ITNOGEN 2% GEL

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Itnogen 20mg/g transdermal 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.

Contents of the pack and other information

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

1. What is Itnogen and what is it used for

The active substance, testosterone, is a male hormone which is a type of androgen.

Itnogen is used in adult men as testosterone replacement therapy to treat various health problems caused by a lack of testosterone (male hypogonadism). This should be confirmed by two separate measurements of testosterone in the blood and also by the presence of clinical symptoms such as:

• impotence
• infertility
• low sexual desire
• fatigue
• depressive mood
• bone loss caused by low hormone levels

2. What you need to know before you use Itnogen

Itnogen should only be used if your doctor has confirmed, in accordance with your symptoms and laboratory test results, that you have hypogonadism. Before starting treatment, your doctor should have excluded other possible causes of your symptoms.

Only men can use Itnogen. Itnogen has not been tested in males under 18 years of age, and there is limited experience in treating men over 65 years of age.

Do not use Itnogen:

If you:

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

If any of these conditions occur, inform your doctor or pharmacist.

Warnings and precautions

A medical check-up is required before starting treatment and periodically during treatment (usually once or twice a year).

If you have a severe heart, liver or kidney disease, treatment with Itnogen may cause serious complications in the form of fluid retention, which may occasionally be accompanied by congestive heart failure.

Before starting treatment and during treatment, your doctor will check the following parameters in your blood test: testosterone level and full blood count.

Inform your doctor if you have high blood pressure or are being treated for high blood pressure, as testosterone may cause an increase in blood pressure.

Treatment with testosterone may increase the risk of developing a disorder characterized by an increase in the size of the prostate (benign prostatic hyperplasia) or prostate cancer. Testosterone treatment may also alter the number of red blood cells, your blood lipid profile, and your liver function.

Inform your doctor before treatment if you:

• have swollen hands and feet
• are overweight or have chronic lung disease, as testosterone treatment may worsen sleep apnea (temporary interruption of breathing during sleep)
• have diabetes and use insulin to control blood sugar, as testosterone treatment may alter your response to insulin
• have epilepsy or migraines, as these conditions may worsen during treatment
• have bone cancer, as your doctor will need to monitor your blood calcium levels during treatment
• have or have had blood clotting problems
• have thrombophilia (a blood clotting disorder that increases the risk of thrombosis - blood clots in blood vessels)
• have factors that increase the risk of blood clots in a vein: previous blood clots in a vein; smoking; obesity; cancer; immobility; if a close family member has had a blood clot in the leg, lung, or other organ at a young age (e.g., under 50 years); or as you get older.

How to recognize a blood clot: painful swelling of a leg or sudden change in skin color, such as paleness, redness, or blueness, sudden difficulty breathing, sudden unexplained cough that may bring up blood; or sudden chest pain, severe dizziness or fainting, severe stomach pain, sudden loss of vision. Seek urgent medical attention if you experience any of these symptoms.

Contact your doctor if you:

• experience frequent or persistent erections
• feel irritable or nervous or notice that you have gained weight
• feel nauseous or vomit, notice changes in skin color or swelling of the ankle joints.
• notice any changes in your breathing patterns, including those during sleep

These symptoms may indicate that your dose of Itnogen is too high and your doctor may need to adjust it.

Contact your doctor if you notice any skin reaction at the application site, such as a burning sensation or itching, dryness, rash, redness, or itching. If the reaction is severe, your doctor should review the treatment and discontinue it if necessary.

Athletes are informed that this medicinal product contains testosterone, which may result in a positive doping control test.

Itnogen should not be used to treat male infertility or sexual impotence.

Women should not use Itnogen due to its potential virilizing effects (such as facial or body hair growth, voice changes, or changes in menstrual cycle).

How to prevent transfer of Itnogen to others:

During repeated or prolonged periods of skin-to-skin contact, this medicine may be transferred to another person. This can cause adverse effects such as facial or body hair growth, voice changes, or changes in menstrual cycle in women or accelerated growth, genital enlargement, and premature puberty (including pubic hair development) in children. Wearing clothing that covers the application site or washing the application site before contact may reduce this risk.

Patients using this medicine and who may have close skin-to-skin contact with children should take extra precautions, as testosterone can pass through clothing. Make sure to follow the application technique (see section 3 of this leaflet) when in skin-to-skin contact with children, which includes covering the application site with clean clothing once the gel has dried. Additionally, wash the application site with soap and water once the recommended time has passed (at least 2 hours) and cover it again with clean clothing before having skin-to-skin contact with children.

In order to ensure the safety of your partner, you should wait at least four hours after applying Itnogen before having sexual intercourse and wear clothing that covers the application site at the time of contact or wash the application site with water and soap before having sexual intercourse.

You should wear clothing that 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 through skin-to-skin contact or if someone is exposed through direct contact with the gel, wash the contact area of the other person with water and soap as soon as possible.

If a healthcare professional or caregiver applies Itnogen to a patient, they should use appropriate disposable gloves. The gloves should be resistant to alcohol, as the gel contains ethanol and isopropyl alcohol.

Contact your doctor if you notice any changes in body hair, a significant increase in acne, or other signs of developing male characteristics in people who are not receiving treatment with Itnogen (i.e., in female partners or children).

Other medicines and Itnogen

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

• anticoagulants
• corticosteroids

Also inform your doctor or pharmacist about any medicine you have obtained without a prescription.

Using Itnogen with food and drink

Consuming food and drink does not affect Itnogen.

Pregnancy and breast-feeding

• Itnogen should only be used in men.
• Pregnant or breast-feeding women should not use Itnogen.
• Pregnant women should avoid any contact with skin areas treated with Itnogen. Itnogen may cause harm or abnormalities to the fetus. If your partner becomes pregnant, you mustfollow the advice in this section on how to avoid transferring the testosterone gel. In case of contact with a treated skin area, the area should be washed immediately with water and soap.

Driving and using machines

Itnogen is unlikely to affect your ability to drive or use machines.

Itnogen contains butylhydroxytoluene, propylene glycol, and ethanol

Butylhydroxytoluene may cause local skin reactions (e.g., contact dermatitis) or irritation of the eyes and mucous membranes.

Itnogen contains propylene glycol and ethanol

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 dry.

3. How to use Itnogen

Follow the instructions for administration of this medicine exactly as told by your doctor. Ask your doctor or pharmacist if you have any doubts about how and when to apply the gel.

The usual starting dose is 3 g of gel (which contains 60 mg of testosterone) per day. Your doctor may adjust your dose, and the maximum dose is 4 g of gel (80 mg of testosterone) per day.

Itnogen is supplied in a bottle with a pump mechanism that delivers 0.5 g of gel (10 mg of testosterone) each time the pump is pressed (when the pump mechanism is pushed down).

Using the pump for the first time:

Before using the pump for the first time, you need to prime the pump. To do this, place the bottle in an upright position and slowly and fully press the actuator several times until the gel appears. Press the actuator another 6 times. Discard the gel dispensed as a result of these six actuations. You only need to prime the pump before the first dose.

Applying Itnogen:

Your doctor will tell you how many times to press the pump to apply the dose of gel you need after priming the pump. The following table provides more information on this.

Apply the gel to a clean, dry, and intact skin area, once a day and at the same time each day, such as in the morning after a shower.

The gel should be either rubbed into the skin of the abdomen (in an area of at least 10 x 30 cm), or divided into two equal parts and rubbed into the inner area of eachthigh (in an area of at least 10 x 15 cm). It is recommended to apply Itnogen to the abdomen and the inner area of boththighs on alternate days.

Application to other areas should be avoided. Itnogen should not be applied to the genitals.

Rub the gel gently with a finger until it dries. Once the gel has dried, cover the application site with clean clothing (e.g., a shirt or shorts). After you have finished, wash your hands thoroughly with water and soap. Before having close skin-to-skin contact with another person (adult or child), wash the application site with water and soap once the recommended time has passed (at least 2 hours) and cover it again with clean clothing.

If you want to take a bath or shower, do so before applying Itnogen or wait at least two hours after application.

Two weeks after starting treatment, your doctor will take blood samples to check if the dose needs to be changed. While you are using Itnogen, you should expect to need regular medical check-ups.

If you are managing to have blood tests done while using Itnogen, you should ensure that all testosterone measurements are carried out in the same laboratory, due to the variability of analytical values between different diagnostic laboratories.

If you use more Itnogen than you should

Contact a doctor, hospital, or pharmacist if you have applied too much of the medicine.

If you forget to use Itnogen

Do not use a double dose to make up for forgotten doses. Apply the next dose at the usual time.

If you stop using Itnogen

Always consult your doctor or pharmacist before stopping treatment with this medicine.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects that are considered very common (affect more than 1 in 10 users)are skin reactions at the application site such as a burning sensation or itching, dryness, rashes, redness, or itching. They are usually mild and temporary side effects, but if they cause you a lot of discomfort or last more than a few days, inform your doctor or pharmacist as soon as possible.

Side effects that are considered common (affect between 1 and 10 users in 100)are: swelling of hands or feet, increased blood pressure, prostate alterations (including an increase in blood levels of a protein called prostate-specific antigen, which is produced by the prostate), increased growth of body hair, breast enlargement, increased red blood cell count (which is measured in blood samples). Increased red blood cell count, hematocrit (percentage of red blood cells in the blood), and hemoglobin (part of red blood cells that carries oxygen), identified in periodic blood tests.

Other side effects whose association with testosterone treatment is known are: baldness, seborrhea, acne, jaundice (liver problems that can sometimes be associated with a yellowish discoloration of the skin and the white of the eyes), abnormalities in 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. Reduced sperm production and testicular size may occur when the medicine is administered at high doses. Prolonged administration of testosterone may cause changes in the levels of salts (electrolytes) in the body.

There is no conclusive evidence that testosterone replacement therapy in hypogonadal men induces prostate cancer. However, testosterone therapy should be avoided in men who are known or suspected to have prostate cancer.

Hyperglycemia (high blood sugar) has been reported in 2 people with a history of diabetes mellitus.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Itnogen

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 bottle after EXP. The expiry date is the last day of the month shown.

Do not store above 25°C.

Do not refrigerate or freeze.

Once opened, store the bottle in an upright position.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Packaging Content and Additional Information

Composition of Itnogen

• The active ingredient is testosterone. One gram of gel contains 20 mg of testosterone.
• The other components are propylene glycol; anhydrous ethanol; isopropyl alcohol; oleic acid; carbomer 1382; tromethamine; butylhydroxytoluene (E321); purified water; and hydrochloric acid (for pH adjustment).

Appearance of Itnogenand Packaging Content

Transparent gel, whose appearance varies from colorless to yellowish.

It is presented in bottles, each of which contains 60 grams of gel. The bottles have a pumping mechanism that supplies a fixed amount of gel.

A box may contain one, two, or three bottles of gel. Only some package sizes may be marketed.

Marketing Authorization 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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Advanz Pharma Spain S.L.U.

Paseo de la Castellana 135 7th Floor

Madrid – 28046 – Spain

Tel. +34 900 834 889

[email protected]

This medication is authorized in the member states of the European Economic Area 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

Date of the last revision of this leaflet:04/2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/