Tostran 2% Gel
Testosterone
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Tostran is and what it is used for
- 2. Before you use Tostran
- 3. How to use Tostran
- 4. Possible side effects
- 5. How to store Tostran
- 6. Further information
What Tostran Is And What It Is Used For
The active substance, testosterone, is a male hormone, which is a type of androgen.
Tostran is used in males who have a deficiency or lack of testosterone, named hypogonadism.
Before You Use Tostran
Tostran must only be used if hypogonadism has been confirmed by your doctor, based on your symptoms and laboratory tests. Other reasons for your symptoms must have been excluded by your doctor prior to the start of treatment.
Only men can use Tostran. Tostran has not been tested in males less than 18 years of age, and there is limited experience of treating men older than 65 years of age.
Do not use Tostran:
If you:
- are allergic (hypersensitive) to testosterone or to any of the other ingredients of Tostran
- have or are suspected of having cancer of the breast or prostate
If any of these applies to you, tell your doctor or pharmacist.
Take special care with Tostran:
A check-up is necessary before you begin treatment, and periodically during treatment (usually once or twice a year). Testosterone treatment may increase the risk of development of an enlarged prostate gland (benign prostatic hyperplasia) or prostate cancer. Testosterone treatment may also affect the number of red blood cells you have, your blood fat profile and your liver function. Your doctor will therefore monitor these at regular intervals.
Tell your doctor before treatment if you:
- have heart, liver or kidney disease, as testosterone treatment may cause water retention in the body, which may result in fluid overload in the heart
- have swollen hands and feet
- are overweight or suffer from a chronic lung disease, as testosterone treatment may worsen sleep apnoea (temporary cessation of breathing during sleep)
- have high blood pressure, as this may get worse during treatment
- have diabetes and use insulin to control your blood sugar levels, as testosterone treatment may affect your response to insulin
- have or develop epilepsy or migraines, as these conditions may get worse during treatment
- suffer from skeletal cancer, as your doctor will have to monitor your blood calcium levels during treatment
Contact your doctor if you:
- have frequently-occurring or persistent erections
- feel irritable, nervous, or notice weight gain
- feel nauseous, vomit, notice changes in your skin colour or your ankle joints become swollen
- notice any changes in breathing patterns including during sleep
These symptoms may mean that your dose of Tostran is too high, and your doctor may need to adjust your dose.
Contact your doctor if you notice any skin reactions at the site of application such as burning or prickling sensation, dryness, rash, redness or itchiness. If the reaction is severe, treatment should be reviewed by your doctor and stopped if necessary.
If you are an athlete please note that Tostran contains testosterone, which may give positive results in a doping test.
Tostran should not be used to treat male sterility or sexual impotence.
Tostran should not be used by women due to possible virilising effects (such as growth of facial or body hair, deepening of the voice or changes in the menstrual cycle).
How to prevent transfer of Tostran to someone else:
It is important not to transfer the product to others, especially women and children. Transfer occurs through close skin to skin contact, resulting in increased testosterone levels in the other person. If the contact is repeated or prolonged, it may cause side-effects such as growth of facial or body hair, deepening of the voice or changes in the menstrual cycle of women.
This transfer can be avoided by covering the application site with loose clothing, or by showering or bathing prior to contact.
The following precautions are therefore recommended:
- wash your hands thoroughly with soap and water after applying the gel;
- cover the application site with loose clothing once the gel has dried;
- shower or bathe before any situation involving close skin to skin contact with someone else.
In order to guarantee the safety of your partner you should wait for at least four hours after application of Tostran before having sexual intercourse and wear clothing which covers the application site at the time of contact or wash the site of application with soap and water before sexual intercourse.
You should wear clothing, which covers the application site when in contact with children in order to avoid the risk of transferring the gel to the child's skin.
If you transfer some of the testosterone gel to another person by skin-to-skin contact, or someone else is exposed by direct contact with the gel itself, wash the contact area of the other person with soap and water as soon as possible.
Contact your doctor if you notice changes in body hair, significantly increased acne or other signs of development of male characteristics in people not being treated with Tostran (ie female partner or children).
Using other medicines:
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, especially the following:
- anticoagulants
- corticosteroids
Also tell your doctor or pharmacist about any medicines that you may have bought for yourself without prescription.
Using Tostran with food and drink:
Tostran is not affected by your intake of food or drink.
Pregnancy and breast-feeding
- Tostran is only intended to be used by men.
- Tostran must not be used by pregnant or breastfeeding women.
- Pregnant women should avoid all contact with skin treated with Tostran. Tostran may cause harm or abnormalities in the unborn baby. If your partner becomes pregnant, you must follow the advice regarding avoiding transfer of the testosterone gel given in this section. In the event of contact with treated skin, the area should be washed immediately with soap and water.
Driving and using machines:
Tostran is unlikely to have an effect on your ability to drive and use machines.
Important information about some of the ingredients of Tostran:
Tostran also contains butylhydroxytoluene which may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes. Tostran contains propylene glycol which may cause skin irritation.
How To Use Tostran
Always use Tostran exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure, about how and when to apply the gel.
The usual starting dose is 3 g of gel (containing 60mg of testosterone) per day. The dose may be adjusted by your doctor, and the maximum dose is 4 g of gel (80 mg of testosterone) per day.
Tostran is supplied in a canister with a pumping mechanism which delivers one half gram of gel (10 mg of testosterone) each time the piston is depressed (when the pump mechanism is pushed right down).
Using the canister for the first time:
Before you use the dosing pump for the first time it must be primed. To do so, with the canister in the upright position, slowly and fully depress the actuator two times. The first depression may result in no discharge of gel. Discard the gel from the two depressions. It is only necessary to prime the pump before the first dose.
Administration of Tostran:
Your doctor will tell you how many depressions of the piston to make to get the correct dose of gel for you. The table below gives you more information on this.
- 1 Depression
- 0.5g of Gel
- 10mg of Testosterone applied to the skin
- 2 Depressions
- 1g of Gel
- 20mg of Testosterone applied to the skin
- 4 Depressions
- 2g of Gel
- 40mg of Testosterone applied to the skin
- 6 Depressions
- 3g of Gel
- 60mg of Testosterone applied to the skin
- 8 Depressions
- 4g of Gel
- 80mg of Testosterone applied to the skin
Apply the gel onto clean, dry intact skin, once a day at the same time each day for example in the morning after showering.
The gel should either be rubbed onto the abdomen (over an area of at least 10 by 30 cm) or divided in half and one half rubbed onto the inside of each thigh (over an area of at least 10 by 15 cm). It is recommended that you rub Tostran onto your abdomen and both your inner thighs on alternate days.
Application to other sites should be avoided. In particular do not apply Tostran to the genitals.
Rub the gel in gently with one finger until dry, and then cover the area with loose clothing (e.g. T-shirt, shorts, pants). When finished, wash your hands thoroughly with soap and water.
If you are thinking of taking a shower or bath, do so either before application of Tostran or wait for at least two hours after the application.
Two weeks after beginning to use your medicine your doctor will take blood samples to see if your dose needs to be changed. Whilst you are taking Tostran, you should expect to have regular medical follow-up.
If you are arranging for testing of blood samples while using Tostran you must ensure that all testosterone measurements are performed in the same laboratory, because of the variability in analytical values among diagnostic laboratories.
If you use more Tostran than you should:
If you have applied too much Tostran, contact a doctor, hospital or pharmacist.
If you forget to use Tostran:
Do not take a double dose to make up for forgotten individual doses. Apply the next dose at the usual time.
If you stop using Tostran:
Always talk to your doctor or pharmacist before stopping using Tostran.
Possible Side Effects
Like all medicines, Tostran can cause side effects, although not everybody gets them.
Very common side effects (more than 1 patient in 10) are skin reactions at the site of application such as burning or prickling sensation, dryness, rash, redness or itchiness. These are usually mild transient side effects of Tostran but if they are troublesome or last for more than a few days, talk to your doctor or pharmacist as soon as possible.
Common side effects (more than 1 in 100 patients but less than 1 in 10 patients) are: Swelling of hands or feet, high blood pressure, prostate changes (including: increased blood levels of a protein called prostate specific antigen that is produced by the prostate), increased body hair growth, increase in breast size, increased number of red blood cells (measured in blood samples).
Other known undesirable effects associated with testosterone treatments include: baldness, seborrhoea, acne, jaundice (liver problems which sometimes may be associated with yellowing of the skin and the whites of the eyes), abnormal liver function tests, nausea, changes in libido, increased frequency of erections, difficulty in passing urine, depression, nervousness, hostility, weight gain, muscle cramps or pain, fluid retention, swelling of ankles, sleep apnoea, and rare cases of painful and persistent erections. A reduction in sperm production and the size of the testicles may occur at high doses. Prolonged testosterone administration may cause changes in the levels of salts (electrolytes) in the body.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist as soon as possible.
How To Store Tostran
Keep out of the reach and sight of children.
Do not use Tostran after the expiry date stated on the canister after EXP.
Do not store above 25°C.
Do not refrigerate.
Further Information
What Tostran contains
- The active substance is testosterone. One gram of gel contains 20 mg of testosterone.
- The other ingredients are propylene glycol; ethanol, dehydrated; isopropyl alcohol; oleic acid; carbomer 1382; trolamine; butylhydroxytoluene (E321) and purified water.
What Tostran looks like and contents of the pack
Tostran is a clear and colourless gel.
Tostran comes in canisters each containing 60 grams of gel. The canisters have a pumping mechanism, which delivers a fixed amount of gel.
A carton may contain one, two or three canisters of gel. Not all pack sizes may be available.
Marketing Authorisation Holder:
Manufacturer:
This leaflet was last approved on 10/2006.
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