TESTOGEL 50 mg TRANSDERMAL GEL IN SACHETS

2. What you need to know before taking Testogel

Who can use this medicine

• Only men can use this medicine.
• Men under 18 years of age should not use this medicine.
• Women, of any age, should not use this medicine.
• Women (especially pregnant or breastfeeding women) or children should not come into contact with this medicine or the skin areas where this medicine has been applied.

Do not use this medicine

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

Warnings and precautions

Talk to your doctor before using this medicine:

Before starting any 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, decreased sex drive, inability to have/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 you are in any of the following situations (or are unsure), consult your doctor before using this medicine, as its use may worsen these conditions.

• you have difficulty urinating due to an enlarged prostate
• you have bone cancer - your doctor will check your calcium levels
• you have high blood pressure or are being treated for high blood pressure, as testosterone may cause an increase in blood pressure
• you have severe 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)
• you have ischemic heart disease (affecting blood supply to the heart)
• blood clotting problems:
• 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 produce 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.

• you have epilepsy
• you have migraines
• you have breathing problems during sleep - especially if you are overweight or have long-term lung problems

Androgens may increase the risk of prostate enlargement (benign prostatic hyperplasia) or prostate cancer. Regular prostate checks 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 suspended if necessary.

Additional monitoring information

Before starting treatment and during treatment, your doctor will check the following parameters in your blood test: testosterone level 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 high-risk patient) during treatment.

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

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

The following precautions are recommended to protect against transfer:

For the patient:

• wash your hands carefully with soap and water after applying the gel.
• once the gel is dry, cover the application area with clothing. Wait at least 1 hour before showering or bathing.
• shower and wash the application area(s) with water and soap to remove any residual testosterone before any situation where close contact is expected, or 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 especially 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 is dry. Also, please wash the application site with soap 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 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 they experience signs such as acne, changes in hair growth or body hair pattern, deeper voice, changes in menstrual cycle.
• in children, also be aware of signs of early puberty and genital enlargement.

Preferably, you should wait at least 1 hour before showering or bathing after applying this medicine.

Other medicines and this medicine

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

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

If any of the above applies to you (or you are unsure), consult your doctor or pharmacist before using this medicine. These medicines may require your dose of this medicine to be adjusted.

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, you mustfollow the advice on how to avoid transferring the testosterone gel (see "Possible transfer of testosterone" above).

Women who are pregnant or breastfeeding should not use this medicine.

Pregnant women should avoid anyskin-to-skin contact with this medicine, as it may have adverse virilizing effects on the fetus. In case of accidental skin-to-skin contact, your partner should wash the contact area as soon as possible with soap and water.

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

Driving and using machines

This medicine does not affect your ability to drive or use machines.

Athletes

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

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

Be careful to avoid heat sources/open flames when administering the product for the first time, as ethanol is flammable until the gel is dry on the skin.

3. How to use Testogel

This medicine is for use by adult men only.

Follow your doctor's instructions for administering this medicine exactly. If you are unsure, consult your doctor.

The recommended dose is 5 g of gel (equivalent to 50 mg of testosterone), applied once a day, approximately at the same time, and preferably in the morning.

Your doctor may adjust the daily dose individually for each patient, without exceeding 10 g of gel per day.

How to apply the gel:

• The gel should be applied by the patient themselves to clean, dry, and healthy skin on both shoulders or both arms.
• After opening the sachet, the entire contents should be removed and applied immediately to the skin.
• The gel should be spread gently over the clean, dry, and healthy skin.
• Apply in a thin layer to the top of the right and left arm and shoulders. Do not rub 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.

Patient should be informed that other people (adults or children) should not come into contact with the body area where the testosterone gel has been applied.

Once the gel is dry, 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. They may recommend that you wash the application area immediately and that your doctor advise you to suspend treatment.

The following signs may indicate that you are taking too much product and you should contact your doctor:

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

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

If you forget to use this medicine

Do not use a double dose to make up for the forgotten dose. Apply the next dose at the usual time.

If you stop treatment with this medicine

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

If you have any further questions 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 disorders
• emotional symptoms (mood swings, affective disorder, anger, aggression, impatience, insomnia, abnormal dreams, increased libido)
• dizziness
• paresthesia
• amnesia
• hyperesthesia
• headache
• hypertension
• diarrhea
• alopecia
• urticaria
• gynecomastia
• reaction at the application site
• changes in laboratory tests (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 flashes
• phlebitis
• oral pain
• abdominal distension
• acne
• hirsutism
• skin rash
• dry skin
• seborrhea
• skin lesions
• contact dermatitis
• changes in hair color
• hypersensitivity at the application site
• pruritus at the application site
• nipple disorders
• prostate anomalies
• testicular pain
• increased frequency of erections
• edema with fovea
• increased PSA

Rare side effects (may affect up to 1 in 1,000 people)

This medicine may cause:

• priapism
• hepatic neoplasm

Very rare side effects (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
• treatment with high doses of testosterone preparations interrupts or reduces reversibly spermatogenesis, thus reducing testicular size
• malaise
• edema
• hypersensitivity reactions
• weight gain
• electrolyte changes (sodium, chloride, potassium, calcium, inorganic phosphate, and water retention) during treatment with high doses and/or prolonged treatment
• skin reactions (due to the alcohol contained in the product, frequent applications to the skin may cause irritation and dryness)
• increased incidence of water retention and edema

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

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Testogel

This medicine does not require 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 sachet. 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

Composition ofTestogel

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

Appearance ofTestogeland Packaging Content

Colorless gel presented in a 5 g sachet.

Available in packs of 1, 2, 7, 10, 14, 28, 30, 50, 60, 90 or 100 sachets (only some pack sizes may be marketed).

Marketing Authorization Holder

Laboratoires Besins International

3, rue du Bourg l’Abbé

75003 Paris

France

Manufacturers

Laboratoires Besins International Besins Manufacturing Belgium

13, rue Périer Groot Bijgaardenstraat, 128

92120 Montrouge 1620 Drogenbos

France Belgium

Local Representative of the Marketing Authorization Holder:

LABORATORIOS RUBIO, S.A. Industria 29 - Pol. Ind. Comte de Sert.

08755 Castellbisbal (Barcelona) Spain

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

Germany, Austria, Belgium, Cyprus, Denmark, Spain, Finland, France, Greece, Ireland, Iceland, Italy, Luxembourg, Norway, Netherlands, Portugal, Sweden: TESTOGEL.

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