Tostran 2% Gel
D ProStrakani
'PACKAGE LEAFLET: INFORMATION FOR THE USER-
Tostran® 2% Gel
Testosterone
Read all of this leaflet carefully before you start using this medicine because it contains important information for you
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Tostran is and what it is used for
2. What you need to know before you use Tostran
3. How to use Tostran
4. Possible side effects
5. How to store Tostran
6. Contents of the pack and other information
5. HOWTO USETOSTRAN
lAlways use this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist jf 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 lyour 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 eight times. The first few depressions may result in no discharge of gel. Discard the gel from the eight depressions. It is only necessary to prime the pump before the first dose.
Administration of Tostran:
lYour doctor will tell you how many depressions of the piston to make to get the correct dose of gel for you once
■the pump has been primed. The table below gives you more information on this.
|
Number of Depressions |
Amount of Gel (g) |
Quantity of Testosterone Applied to the Skin (mg) |
|
r |
0.5 |
10 |
|
2~ |
1 |
20 |
|
4 |
2 |
40 |
|
3 |
60 | |
|
I 8 |
4 |
80 |
|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 lone half rubbed onto the inside of each thigh (over an area of at least 10 by 15 cm). It is recommended that you pjb 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.
iRub 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 kneasurements are performed in the same laboratory, because of the variability in analytical values among jdiagnostic laboratories.
Jf you use more Tostran than you should:
If you have applied too much Tostran, contact a doctor, hospital or pharmacist, 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.
^f you stop using Tostran:
Always talk to your doctor or pharmacist before stopping using Tostran.
I|f you have any further questions on the use of this medicine, ask your doctor or pharmacist.
l4. POSSIBLE SIDE EFFECTS
|Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (affects more than 1 user 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 pf Tostran but if they are troublesome or last for more than a few days, talk to your doctor or pharmacist as soon as possible.
bommon side effects (affects 1 to 10 users in 100) are: swelling of hands or feet, high blood pressure, prostate phanges (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). Increase in red blood cell count, haematocrit (percentage of red blood cells in blood) and paemoglobin (the component of red blood cells that carries oxygen), identified by periodic blood tests.
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.
There is no convincing evidence that testosterone replacement in hypogonadal men induces prostate cancer. However, testosterone therapy is to be avoided in men already known or thought to have prostate cancer. jHyperglycaemia (too much sugar in the bloodstream) has been reported in the case of 2 people with a history of diabetes mellitus.
^Reporting of side effects
|lf you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not isted in this leaflet. You can also report side effects directly via:
Ireland
HPRA Pharmacovigilance Earlsfort Terrace IRL-Dublin 2 Tel: +353 1 6764971 Fax:+353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie
by reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE TOSTRAN
jKeep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the canister after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
|Do not refrigerate or freeze.
|Store canister upright.
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.
fe. CONTENTS OF THE PACK AND OTHER INFORMATION IWhat Tostran contains
.• The active substance is testosterone. One gram of gel contains 20 mg of testosterone.
• The other ingredients are propylene glycol; ethanol, anhydrous; isopropyl alcohol; oleic acid; carbomer 1382;
| trolamine; butylhydroxytoluene (E321), water, purified and hydrochloric acid (for pH adjustment).
{What Tostran looks like and contents of the pack
Tostran is a clear gel, which varies from colourless to slightly yellow in appearance.
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:
ProStrakan Ltd |Galabank Business Park Galashiels TD11QH |United Kingdom
Manufacturer:
PHARBIL Waltrop GmbH llm Wirrigen 25 |45731 Waltrop Germany
^This medicinal product is authorised in the Member States of the EEA under the following names:
Austria, Denmark, Finland, Germany, Greece, Hungary, Ireland, Netherlands, Norway, Poland, Portugal,
|United Kingdom: Tostran
Italy, Sweden: Tostrex
Belgium, Spain, Luxembourg: Itnogen France: Fortigel
I .This leaflet was last revised in 19/08/2015
LFT-TOS-G B-001