Testogel

TESTOGEL 50 mg transdermal gel in sachet
Testosterone
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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

TESTOGEL 50 mg transdermal gel in sachet will 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 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

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

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

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

2. What you should know before using this medicine

Who can use this medicine

• Only men may use this medicine.
• Boys under the age of 18 must not use this medicine.
• This medicine must not be used by women of any age.
• Do not allow women (especially pregnant or breastfeeding women) 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 to any of the other ingredients of this medicine (listed in section 6),
• If you have prostate cancer,
• If you have 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, reduced lean body mass, weakness or fatigue, reduced libido, inability to achieve/maintain an erection, etc.) and confirmed by laboratory tests. Your doctor will perform the necessary examinations before you can use this medicine and will carry out follow-up checks with periodic blood tests.
If any of the following conditions apply to you (or if you are unsure), discuss them with your doctor before using this medicine, as treatment with this medicine may worsen these conditions.

• You have difficulty urinating due to an enlarged prostate gland
• You have bone cancer – your doctor will check your calcium levels
• You suffer from high blood pressure or are being treated for high blood pressure, as this medicine may cause an increase in blood pressure
• You suffer from severe heart, liver, or kidney disease, as treatment with this medicine may cause serious complications such as fluid retention in the body, sometimes accompanied by heart failure (congestive heart failure) (fluid overload in the heart)
• You have ischemic heart disease (affecting blood supply to the heart)
• You have blood clotting problems
  • (thrombophilia, a blood clotting disorder 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 had a blood clot in the leg, lung, or another organ at a young age (e.g., under about 50 years); or advancing age.
  • How to recognize a blood clot: painful swelling of one leg or sudden skin color change, 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 vertigo, severe stomach pain, sudden loss of vision. Seek urgent medical advice if any of these symptoms occur.
• You suffer from epilepsy
• You suffer from migraine
• You have breathing difficulties during sleep – this is more likely if you are overweight or have long-standing lung problems

Androgenic hormones may increase the risk of prostate enlargement (benign prostatic hyperplasia) or prostate cancer. Therefore, regular prostate examinations must be performed before and during treatment, as directed by your doctor.
If you have diabetes and use insulin to control your blood sugar levels, testosterone treatment may affect your response to insulin, and adjustment of your antidiabetic medication dosage may be necessary.
If you experience severe skin reactions, treatment should be reconsidered and possibly discontinued.
This medicine must not be used by women due to possible virilizing effects (such as facial or body hair growth, voice lowering, or changes in menstrual cycle).

Information on additional monitoring
The following blood tests must be performed by your doctor before and during treatment: blood testosterone levels, complete blood count.
During treatment, you will need regular check-ups (at least once a year, and twice a year if you are elderly or considered by your doctor to be at risk).
If you receive long-term testosterone replacement therapy, you may develop an abnormal increase in the number of red blood cells in the blood (polycythaemia). You will need regular blood tests to monitor for this.

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

Potential transfer of testosterone
With repeated or prolonged skin-to-skin contact, the medicine may be transferred to another person. This may cause adverse effects such as facial or body hair growth, voice lowering, or changes in menstrual cycle in women, or rapid height increase, genital enlargement, and early puberty (including pubic hair development) in children.
The following precautions are recommended to prevent transfer:

• Wash your hands thoroughly with water and soap after applying the gel,
• Once the gel has dried, cover the application site with clothing. After applying the medicine, wait at least 1 hour before taking a shower or bath.
• Take a shower and wash the application site(s) thoroughly with water and soap to remove any residual testosterone 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 periods of close contact.

Patients using this product who may have close physical contact with children must take extra care, as testosterone may pass through clothing.
Make sure to follow the application instructions (see section 3 of this leaflet) when in physical contact with children, covering the application site with clean clothing once the gel has dried. In addition, wash the application site with soap after the recommended time has passed (at least 1 hour) and cover again with clean clothing before physical contact with children.
If you suspect that testosterone has been transferred to another person (man, woman, or child), that person should:

• Immediately wash the skin surface that may have been exposed to testosterone transfer with water and soap,
• Contact a doctor if symptoms such as acne, changes in body or facial hair growth pattern, voice lowering, or changes in menstrual cycle occur.
• In children, signs of early puberty and genital enlargement should also be monitored.

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, especially:

• 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).
  The dose of insulin may need to be reduced when using this medicine.

If any of the above situations apply to you (or if you are unsure), discuss them with your doctor or pharmacist before using this medicine. These specific medicines may require adjustment of the dose of this medicine.

Pregnancy and breastfeeding
This medicine must not be used by women.
Sperm production may be reversibly suppressed with this medicine.
If your partner is pregnant or becomes pregnant, or if you are planning to have a child, you must follow the instructions to prevent transfer of testosterone gel (see “Potential transfer of testosterone” above).
This medicine must not be used by pregnant or breastfeeding women.
Pregnant women must avoid any contact with this medicine, as the product may have harmful virilizing effects on the fetus. In case of accidental skin-to-skin contact, the partner must wash the contact area immediately and thoroughly with water and soap.
If your partner is pregnant, the patient must carefully observe the above-mentioned precautions to avoid transfer of testosterone-containing gel.

Driving and using machines
This medicine does not affect the ability to drive or use machinery.

Warnings for athletes
For those engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

This medicine contains alcohol (ethanol)
This medicine contains 3.6 g of alcohol (ethanol) in each sachet.
It may cause a burning sensation on damaged skin.
When administering the medicine for the first time, avoid sources of heat or open flames, as 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 males only.
Use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor.
The recommended dose is 5 g of gel (50 mg of testosterone) applied once daily, at approximately the same time each day, preferably in the morning.
The daily dose may be adjusted by your doctor according to individual patient needs, without exceeding 10 g of gel per day.
How to apply the gel:

• The gel should be applied by the patient himself.
• Once the sachet is opened, the entire contents should be squeezed out and applied immediately to the skin.
• The gel should be gently spread onto clean, dry, and intact skin.
• Apply a thin layer to the shoulders, arms, and abdomen. Do not rub the medicine into the skin.
• Allow the gel to dry for at least 3–5 minutes before dressing.
• Wash your hands thoroughly with soap and water 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) must 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 clothing (e.g., a T-shirt).
Before engaging in close physical contact with another person (adult or child), wash the application site with soap and water after the recommended time has passed (at least 1 hour), and cover it again with clean clothing.
If you use more than you should
Contact your doctor or pharmacist for advice. You may be advised to wash the application site immediately, and your doctor may recommend that you stop treatment.
The following signs may indicate that you are receiving too much of the product and that you should 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, section 2).
If you forget to use this medicine
Do not apply a double dose to make up for the missed dose. Apply the next dose at your usual time.
If you stop using this medicine
Do not stop treatment with this medicine unless instructed to do so by your doctor.
If you have any doubts about how to use this medicine, consult 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
• Application site reaction
• Laboratory test abnormalities (polycythemia, lipids)
• Increased hematocrit
• Increased hemoglobin
• Increased red blood cell count

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

• Priapism
• Hepatic neoplasm

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

• Jaundice
• Urinary tract obstruction

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

• Prostate cancer
• Asthenia
• Nervousness
• Depression
• Hostility
• Sleep apnea
• Urinary tract obstruction
• Muscle cramps
• Changes in libido
• Testosterone therapy, particularly with high-dose preparations, commonly interrupts or reversibly reduces spermatogenesis, thereby reducing testicular size
• Malaise
• Edema
• Hypersensitivity reactions
• Weight gain
• Electrolyte changes (sodium, chloride, potassium, calcium, inorganic phosphate and water retention) during high-dose and/or prolonged treatment
• Skin reactions (due to the alcohol contained in the product, frequent applications to the skin may cause irritation and skin dryness)
• Increased fluid retention and edema

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What this medicine contains

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

Description of the appearance of this medicine and the contents of the pack
This medicine, 50 mg, is a colourless gel supplied in 5 g sachets.
This medicine is available in packs containing 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 European Economic Area countries under the following names:
Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, the Netherlands, United Kingdom: TESTOGEL