Tostrex

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tostrex 20 mg/g transdermal gel

Testosterone
Please read this leaflet carefully before using this medicine because 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. Never give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT TOSTREX IS AND WHAT IT IS USED FOR

The active substance, testosterone, is a male androgenic hormone.
Tostrex is used to replace testosterone in adult men for the treatment of various health problems caused by testosterone deficiency (male hypogonadism). This condition must be confirmed by two separate blood measurements of testosterone and must include clinical symptoms such as:

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

2. WHAT YOU SHOULD KNOW BEFORE USING TOSTREX

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

Do not use Tostrex:

• 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 breast or prostate cancer.

If you fall into either of these categories, inform 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 severe heart, liver, or kidney disease, treatment with Tostrex may cause serious complications such as fluid retention in the body, sometimes accompanied by heart failure (congestive).
Before and during treatment, your doctor should perform the following blood tests: blood testosterone levels and complete blood count.
Inform your doctor if you have high blood pressure or are taking medicines for high blood pressure, as testosterone may increase blood pressure.
Treatment with testosterone may increase the risk of developing an enlarged prostate (benign prostatic hyperplasia) or prostate cancer. Testosterone treatment may also affect the number of red blood cells, blood lipid profile, and liver function.

Before treatment, inform your doctor if:

• you have swollen hands or feet
• you are overweight or suffer from chronic lung disease, as testosterone treatment may worsen sleep apnea (temporary interruption of breathing during sleep)
• you have diabetes and use insulin to control your blood sugar levels, as testosterone treatment may alter your response to insulin
• you suffer from epileptic seizures or migraines, as these conditions may worsen during treatment
• you have a bone tumor, as your doctor will need to monitor your blood calcium levels during treatment
• you have or have had blood clotting disorders
• thrombophilia (a blood clotting disorder that increases the risk of thrombosis)
• blood clots in blood vessels
• factors that increase the risk of venous blood clots: previous venous blood clots; smoking; obesity; cancer; immobility; if a close relative had a blood clot in the leg, lung, or other organ at a young age (e.g., under 50 years); or increasing age.
  How to recognize a blood clot: painful swelling of one leg or sudden change in skin color, e.g., becoming pale, red, or blue; sudden shortness of breath; sudden unexplained cough possibly with blood; or sudden chest pain, severe dizziness or vertigo, severe stomach pain, sudden loss of vision. Seek urgent medical advice if you experience any of these symptoms.

Contact your doctor if:

• you have frequent or prolonged erections
• you feel irritable, nervous, or notice weight gain
• you have nausea or vomiting, notice changes in skin color, or develop swollen ankles
• you notice changes in breathing, even during sleep

These symptoms may indicate that your Tostrex dosage is too high, and your doctor may need to adjust it.
Contact your doctor if you experience a skin reaction at the application site, such as a burning or tingling sensation, dryness, rash, redness, or itching. If the reaction is severe, your doctor should reassess the treatment and may need to discontinue it.
If you are an athlete, be aware that Tostrex contains testosterone, which may result in a positive doping test.
For athletes: Using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test regardless.
Tostrex must not be used to treat male infertility or sexual impotence.
Tostrex must not be used in women due to possible virilizing effects, such as growth of facial or body hair, lowering of voice pitch, or changes in the menstrual cycle.

How to avoid transferring Tostrex to others:

During repeated or prolonged physical contact, this medicine may be transferred to another person. This could cause unwanted effects such as growth of facial or body hair, voice lowering, or changes in the menstrual cycle in women, or accelerated growth, genital enlargement, and early puberty (including development of pubic hair) in children.
Wearing clothing to cover the application site or washing the area before contact can reduce this risk.
Patients using this product must take extra care when in close physical contact with children, as testosterone can pass through clothing. Please strictly follow the application technique (see section 3 of this leaflet) when in physical contact with children, even covering the application site with clean clothing once the gel is dry. In addition, please wash the application site with soap after the recommended time has passed (at least 2 hours) and cover it again with clean clothing before any physical contact with children.
To ensure maximum safety for your partner, wait at least four hours after applying Tostrex before having sexual intercourse, and wear clothing covering the application site at the time of contact, or wash the application site with water and soap before sexual intercourse.
When in contact with children, wear clothing that covers the application site to avoid the risk of transferring the gel to their skin.
If you have transferred testosterone gel to another person through skin contact, or if someone else has been exposed to the gel through direct contact, wash the affected area of the other person’s skin with water and soap as soon as possible.
Healthcare professionals and caregivers who assist patients must use disposable gloves if they need to apply Tostrex to the patient. Gloves must be alcohol-resistant, as the gel contains ethanol and isopropyl alcohol.
Contact your doctor if you notice changes in body hair, a marked increase in acne, or other signs of development of male characteristics in individuals not being treated with Tostrex (female partners or children).

Other medicines and Tostrex:

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially the following:

• anticoagulants
• corticosteroids

Also inform your doctor or pharmacist if you are taking any medicines you have purchased without a prescription.

Tostrex with food and drink:

Tostrex is not affected by food or drink intake.

Pregnancy and breastfeeding

• Tostrex is intended for use only in males.
• Pregnant or breastfeeding women must not use Tostrex.
• Pregnant women must avoid any contact with skin treated with Tostrex. Tostrex may harm or cause abnormalities in the fetus. If your partner becomes pregnant, you must follow the advice provided in this section on how to avoid transferring testosterone gel. In case of contact with treated skin, wash the area immediately with water and soap.

Driving and using machines:

It is unlikely that Tostrex will have any effect on your ability to drive or operate machinery.

Tostrex contains butylated hydroxytoluene, propylene glycol, and ethanol.

Butylated hydroxytoluene may cause localized skin reactions (e.g., contact dermatitis) or irritation to the eyes and mucous membranes.
This medicine contains 175 mg of propylene glycol in each pump actuation.
This medicine contains 75 mg of alcohol (ethanol) in each pump actuation.
It may cause a burning sensation on damaged skin.
This product is flammable until it is dry.

3. HOW TO USE TOSTREX

Use this medicine exactly as directed by your doctor. If you have any doubts, check with your doctor or pharmacist about the method and timing of application of the gel.
The usual starting dose is 3 g of gel (containing 60 mg of testosterone) per day. Your doctor may adjust the dose up to a maximum of 4 g of gel (80 mg of testosterone) per day.
Tostrex is supplied in a container with a pump mechanism that delivers half a gram of gel (10 mg of testosterone) each time the plunger is pressed down (when the pump mechanism is fully depressed).

First use of the container:
Before using the pump dispenser for the first time, it must be primed. To do this, with the container in an upright position, press the actuator down slowly and completely, repeating this action until gel appears. Then press the actuator an additional six times. Discard the gel dispensed during these six presses.
Priming the pump is required only once, before the first dose.

Administration of Tostrex:
Your doctor will tell you how many times you need to press the plunger to obtain the correct dose of gel for you after the pump has been primed. The table below provides further information on this.

Apply the gel to clean, dry, and intact skin once daily, at the same time every day, for example in the morning after showering.
Gently rub the gel onto the abdomen (over an area of at least 10x30 cm) or, divided into two equal parts, onto the inner side of each thigh (over an area of at least 10x15 cm). It is recommended to use Tostrex alternately—one day on the abdomen and the next day on the inner side of both thighs.
Avoid application at other sites. Tostrex must not be applied to the genital area.
Gently massage the gel with one finger until it dries completely. Once the gel is dry, cover the application site with clean clothing (such as a T-shirt, shorts, or underwear). After completing the application, wash your hands thoroughly with water and soap. Before engaging in close physical contact with another person (adult or child), wait the recommended time period (at least two hours), then wash the application site with water and soap and cover it again with clean clothing.
If you plan to take a shower or bath, do so before applying Tostrex, or wait at least two hours after application.
Two weeks after starting treatment, your doctor will take two blood samples to determine whether a dosage adjustment is necessary. During treatment with Tostrex, you should expect to undergo periodic medical check-ups.
If you are preparing to have blood tests performed during treatment with Tostrex, ensure that all evaluations are carried out at the same laboratory, due to variability in analytical values between different diagnostic laboratories.

If you use more Tostrex than you should:
If you have applied an excessive amount of Tostrex, contact your doctor, hospital, or pharmacist immediately.

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

If you stop using Tostrex:
Always consult your doctor or pharmacist before stopping treatment with Tostrex.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Very common adverse reactions (occurring in more than 1 in 10 users) are skin reactions at the application site, such as burning or tingling sensation, dryness, rash, redness, or itching. These are usually mild and transient side effects of Tostrex, but if they are bothersome or persist for more than a few days, consult your doctor or pharmacist as soon as possible.

Common adverse reactions (occurring in 1 to 10 in 100 users) include: 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 red blood cell count (measured in blood samples). Increase in red blood cell count, haematocrit (percentage of red blood cells in the blood), and haemoglobin (the component of red blood cells that carries oxygen), detected through periodic blood tests.

Other known adverse reactions associated with testosterone treatments include: baldness, seborrhoea, acne, jaundice (liver problems which may sometimes be associated with yellowing of the skin and whites of the eyes), abnormal liver function tests, nausea, changes in libido, increased frequency of erections, difficulty urinating, depression, nervousness, hostility, weight gain, muscle cramps or muscle pain, fluid retention, swelling of the ankles, sleep apnoea, and rare cases of painful and prolonged erections. At high doses, reduced sperm production and testicular size may occur. Prolonged administration of testosterone may cause changes in 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.

Hyperglycaemia (excess blood sugar) has been reported in 2 cases of individuals with diabetes mellitus.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE TOSTREX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container after "Exp.".
The expiry date refers to the last day of the month.
Do not store above 25 °C.
Do not refrigerate or freeze.
Keep the container in an upright position once opened.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Tostrex contains

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

Description of the appearance of Tostrex and contents of the pack
Tostrex is a transparent gel, which may vary in appearance from colourless to pale yellow.
Tostrex is supplied in containers with a capacity of 60 grams of gel. The containers are equipped with a pump mechanism that delivers a constant amount of gel.
A carton may contain one, two or three gel containers. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Advanz Pharma Limited
Unit 17, Northwood House,
Northwood Crescent, Dublin 9,
D09 V504, Ireland
Manufacturer
PHARBIL Waltrop GmbH
Im Wirrigen 25
45731 Waltrop
Germany
This medicinal product is authorised in the European Economic Area Member States and in the United Kingdom (Northern Ireland) under the following names:
Cyprus, Denmark, Finland, Germany, Greece, Ireland, Netherlands, Norway, United Kingdom (and Northern Ireland): Tostran
Italy, Sweden: Tostrex
Spain: Itnogen
France: Fortigel