TOSTREX 2% Żel

Treść ulotki

1. Tostrex 2% gel
   1. WHAT IS TOSTREX 2% GEL AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING TOSTREX 2% GEL
   3. HOW TO USE TOSTREX 2% GEL
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE TOSTREX 2% GEL
   6. PACKAGE CONTENTS AND OTHER INFORMATION

Tostrex 2% gel

Testosterone

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Tostrex 2% gel is and what it is used for
• 2. What you need to know before you use Tostrex 2% gel
• 3. How to use Tostrex 2% gel
• 4. Possible side effects
• 5. How to store Tostrex 2% gel
• 6. Contents of the pack and other information

1. WHAT IS TOSTREX 2% GEL AND WHAT IS IT USED FOR

The active ingredient, testosterone, is a male androgen hormone.
Tostrex 2% gel is used to replace testosterone in adult men, for the treatment of various
health problems due to its testosterone deficiency (male hypogonadism). This condition
must be confirmed with two distinct measurements of testosterone in the blood and must include
clinical symptoms such as:

• impotence
• infertility
• low libido
• fatigue
• depressed mood
• loss of bone tissue due to low hormone levels

2. WHAT YOU NEED TO KNOW BEFORE USING TOSTREX 2% GEL

Tostrex 2% gel should only be used if hypogonadism has been confirmed by a doctor based on symptoms and diagnostic tests.
Before starting treatment, the doctor must have ruled out other causes underlying the symptoms.
Tostrex 2% gel can only be used by males. Tostrex 2% gel has not been studied in men under 18 years of age and experience in the treatment of men over 65 years of age is limited.

Do not use Tostrex 2% gel:

• if you are allergic to testosterone or any of the other ingredients of this medicine (listed in section 6).
• if you have or suspect you have cancer of the breast or prostate

If any of these apply to you, tell your doctor or pharmacist.

Warnings and precautions:
Before starting treatment, and at regular intervals during treatment (usually once or twice a year), check-ups are necessary.
If you have a severe heart, liver or kidney disease, treatment with Tostrex 2% gel may cause serious complications in the form of fluid retention in the body, sometimes accompanied by heart failure (congestion).
Before and during treatment, the doctor must perform the following blood tests: testosterone levels in the blood, complete blood count.
Tell your doctor if you suffer from high blood pressure or are taking medicines for the treatment of high blood pressure, because testosterone may cause an increase in blood pressure.
Treatment with testosterone may increase the risk of developing an enlarged prostate (benign prostatic hyperplasia) or prostate cancer. Treatment with testosterone may also affect the number of red blood cells, the lipid profile in the blood and liver function.
Before treatment, tell your doctor if:

• your hands and feet are swollen
• you are overweight or suffer from chronic lung disease, as treatment with testosterone may worsen sleep apnea (temporary interruption of breathing during sleep)
• you have diabetes and use insulin to control blood sugar levels, as treatment with testosterone may alter your response to insulin
• you suffer from seizures or migraines, as these conditions may worsen during treatment
• you have bone cancer, as your doctor will need to check your calcium levels during treatment.
• you have or have ever had blood clotting problems
• thrombophilia (an abnormality of blood coagulation that increases the risk of thrombosis
• blood clots in blood vessels
• factors that increase the risk of blood clots in the veins: previous blood clots in the veins; smoking; obesity; cancer; inactivity; if a close relative has had a blood clot in the leg, lung or other organs at a young age (e.g. under 50); or with increasing age. How to recognize a blood clot: painful swelling of a leg or sudden change in skin color, e.g. becomes pale, red or blue, sudden shortness of breath, sudden unexplained cough with possible appearance of blood; or sudden chest pain, severe dizziness or vertigo, severe stomach pain, sudden loss of vision. Seek medical attention urgently if any of these symptoms occur.

Consult your doctor if:

• you have frequent or persistent erections
• you feel irritable, nervous or notice weight gain
• you have nausea, vomiting, notice changes in skin color or if your ankles swell
• you notice changes in breathing, even during sleep.

These symptoms may mean that the dose of Tostrex 2% gel is too high and your doctor may need to adjust it.
Consult your doctor if you notice a skin reaction at the application site, such as a burning or tingling sensation, dryness, rash, redness or itching. If the reaction is severe, the doctor should re-evaluate the treatment and, if necessary, discontinue it.
If you are an athlete, be aware that Tostrex 2% gel contains testosterone, which may give positive results in doping tests.

For those who engage in sports:The use of the drug without a therapeutic need constitutes doping and may still result in a positive anti-doping test.
Tostrex 2% gel should not be used to treat male infertility or impotence.
Tostrex 2% gel should not be used in women due to possible virilizing effects, such as the growth of facial or body hair, lowering of the voice or changes in the menstrual cycle.

How to avoid transferring Tostrex 2% gel to others:
It is important not to transfer the product to others, especially women and children. Transfer occurs through close skin contact and causes an increase in testosterone levels in the other person. If the contact is repeated or prolonged, it can cause unwanted effects such as the growth of facial or body hair, lowering of the voice or changes in the menstrual cycle in women.
Transfer can be avoided by covering the application site with loose clothing or by showering or bathing before 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 after the gel has dried;
• shower or bathe before being in close skin contact with others.

To ensure the maximum safety of your partner, wait at least four hours before having sexual intercourse after applying Tostrex 2%, wear clothing that covers the application site at the time of contact, or wash the application site with soap and water before sexual intercourse.
When in contact with children, wear clothing that covers the application site to avoid the risk of transferring the gel to children's skin.
If you have transferred testosterone gel to another person through skin contact, or someone else has been exposed to the gel through direct contact, wash the contact surface of the other person with soap and water as soon as possible.
Healthcare professionals and those assisting patients should use disposable gloves when applying Tostrex to the patient. Gloves should be alcohol-resistant as the gel contains ethanol and isopropyl alcohol.
Consult your doctor if you notice changes in body hair, a significant increase in acne or other signs of the development of male characteristics in people not treated with Tostrex 2% gel (female partner or children).
Other medicines and Tostrex 2% gel:
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines, especially the following:

• anticoagulants
• corticosteroids

Also tell your doctor or pharmacist if you are taking any medicines that you have purchased yourself, without a prescription.

Tostrex 2% gel with food and drink:
Tostrex 2% gel is not affected by the intake of food or beverages.

Pregnancy and breastfeeding

• The use of Tostrex 2% gel is intended only for males.
• Pregnant or breastfeeding women should not use Tostrex 2% gel
• Pregnant women should avoid any contact with the skin treated with Tostrex 2% gel. Tostrex 2% gel can harm or cause abnormalities in the fetus. If your partner becomes pregnant, follow the advice on how to avoid transferring testosterone gel provided in this paragraph. If contact with the treated skin occurs, wash the area immediately with soap and water.

Driving and using machines:
It is unlikely that Tostrex 2% gel will have any effect on the ability to drive and use machines.

Tostrex 2% gel containsbutylhydroxytoluene and propylene glycol
Butylhydroxytoluene may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes. This medicine contains up to 1400 mg of propylene glycol in each dosage unit, equivalent to 350 mg/g.

3. HOW TO USE TOSTREX 2% GEL

Use this medicine following the doctor's instructions exactly. If you have any doubts, check with your
doctor or pharmacist regarding the method and timing of gel application.
Usually the initial dose is 3g of gel (containing 60mg of testosterone) per day. The doctor may
adjust the dose, up to a maximum of 4g of gel (80mg of testosterone) per day.
Tostrex 2% gel is supplied in a container with a pumping mechanism that releases half a
gram of gel (10mg of testosterone) each time the plunger is pressed down (when the mechanism
is lowered all the way down).

Using the container for the first time:
Before using the dosing pump for the first time, it is necessary to prime it. To do this, with the container
in a vertical position, repeatedly press the actuator, slowly and all the way down, until
the gel appears. Press the actuator another six times. Discard the gel obtained with the six presses.
It is necessary to prime the pump only before the first dose.

Administration of Tostrex 2% gel:
The doctor will tell you how many times you will need to press the plunger to obtain the correct dose of gel for you after
priming the pump. The table below provides further information on this.
Apply the gel to clean, dry, and intact skin once a day, every day at the same time, for
example in the morning after showering. Rub the gel onto the abdomen (over an area of
at least 10x30cm) or, dividing it into two equal parts, on the inside of each thigh (over an
area of at least 10x15cm). It is recommended to use Tostrex 2% gel alternately, one day
on the abdomen and one day on the inside of boththighs.
Avoid application to other areas. In particular, do not apply Tostrex 2% gel to the genitals.

Gently rub the gel with a finger until it is dry, then cover the area with
loose-fitting clothing (e.g. T-shirt, underwear, trousers). Once finished, wash
your hands thoroughly with water and soap.
If you are thinking of taking a shower or bath, do so before applying Tostrex 2% gel, or
wait at least two hours after application.
Two weeks after starting to use the medicine, the doctor will take two blood samples to
check if it is necessary to adjust the dosage. During the use of Tostrex 2% gel you should
expect to undergo periodic medical check-ups.
If you are preparing the blood test to be performed during treatment with Tostrex 2% gel you must
ensure that all evaluations are performed in the same laboratory, due to the variability of
analytical values between diagnostic laboratories.

If you use more Tostrex 2% gel than you should:
If you have applied an excessive amount of Tostrex 2% gel, always consult a doctor, hospital or
pharmacist.

If you forget to use Tostrex 2% gel:
Do not use a double dose to make up for a missed dose. Apply the next dose
at the usual time.

If you stop using Tostrex 2%:
Before stopping treatment with Tostrex 2% gel, always talk to your doctor or
pharmacist.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (which occur in more than 1 in 10 users)are skin reactions at the application
site, such as a burning or tingling sensation, dryness, rash, redness or itching. These are usually mild and
transient side effects of Tostrex 2% gel, but if they are bothersome or persist for more than a few days, contact
your doctor or pharmacist as soon as possible.
Common side effects (which occur in 1 to 10 users out of 100)are: swelling of the hands or
feet, high blood pressure, prostate changes (including increased blood levels of a protein called prostate
specific antigen, produced by the prostate), increased body hair growth, breast enlargement, increased
number of red blood cells (measured in blood samples). Increase in red blood cell count, hematocrit
(percentage of red blood cells in the blood) and hemoglobin (the component of red blood cells that carries
oxygen), detected through periodic blood tests.
Other known side effects associated with testosterone treatments include: baldness, seborrhea, acne,
jaundice (liver problems that can sometimes be associated with a yellowing of the skin and
whites of the eyes), altered liver function tests, nausea, changes in libido, increased frequency of
erections, difficulty urinating, depression, nervousness, hostility, weight gain, muscle cramps or pain,
fluid retention, swelling of the ankles, sleep apnea and rare cases of painful and persistent erections. At
high doses, a reduction in sperm production and testicular size may occur. Prolonged administration of
testosterone can cause changes in salt (electrolyte) levels in the body.
There is no convincing evidence that testosterone replacement therapy in hypogonadal men
induces prostate cancer. However, testosterone therapy should be avoided in men known or suspected to
have prostate cancer.
Hyperglycemia (an excessive amount of sugar in the blood) has been reported in 2 cases of people
with diabetes mellitus.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly via
Website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects you can help provide more information on the safety of
this medicine.

5. HOW TO STORE TOSTREX 2% 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 pack after "Exp.". The
expiry date refers to the last day of the month.
Do not store at a temperature above 25 °C.
Do not refrigerate or freeze.
Keep the container in an upright position once opened.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Tostrex 2% gel contains

• The active ingredient is testosterone. One gram of gel contains 20mg of testosterone.
• The excipients are propylene glycol, anhydrous ethanol, isopropyl alcohol, oleic acid, carbomer 1382, trolamine, butylated hydroxytoluene (E321), purified water and hydrochloric acid (to adjust the pH).

Description of the appearance of Tostrex 2% gel and contents of the pack
Tostrex 2% gel is a transparent gel, whose appearance may vary from colourless to pale yellow.
Tostrex 2% gel is supplied in containers with a capacity of 60 grams of gel. The containers are equipped
with a pumping mechanism that releases a constant amount of gel.
A carton may contain one, two or three containers of gel. Not all pack sizes may be
marketed.

Marketing Authorisation Holder:
Advanz Pharma Limited
Suite 17, Northwood House, Northwood Avenue,
Santry, Dublin 9
Ireland

Manufacturer responsible for batch release
PHARBIL Waltrop GmbH
Im Wirrigen 25
45731 Waltrop
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Austria, Denmark, Finland, Germany, Greece, Hungary, Ireland, Netherlands, Norway, Poland,
Portugal, United Kingdom: Tostran
Italy, Sweden: Tostrex
Belgium, Spain, Luxembourg: Itnogen
France: Fortigel