Androgel. gel 50 mg. 30 sachets
Androgel. gel 50 mg. 30 sachets
Androgel WHAT IS AND WHAT IT IS USED
Androgel Testosterone contains the active substance . Testosterone is a hormone from the group of male hormones responsible for the development of internal and external genitalia and secondary sex characteristics and is excreted in the human body. This medicine is for hormonal treatment. Used for symptoms of testosterone deficiency in men over 18 years old.
2 . BEFORE YOU USE androgel
You should not apply if androgel :
are allergic to testosterone or any of the excipients of the gel ;
have prostate cancer;
have breast cancer .
Take special care with androgel
Before starting treatment, your doctor will do a full review. Your doctor may take blood in two consecutive visits to measure testosterone levels in your body before you are given this medicine. During the treatment you will have regular check-ups (at least once a year) .
Androgel are not used for the treatment of male infertility and impotence . Androgens not be used by children or women.
Androgel may increase the risk of benign prostatic hypertrophy ( enlargement of the prostate ), or cancer of the prostate, so regularly has to make complete examination of the prostate before treatment initiation and at least annually thereafter , depending on the doctor 's recommendations .
In patients suffering from severe heart, liver or kidney disease , treatment with androgens may cause severe complications in the form of edema ( water retention in the body) or not accompanied by congestive heart failure (increased load on the heart with liquids) . If this happens, the androgen should be stopped immediately and , if necessary, be appointed treatment with diuretics (water pills drainage ) .
Androgel should be used with caution in patients with ischemic heart disease ( poor circulation in the heart).
Since androgens may lead to increased blood pressure , it should be used cautiously in patients with high blood pressure (hypertension) .
Sleep apnea (worsening respiratory / cessation of breathing during sleep ) was observed in treatment with testosterone in susceptible individuals , in particular in people who are overweight ( obese ) or who are suffering from a respiratory disease .
If you suffer from cancer affecting your bones, you may increase calcium levels in the blood or urine. Androgens may lead to further increases of the calcium. Your doctor may wish to monitor calcium levels with blood tests while you are being treated with androgens.
Certain symptoms such as irritability , nervousness, weight gain, frequent or prolonged erection can indicate an excessive effect of the drug. Report them to your doctor to adjust the daily dose of androgen.
If you are on hormone replacement therapy with testosterone for a long period you will have regular blood tests the following laboratory parameters : hemoglobin, hematocrit (to diagnose polycythemia - an abnormal increase in red blood cells in the blood) and liver function .
It may be necessary to adjust the therapeutic dose in patients who have been treated with :
oral anticoagulants ( medicines for blood clotting) ;
corticosteroids ( as there is an increased risk of edema - fluid retention in the body if you suffer from heart, liver or kidney disease ) ;
Androgel should be used with caution in patients with epilepsy or migraine as these conditions may worsen.
Androgel may lead to certain changes in laboratory tests to study the thyroid hormone . Their levels remain unchanged and no clinical symptoms of thyroid deficiency .
Since this medicine contains the active substance testosterone, it can lead to positive anti- doping test and the appearance of male secondary sexual characteristics in females.
When you need to be especially careful
Testosterone may fall into another person through close and prolonged skin contact with the area that is attached gel if you do not take appropriate precautions. If the contact is performed frequently or for a long time can lead to symptoms of increased testosterone in your partner such as increased facial hair , deepened voice . In women can lead to menstrual disorders .
Wearing clothes covering the application site , or washing before contact prevent such transmission .
The following precautions are recommended :
Wash your hands with soap and water after applying the gel,
after the gel has dried , cover the application area with clothing ;
take a shower before intimate contact .
For people who have not been treated with androgens :
If your skin has been in contact with the application of the gel , wash immediately with soap and water area of possible transfer of testosterone ;
tell your doctor if you develop symptoms such as acne or changes in body hair or face.
It is preferable to wait at least 6 hours after application of the gel before washing or bathing. If need to wash or bathe between the first and sixth hour of the application of the gel , it will not have a significant effect of treatment .
To make sure that will not put your partner at risk of transmission of testosterone , it is necessary to leave as a longer period of time between the application of the gel and sexual contact . Also, you should wear a T-shirt covering the site of administration of androgens during close contact with your partner or to wash or bathe before sexual intercourse .
You should wear a T-shirt covering the application site of androgen if you will be in close contact with children to prevent transmission of the drug on the child's skin .
Taking other medicines
Please tell your doctor if you are taking or have recently used any other medicines , even those not prescribed , especially oral anticoagulants ( blood-thinning ) and corticosteroids.
Pregnancy, lactation and fertility
Please tell your doctor if you are pregnant or breast-feeding or plan to become pregnant !
Androgens not be administered to pregnant and lactating women.
Pregnant women should avoid any contact with the application site of androgen. This medicine may cause unwanted male characteristics in the developing child. In case of contact , wash immediately with soap and water.
If your partner becomes pregnant , you should follow the advice to avoid the transfer of testosterone gel.
Before taking any medicine, ask your doctor for advice.
Driving and using machines
No data available.
3 . HOW TO USE androgel
Always androgen exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist.
This medicine is given only in adult men !
The recommended dose is 5 g gel ( i.e. 50 mg of testosterone) , administered once daily at approximately the same time , preferably in the morning .
The daily dose may be adjusted by the doctor using doses of 2,5 g , depending on the individual response , but without exceeding the daily dose of 10 g of gel .
The gel should be applied gently onto clean , dry, healthy skin in a thin layer on the shoulders, arms or abdomen. No need to rub the gel into the skin.
After opening the sachet , the entire contents must be immediately applied to the skin . Before dressing Allow the gel to dry for at least 3-5 minutes. Wash your hands with soap and water after application.
Do not apply and the genital areas (penis and testicles ) , and the high levels of alcohol can lead to skin irritation.
If you have taken more than the amount of androgens : Seek advice your doctor .
If you forget to use androgel :
Do not take a double dose to make up for missed .
You should not stop treatment with androgens , unless your doctor tells you that.
4 . POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Like all medicines, androgens can have side effects:
Skin reactions at the application site - erythema ( irritation, redness) , acne, and dry skin are rare.
Androgel can cause headaches , dizziness , changes in behavior , memory loss , numbness , skin hypersensitivity , burning, hair loss, onset of pain, tenderness or breast enlargement , changes in the prostate, diarrhea, increases in blood pressure , changes in laboratory parameters (changes in lipids , increase the number of red blood cells in the blood).
Gynecomastia ( breast enlargement ) could be permanent and is common in patients treated for testosterone deficiency .
Other adverse reactions have been observed during treatment with oral or injectable testosterone - enlargement of the prostate and progression of early , undiagnosed prostate cancer , urinary obstruction ( swelling of the obstacles in the urine) , pruritus ( itching ) , arterial vasodilation ( causing redness face and neck ) , nausea, cholestatic jaundice (yellowing of the skin) , changes in liver function , increased libido , depression , nervousness , myalgia ( muscle pain ) and high doses given long - electrolyte changes ( changes of salts in the blood - sodium, potassium , calcium, inorganic phosphate and water retention) , oligospermia (decreased sperm count ) and priapism ( frequent or prolonged erections ) .
Due to the presence of alcohol in the gel , frequent use may lead to irritation and dry skin .
If any of the side effects gets serious, or you notice other effects not listed in this leaflet , please tell your doctor or pharmacist !
5 . HOW TO STORE androgel
No special storage conditions !
Store in original container.
Keep out of reach of children.
Shelf life - 3 (three) years.
Do not use the gel after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . ADDITIONAL INFORMATION
Contents of androgel
The active ingredient is testosterone .
The other ingredients are Carbopol 980 , isopropyl myristate, ethanol 96% , sodium hydroxide , purified water .
Looks like androgens and contents of the pack
Androgel clear or slightly opalescent , colorless gel.
Sachets ( PET / Aluminium / LDPE) 5 g gel , 30 pieces sachets in a box.