Patient Leaflet Updated 21-Oct-2020 | Endo Ventures Limited
testim
Package leaflet: Information for the user
TESTIM 50 mg Transdermal Gel
Testosterone
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Testim Gel is and what it is used for
2. What you need to know before you use Testim Gel
3. How to use Testim Gel
4. Possible side effects
5. How to store Testim Gel
6. Contents of the pack and other information
1. What Testim GEL is and what it is used for
Testim gel is a clear gel that contains testosterone. Testosterone is a male hormone. The gel is put on to your skin (shoulders and/or upper arms) and testosterone is absorbed into your body through your skin. It then enters your bloodstream and helps to raise your testosterone to normal levels. The type of testosterone delivered into your body by Testim gel is the same as the testosterone produced by your body.
Testim Gel is used to replace testosterone in men who do not produce sufficient natural testosterone, a condition known as hypogonadism. Testosterone is made naturally in your body in your testicles. It helps produce sperm and to develop and maintain the male sexual characteristics such as a deep voice and body hair. It is also necessary for normal sexual function and sex drive. Testosterone also helps to maintain muscle size and strength.
Testim is used in adult men for testosterone replacement to treat various health problems caused by a lack of testosterone (male hypogonadism). This should be confirmed by two separate blood testosterone measurements and also include clinical symptoms such as:
Other medicines may be needed as well as Testim if you are being treated for infertility.
2. What you need to know before you use Testim Gel
Only men can use Testim Gel. Do not allow women or children to come into contact with the areas of skin to which Testim Gel has been applied. Males under the age of 18 years should not use this product. This product should also not be used by females of any age.
Do not use Testim Gel:
Warnings and precautions
Talk to your doctor before using Testim Gel
These conditions may be aggravated when using Testim Gel. If you have any of the above conditions go back to your doctor to seek advice.
If you develop serious reactions on your skin where you applied the Testim Gel, go back to your doctor to seek advice.
If you have close skin-to-skin contact, testosterone may be transferred to someone else. For further information, please refer to section 3 (How to use).
The following blood checks should be carried out by your doctor before and during the treatment: testosterone blood level, full blood count. Testosterone treatment may accelerate the progression of pre-existing prostate cancer. Your doctor will perform the necessary tests before starting treatment and then check by carrying out periodic blood tests and prostate examinations.
If you are an athlete, be aware that this product may produce a positive reaction in anti-doping tests.
Testosterone must not be used to increase muscles or improve physical strength in healthy individuals.
Children
TESTIM is not indicated in children.
Other medicines and Testim Gel
Tell your doctor if you are using, have recently used or might use any other medicines.
TestimGel may affect how these medicines work and you may need to have your doses adjusted. This is particularly important if you are taking:
Other forms of interactions: laboratory test interactions. Treatment with testosterone may alter the levels of thyroid hormones in your body. The thyroid function is not affected by these minor changes in levels of thyroid hormones. The thyroid is a gland located in the neck and is involved in the regulation of the body’s metabolism and growth.
Pregnancy and breast-feeding
Testim Gel is not intended for use by women.
Pregnant women should avoid skin contact with Testim Gel application sites in men as testosterone can cause the appearance of male secondary sex characteristics in the female foetus.
Breast-feeding women should also avoid any contact with Testim Gel application sites in men.
If your partner is or becomes pregnant, you must follow the advice under the heading ‘How to prevent transfer of Testim Gel to someone else’ on the other side of this leaflet
Testim Gel contains propylene glycol
This product contains propylene glycol which may irritate your skin.
3. How to use Testim Gel
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
Testim Gel is intended for transdermal use, which means application on the skin (shoulders and/or upper arms).
Before you start to use Testim Gel, your doctor will check that you have low testosterone levels in your blood. Always use Testim Gel exactly as your doctor has told you. Check with your doctor if you are not sure. Each 5g tube contains 50mg of testosterone. The usual starting dose of Testim Gel is one tube of gel (5g) each day. Some patients may require a higher dose and your doctor may prescribe two tubes of gel every day. The correct dose of Testim Gel that you need will be decided by regularly measuring the levels of testosterone that are in your blood, as well as by assessing the clinical response to Testim Gel treatment. If you have the impression that the effect of Testim Gel is too strong or too weak, you should talk to your doctor. Signs of irritability, nervousness, weight gain and prolonged or frequent erections may be suggestive of excessive use.
It is important that you read and follow these directions on how to use Testim Gel properly. Apply Testim Gel only to healthy, normal skin. Never apply Testim Gel to your genitals (penis and testes) or to skin that is broken or damaged and avoid contact with open sores, wounds or irritations.
1. Apply Testim Gel at the same time each day (preferably every morning).
2. Apply the contents of one (1) or two (2) tube(s) of gel on the shoulders and/or upper arms, every morning as instructed by your doctor. If you take a bath or shower in the morning, use Testim Gel after your bath or shower.
3. Make sure that your shoulders and/or upper arms are clean and completely dry before putting on the gel.
4. Open the Testim Gel aluminium tube by piercing the end of the tube with the top part of the cap.
5. Squeeze the entire contents of the tube into the palm of your hand. Squeeze the gel out from the bottom of the tube towards the top.
6. Apply Testim Gel only to your shoulders and/or upper arms as a thin layer. In this way your body will absorb the right amount of testosterone.
7. Use a circular motion to rub the gel in to your skin for several seconds. Do this until no gel is left on the skin area. This process should be repeated with a second tube of Testim Gel by patients who have been prescribed a daily dose of testosterone 100mg. It is suggested that patients who require two tubes of gel each day use both shoulders (one tube per shoulder) and/or upper arms as application sites.
8. Thoroughly wash your hands with soap and water immediately after application. This will also reduce the chance that the medicine will spread from your hands to other people.
9. Let Testim Gel dry for a few minutes before you dress. This prevents your clothing from wiping the gel off your skin and ensures that your body will absorb the correct amount of testosterone.
10. If you wash the application site within 6 hours after applying Testim Gel you may lower the amount of testosterone that is absorbed by your body. Therefore, wait at least 6 hours after applying the gel before showering or swimming to ensure that the greatest amount of Testim Gel is absorbed into your body.
Always use this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor if you are not sure.
How to prevent transfer of Testim Gel to someone else
It is important that you do not spread the medicine to others, especially women and children. If you do not take appropriate precautions, you can transfer testosterone gel to other persons by close skin-to-skin contact.
This may result in increased testosterone serum levels in the other person. If the contact is repeated or prolonged, this may cause unwanted side effects such as the growth of facial and/or body hair, acne, deepening of the voice or changes in the menstrual cycles of women. Similarly, children have naturally low concentrations of testosterone and could be harmed by higher levels.
To stop the gel being transferred from your skin to someone else, the following precautions are recommended:
What to do if someone else is exposed to Testim Gel
If someone else is exposed to Testim Gel either as a result of contact with the gel itself or because of contact with the application area on your skin, the person should wash their area of skin contact with soap and water as soon as possible. The longer that the gel is in contact with the skin before washing, the greater the chance that the person will absorb some testosterone. This is particularly important for women, especially pregnant or breast-feeding women, and children.
If they develop signs such as acne or changes in the growth or pattern of hair on their face or body, they should see their doctor.
If you use more Testim Gel than you should
If you have applied too much Testim Gel by mistake, wash the application area with soap and water as soon as you realise. For further information about any possible side effects, please refer to section 4 (Possible side effects).
If you forget to use Testim Gel
If you miss a dose, do not double your dose the next day to catch up. If your next dose is less than 12 hours away, do not take the missed dose but continue with your next dose as normal. If it is more than 12 hours until your next dose, take the dose that you have missed. Continue as normal the following day.
If you have any further questions on the use of this product, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Important side effects or symptoms to look out for - and what to do if you are affected
If you have been told after a clinical examination or periodic blood test that you have developed any of the following side effects, see a doctor immediately. Your doctor may review or discontinue your treatment.
The following are common side effects, probably affecting up to 1 in every 10 people taking Testim Gel:
If you think you have any of the following side effects, see your doctor as soon as possible. Depending on your doctor’s decision and/or in the case of a severe reaction, your treatment may be reviewed or discontinued.
The following are common side effects. They probably affect up to 1 in every 10 people taking Testim Gel:
The following are uncommon side effects. They probably affect fewer than 1 in every 100 people taking Testim Gel:
Azoospermia (no sperm count) may occur very rarely (in fewer than 1 in 10,000 people taking Testim Gel)
Tell your doctor as soon as possible if you notice any of the following symptoms while taking Testim Gel. Your doctor may decide to adjust your treatment:
Other possible side effects
The following side effects have not been reported with Testim Gel, but may occur as with any other testosterone treatment:
In case of prolonged use or excessive dose:
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any side effects not listed in this leaflet.
You can also report side effects directly via;
UK:
Ireland:
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Testim Gel
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the bottom of each tube. The expiry date stated after EXP refers to the last day of that month.
Do not store above 25°C.
Keep the tubes of Testim Gel away from direct heat and direct sunlight as the contents are flammable.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Testim Gel contains
What Testim Gel looks like and contents of the pack
This medicinal product is presented as a gel in a single dose container, the gel is a clear to translucent gel.
Testim Gel is provided in single dose aluminium tubes with screw caps, each containing 5g gel. Testim Gel is available in cartons containing 7, 14, 30 or 90 single dose containers.
Not all pack sizes may be available in the country where it is purchased.
Marketing Authorisation Holder and Manufacturer
UK: PL 43808/0018
IE: PA 2311/001/001
This leaflet was last revised in January 2020.
First Floor, Minerva House, Simmonscourt Road, Ballsbridge, Dublin 4, Ireland
+353 1 268 2000
http://www.endo.com
+353 1 268 2030
0-800-069-8421
