TESTOGEL 16.2 mg/g GEL

Introduction

Package Leaflet: Information for the Patient

Testogel 16.2 mg/g Gel

Testosterone

Read all of this leaflet carefully before using this medicine, because it contains important information for you.

• Keep this leaflet, as 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.

Testogel 16.2 mg/g Gel will be referred to as “this medicine” throughout this leaflet.

Contents of the pack:

1. What is Testogel and what is it used for
2. What you need to know before you start using Testogel
3. How to use Testogel
4. Possible side effects
5. Storing Testogel
6. Contents of the pack and other information

1. What is Testogel and what is it used for

This medicine contains testosterone, a male hormone produced naturally by the body.

This medicine is used in adult men for testosterone replacement therapy to treat various health problems caused by a lack of testosterone (male hypogonadism). This should be confirmed by two separate blood tests for testosterone and clinical symptoms such as:

• impotence
• infertility
• low sexual desire
• fatigue
• depressive mood
• bone loss caused by low hormone levels

2. What you need to know before you start using Testogel

Who can use Testogel

• Only men can use this medicine.
• Men under 18 years of age should not use this medicine.
• This medicine should 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 the skin areas where it has been applied.

Do not usethis medicine

• if you have prostate cancer or are suspected of having it
• if you have breast cancer or are suspected of having it
• if you are allergic to testosterone or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

Consult your doctor or pharmacist before using this medicine.

Before starting treatment with this medicine, your testosterone deficiency must be clearly demonstrated by clinical signs (regression of male characteristics, reduction of lean body mass, weakness or fatigue, reduction of sexual desire, inability to have or maintain an erection, etc.) and confirmed by laboratory tests. Your doctor will perform the necessary tests before you can use this medicine and will perform follow-up checks with periodic blood tests.

If any of the following situations apply to you (or you are not sure), talk to your doctor before using this medicine, as its use may worsen these conditions.

• if you have bone cancer - your doctor will monitor your calcium levels
• if you have high blood pressure or are being treated for high blood pressure, as testosterone may cause an increase in blood pressure
• if you have a serious heart, liver, or kidney disease, treatment with this medicine may cause serious complications in the form of water retention in the body, sometimes accompanied by congestive heart failure (fluid overload in the heart).
• if you have ischemic heart disease (affecting blood supply to the heart)
• if you have or have ever had blood clotting problems, such as:

• thrombophilia (a blood clotting abnormality 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 a close family member has had a blood clot in the leg, lung, or other organ at a young age (e.g., under 50 years); or as you get older
• how to recognize a blood clot: painful swelling of a leg or sudden change in skin color, such as paleness, redness, or blueness, sudden difficulty breathing, sudden unexplained cough that may bring up blood; or sudden chest pain, severe dizziness or fainting, severe stomach pain, sudden loss of vision. Seek urgent medical attention if you experience any of these symptoms.

• if you have epilepsy
• if you have migraine
• if you have breathing problems during sleep, especially in those who are overweight or already have breathing difficulties

Androgens may increase the risk of enlarged prostate gland (benign prostatic hyperplasia) or prostate cancer. Regular checks of the prostate gland should be performed before starting treatment and during treatment, as recommended by your doctor.

If you have diabetes and use insulin to control your blood sugar levels, treatment with testosterone may affect your response to insulin, and it may be necessary to adjust your antidiabetic medication.

In case of severe skin reactions, treatment should be reviewed and discontinued if necessary.

Women should not use this medicine due to its potential virilizing effects (such as facial or body hair growth, deepening of the voice, and changes in the menstrual cycle).

Information on additional checks

Your doctor should perform the following blood tests before and during treatment: blood testosterone levels and complete blood count.

You will have regular check-ups (at least once a year and twice a year if you are an elderly person or if your doctor considers you a risk patient) during treatment.

If you receive testosterone replacement therapy for prolonged periods, you may develop an abnormal increase in the number of red blood cells (polycythemia). You will need regular blood tests to check that this does not occur.

Use in children and adolescents

This medicine is not recommended for children, as there is no clinical information available for children under 18 years of age.

Possible transfer of testosterone

During repeated or prolonged periods of physical contact, this medicine may be transferred to another person. This can cause side effects such as facial or body hair growth, deepening of the voice, or changes in the menstrual cycle in women, or accelerated height, genital enlargement, and early puberty (including the development of pubic hair) in children.

The following precautions are recommended:

• wash your hands carefully with water and soap after applying the gel
• once the gel is dry, cover the application area with clothing. After applying this medicine, wait at least 1 hour before showering or bathing.
• shower and wash the application area(s) with water and soap to remove any remaining testosterone before any situation where close contact is expected, or, if not possible, wear clothing such as a shirt or t-shirt that covers the application area during the contact period

Patients using this product who may be in close physical contact with children should be particularly careful, as testosterone can pass through clothing. Make sure to follow the application technique (see section 3 of this leaflet) when in physical contact with children, including covering the application area with clean clothing once the gel has dried. Additionally, please wash the application site with soap and water once the recommended time has passed (at least 1 hour) and cover it again with clean clothing before physical contact with children.

If you think that testosterone has been transferred to another person (man, woman, or child), that person should:

• wash the affected skin area immediately with water and soap
• contact a doctor if symptoms such as acne, changes in hair growth or body hair pattern, deepening of the voice, or changes in the menstrual cycle appear.
• in children, you should also be alert for signs of early puberty and genital enlargement.

Preferably, you should wait at least 1 hour before taking a shower or bath after applying this medicine.

Using this medicine with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially:

• oral anticoagulants (used to make the blood more fluid)
• corticosteroids
• insulin (medicines used to control blood sugar levels in diabetes). You may need to reduce your insulin dose when using this medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

These specific medicines may require you to adjust your dose of this medicine.

Pregnancy, breastfeeding, and fertility

This medicine should not be used by women.

Sperm production may be suppressed in a reversible way with this medicine.

If your partner becomes pregnant, you mustfollow the advice to avoid transferring the testosterone gel.

Pregnant women should avoid anycontact with the application areas of this medicine, as it may cause unwanted development of male characteristics in the developing baby. In case of skin-to-skin contact, as recommended earlier, wash the area carefully with soap and water as soon as possible.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is negligible or non-existent.

Athletes

Athletes should be reminded that this patented medicine contains an active ingredient (testosterone) that may produce a positive reaction in doping tests.

This medicine contains alcohol (ethanol)

This medicine contains 0.9 g of alcohol (ethanol) in each 1.25 g dose of gel.

Caution should be exercised to avoid sources of heat/open flames when administering the product for the first time, as ethanol is flammable until the gel has dried on the skin.

It may cause a burning sensation on damaged skin.

3. How to use Testogel

This medicine is for use in adult men only.

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, ask your doctor or pharmacist.

Using the pump for the first time

Before using the pump for the first time, you need to prepare it for use as follows:

• Remove the cap from the container to uncover the plunger
• Press the plunger down three times
• Do not usethe gel from these three presses of the plunger. This dose should be discarded safely.
• Now the pump is ready for use. You do not need to prime it again.
• Each time you press the plunger, 1.25 g of gel will be dispensed.

The recommended dose is 2.5 g of gel (i.e., 40.5 mg of testosterone) applied once daily, approximately at the same time each day, preferably in the morning. To obtain 2.5 g of gel, press the plunger twice. The dose may be adjusted by your doctor, and the maximum dose is 5 g of gel per day (no more than four presses of the plunger).

Your doctor will tell you how many presses of the plunger you need to get the correct dose of gel that you need. The following table provides more information.

The gel should be spread thinly and evenly over clean, dry, and healthy skin on the shoulders and upper arms. Do not rub it into the skin. Allow the gel to dry for at least 3-5 minutes before dressing. Wash your hands with water and soap after applying. Do not apply to the genital area (penis and testicles) as the high alcohol content may cause local irritation.

After priming the pump as described above, the gel is ready to use.

How to apply the gel:

The gel should be applied by the patient himself.

1. Press the plunger down once to dispense the gel onto the palm of your hand.
2. Select a clean, dry, and healthy skin area on the shoulder and upper arm (see the marked areas in the image below).
3. With your fingers, spread the gel evenly and thinly over one shoulder and upper arm. Do not rub it into the skin.
4. Repeat steps 2 and 3 on the other shoulder and upper arm.
5. If you are using 3 or more pumps, apply up to 2 pumps on the first shoulder and upper arm and up to 2 pumps on the other shoulder and upper arm.
6. After applying the gel, wash your hands with water and soap.
7. You should let the gel dry completely before dressing.

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

Patients should 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 has dried, cover the application area with clean clothing (such as a t-shirt).

Before close physical contact with another person (adult or child), wash the application area with water and soap once the recommended time has passed (at least 1 hour) and cover it again with clean clothing.

If you use more of this medicine than you should

Ask your doctor or pharmacist for advice.

If you forget to use this medicine

Do not use a double dose to make up for the forgotten dose. Apply the next dose when it is due.

If you stop using this medicine

Do not stop treatment with this medicine unless your doctor tells you to.

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:

Very common (≥1/10)

Due to the alcohol contained in this medicine, frequent applications to the skin may cause:

• anxiety
• skin reactions

Uncommon (≥1/1,000 to <1>

This medicine may cause:

• prostate cancer
• change in libido
• hypertension
• hot flushes
• headaches
• hair loss
• development of painful, sensitive, or enlarged breasts
• changes in your prostate gland
• diarrhea
• dizziness
• nausea
• acne
• itching
• hair loss
• hirsutism
• muscle cramps
• increase in APE
• increase in hematocrit or hemoglobin
• weight change
• increase in blood pressure
• gynecomastia
• prostate anomalies
• prostatomegaly, prostatic disorder
• disorders of spermatogenesis and semen
• testicular atrophy
• peripheral edema

Rare (≥1/10,000 to <1>

• emotional symptoms
• seborrhea
• priapism
• increased erection
• azoospermia

Very rare (<1>

• abnormal blood electrolytes
• jaundice

Other side effects observed during treatment with this medicine: fatigue, depression, anxiety, headache, dizziness, tingling of the skin, blood clots, difficulty breathing, nausea, sweating, abnormal body hair growth, muscle or bone pain, difficulty urinating, reduced sperm count, muscle weakness, malaise, weight gain.

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

Reporting of side effects

It is important to report any suspected side effects to the medicine after authorization. This allows for continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are invited to report any suspected side effects via the national reporting system for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es

5. Storing Testogel

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 stated on the carton and blister. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Packaging Content and Additional Information

Testogel Composition

• The active substance is testosterone.
• The other ingredients are carbomer 980, isopropyl myristate, ethanol 96%, sodium hydroxide, and purified water.

Appearance of Testogel and Packaging Content

Colorless gel presented in a multidose container with a metering pump that contains 88 g of gel and provides a minimum of 60 doses.

Available in packages containing one, two, three, or six containers.

Marketing Authorization Holder

Besins Healthcare

Rue Washington 80

1050 Ixelles

Belgium

Manufacturer

Laboratoires Besins International

13, rue Périer

92120 Montrouge

France

Or

Besins Manufacturing Belgium

Groot-Bijgaardenstraat 128

1620-Drogenbos

Belgium

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria, Belgium, France, Luxembourg, Romania, Netherlands, Czech Republic, Hungary: Androgel 16.2 mg/g

Germany: Testogel Dosiergel 16.2 mg/g Gel

Ireland: Testogel 16.2mg/g Gel

Poland: Androtop

Slovenia: Androtop 20.25 mg/trigger gel

Spain: Testogel 16.2 mg/g Gel

Date of the last revision of this leaflet:February 2024.