Tostran Gel

You can use Tostran gel if you:

• are not allergic to any ingredients in Tostran gel
• do not have breast cancer or prostate cancer
• have taken a test and seen a doctor to confirm you have low levels of testosterone or hypogonadism

You should speak to a doctor before using Tostran gel if you have:

• liver or kidney problems
• heart disease such as heart failure
• high blood pressure
• sleep apnoea
• diabetes which is being treated with insulin
• epilepsy
• migraines
• a condition that affects your blood clotting or red blood cells
• benign prostatic hyperplasia (BPH)
• bone cancer

Before starting Tostran gel you will need to have blood tests to check your testosterone levels and other hormones. You will also need checks of your prostate gland and tests to look for reasons why your testosterone level is low. After starting treatment you need regular blood test monitoring for the first year and then at least one a year.

If you get side effects after using Tostran gel, you should speak to your doctor about them. You might need to change how much Tostran gel you use.

Side effects where you have applied Tostran gel include:

• dry skin
• rash
• red skin
• feeling itchy or hot

Common side effects of Tostran gel include:

• more body hair growth
• water retention that can make your hands or feet look swollen
• your blood pressure going up
• breasts getting bigger (gynaecomastia)
• changes to your prostate that cause it to produce more PSA
• having more red blood cells
• having more haemoglobin (to carry more oxygen in your red blood cells)

You should speak to a doctor if you:

• get erections that last a long time, especially if they are painful
• start to put on weight
• feel sick or vomit
• start to see your skin colour change
• find it difficult to breathe normally when you sleep

You can report side effects using the MHRA Yellow Card Scheme online or in the Google Play or Apple App Store.

Tostran gel and other medicines

Tostran gel can affect how other medicines work, so speak to a doctor if you are taking any of the following:

• blood thinners, also known as anticoagulants, such as aspirin, warfarin or apixaban
• corticosteroids, such as prednisolone, hydrocortisone or betamethasone
• medicines that contain testosterone or stimulate testosterone production, such as Testogel 50mg sachets

You can find more information about Tostran gel in the patient information leaflet.

Which active ingredients does Tostran gel contain?

The active ingredient in Tostran gel is testosterone. In 1 gram (2 pumps) of Tostran gel, there is 20mg of testosterone.

The other ingredients in Tostran gel are propylene glycol, ethanol (anhydrous), isopropyl alcohol, oleic acid, carbomer 1382, trolamine, butylhydroxytoluene (E321), water (purified) and hydrochloric acid.

How should Tostran gel be disposed of?

You can dispose of Tostran gel canisters safely by taking them to a nearby pharmacy. Avoid throwing away Tostran gel at home, even if you do not want to use it anymore.

How should Tostran gel be stored?

As soon as you open a Tostran gel canister, store it upright. You should keep Tostran gel at room temperature, ideally below 25°C.

What does Tostran gel look like?

Tostran gel looks like a clear, yellowish jelly. Tostran gel canisters are tall tubes that have a pump on top. You get a 10mg drop of testosterone gel every time you press down on a Tostran gel pump.

In which pack sizes is Tostran gel available?

Tostran gel is available in pack sizes of 1, 2, or 3 canisters, containing 60g each.

Information on the manufacturer

The marketing authorisation holder for Tostran gel is Kyowa Kirin Ltd, Galabank Business Park, Galashiels, TD1 1QH, UK.

Tostran gel is manufactured by Pharbil Waltrop GmbH, Im Wirrigen 25, 45731 Waltrip, Germany.