoiding transfer of testosterone gel (see “Possible transfer of testosterone” above).
This medicine should not be used by pregnant or breastfeeding women.
Pregnant women should avoid any contact with this medicine because the product can
have negative virilizing effects on the fetus. In case of accidental skin-to-skin contact, the partner should
wash the area of contact thoroughly with soap and water as soon as possible.
If your partner is pregnant, you mustcarefully observe the precautions for use
above to avoid transferring testosterone-based gel.

Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

Warnings for athletes
For those who play sports: the use of the drug without a therapeutic need constitutes doping and may
still result in a positive doping test.

This medicine contains alcohol (ethanol)
This medicine contains 3.6 g of alcohol (ethanol) per sachet.
It may cause a burning sensation on damaged skin.
When administering the medicine for the first time, it is necessary to avoid sources of heat or open flames
because ethanol is flammable until the gel has dried on the skin.

3. How to use this medicine

This medicine is for transdermal use in adult men only.
Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor.
The recommended dose is 5 g of gel (50 mg of testosterone) applied once a day, more or less
at the same time, preferably in the morning.
The daily dose will possibly be adjusted by the doctor according to the individual patient, without
exceeding 10 g of gel per day.

How to apply the gel:

• The gel should be distributed by the patient himself on clean, dry and healthy skin on both shoulders or on both arms
• Once the sachet is opened, all the contents must be removed and applied immediately to the skin.
• The gel must be gently distributed on clean, dry and healthy skin.
• Apply a thin layer to the upper part of the arms and shoulders, to the right and to the left. Do not rub the medicine into the skin.
• Allow the gel to dry for at least 3-5 minutes before dressing.
• Wash your hands with water and soap after application

Do not apply to the genitals (penis and testicles), as the high alcohol content may cause local irritation.

Patients must be informed that other people (adults or children) should not come into contact
with the area of the body where the testosterone gel has been applied.
Once the gel is dry, cover the application site with clean clothes (e.g. a
t-shirt).
Before close physical contact with another person (adult or child), wash the site of
application with water and soap once the recommended time has elapsed (at least 1 hour) and
cover again with clean clothes.

If you use more of this medicine than you should
Seek the advice of your doctor or pharmacist. You may be advised to wash
the application site immediately and your doctor may advise you to stop treatment.
The following signals may indicate that you are taking an excessive amount of product and that it is
necessary to contact your doctor:

• irritability
• nervousness
• weight gain
• frequent or prolonged erections

These symptoms may indicate that the dose of this medicine is too high and your doctor may
need to adjust the dose (see Warnings and precautions, paragraph 2)

If you forget to use this medicine
Do not use a double dose to make up for a missed dose. Apply the next dose at the
usual time..

If you stop using this medicine
You should not stop treatment with this medicine unless your doctor tells you to.
If you have any doubts about 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.

Common side effects (may affect up to 1 in 10 people)

• mood disturbances
• emotional symptoms (mood swings, affective disorders, anger, aggression, impatience, insomnia, abnormal dreams, increased libido
• dizziness
• paresthesia
• amnesia
• hyperesthesia
• headache
• hypertension
• diarrhea
• alopecia
• urticaria
• gynecomastia
• reaction at the application site
• laboratory test alterations (polycythemia, lipids)
• increased hematocrit
• increased hemoglobin
• increased red blood cell count

Uncommon side effects (may affect up to 1 in 100)
This medicine can cause

• malignant hypertension
• hot flushes
• phlebitis
• oral pain
• abdominal distension
• acne
• hirsutism
• skin rash
• dry skin
• seborrhea
• skin lesions
• contact dermatitis
• hair color changes
• hypersensitivity at the application site
• pruritus at the application site
• nipple disorders
• prostate anomalies
• testicular pain
• increased frequency of erections
• edema
• increased PSA

Rare (may affect up to 1 in 1,000)
This medicine can cause

• priapism
• hepatic neoplasm

Very rare (may affect up to 1 in 10,000)
This medicine can cause

• jaundice
• urinary obstruction

Frequency not known (cannot be estimated from available data)
This medicine can cause:

• prostate cancer
• asthenia
• nervousness
• depression
• hostility
• sleep apnea
• urinary obstruction
• muscle cramps
• libido alterations
• therapy with high-dose testosterone preparations commonly interrupts or reversibly reduces spermatogenesis, thus reducing testicle size
• malaise
• edema
• hypersensitivity reactions
• weight gain
• electrolyte alterations (retention of sodium, chloride, potassium, calcium, inorganic phosphate and water) during high-dose and/or prolonged treatment
• skin reactions (due to the alcohol contained in the product, frequent applications to the skin can cause irritation and dryness)
• increases water retention and edema

Due to the alcohol contained in this medicine, frequent applications to the skin can cause
irritation and dryness.

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 the website: 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 this medicine

This medicine does not require any special storage conditions.
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 pack. The expiry date refers to the last day of that month.
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 this medicine contains

• The active ingredient is testosterone. Each 5 g sachet contains 50 mg of testosterone.
• The other ingredients are Carbomer 980, isopropyl myristate, 96% ethanol, sodium hydroxide, purified water.

Description of the appearance of this medicine and contents of the pack
This 50 mg medicine is a colorless gel presented in 5 g sachets.
This medicine is available in packs of 1, 2, 7, 10, 14, 28, 30, 50, 60, 90 or 100 sachets (not all pack sizes may be marketed).

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratoires Besins International
3, rue du Bourg l’Abbé
75003 Paris
France
Manufacturers
Laboratoires Besins International or Besins Manufacturing Belgium
13, rue Périer Groot Bijgaardenstraat, 128
92120 Montrouge 1620 Drogenbos
France Belgium

This medicine is authorised in the Member States of the European Economic Area under the
following designations:
Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,
Luxembourg, Norway, Portugal, Spain, Sweden, Netherlands, United Kingdom: TESTOGEL