16.2 mg/g transdermal gel
testosterone
What Testogel is and what it is used for
This medicine contains testosterone , a male hormone that is produced naturally in the body.
This medicine is given to adult men as a testosterone replacement to treat various problems caused by testosterone deficiency (male hypogonadism ). These complaints should be confirmed by two separate blood test testosterone measurements and also include clinical symptoms such as:
- impotence,
- infertility,
- low sex drive,
- fatigue,
- Depression,
- osteoporosis caused by low hormone levels,
The testosterone contained in Testogel may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have further questions, and always follow their instructions.
What you need to know before using Testogel
Who can use Testogel?
- Only men can use Testogel.
- Young men under the age of 18 should not use Testogel.
- This medicine should not be used by women of any age.
- Women (especially pregnant or breastfeeding) or children should not come into contact with Testogel or areas of the skin where Testogel has been applied.
Do not use Testogel
if you have or suspect you have prostate cancer
- if you have or suspect you have breast cancer
- if you are allergic to testosterone or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Your doctor will carry out the necessary examinations before you can start using this medicine and follow up through regular blood tests.
Talk to your doctor or pharmacist before using Testogel:
- if you have difficulty urinating due to an enlarged prostate
- if you have bone cancer – your doctor will check your calcium levels
- if you have high blood pressure or if you are being treated for high blood pressure because testosterone can cause an increase in blood pressure
- if you suffer from severe heart, liver, or kidney disease treatment with this medicine can lead to severe complications in the form of fluid accumulation in the body which is sometimes accompanied by heart failure (fluid accumulates in the heart)
- if you have ischemic heart disease (which affects the supply of blood to the heart)
- if you have or have ever had a blood clotting disorder:
- thrombophilia (a disorder of blood coagulation that increases the risk of thrombosis – blood clots in the blood vessels).
- factors that increase your risk of blood clots in the veins: previous blood clots in a vein, smoking, obesity, cancer, immobility, if a close relative has had a blood clot in a leg, lung, or another organ at a young age (that is, before the age of 50 ); or when you get older
- how to recognize a blood clot: painful swelling in a leg or a sudden change in skin color, such as pale, red, or blue skin, sudden shortness of breath, sudden unexplained cough that may contain blood, or sudden chest pain, lightheadedness or dizziness, severe stomach pains, sudden loss of vision. Seek immediate medical attention if you experience any of these symptoms.
- if you have epilepsy
- if you have migraines
If any of the above applies to you (or if you are not sure) you should talk to your doctor before using this medicine as its use may worsen these conditions.
Androgens can increase the risk of prostate gland enlargement (benign prostatic hypertrophy ) or prostate cancer. Regular examinations of the prostate gland must be performed before starting treatment and during treatment by your doctor’s recommendations.
Worsening breathing difficulties during sleep has been reported in some people during treatment with testosterone, especially in people who are severely overweight or people who already suffer from breathing difficulties
If you have diabetes and use insulin to control blood sugar levels, treatment with testosterone may affect the effect of insulin and your diabetes medication may need to be adjusted.
If you get severe skin reactions where the medicine is applied, you should contact a doctor for advice. It may be necessary to interrupt the treatment.
This medicine should not be used by women because of the possible development of male characteristics (such as increased facial or body hair growth, deeper voice, and menstrual cycle disturbances).
Information on further follow-up
The following blood tests should be performed by your doctor before and during treatment: testosterone levels in the blood, and complete blood cell count.
You will undergo regular examinations (at least annually or twice a year if you are elderly or if your doctor assesses you as a high-risk patient) during treatment.
If you receive testosterone replacement therapy for a long time, the number of red blood cells in the blood may increase in an abnormal way ( polycythemia ). You will need to have regular blood tests to make sure this does not happen.
Possible transfer of testosterone
In case of close skin contact, testosterone can be transferred to another person if you do not cover the treated area and may result in the other person showing signs typical of testosterone increase (see below).
The following precautions are recommended:
For the patient:
- wash your hands with soap and water after applying the gel,
- put on clothes that cover the application area as soon as the gel has dried,
- wash the application area before having close skin contact with another person. If this is not possible, use clothing that covers the application area, such as a shirt or t-shirt.
- wear clothing (eg shirt with sleeves) that covers the application area when in contact with children.
If you believe that testosterone has nevertheless been transferred to someone else (man, woman, or child), this person should
- immediately wash the skin area in question with soap and water,
- if the other person develops changes such as acne or new hair growth on the body or face, deepening of the voice or changes in the menstrual cycle, you must contact a doctor
- In children, attention should be paid to early puberty or enlargement of the genitals.
You should preferably wait at least 1 hour before showering or bathing after applying for this medicine.
Children and young people
This medicine is not recommended for children, as there is no clinical information for boys under 18 years of age.
Other medicines and Testogel
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially the following:
- oral anticoagulants (blood thinners)
- corticosteroids (agent for inflammation )
- insulin (used to control blood sugar levels in diabetes ). You may need to reduce your insulin dose while using this medicine.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using this medicine.
These medicines may cause your dose of this medicine to need to be adjusted.
Pregnancy, breastfeeding, and fertility
This medicine should not be used by women.
The production of sperm may be inhibited temporarily by this medicine.
If your partner becomes pregnant or plans to have a child, you must follow the advice to avoid the transfer of testosterone gel (see Potential transfer of testosterone above). Pregnant women should avoid all contact with application sites for this medicine. This medicine may harm the unborn baby. In the event of contact with your partner, the contact area must be washed off as soon as possible with soap and water.
Driving ability and use of machinery
This medicine does not affect the ability to drive or use machines.
Testogel contains ethanol
This medicine contains 0.9 g of alcohol ( ethanol ) in each dose of 1.25 g of gel.
It can cause a burning sensation on damaged skin.
This medicine is flammable before it has dried.
How to use Testogel
This medicine should only be used by adult men.
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
When using the pump for the first time
Before using the pump for the first time, you need to prepare it for use by:
- Remove the cap from the container to expose the pump head
- Press the pump head down three times
- Do not use gel one from these three pumps. This dose should be safely disposed of by wiping off the excess with paper. Dispose of the paper safely so that no transfer occurs to women, children, or pets.
- Your pump is now ready to use.
- Each time the pump is pressed, it delivers 1.25 g of gel.
The recommended dose is 2 pumps applied daily at approximately the same time, preferably in the morning. Dose one can be adjusted by your doctor and the maximum dose one is 4 pumps per day.
Your doctor will tell you the number of pump strokes that will deliver the right amount of gel for you.
When the pump is prepared as described above, the gel is ready to use.
How gel one is applied
- Press the pump head down once to dispense gel into the palm of your hand.
- Choose a clean, dry and healthy area of skin on the shoulder and upper arm (see marked areas in the picture).
- Gently and evenly spread the gel on one shoulder and upper arm using your fingers. Do not rub the gel on the skin.
- Repeat steps 2 and 3 on the opposite shoulder and upper arm.
- If using three or more pumps, use 2 pumps to the first shoulder and arm and up to 2 pumps to the opposite shoulder and upper arm.
- Wash your hands with soap and water after applying the gel.
- Allow the gel to dry completely before getting dressed.
Testogel must not be applied to the genitals (penis and testicles) because the high alcohol content can cause local irritation.
If you have used too much Testogel
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Consult a doctor or pharmacist. You may be asked to immediately wash the application area and your doctor may stop your treatment.
The following may be signs that you are using too much of the product and you should contact a doctor in this case:
- irritation
- nervousness
- weight gain
- frequent erections
These symptoms may be because your dose is too high and your doctor would need to adjust your dose (see section 2 Warnings and precautions).
If you forget to use Testogel
Do not take a double dose to make up for a missed dose. Take the next dose when it is due.
If you stop using Testogel
You should not stop treatment with this medicine unless your doctor tells you to.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (may affect up to 10 in 100 patients)
This medicine can cause:
- changes in your emotional state which mean
- mood changes
- anger or aggression
- impatience
- insomnia
- abnormal dreams
- increased sex drive
- skin reactions such as:
- acne
- hair loss
- dry skin
- skin irritation
- hair color changes
- rash
- delicate skin
- increased number of red blood cells:
- hematocrit (proportion of red blood cells in the blood)
- hemoglobin (the substance that carries oxygen in the blood), is tested through regular blood tests
- changes in the prostate (including increased levels in the blood of a protein called a prostate- specific antigen, which is produced in the prostate)
Uncommon side effects (may affect up to 1 in 100 patients)
This medicine can cause:
- increase in blood pressure et
- redness
- inflammation of the veins
- diarrhea
- open stomach
- pain in the mouth
- breast development
- sore nipples
- pain in the testicles
- fluid accumulation
- increased erection er
Other side effects that have been observed during treatment with this medicine: fatigue, depression, anxiety, headache, dizziness, skin sensations, blood clots, difficulty breathing, feeling sick, sweating, abnormal body hair growth, muscle or bone pain, difficulty urinating, reduced sperm count, muscle weakness, feeling unwell, weight gain.
As this medicine contains alcohol, frequent applications may cause skin irritation and dry skin.
How Testogel should be stored
No special storage instructions.
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and bottle after EXP. The expiration date is the last day of the specified month.
Contents of the packaging and other information
Contents declaration
- The active substance is testosterone. One gram of gel contains 16.2 mg of testosterone. One pump pressure gives 1.25 g of gel containing 20.25 mg of testosterone.
- Other ingredients are carbomer, isopropyl myristate, ethanol, sodium hydroxide, and water.
Appearance and package sizes of the medicine
This medicine is a colorless, transdermal gel supplied in a multi-dose container with a pump containing 88 g of gel and a minimum of 60 doses.
This medicine is supplied in packs of 1, 2, 3, or 6 containers. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Laboratoires Besins International
3, rue du Bourg l’Abbé
75003 Paris
France
Manufacturer
Laboratoires Besins International
13, rue Périer
92120 Montrouge
France
Or
Delpharm Drogenbos
Groot Bijgaardenstraat 128
1620 Drogenbos
Belgium
This medicine is approved in the European Economic Area under the names:
The Netherlands Testogel 16.2 mg/g transdermal gel
Norway Testogel