ANDROTOP 16.2 mg/g Gel

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Androtop, 16.2 mg/g, Transdermal Gel
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Androtop and what is it used for
4. Important information before using Androtop
   1. Who can use Androtop
   2. When not to use Androtop
   3. Warnings and precautions
   4. Information on additional monitoring
   5. Children and adolescents
   6. Potential transfer of testosterone
   7. Androtop and other medicines
   8. Pregnancy, breastfeeding, and fertility
   9. Driving and using machines
   10. Athletes and women
   11. The medicine contains ethanol (alcohol)
5. How to use Androtop
   1. This medicine is intended for use by adult men only.
   2. Using the pump for the first time
   3. How to apply the gel:
   4. Using a higher dose of Androtop than recommended
   5. Missing a dose of Androtop
   6. Stopping treatment with Androtop
6. Possible side effects
   1. Common (may affect up to 1 in 10 people)
   2. Uncommon (may affect up to 1 in 100 people)
   3. This medicine may cause:
   4. Rare (may affect up to 1 in 1,000 people)
   5. This medicine may cause:
   6. Very rare (may affect up to 1 in 10,000 people)
   7. This medicine may cause:
   8. This medicine may cause:
   9. Reporting side effects
7. How to store Androtop
8. Contents of the pack and other information
   1. What Androtop contains
   2. What Androtop looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet: 10/2024

Package Leaflet: Information for the Patient

Androtop, 16.2 mg/g, Transdermal Gel

Testosterone

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Androtop and what is it used for
• 2. Important information before using Androtop
• 3. How to use Androtop
• 4. Possible side effects
• 5. How to store Androtop
• 6. Contents of the pack and other information

1. What is Androtop and what is it used for

This medicine contains testosterone, a male hormone produced naturally in the body.
Androtop is used in adult men as testosterone replacement therapy for various diseases resulting from a deficiency of testosterone (male hypogonadism). To confirm the disease, two independent measurements of testosterone levels in the blood and the following clinical symptoms are required:

• impotence,
• infertility,
• decreased sex drive,
• fatigue,
• depressive moods,
• bone mass loss due to low hormone levels,
• regression of male characteristics,
• decreased fat-free body mass,
• inability to achieve or maintain an erection.

2. Important information before using Androtop

Who can use Androtop

• This medicine can only be used by men.
• Young men under 18 years of age should not use this medicine.
• Women should not use this medicine at any age.
• Women (especially pregnant or breastfeeding women) or children should not come into contact with this medicine or areas of skin where the medicine has been applied.

When not to use Androtop

• in case of diagnosed or suspected prostate cancer,
• in case of diagnosed or suspected breast cancer.

Warnings and precautions

Before starting treatment with this medicine, discuss it with your doctor or pharmacist.
Before starting treatment with this medicine, a clear testosterone deficiency should be demonstrated, manifested by clinical symptoms (regression of male sex characteristics, decreased fat-free body mass, weakness or fatigue, decreased libido, etc.) and confirmed by laboratory tests. Before applying this medicine, the doctor will perform the necessary examinations and will perform control examinations, performing periodic blood tests.
If any of the following situations occur in the patient (or the patient is unsure), before using this medicine, they should talk to their doctor, as using this medicine may worsen these conditions.

• the patient has difficulty urinating due to an enlarged prostate
• the patient has bone cancer - the doctor will check the calcium level
• the patient has high blood pressure or is being treated for hypertension, as this medicine may cause an increase in blood pressure
• the patient has severe heart, liver, or kidney disease, as treatment with this medicine may cause severe complications in the form of water retention in the body, which is sometimes accompanied by congestive heart failure (fluid overload in the heart)
• the patient has ischemic heart disease (which affects blood flow to the heart)
• blood clotting problems
• (thrombophilia, blood clotting disorder that increases the risk of thrombosis, blood clots in blood vessels)
• factors that increase the risk of blood clots in veins: previous blood clots in a vein; smoking; obesity; cancer; immobility; if someone in the immediate family has had a blood clot in the leg, lung, or other organ at a young age (e.g. under about 50 years of age); or at a later age.
• how to recognize a blood clot: painful swelling of one leg or sudden change in skin color, e.g. paleness, redness, or blueness, sudden shortness of breath, sudden unexplained cough that may cause bleeding; or sudden chest pain, strong feeling of emptiness in the head or dizziness, strong abdominal pain, sudden loss of vision. If one of these symptoms occurs, medical help should be sought immediately.
• the patient has epilepsy
• the patient has migraines
• the patient has difficulty breathing during sleep - this is more likely if the patient is overweight or has long-term lung problems.

Androgens may increase the risk of prostate enlargement (benign prostatic hyperplasia) or prostate cancer. Regular prostate examinations should be performed in accordance with the doctor's recommendations before starting and during treatment.
In patients with diabetes who use insulin to control blood sugar levels, testosterone treatment may change the response to insulin, resulting in the need to adjust the dose of antidiabetic drugs.
In case of severe skin reactions, the need for treatment should be verified and, if necessary, discontinued.
This medicine should not be used by women due to possible virilizing effects (e.g. hair growth on the face and/or body, deepening of the voice, or menstrual cycle disorders).

Information on additional monitoring

Before starting treatment and during treatment, the doctor should perform the following blood tests: testosterone level in the blood, full blood count.
During treatment, the patient will be subject to regular check-ups (at least once a year and twice a year if the patient is elderly or if the doctor considers the patient to be at risk).
In the case of long-term testosterone treatment, abnormal increased red blood cell count in the blood (erythrocytosis) may occur. Regular blood tests should be performed to check if this is happening.

Children and adolescents

The use of this medicine is not recommended in children, as there are no clinical data available on its use in boys under 18 years of age.

Potential 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 hair growth on the face or body, deepening of the voice, or changes in the menstrual cycle in women, accelerated growth, enlargement of sex organs, and premature puberty (including the development of pubic hair) in children.
The following precautions are recommended:

• wash hands thoroughly with soap and water after applying the gel,
• cover the application site with clothing (e.g. a T-shirt) after the gel has dried. After applying this medicine, patients should wait at least 1 hour before showering or bathing.
• shower and wash the application site with soap and water to remove any remaining testosterone before expected close contact with another person, and if this is not possible, wear clothing such as a shirt or T-shirt that covers the application site during contact.

Patients using this medicine who may have close physical contact with children should exercise increased caution, as testosterone can penetrate through clothing. In case of physical contact with children, the technique of applying the gel (see section 3 of this leaflet) should be followed, including covering the application site with clean clothing after the gel has dried. Additionally, the application site should be washed with soap and water after the recommended time (at least 1 hour) and covered with clean clothing again before physical contact with children.
If it is found that testosterone may have been transferred to another person (man, woman, or child), that person should:

• immediately wash the affected skin area with soap and water,
• report the occurrence of symptoms such as acne, changes in hair growth or distribution on the body or face, deepening of the voice, or changes in the menstrual cycle,
• in children, also pay attention to symptoms of premature puberty and enlargement of sex organs.

It is recommended that after applying the medicine, the patient waits at least 1 hour before showering or bathing.

Androtop and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, especially:

• oral anticoagulants (used to thin the blood),
• corticosteroids.
• insulin (a medicine used in diabetes to control blood sugar levels). It may be necessary to reduce the dose of insulin when using insulin and this medicine together.

If any of the above situations apply to you (or you are unsure), consult your doctor or pharmacist before using this medicine.
Using these medicines may lead to the need to adjust the dose of Androtop.

Pregnancy, breastfeeding, and fertility

This medicine should not be used by women.
This medicine may reversibly inhibit sperm production.
If the patient's partner becomes pregnant, it is necessaryto follow the recommendations for avoiding the transfer of the testosterone gel.
This medicine is not intended for use in pregnant or breastfeeding women.
Pregnant women should avoid anycontact with the application sites of this medicine, as it may have unwanted virilizing effects on the fetus. In case of accidental skin contact, the affected area should be washed with soap and water as soon as possible, as recommended above.

Driving and using machines

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

Athletes and women

Athletes and women are informed that this patented medicine contains the active substance (testosterone), which may give a positive result in doping tests.

The medicine contains ethanol (alcohol)

This medicine contains 0.9 g of ethanol in a single dose of 1.25 g of gel.
It may cause a burning sensation on damaged skin.
When applying the medicine, caution should be exercised and sources of heat/open flames should be avoided, as ethanol is flammable until the gel dries on the skin.

3. How to use Androtop

This medicine is intended for use by adult men only.

This medicine should always be used according to the doctor's instructions. If you are unsure, consult your doctor or pharmacist.

Using the pump for the first time

Before using the pump for the first time, it should be prepared for use as follows:

• Remove the cap from the container to expose the piston.
• Remove the plug from the end of the piston.
• Press the piston three times.
• Do not usethe gel obtained from the first three piston presses. Dispose of this dose of gel safely.
• The pump is now ready for use. There is no need to refill it.
• Each piston press delivers 1.25 g of gel.

The recommended dose is 2 piston presses, which should be used once a day, approximately at the same time, preferably in the morning. The dose may be adjusted by the doctor, and the maximum daily dose is 4 piston presses per day.
The doctor will inform the patient how many piston presses are needed to achieve the correct dose of gel. More information on this can be found in the table below.

The gel should be gently spread in a thin layer on clean, dry, healthy skin of both shoulders and upper arms. Do not rub it into the skin. Allow the gel to dry for at least 3 to 5 minutes before dressing. After applying the gel, wash your hands with soap and water. Do not apply to the genital area (penis and testicles), as the high alcohol content in the medicine may cause local irritation.

How to apply the gel:

The gel should be applied by the patient themselves.

• 1. Press the piston once to dispense a portion of gel onto the palm of your hand.
• 2. Choose a clean, dry, and healthy skin area on the shoulder and upper arm (upper part of the arm) (see the marked areas in the diagram below).
• 3. Gently and evenly spread the gel with your fingers on one shoulder and upper arm. Do not rub it into the skin.
• 4. If using 2 piston presses, repeat steps 1, 2, and 3 on the other shoulder and upper arm.
• 5. If using 3 or more piston presses, apply a maximum of 2 portions to the first shoulder and upper arm and a maximum of 2 portions to the other shoulder and upper arm.
• 6. After applying the gel, wash your hands with soap and water.
• 7. Before dressing, allow the gel to dry completely.

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

Patients should be informed that other people (adults and children) should not come into contact with the area of the body where the gel has been applied.
After the gel has dried, cover the application site with clean clothing (e.g. a T-shirt).
Before close physical contact with another person (adult or child), wash the application site with soap and water after the recommended time (at least 1 hour) and cover with clean clothing again.
The patient should apply the gel themselves to clean, dry, and healthy skin of both shoulders or both upper arms.

Using a higher dose of Androtop than recommended

Consult a doctor or pharmacist. The patient may be asked to wash the application site immediately and the doctor may recommend stopping treatment.
The following symptoms may indicate that the patient is using too high a dose of the medicine and should contact their doctor:

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

These symptoms may indicate that the dose of this medicine is too high and the doctor should adjust it (see Warnings and precautions, section 2).

Missing a dose of Androtop

Do not use a double dose to make up for a missed single dose. Apply the next dose at the scheduled time.

Stopping treatment with Androtop

Do not stop treatment with this medicine unless your doctor tells you to.
If you have any further 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 (may affect up to 1 in 10 people)

• mood disorders
• emotional symptoms (mood swings, affective disorders, anger, aggression, impatience, insomnia, unusual dreams, increased libido)
• dizziness
• paresthesia
• amnesia
• hypersensitivity
• headache
• hypertension
• diarrhea
• hair loss
• hives
• gynecomastia
• reaction at the application site
• changes in laboratory test results (erythrocytosis, lipids)
• increased hematocrit level
• increased hemoglobin level
• increased red blood cell count

Uncommon (may affect up to 1 in 100 people)

This medicine may cause:

• malignant hypertension
• heat strokes/flushing
• phlebitis
• mouth pain
• abdominal bloating
• acne
• hirsutism
• rash,
• dry skin,
• seborrhea,
• skin damage,
• contact dermatitis,
• changes in hair color,
• hypersensitivity at the application site,
• itching at the application site
• breast disorders,
• prostate abnormalities,
• testicular pain,
• increased frequency of erections
• pit-like edema
• increased PSA levels

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

This medicine may cause:

• priapism
• liver tumor

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

This medicine may cause:

• jaundice
• abnormal liver function test results

Frequency not known(cannot be estimated from the available data)

This medicine may cause:

• prostate cancer
• weakness
• nervousness
• depression
• hostility
• sleep apnea
• urinary tract obstruction
• muscle cramps
• changes in libido
• high-dose testosterone therapy usually reversibly interrupts or decreases spermatogenesis, thereby reducing testicular size;
• malaise
• edema
• allergic reactions
• weight gain
• electrolyte disorders (sodium, chloride, potassium, calcium, inorganic phosphates, and water retention) during high-dose and/or long-term use
• skin reactions (due to the alcohol content, frequent application to the skin may cause irritation and dryness)
• increased occurrence of water retention and edema

Due to the alcohol content in the medicine, its frequent application to the skin may cause irritation and dryness.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Androtop

There are no special precautions for storing the medicine.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The batch number is the lot number. The expiry date refers to 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. Contents of the pack and other information

What Androtop contains

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

What Androtop looks like and contents of the pack

This medicine is a colorless gel in a multi-dose container with a dosing pump, containing 88 g of gel and providing at least 60 doses.
This medicine is available in a cardboard box containing one, two, three, or six containers.
Not all pack sizes may be marketed.

Marketing authorization holder

Besins Healthcare S.A.
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, Czech Republic, France, Netherlands, Luxembourg, Romania, Hungary: Androgel 16,2 mg/g
Germany: Testogel Dosiergel 16,2 mg/g Gel
Ireland: Testogel 16.2 mg/g Gel
Poland: Androtop
Slovenia: Androtop 20,25 mg/dose gel
Spain: Testogel 16,2 mg/g Gel
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder.
Besins Healthcare Poland Sp. z o.o.
ul. Wiśniowa 40B/4
02-520 Warsaw
e-mail: [email protected]

Date of last revision of the leaflet: 10/2024