Androtop

Patient Information Leaflet

Androtop, 16.2 mg/g, transdermal gel
Testosterone
Please 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Androtop is and what it is used for
2. What you need to know 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 Androtop is and what it is used for

This medicine contains testosterone, a male hormone naturally produced in the body.
Androtop is used in adult men as testosterone replacement therapy for the treatment of
various conditions resulting from testosterone deficiency (male hypogonadism). Diagnosis
of the condition requires two independent measurements of low blood testosterone levels
together with the following clinical symptoms:

• impotence,
• infertility,
• reduced sexual desire,
• fatigue,
• depressive mood,
• loss of bone mass due to low hormone levels,
• regression of male characteristics,
• decreased lean body mass,
• inability to achieve or maintain an erection.

2. Important information before using Androtop

Who can use Androtop

• This medicine is intended exclusively for men.
• Young men under the age of 18 should not use this medicine.
• Women of any age must not use this medicine.
• Avoid contact between this medicine (or skin areas where the medicine has been applied) and women (especially pregnant or breastfeeding women) or children.

When not to use Androtop

• if the patient is allergic to testosterone or any of the other ingredients of this medicine (listed in section 6),
• 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 beginning treatment with this medicine, a clear diagnosis of testosterone deficiency must be established, based on clinical symptoms (such as loss of male sexual characteristics, reduced lean body mass, weakness or fatigue, reduced libido (sex drive), inability to achieve and (or) maintain an erection, etc.) and confirmed by laboratory tests. Prior to using this medicine, your doctor will perform necessary examinations and will continue to monitor you regularly, including periodic blood tests.
If any of the following conditions apply to the patient (or if the patient is unsure), speak with a doctor before using this medicine, as treatment with this medicine may worsen these conditions.

• the patient has difficulty urinating due to an enlarged prostate gland,
• the patient has bone cancer – the doctor will check calcium levels,
• 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, because treatment with this medicine may lead to serious complications such as fluid retention, which may sometimes be associated with heart failure (fluid overload in the heart),
• the patient has ischemic heart disease (a condition affecting blood flow to the heart),
• blood clotting disorders:
  • (thrombophilia, a blood clotting disorder increasing the risk of thrombosis, blood clots in blood vessels),
  • factors increasing the risk of venous blood clots: previous history of blood clots in veins; smoking; obesity; cancer; immobility; family history of blood clots in a leg, lungs, or other organ at a young age (e.g. under approximately 50 years); or at an older age.
  • how to recognize a blood clot: painful swelling in one leg or sudden skin discoloration such as paleness, redness, or blueness; sudden shortness of breath; sudden unexplained cough, possibly with blood; or sudden chest pain, intense feeling of emptiness in the head or dizziness, severe abdominal pain, sudden loss of vision. If any of these symptoms occur, seek immediate medical help.
• the patient has epilepsy,
• the patient suffers from migraines,
• the patient has breathing difficulties during sleep – this is more likely if the patient is overweight or has long-term lung problems.

Androgens may increase the risk of developing an enlarged prostate gland (benign prostatic hyperplasia) or prostate cancer. Regular prostate examinations should be performed as recommended by the doctor, both before starting and during treatment.
In patients with diabetes who use insulin to control blood glucose levels, testosterone treatment may alter insulin requirements, necessitating adjustment of antidiabetic medication.
If severe skin reactions occur, reassess the need for continued treatment and discontinue if necessary.
This medicine must not be used by women due to the risk of virilizing effects (e.g. facial and/or body hair growth, voice lowering, or menstrual cycle disturbances).

Information about additional monitoring
Before starting treatment and during therapy, the doctor should perform the following blood tests: blood testosterone levels and complete blood count.
During treatment, the patient will undergo regular follow-up examinations (at least once a year, or twice a year if the patient is elderly or considered by the doctor to be at higher risk).
Long-term testosterone treatment may lead to an abnormal increase in the number of red blood cells (polycythemia). Regular blood tests should be performed to monitor for this condition.

Children and adolescents
This medicine is not recommended for use 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 physical contact, this medicine may be transferred to another person. This may cause adverse effects such as facial or body hair growth, voice lowering, or menstrual cycle changes in women, or accelerated growth, genital enlargement, and premature puberty (including 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 medicine has dried. After applying this medicine, patients should wait at least 1 hour before taking a shower or bath.
• take a shower and thoroughly wash the application site with soap and water to remove any residual testosterone before anticipated close contact with another person; if this is not possible, wear clothing such as a shirt or T-shirt covering the application site during contact.

Patients using this medicine who may have close physical contact with children should take extra precautions, as testosterone may pass through clothing. In case of physical contact with children, follow the gel application instructions (see section 3 of this leaflet), including covering the application site with clean clothing after the gel has dried. Additionally, wash the gel application site with soap after the recommended time (at least 1 hour) and cover it again with clean clothing before physical contact with children.
If transfer of testosterone to another person (man, woman, or child) is suspected, that person should:

• immediately wash the skin area that may have been exposed to the gel with soap and water,
• consult a doctor if symptoms such as acne, changes in hair growth or body/facial hair distribution, voice lowering, or menstrual cycle changes occur,
• in children, also watch for signs of premature puberty and genital enlargement.

It is recommended to wait at least 1 hour after applying the medicine before taking a shower or bath.

Androtop with other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take, especially the following:

• oral anticoagulants (used to thin the blood),
• corticosteroids,
• insulin (used in diabetes to control blood sugar levels). A reduction in insulin dose may be necessary when insulin is used concurrently with this medicine.

If any of the above situations apply to the patient (or if you are unsure), consult your doctor or pharmacist before using this medicine.
Concurrent use of these medicines may require adjustment of the Androtop dose.

Pregnancy, breastfeeding, and fertility
This medicine must not be used by women.
This medicine may reversibly suppress sperm production.
If the patient’s partner becomes pregnant, it is essential to follow the recommendations to avoid transferring the testosterone-containing gel.
This medicine is not intended for use by pregnant or breastfeeding women.
Pregnant women must avoid all contact with application sites of this medicine, as it may cause undesirable virilizing effects on the fetus. In case of accidental skin contact, the affected skin area should be washed immediately and thoroughly with soap and water, as advised above.

Driving and operating machinery
This medicine has no effect on the ability to drive or operate machinery.

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

The medicine contains ethanol (alcohol)
This medicine contains 0.9 g of ethanol per 1.25 g dose of gel.
It may cause a burning sensation on damaged skin.
Exercise caution when applying the medicine and avoid sources of heat/open flames, as ethanol is flammable until the gel has dried completely on the skin.

3. How to use Androtop

This medicine is intended for use in adult men only.
Always use this medicine exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
First use of the dosing pump
Before using the dosing pump for the first time, prepare it as follows:

• Remove the cap from the container to expose the piston.
• Remove the cap from the end of the piston.
• Press the piston down three times.
• Do not use the gel obtained from the first three presses of the piston. Safely discard this amount of gel.
• The dosing pump is now ready for use. There is no need to refill it again.
• Each press of the piston delivers 1.25 g of gel.

The recommended dose is 2 presses of the piston, to be applied once daily at approximately the same time each day, preferably in the morning. The dose may be adjusted by the doctor, and the maximum daily dose is 4 presses of the piston per day.
Your doctor will inform you how many presses of the piston are required to achieve the appropriate dose of gel. Further information on this is provided in the table below.

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

Once the pump is primed according to the above instructions, the gel is ready for use.

How to apply the gel:

The gel should be applied by the patient himself.

1. Press the pump once to dispense a dose of gel onto the palm of the hand.
2. Select a clean, dry, and healthy area of skin on the shoulder and upper arm (see the marked areas in the illustration below).
3. Gently and evenly spread the gel with the fingers over one shoulder and arm. Do not rub it into the skin.
4. If using two pump presses, repeat steps 1, 2, and 3 on the other shoulder and arm.
5. If using three or more pump presses, apply up to two doses on the first shoulder and arm, and up to two doses on the second shoulder and arm.
6. After application, wash hands thoroughly with soap and water.
7. Allow the gel to dry completely before putting on clothes.

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

Patients should be advised that other people (adults and children) should avoid contact with the area of skin where the gel has been applied.

After the gel has dried, cover the application site with clean clothing (e.g. a T-shirt).

Before engaging in close physical contact with another person (adult or child), the application site should be washed thoroughly with soap and water after the recommended time (at least 1 hour) and then covered again with clean clothing.

The patient should apply the gel himself to clean, dry, and healthy skin on both shoulders or both upper arms.

Use of more than the recommended dose of Androtop

Contact a doctor or pharmacist immediately. The patient may be advised to immediately wash off the gel from the skin, and the doctor may recommend discontinuing treatment.

The following symptoms may indicate that the patient is using too high a dose and should contact a 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 the dose (see Warnings and precautions, point 2).

Missed dose of Androtop

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

Stopping treatment with Androtop

Do not stop treatment with this medicine unless advised by a doctor.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them:

Common (may affect up to 1 in 10 people)

• Mood disorders
• Emotional symptoms (mood changes, affective disorders, anger, aggression, impatience, insomnia, unusual dreams, increased libido)
• Dizziness
• Paresthesia
• Amnesia
• Hypersensitivity
• Headache
• Hypertension
• Diarrhea
• Alopecia
• Urticaria
• Gynaecomastia
• Reaction at the application site
• Changes in laboratory test results (polycythaemia, lipids)
• Increased haematocrit level
• Increased haemoglobin level
• Increased number of red blood cells

Uncommon (may affect up to 1 in 100 people)
This medicine may cause:

• Malignant hypertension
• Hot flushes/flushing
• Phlebitis
• Oral pain
• Abdominal distension
• Acne
• Hirsutism
• Rash
• Dry skin
• Seborrhoea
• Skin damage
• Contact dermatitis
• Hair colour changes
• Hypersensitivity at the application site
• Itching at the application site
• Breast disorders
• Prostate abnormalities
• Testicular pain
• Increased frequency of erections
• Pitting oedema
• Increased PSA concentration

Rare (may affect up to 1 in 1,000 people)
This medicine may cause:

• Priapism
• Liver tumour

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

• Jaundice
• Abnormal liver function tests

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

• Prostate cancer
• Fatigue
• Nervousness
• Depression
• Hostility
• Periodic sleep apnoea
• Urinary tract obstruction
• Muscle cramps
• Changes in libido
• High-dose testosterone therapy usually reversibly interrupts or reduces spermatogenesis, thereby reducing testicular size;
• Malaise
• Oedema
• Hypersensitivity reactions
• Increased body weight
• Electrolyte disturbances (retention of sodium, chlorides, potassium, calcium, inorganic phosphates and water) during high-dose and/or prolonged use
• Skin reactions (due to the alcohol content, frequent application to the skin may cause irritation and dryness of the skin)
• Increased incidence of water retention and occurrence of oedema

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions enables better assessment of the safety profile of the medicine.

5. How to store Androtop

There are no special storage requirements for this 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 Lot abbreviation refers to the batch number. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Androtop contains

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

What Androtop looks like and contents of the pack
This medicine is a clear gel in a multidose container with a pump dispenser,
containing 88 g of gel, 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 Authorisation 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
Or
Besins Manufacturing Espana S.L.
Poligono industrial el Pitarco, Parcela 4
Muel
50450 Zaragoza
Spain
This medicinal product is authorised in the European Economic Area countries 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/sprožitev gel
Spain: Testogel 16.2 mg/g Gel
For more detailed information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Besins Healthcare Poland Sp. z o.o.
Wiśniowa Street 40B/4
02-520 Warsaw
e-mail: [email protected]