Label: information for the user

Testavan®20 mg/g transdermal gel

Testosterone

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

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for 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 are not listed in this label. See section 4.

1.What isTestavanand how it is used

2. What you need to know before starting to useTestavan

3. How to useTestavan

4. Possible adverse effects

5. Storage ofTestavan

6. Contents of the package and additional information

What is Testavan
Testavan is a transparent gel that contains testosterone, a male hormone that is naturally synthesized in the body.

Testavan is used to replace testosterone in adult males when they do not produce enough testosterone naturally – this is known as «hypogonadism». This medication helps to increase the amount of testosterone to normal levels.

What does testosterone do

The body naturally synthesizes testosterone in the testicles.

• It helps to produce sperm, develop and maintain male characteristics, such as a deep voice and body hair.
• It is necessary for normal sexual function and sexual desire.
• It also helps to maintain muscle size and strength.

How is Testavan used

Testavan is used as testosterone replacement therapy in males to treat various health problems resulting from a lack of testosterone (male hypogonadism). This must be confirmed by performing two separate blood tests for testosterone and also presenting clinical signs and symptoms such as:

• impotence
• infertility
• low sexual desire
• fatigue
• depressed mood
• bone loss due to low hormone levels
• partial loss of secondary sex characteristics such as changes in voice and fat distribution
• partial loss of facial and body hair.

Who can use Testavan

• Only men can use Testavan.
• Young men under 18 years old should not use this medication.
• Women, regardless of age, should not use this product.
• Do not allow women (especially pregnant women or breastfeeding women) or children to come into contact with Testavan gel or with areas of the skin where Testavan has been applied.

Do not use Testavan:

• If you are allergic to testosterone or any of the other components of this medication (listed in section 6)
• If you have or suspect you have prostate cancer
• If you have or suspect you have breast cancer (a rare condition in men).

Warnings and precautions

The treatment with testosterone may accelerate the progression of existing prostate cancer. Your doctor will perform the necessary tests before you can use Testavan and will monitor you with periodic blood tests and prostate examinations.

Consult your doctor before starting to use Testavan, if you have or have ever had any of the following conditions:

• You have difficulty urinating due to an enlarged prostate gland
• You have bone cancer, your doctor should check your calcium levels
• You have high blood pressure or are being treated for high blood pressure, as Testavan may increase blood pressure
• You have a serious heart, liver, or kidney disease, the treatment with Testavan may cause serious complications in the form of fluid retention, which may be accompanied by congestive heart failure (fluid overload in the heart)
• You have a heart disease called ischemic cardiopathy (a disease that affects blood supply to the heart)
• You have blood clotting problems:
• Thrombophilia (a blood clotting abnormality – 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 the leg, lung, or other organ at a young age (for example, 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, sudden difficulty breathing, sudden cough, or unexpected bleeding; or sudden intense pain in the chest, intense dizziness, or intense stomach pain, sudden loss of vision. Seek urgent medical attention if you experience one of these symptoms.
• You have epilepsy
• You have migraines
• You experience difficulty breathing when sleeping - this is more likely if you are overweight or have a chronic lung disease.

If you have any of the mentioned diseases (or are unsure), consult your doctor or pharmacist before using Testavan – the use of this medication may worsen these conditions.

If you develop skin reactions in the areas where Testavan is applied, seek medical advice. You may need to discontinue Testavan treatment.

Your doctor will perform the following blood tests before and/or during treatment: testosterone levels in blood, complete blood count.

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

Testosterone should not be used to increase muscle mass or improve physical strength in healthy individuals.

Do not use moisturizers or sunscreens on the area where Testavan has been applied immediately before or after daily application.

How to prevent the transfer of Testavan to others

Testavan can be transferred to others through direct skin contact. This may cause an increase in testosterone levels in the other person's body, which may be hazardous. Transfer can occur through a single contact or gradually with small contacts over time.

• This is particularly important for women and children, as they often have low levels of testosterone in their bodies.
• Pregnant women should not come into contact with Testavan. If your partner is pregnant, be careful and try to protect her from any possible contact with the medication and the application area.

To prevent the transfer of the gel from your skin to another person, you should:

• Use the applicator to apply the medication instead of your fingers.
• Wash your hands with water and soap immediately if your hands come into contact with Testavan.
• Cover the treated area with clothing, after the gel has dried.
• Shower or bathe, or wear something to cover the application area (for example, a t-shirt), before having close skin-to-skin contact with someone.

To ensure the safety of your partner, wash the treated area with water and soap, for example, showering before sexual contact, or, if not possible, wear a shirt that covers the application area at the time of contact.

What to do if another person is exposed to Testavan

If another person touches the gel or comes into direct contact with a skin area treated with the gel, they should wash the skin area with water and soap as soon as possible. The longer the gel remains on the skin before washing, the greater the likelihood that the person will absorb the testosterone.

In case of Testavan transfer to another person, be aware of any possible changes in the person's body or behavior. If someone close to you develops any of the following symptoms, seek medical attention:

• Acne
• Change in voice to a deeper tone
• Facial or body hair growth
• Changes in menstrual cycle
• Precocious puberty, increased genital size, or changes in sexual behavior in children

Other medications and Testavan

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes medications obtained without a prescription and herbal remedies. Testavan may affect how these medications work, and you may need to adjust the dosage.

Specifically, inform your doctor or pharmacist if you take:

• Blood-thinning medications (anticoagulants) - Testavan may increase the effect of these medications;
• Corticosteroids or any other medication that may increase the production of these hormones. Corticosteroids and Testavan may cause the body to retain more fluids;
• Insulin to control blood sugar levels (in diabetes); you may need to reduce your insulin dose when taking Testavan.

If any of the above options apply to you (or you are unsure), consult your doctor or pharmacist before using Testavan.

Pregnancy, breastfeeding, and fertility

Pregnant women or breastfeeding women should not use Testavan.

If your partner becomes or remains pregnant, youmustfollow the guidelines included in the section‘How to prevent the transfer of Testavan to others’.

Pregnant women should avoidallcontact with skin areas treated with Testavan from a man. This medication may cause harm to the fetus. In case of contact, the area should be washed as soon as possible with water and soap.

Women who are breastfeeding should avoidallcontact with skin areas treated with Testavan from a man.

Testavan may cause reversible suppression of sperm production.

Testavan contains propylene glycol

This medication may cause skin irritation because it contains propylene glycol.

Testavan contains ethanol

This medication contains 538.70 mg of alcohol (ethanol) in each dose of 1.15 g, which is equivalent to 468.40 mg/g (46.84% w/w). This may cause a stinging sensation on damaged skin.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much to use

• The initial recommended dose of Testavan is 23 mg of testosterone (one pump of the pump dispenser) applied once a day at approximately the same hour each day, preferably in the mornings, although some patients may require a higher dose.
• The maximum recommended dose is 69 mg of testosterone per day (three applications of the pump dispenser).

Your doctor will determine the correct dose of Testavan you need. To do this, he will perform the following determinations regularly:

• blood level analysis of the drug
• how well the medication works for you

Consult your doctor if you feel that any of the medication's effects are too strong or too weak.

Use of this medication

It is essential to read and follow these instructions on how to use Testavan correctly.

Apply Testavan to the skin using the applicator. This is called "transdermal administration," the medication passes through the skin and enters the body.

Apply the medication only to healthy, clean, and dry skin on the shoulders or upper arms.

Never apply Testavan to:

- the penis or testicles

- broken or damaged skin

- open wounds, cuts, or irritations.

Components needed

•Testavan gel kit.See Image A.

•paper towels.

Tape Applicator Head of Pump dispenser

the pump

Image A

Nota: Multiple containers contain a lid on the top of each pump dispenser head

Charging the pump dispenser of gel – only the first time it is used

Before using a new pump dispenser of Testavan, you must prepare it for use. This is called "charging" the pump:

Remove the applicator from the pump dispenser in the case of the individual container or remove the lid from the pump in the case of the multiple container.

See Image B.

• Charge the pump dispenser by pressing the pump head down on a paper towel. Repeat the process until gel appears.See Image C.

• Do not use the gel obtained in the charging process as it may not be the correct dose.
• Dispose of the used paper towels safely to avoid transfer to others, including children and pets.
• The Testavan pump dispenser is now ready for use.

For daily administration, follow steps 1-4

Step 1: Prepare for Testavan gel application

• Select a healthy, clean, and dry area of skin on the upper arm and shoulder that will be covered by a shirt sleeve.See Image D.
• Use Testavan gelonlyon the upper arm and shoulder.

• Remove the applicator from the pump dispenser.See Image E.

• Remove the lid from the applicatorSee Image F.

Step 2: Apply Testavan gel

• Hold the pump dispenser with the nozzle over the application surface of the applicator.
• Press the pump head downonce. See Image G.

• Use the applicator to spread the gel evenly over the upper arm and shoulder, making sure not to get the gel on your hands.See Image H.

• Wipe off any excess with a paper towel. Dispose of the used paper towel safely to avoid transfer to others, including children and pets.

Consult the doseaccording to your doctor's prescription in the table below.

Step 3: Clean the Testavan applicator

• After use, clean the applicator with a paper towel.See Image I.

• Dispose of the used paper towel safely. It is essential to avoid transfer to others, including children and pets.

• REMEMBERto put the lid back on the applicator and replace the applicator in the pump.See Image J.

• Store the product safely and keep it out of the reach of children.

Step 4: After applying Testavan

• Wash your hands with water and soap immediately if you have gotten the gel on them.
• Testavan gel is flammable until it dries. Let the Testavan gel dry before smoking or approaching a flame.

• Allow the application area to dry completely before dressing.

• Wear clothing that covers the application area at all times to avoid accidental transfer of the product to others.
• Wait at least 2 hoursbefore showering, bathing, or swimming.
• Clean the application area with water and soap before any situation where skin-to-skin contact with another person may occur.

If you use more Testavan than you should

If too much medication has been applied by mistake, wash the application area with water and soap as soon as possible.

Only use the prescribed amount of medication. If you feel irritable, nervous, gain weight, or experience frequent or prolonged erections, these may be symptoms of using too much medication.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Testavan

Do not apply a double dose to make up for the missed dose.

- If the next dose is due in less than 12 hours, do not apply the missed dose. Apply the next dose normally.

- If more than 12 hours must pass before the next dose, apply the missed dose. Follow the normal dosing schedule the next day.

If you interrupt treatment with Testavan

Consult your doctor before stopping treatment with this medication.

If you have any other questions about using this medication, ask your doctor or pharmacist.

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

Frequent (can affect up to 1 in 10 people)

• Skin irritation in the area where the gel is applied (including rash, dryness, and redness).
• High levels of fats (triglycerides) in the blood.
• Hypertension.
• Increased levels of the prostate-specific antigen (PSA). PSA is a protein produced by the prostate gland, which can be used to detect prostate disease.
• Increased hematocrit (percentage of red blood cells in the blood), identified through periodic blood tests.

Less frequent (can affect up to 1 in 100 people)

• Increased hemoglobin (the component of red blood cells responsible for carrying oxygen) identified through periodic blood tests.
• Headache

Other known adverse reactions associated with testosterone treatment are:

acne, seborrhea, baldness, sweating, increased body hair growth, numbness or tingling in the skin, headache, dizziness, nausea, hot flashes, fluid retention (such as swelling of the ankles), weight gain, sleep apnea, shortness of breath, hypersensitivity reactions, feeling unwell, changes in mood (aggression, hostility, nervousness, anxiety, depression), insomnia, muscle pain or cramps, breast development, increased red blood cell count, decreased red blood cell count, blood clots, jaundice (liver problems that may be associated with yellowing of the skin and the white of the eyes), abnormal liver function test results.

Changes in sexual desire, increased erections, priapism (prolonged and painful erections), testicular disorder, reduced sperm count, difficulty urinating, changes in the prostate gland, prostate cancer (there is no convincing evidence that testosterone replacement in men with hypogonadism is associated with the development of prostate cancer; however, testosterone therapy should be avoided in men known or suspected to have prostate cancer).

Prolonged administration of testosterone can cause changes in the levels of salts (electrolytes) and water in the body.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist,even if it is a possible side effect that does not appear in this leaflet.You can also report them directlythrough the Spanish System of Pharmacovigilance of Medicines for Human Use:https://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.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the pump label and on the outer box after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Dispose of the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Testavan

The active principle is testosterone.

The other excipients are: 96% ethanol, propylene glycol (E 1520), monoethyl ether of diethylene glycol, carbomer 980, triethanolamine, disodium edetate, purified water.

One gram of gel contains 20 mg of testosterone. Each pump dose administers 1.15 g of gel (1.25 ml), which contains 23 mg of testosterone.

Appearance of the product and contents of the package

Testavan is a homogeneous, translucent to slightly opalescent gel.

The following package sizes are available with or without an applicator and hygienic cap:

Individual package containing 1 pump dose

Multi-pack containing 3 pump doses

Each pump dose contains 85.5 g of Testavan gel and can dispense 56 measured doses.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

The Simple Pharma Company Limited
Ground Floor, 71 Lower Baggot St
Dublin D02 P593
Ireland

Manufacturer responsible:

Copea Pharma Europe Limited,

Medici House, Unit 2,

Ashbourne Manufacturing Park, Ashbourne,

Co. Meath, A84 KH58,

Ireland

Applicator CAP:

The Simple Pharma Company Limited

Ground Floor, 71 Lower Baggot St.

Dublin. D02 P593

Ireland

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following denominations:

AustriaTestavan 20 mg/g transdermal gel;BelgiumTestarzon 20 mg/g transdermal gel ; gel transdermique ; transdermal gel;BulgariaTestavan 20 mg/g ???????????;CroatiaTestarzon 20 mg/g transdermalni gel;Czech RepublicTestavan;DenmarkTestavan 20 mg/g transdermal gel,EstoniaTestavan;FinlandTestavan 20 mg/g transdermaaligeeli;FranceTestavan 20 mg/g gel transdermique;GermanyTestavan 20 mg/g transdermal gel;GreeceTestarzon 20 mg/g ???????????;HungaryTestarzon 20 mg/g transzdermális gél;IrelandTestarzon 20 mg/g transdermal gel;IcelandTestavan 20 mg/g ???????????;ItalyTestavan 20 mg/g gel transdermico;LatviaTestarzon 20 mg/g transdermalais gels;LiechtensteinTestavan 20 mg/g transdermal gel;LithuaniaTestavan 20 mg/g ???????????;LuxembourgTestarzon 20 mg/g transdermal gel ; gel transdermique ; transdermal gel;NetherlandsTestavan 20 mg/g gel voor transdermaal gebruik;NorwayTestavan 20 mg/g transdermal gel;PolandTestavan;PortugalTestavan 20 mg/g gel transdérmico;RomaniaTestavan 20 mg/g gel transdermic;SlovakiaTestavan 20 mg/g transdermálny gél;SloveniaTestarzon 23 mg/press transdermalni gel;SpainTestavan 20 mg/g gel transdérmico;SwedenTestavan 20 mg/g transdermal gel;United KingdomTestavan 20 mg/g transdermal gel.

Last review date of this leaflet: August 2023.

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