Androtop

Androtop
50 mg, gel in sachet
(Testosteronum)
Please read the entire leaflet before using the medicine, as it contains important information

• Keep this leaflet, so that you can read it again if necessary.
• Consult your doctor or pharmacist if you need advice or further information. This medicine has been prescribed for a specific individual and should not be passed on to others, as it may harm them even if their symptoms are the same. If any adverse reactions occur, inform your doctor or pharmacist. This also applies to any adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Androtop is and what it is 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 ANDROTOP IS AND WHAT IT IS USED FOR

Androtop contains testosterone, the 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 this condition requires two independent blood tests showing low testosterone levels, along with the following clinical symptoms:

• Impotence
• Infertility
• Reduced sexual desire
• Fatigue
• Depressive mood
• Loss of bone mass due to low hormone levels
• Loss of muscle mass
• Regression of male characteristics
• Inability to achieve or maintain erection

2. IMPORTANT INFORMATION BEFORE USING ANDROTOP

When not to use Androtop

• In case of known hypersensitivity to testosterone or to any of the other ingredients of the medicine (listed in section 6)
• If prostate cancer is diagnosed or suspected
• If breast cancer is diagnosed or suspected

When to exercise special caution with Androtop

Androtop should only be used in patients whose testosterone deficiency is confirmed by laboratory tests (performed in the same laboratory) and who present clear clinical symptoms (such as regression of secondary sexual characteristics, reduced lean body mass, weakness or fatigue, reduced libido, inability to achieve or maintain erection, etc.).

Androtop is not indicated:

• For the treatment of infertility or impotence in men
• In children, due to lack of clinical data on use in boys under 18 years of age
• In women, due to the risk of developing male characteristics

Androgens may increase the risk of benign prostatic hyperplasia or prostate cancer. Regular prostate examinations should be performed before starting and during treatment, as recommended by the physician.

If the patient has severe heart, liver, or kidney disease, treatment with Androtop may lead to serious complications, such as fluid retention and, occasionally, congestive heart failure.

The following blood tests should be ordered by the doctor before and during treatment: blood testosterone levels and complete blood count.

Inform your doctor if you have high blood pressure or are taking antihypertensive medications, as testosterone may increase blood pressure.

Worsening of sleep apnea has been reported in some patients treated with testosterone, especially in those with risk factors such as obesity and breathing problems.

In patients with bone cancer, increased calcium levels in blood or urine may occur. Androtop may further increase these levels. Your doctor may recommend monitoring blood calcium levels during treatment.

Long-term testosterone replacement therapy may lead to an increase in red blood cell count (polycythaemia). Regular blood tests should be performed during treatment to monitor for this complication.

Androtop should be used with caution in patients with epilepsy and/or migraine, as it may worsen these conditions.

If severe skin reactions occur, treatment should be re-evaluated and possibly discontinued.

Certain clinical symptoms such as irritability, nervousness, weight gain, or frequent/prolonged erections may indicate overdosage. These symptoms should be reported to the doctor, who may adjust the daily dose of Androtop.

Before starting treatment, the doctor should perform a thorough examination. Blood samples must be taken during two separate visits prior to treatment to measure testosterone levels. During treatment, regular follow-up examinations should be performed (at least once a year, or twice a year in elderly patients or those at increased risk).

Potential transfer of testosterone:

Testosterone may be transferred to another person through close and relatively prolonged skin-to-skin contact with the area where the gel was applied, especially if the application site is not covered. This may cause symptoms of elevated testosterone levels in female partners, such as facial and body hair growth and voice deepening. It may also alter the menstrual cycle in women. Wearing clothing that covers the application site or taking a shower before close contact can prevent transfer of testosterone to others.

The following precautions are recommended:

• Wash hands thoroughly with soap and water after applying the gel
• Cover the application site with clothing after the gel has dried
• Take a shower before intimate contact

If the gel is accidentally transferred to another person (woman or child):

• Immediately wash the affected skin area with soap and water
• Inform the doctor if symptoms such as acne, changes in hair growth, or altered body or facial hair distribution occur

To avoid exposing others to the risk of accidental testosterone exposure, a sufficient time interval should be maintained between application of Androtop and physical contact. During close contact, wear a short-sleeved undershirt to cover the application site, or take a shower or bath before planned contact.

It is recommended to wait at least 6 hours between applying the gel and bathing or showering. Bathing or showering may occasionally be performed 1 to 6 hours after gel application, which should not significantly affect treatment efficacy.

Other medicines and Androtop

Inform your doctor about all medicines you are currently taking, including those obtained without a prescription, especially oral anticoagulants (used to thin the blood), insulin, or corticosteroids. Concomitant use of these medicines may require adjustment of the Androtop dose.

Pregnancy and breastfeeding

Androtop is not intended for use in pregnant or breastfeeding women. Pregnant women must avoid all contact with areas where Androtop has been applied. This medicine may cause the development of unwanted male characteristics in the developing fetus. If contact with the application site occurs, the exposed skin area should be washed immediately with soap and water, as recommended above.

If the partner of a patient treated with Androtop becomes pregnant, it is essential to follow the recommendations to prevent transfer of the testosterone-containing gel.

Driving and operating machinery

Androtop has no effect on the ability to drive motor vehicles or operate mechanical equipment.

Athletes and women

Athletes and women should be aware that the active substance in Androtop (testosterone) may result in a positive outcome in anti-doping tests.

3. HOW TO USE ANDROTOP

This medicinal product is intended for use in adult men only.
Androtop should always be used exactly as recommended by the doctor. If in doubt,
consult the doctor again.
The recommended dose is 5 g of gel (i.e. 50 mg of testosterone), to be applied once daily at approximately the same time each day, preferably in the morning.
The daily dose may be individually adjusted by the doctor for each patient, but should not exceed 10 g of gel per day.
The gel should be gently applied in a thin layer onto clean, dry, healthy skin of both shoulders, upper arms, or abdomen.
After opening the sachet, the entire contents should be removed and immediately applied in a thin layer to the skin. Allow the gel to dry for at least 3 to 5 minutes before dressing. After applying the gel, hands should be washed thoroughly with soap and water.
Do not apply to the genital area (penis and testicles), as due to the high alcohol content of Androtop, this may cause local irritation.

Use of more than the recommended dose of Androtop
If more than the recommended dose is used, consult a doctor immediately.
Missed dose of Androtop
Do not apply a double dose to make up for a missed dose.
Stopping treatment with Androtop
Do not stop treatment with Androtop unless instructed to do so by a doctor.
If in doubt about how to use the medicine, consult a doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Very common adverse reactions, may affect 10 out of 100 patients
Due to the alcohol content in Androtop, frequent application to the skin may cause skin irritation and dryness. Acne may also occur.
Common adverse reactions (between 1 and 10 out of 100 patients)
Use of Androtop may cause headache, hair loss, pain, tenderness or enlargement of the breasts, changes in the prostate gland, diarrhoea, dizziness, increased blood pressure, mood changes, increased number of red blood cells, haematocrit (percentage of red blood cells in blood) and haemoglobin concentration (the component of red blood cells that carries oxygen), identified in periodic blood tests, changes in lipid levels, skin hypersensitivity reactions, skin burning sensation and memory disturbances.
Other adverse reactions observed during treatment with orally administered or injected testosterone:
Increased body weight, changes in blood electrolyte levels, muscle pain, nervousness, depression, hostility, breathing difficulties during sleep, yellowing of the skin (jaundice), changes in liver function test results, seborrhoea, changes in sexual drive, reduced sperm count, frequent or prolonged erections, blockage making urination difficult, fluid retention, hypersensitivity reactions.
Reporting of adverse reactions
If any adverse reactions occur, inform your doctor or pharmacist. This also applies to any adverse reactions not listed in this leaflet. You may also report adverse reactions directly via the national reporting system:
Department for Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: [email protected]
Reporting adverse events helps to provide more information on the safety of the medicine.

5. HOW TO STORE ANDROTOPT
Storage: no special requirements.
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Androtop contains
The active substance is testosterone. Each 5 g sachet contains 50 mg of testosterone.
Other ingredients of the medicine are: carbomer 980, isopropyl myristate, ethanol 96% (v/v), 0.1N sodium hydroxide, purified water.

What Androtop looks like and contents of the pack
Androtop is a clear gel packed in 5 g sachets.
Androtop is available in packs containing 30 sachets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Laboratoires BESINS INTERNATIONAL
3, rue du Bourg l’Abbé
75003 Paris
France

Manufacturer:
Laboratoires Besins International or Besins Manufacturing Belgium
13, rue Périer Groot Bijgaardenstraat, 128
92120 Montrouge 1620 Drogenbos
France Belgium

This medicinal product is authorised in the European Economic Area under the following names:
ANDROGEL: Austria, Belgium, Czech Republic, Denmark, France, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Portugal, Netherlands.
ANDROTOP GEL: Germany.
ANDROTOP: Poland, Slovenia