Testogel 50 mg transdermal gel in sachets

Testosterone

Testogel 50 mg transdermal gel in sachetswill be referred to as "this medicine" throughout this leaflet.

1. What is Testogel and what it is used for

2. What you need to know before starting touse Testogel

3. How to use Testogel

4. Possible side effects

5. Storage of Testogel

6. Contents of the pack and additional information

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

This medication is used in adult men for testosterone replacement therapy to treat various health problems caused by low testosterone levels (male hypogonadism). This must be confirmed by two separate blood tests for testosterone and accompanied by clinical symptoms such as:

• impotence
• infertility
• low libido
• fatigue
• depressive mood states
• bone loss due to low hormone levels
• regression of male characteristics
• body composition changes
• inability to achieve/maintain an erection

Who can use this medication

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

Do not use this medication

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

Warnings and precautions

Consult with your doctor before using this medication:

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

If you are in any of the following situations (or are unsure), consult with your doctor before using this medication, 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, as treatment with this medication 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 (an abnormality of blood clotting 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 age

How to recognize a blood clot: painful swelling of a leg or sudden change in skin color, for example, paleness, redness, or blue, sudden difficulty breathing, sudden and inexplicable cough that may cause bleeding; or sudden chest pain, intense dizziness, or dizziness, intense stomach pain, sudden loss of vision. Seek urgent medical attention if you experience one of these symptoms.

• You have epilepsy
• You have migraines
• You have respiratory problems during sleep - especially in cases of obesity or have long-term lung problems

Androgens may increase the risk of prostate gland enlargement (benign prostatic hyperplasia) or prostate cancer. Regular prostate gland 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 you may need to adjust your antidiabetic medication.

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

Additional follow-up 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 periodic checks (at least once a year and twice a year if you are over 50 or if your doctor considers you a high-risk patient) during treatment.

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 periodic blood tests to check that this is not happening.

Children and adolescents

This medication is not recommended for children, as there is no available clinical information for children under 18 years old.

Possible testosterone transfer

During repeated or prolonged physical contact, this medication may be transferred to another person. This may cause side effects such as facial or body hair growth, deeper voice, or changes in menstrual cycle in women, or accelerated growth, genital enlargement, and early puberty (including pubic hair growth) 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. After applying this medication, wait at least 1 hour before showering or bathing.
• Shower and wash the application area thoroughly with water and soap to remove any remaining testosterone before any situation where close contact is anticipated, or if not possible, wear clothing such as a shirt or a t-shirt that covers the application area during the contact period.

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

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

- Wash the affected skin area immediately with soap and water

- Contact a doctor if they experience symptoms such as acne, changes in body or facial hair growth, deeper voice, changes in menstrual cycle, or in children, signs of early puberty and genital enlargement.

- In children, also be aware of signs of precocious puberty and genital enlargement.

It is recommended to wait at least 1 hour before showering or taking a bath after applying this medication.

Other medications and this medication

Inform your doctor or pharmacist if you are taking,have takenrecentlyor may need to take any other medication, particularly the following:

• Oral anticoagulants (medications used to thin the blood)
• Corticosteroids (medications used to reduce inflammation)
• Insulin (medications used to control blood sugar levels in diabetes). You may need to reduce your insulin dose when using this medication.

If any of the above situations affect you (or you are unsure), consult your doctor or pharmacist before using this medication. These medications in particular may require you to adjust your dose of this medication.

Pregnancy and breastfeeding

This medication should not be used by women.

Testosterone production may be suppressed in women.

If your partner is or becomes pregnant or is planning to have a baby,you mustfollow the advice on how to avoid transferring testosterone gel (see “Possible testosterone transfer” above).

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

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

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

Driving and operating machinery

This medication has no effect on the ability to drive or operate machinery.

Athletes

Remember that this medication contains an active ingredient (testosterone) that may produce a positive reaction in doping tests.

This medication contains alcohol (ethanol)

This medication contains 3.6 g of alcohol (ethanol) in each sachet.

It may cause a burning sensation on damaged skin

Care should be taken 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.

This medication is for exclusive use by adult males.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, 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 hour 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 this gel:

• The gel must be applied by the patient themselves on clean, dry, and healthy skin of both shoulders or both arms.

• After opening the package, the entire content of the package must be extracted and applied immediately on the skin.

• The gel must be spread smoothly on clean, dry, and healthy skin.

• Apply in a thin layer on the upper part of the right and left arm and shoulders. Do not rub on the skin.

• Leave the gel to dry for at least 3-5 minutes before dressing.

• Wash your hands with water and soap after applying it.

Do not apply it in genital areas (penis and testicles) because the high alcohol content may cause local irritation.

Inform patients that other people (adults or children) should not come into contact with the area of the body where the testosterone gel was 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 after the recommended time (at least 1 hour) and cover again with clean clothing.

If you use more of this medication than you should:

Ask your doctor or pharmacist for advice. It may be recommended 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 should contact your doctor:

• irritability

• nervousness

• weight gain

• frequent or prolonged erections

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

If you forgot to use this medication:

Do not use a double dose to compensate for the missed dose. Apply the next dose at the usual time.

If youinterrupt the treatment ofthis medication:

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them:

Frequent 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

Infrequent side effects (may affect up to 1 in 100 people)

This medicine may cause:

• Malignant hypertension

• Hot flashes/flushes

• Phlebitis

• Oral pain

• Abdominal distension

• Acne

• Hirsutism

• Skin eruption

• Dry skin

• Seborrhea

• Skin lesions

• Contact dermatitis

• Changes in hair color

• Hypersensitivity at the application site

• Pruritus at the application site

• Breast disorders

• Prostatic anomalies

• Testicular pain

• Increased frequency of erections

• Edema with pitting

• Increased PSA

Rare (may affect up to 1 in 1000 people)

This medicine may cause:

• Priapism
• Hepatic neoplasia

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

This medicine may cause:

• Jaundice
• Urinary tract obstruction

Unknown frequency (cannot be estimated from available data)

This medicine may cause:

• Prostatic cancer

• Asthenia

• Nervousness

• Depression

• Hostility

• Sleep apnea

• Urinary tract obstruction

• Muscle cramps

• Changes in libido

• Treatment with high doses of testosterone preparations interrupts or reversibly reduces spermatogenesis, thus reducing testicular size

• Discomfort

• Edema

• Hypersensitivity reactions

• Weight gain

• Electrolyte changes (sodium, chloride, potassium, calcium, inorganic phosphate, and water retention) during treatment with high and/or prolonged doses

• Skin reactions (due to the alcohol contained in the product, frequent applications on the skin may cause irritation and dry skin)

• Increases the incidence of fluid retention and edema

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

Reporting of side effects

If you experience any type of side effects, consult your doctor or pharmacist, even if they are possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This medication does not require special storage conditions.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the pouch. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

Composition ofTestogel

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

Appearance ofTestogeland contents of the packaging

Colourless gel presented in a sachet of 5 g.

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

Marketing Authorization Holder

Laboratoires Besins International

3, rue du Bourg l’Abbé

75003 Paris

France

Manufacturers

Laboratoires Besins InternationalBesins Manufacturing Belgium

13, rue PérierGroot Bijgaardenstraat, 128

92120 Montrouge1620 Drogenbos

FranceBelgium

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 with the following name:

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

Last review date of this leaflet:October 2024.