PROSPECTO: INFORMATION FOR THE USER

Itnogen 20mg/g transdermal gel

Testosterone

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

1.What Itnogen is and for what it is used

2.What you need to know before starting to use Itnogen

3.How to use Itnogen

4.Possible adverse effects

5.Storage of Itnogen

6.Contents of the package and additional information

The active ingredient, testosterone, is a male hormone that is a type of androgen.

Itnogen is used in adult men as testosterone replacement therapy to treat various health problems resulting from low testosterone levels (male hypogonadism). This must be confirmed by two separate blood tests for testosterone and the presence of clinical symptoms such as:

• impotence
• infertility
• low libido
• fatigue
• depressive mood states
• bone loss caused by low hormone levels

This medication should only be used if your doctor has confirmed, based on your symptoms and laboratory test results, that you have hypogonadism. Before starting treatment, your doctor must have ruled out 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 components of this medication (listed in section 6).
• have, or suspect that you may have, breast or prostate cancer.

Inform your doctor or pharmacist if you experience any of these circumstances.

Warnings and precautions:

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

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

Before starting treatment and during treatment, your doctor will check the following parameters in your blood test: testosterone level and complete 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 condition characterized by an increase in prostate size (benign prostatic hyperplasia) or prostate cancer. Treatment with testosterone may also alter your red blood cell count, lipid profile, and liver function.

Inform your doctor before treatment if you:

- have swollen hands and feet

- have obesity or chronic lung disease, as treatment with testosterone may worsen sleep apnea (transient interruption of breathing during sleep)

- have diabetes and use insulin to control blood sugar, as treatment with testosterone 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 calcium levels in the blood during treatment

• have or have had bleeding problems
• thrombophilia (abnormal blood clotting that increases the risk of thrombosis - blood clots in blood vessels)
• 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 a leg, lung, or other organ at a young age (e.g., under 50 years); or as you age.

How to recognize a blood clot: painful swelling of a leg or sudden change in skin color, for example, paleness, redness, or blue discoloration, sudden difficulty breathing, sudden and inexplicable cough that may cause bleeding; or sudden chest pain, intense dizziness, or intense stomach pain, sudden loss of vision. Seek urgent medical attention if you experience one 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 have swollen joint ankles.

- notice any changes in your breathing patterns, including those during sleep

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

Contact your doctor if you notice any type of skin reaction in the application area, such as, for example, burning or itching, dryness, rash, redness, or itching. If the reaction is severe, your doctor will review the treatment and suspend it if necessary.

It is reported to athletes that this medication contains testosterone, which may establish a positive analytical result for doping control.

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 to a deeper tone, or changes in menstrual cycle).

How to prevent the transfer of Itnogen to others:

During repeated or prolonged periods of physical contact, this medication may be transferred to another person. This may cause adverse effects such as facial or body hair growth, voice changes to a deeper tone, or changes in menstrual cycle in women, or precocious puberty (including pubic hair growth) in children. Wearing clothing that covers the application area or washing the application area before contact may reduce this risk.

Patients using this medication and who may be in close physical contact with children should take additional precautions, as testosterone may pass through clothing. Make sure to follow the application technique (see section 3 of this prospectus) when in contact with children, which includes covering the application area with clean clothing once the gel has dried. Additionally, wash the application area with soap once the recommended time has passed (at least 2 hours) and cover it again with clean clothing before coming into contact with children.

To ensure the safety of your partner, wait at least four hours after applying Itnogen before having sex and wear clothing that covers the application area at the time of contact or wash the application area with water and soap before having sex.

Wear clothing that covers the application area when in contact with children 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 contact or someone is exposed directly to 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, significant weight gain, or other signs indicative of the development of male characteristics in individuals not receiving Itnogen treatment (i.e., female partners or children).

Other medications and Itnogen:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, especially the following:

• anticoagulants
• corticosteroids

Also inform your doctor or pharmacist about any medication you have purchased without a prescription.

Use of Itnogen with food and drinks:

The consumption of food and drinks does not affect Itnogen.

Pregnancy and breastfeeding:

• Itnogen should only be used in men.
• Pregnant women or breastfeeding women should not use Itnogen.
• Pregnant women should avoid all contact with skin areas treated with Itnogen. Itnogen may cause damage or abnormalities in the fetus. If your partner becomes pregnant, you must follow the advice included 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 operating machinery:

It is unlikely that Itnogen will affect your ability to drive and operate machinery.

Itnogen contains butylhydroxytoluene, propylene glycol, and ethanol

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

Itnogen contains propylene glycol and ethanol

This medication contains 175 mg of propylene glycol in each pump stroke.

This medication contains 75 mg of alcohol (ethanol) in each pump stroke.

It may cause a burning sensation on damaged skin.

This product is flammable until it dries.

Follow exactly the administration instructions of this medication as indicated by your doctor. Consult your doctor or pharmacist if you have doubts about how and when to apply the gel.

The usual starting dose is3 gof gel (containing 60 mg of testosterone) per day. Your doctor may adjust the dose, and the maximum dose is4 gof gel (80 mg of testosterone) per day.

Itnogen is supplied in a bottle with a pumping mechanism that administers 0.5 grams of gel (10 mg of testosterone) each time the piston is pressed (when the pumping mechanism is pushed down).

First-time use of the device:

Before using the dosing pump for the first time, it is necessary to expel the air from the pump. To do this, place the container in a vertical position and press the actuator slowly and completely several times until the gel appears. Press the actuator another 6times. Discard the gel discharged as a result of these six pulses. It is only necessary to expel the air from the pump before the first dose.

Administration of Itnogen:

Your doctor will tell you how many times to press the piston to administer the dose of gel that you need after the pump is primed. The following table includes more information for this.

Apply the gel to an intact, clean, and dry area of skin, once a day, and at the same time each day, for example, in the morning after a shower.

The gel should either be rubbed onto the skin of the abdomen (in an area of at least 10 by30 cm), or divided into two equal parts and rubbed each one onto the inner region ofeachthigh (in an area of at least 10 by15 cm). It is recommended to administer Itnogen to the abdomen and the inner region ofboththighs on alternate days.

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

Gently rub the gel with a finger until it dries. Once the gel has dried, cover the application area with clean clothing (for example, a shirt or shorts or pants). When finished, wash your hands thoroughly with water and soap. Before having close physical contact with another person (adult or child), wash the application area with water and soap after the recommended time (at least 2hours) and cover it again with clean clothing.

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

Two weeks after starting to use the medication, your doctor will take blood samples to check if the dose needs to be changed. While using Itnogen, you should anticipate the need for regular medical follow-up.

If you are the one managing the blood tests during Itnogen use, make sure that all testosterone determinations are performed 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 an excessive amount of the medication.

If you forgot to use Itnogen:

Do not use a double dose to compensate for the missed doses. Apply the next dose at the usual time.

If you interrupt treatment with Itnogen:

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects classified as very frequent(affect more than 1 in 10 users)are skin reactions at the application site such as a burning or stinging sensation, dryness, skin rashes, redness, or itching. They are usually mild and transient side effects, but if they cause significant discomfort or last more than a few days, inform your doctor or pharmacist as soon as possible.

The side effects classified as frequent(affect between 1 and 10 users in every 100)are: swelling of hands or feet, increased blood pressure, prostate alterations (including an increase in blood concentrations of a protein called prostate-specific antigen, which is produced by the prostate), increased body hair growth, breast enlargement, increased red blood cell count (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 sometimes can be associated with a yellowish discoloration of the skin and the white part 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. It is possible that there will be a reduction in sperm production and testicular size when the medication is administered in high doses. Prolonged administration of testosterone may cause changes in the levels of salts (electrolytes) in the body.

There is no convincing evidence that testosterone substitution in hypogonadal men induces prostate cancer. However, testosterone therapy should be avoided in men who already know or are believed to have prostate cancer.

Hyperglycemia (too much sugar in the bloodstream) has been reported in 2 people with a history of diabetes mellitus.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is possible side effects that do not appear in this leaflet. You can also report them directly through:

Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the bottle after CAD.The expiration date is the last day of the month indicated.

Do not store at a temperature above25°C.

Do not refrigerate or freeze.

Once opened, store the bottle in an upright position.

Medicines should not be thrown down the drains or in the trash.Dispose of containers and medicines you no longer need at the SIGRE collection pointat the pharmacy.Ask your pharmacist how to dispose of containers and medicines you no longer need.This will help protect the environment.

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; trolamine; butylhydroxytoluene (E321); purified water, and hydrochloric acid (for pH adjustment).

Appearance of Itnogenand contents of the packaging

Transparent gel, whose appearance varies from colorless to yellowish.

It is presented in bottles, each containing60 gramsof 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 packaging sizes may be commercially available.

Marketing Authorization Holder:

Advanz Pharma Limited

Unit 17, Northwood House,

Northwood Crescent,

Dublin 9, D09 V504,

Ireland

Responsible for Manufacturing:

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 7ª Planta

Madrid – 28046 – Spain

Phone: +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) with the following names:

Cyprus, Denmark, Finland, Germany, Greece, Ireland, Netherlands, Norway, United Kingdom (and Northern Ireland): Tostran

Italy, Sweden: Tostrex

Spain: Itnogen

France: Fortigel

Last review date of this leaflet:04/2024

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