Testavan 20 mg/g transdermal gel

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Testavan® 20 mg/g transdermal gel

Testosterone

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Testavan is and what it is used for

2. What you need to know before using Testavan
3. How to use Testavan
4. Possible side effects
5. How to store Testavan
6. Contents of the pack and other information

1. What Testavan is and what it is used for

What Testavan is
Testavan is a clear gel containing testosterone, a male hormone that is naturally produced in the body.

Testavan is used to replace testosterone in adult males when their bodies do not produce enough natural testosterone—a condition known as "hypogonadism." This medicine helps increase testosterone levels to normal ranges.

What testosterone does
The body naturally produces testosterone in the testes.

• It helps in sperm production and in developing and maintaining male characteristics such as a deep voice and body hair.
• It is necessary for normal sexual function and sex drive.
• It also helps maintain muscle size and strength.

What Testavan is used for
Testavan is used as testosterone replacement therapy in men to treat various health problems caused by low testosterone (male hypogonadism). This diagnosis must be confirmed by two separate blood testosterone measurements, along with clinical signs and symptoms such as:

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

2. What you need to know before using Testavan

Who can use Testavan

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

Do not use Testavan:

• 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 prostate cancer
• If you have or suspect you have breast cancer (a rare condition in men)

Warnings and precautions

Testosterone treatment may accelerate the progression of existing prostate cancer. Your doctor will carry out the necessary tests before you start using 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:

• Difficulty passing urine (urinating) due to enlargement of the prostate gland
• Bone cancer; your doctor should check your calcium levels
• High blood pressure or are being treated for high blood pressure, as Testavan may increase blood pressure
• Severe heart, liver, or kidney disease; treatment with Testavan may lead to serious complications such as fluid retention, which may be accompanied by congestive heart failure (fluid overload in the heart)
• A heart condition called ischemic heart disease (a disease affecting blood supply to the heart)
• Blood clotting disorders:
• Thrombophilia (a blood coagulation abnormality – increasing the risk of thrombosis, i.e., blood clots in blood vessels)
• Factors increasing 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 another organ at a young age (e.g., under 50 years); or as you get older.
• How to recognize a blood clot: painful swelling of one leg or sudden change in skin color, for example paleness, redness, or blueness; sudden shortness of breath; sudden unexplained cough possibly producing blood; or sudden chest pain, severe dizziness or lightheadedness, severe stomach pain, sudden loss of vision. Seek urgent medical attention if you experience any of these symptoms.
• Epilepsy
• Migraine
• Breathing difficulties during sleep – this is more likely if you are overweight or have chronic lung disease

If you have any of the conditions listed above (or are unsure), consult your doctor or pharmacist before using Testavan – using this medicine may worsen these conditions.

If you develop skin reactions at the sites where Testavan is applied, seek medical advice. You may need to stop treatment with Testavan.

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

Athletes are advised that this medicine contains testosterone, which may result in a positive doping test.

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

At the time of, or immediately after, the daily application of Testavan, do not apply moisturizers or sunscreen to the area where the gel has been applied.

How to prevent transfer of Testavan to other people

Testavan can be transferred to other people through direct skin contact. This may increase testosterone levels in the other person’s body, which could be dangerous. Transfer may occur after a single contact or gradually over time with repeated small contacts.

• This is particularly important for women and children, who normally have low levels of testosterone in their bodies.
• Pregnant women must not come into contact with Testavan. If your partner is pregnant, take care and try to protect her from any possible contact with the medicine and the application site.

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

• Use the applicator to apply the medicine instead of your fingers.
• Wash your hands immediately with soap and water if they come into contact with Testavan.
• Cover the gel-treated area with clothing after the gel has dried.
• Shower, bathe, or wear clothing to cover the gel application site (e.g., a T-shirt) before having close skin-to-skin contact with another person.

To ensure your partner’s safety, wash the treated area with soap and water—for example, by showering—before sexual activity. If this is not possible, wear a T-shirt covering the application site at the time of contact.

What to do if someone else is exposed to Testavan

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

In case of transfer of Testavan to another person, watch for any possible changes in that person’s body or behavior. If someone close to you develops any of the following symptoms, they should see a doctor:

• Acne
• Voice deepening
• Growth of facial or body hair
• Changes in menstrual cycle
• Early puberty, genital enlargement, or changes in sexual behavior in children

Other medicines and Testavan

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription and herbal remedies. Testavan may affect how these medicines work, and you may need a dose adjustment.

Specifically, inform your doctor or pharmacist if you are taking:

• Medicines to thin the blood (anticoagulants) – Testavan may increase the effect of these drugs;
• Corticosteroids or any other medicine that may increase the production of these hormones. Corticosteroids and Testavan may cause the body to retain more fluid;
• Insulin to control blood sugar levels (in diabetes); you may need to reduce your insulin dose when receiving Testavan.

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

Pregnancy, breastfeeding, and fertility

Testavan must not be used by pregnant or breastfeeding women.

If your partner is pregnant or becomes pregnant, you must follow the advice given above in the section ‘How to prevent transfer of Testavan to other people’.

Pregnant women must avoid all contact with skin areas treated with Testavan in a man. This medicine may harm the unborn baby. In case of contact, the area must be washed as soon as possible with soap and water.

Breastfeeding women must avoid all contact with skin areas treated with Testavan in a man.

Testavan may cause reversible suppression of sperm production.

Testavan contains propylene glycol

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

Testavan contains ethanol

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

3. How to use Testavan

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much to use

• The recommended starting dose of Testavan is 23 mg of testosterone (one pump actuation) applied once daily at approximately the same time each day, preferably in the morning, although some patients may require a higher dose.
• The maximum recommended dose is 69 mg of testosterone per day (three pump actuations).

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

• blood tests to measure the amount of drug in your blood
• evaluation of how well the medicine is working for you.

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

How to use this medicine

It is important that you read and follow these instructions on how to use Testavan correctly.

Apply Testavan to the skin using the applicator. This is called "transdermal administration," where the medicine passes through the skin and into the body.

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

Never apply Testavan to:

• the penis or testicles
• broken or damaged skin
• open sores, wounds, or irritated areas.

Components you need

• Testavan gel kit. See Image A.
• Paper tissues.

Cap Applicator Pump Head

the pump

Image A

Note: Multiple packs contain a cap on top of each pump head.

Priming the gel pump dispenser – first time use only

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

Remove the applicator from the pump dispenser in the case of the single pack, or remove the cap from the pump in the case of the multiple pack.

See Image B.

Image B

• Prime the dosing pump by pressing the pump head downward onto a tissue. Repeat the process until gel appears. See Image C.

Image C

• Do not use the gel obtained during priming, as it may not be the correct dose.
• Dispose of used tissues safely to prevent 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 application of Testavan gel

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

Image D

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

Image E

• Remove the cap from the applicator See Image F.

Image F

Step 2: Application of Testavan gel

• Hold the dosing pump with the nozzle over the applicator's application surface.
• Press the pump head down once. See Image G.

Image G

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

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

Image H

Consult the dosage according to your doctor's prescription in the table provided below.

Dosage	How to apply
23 mg (1 pump actuation)	Apply one pump actuation as shown in Step 2 – do this once.
46 mg (2 pump actuations)	Apply one pump actuation as shown in Step 2. Repeat to administer another pump actuation on the upper arm and shoulder on the opposite side.
69 mg (3 pump actuations)	Apply one pump actuation as shown in Step 2. Repeat to administer a pump actuation on the upper arm and shoulder on the opposite side. Then repeat again to administer the third pump actuation on the initial upper arm and shoulder where treatment was first applied.

Step 3: Clean the Testavan applicator

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

Image I

• Dispose of the used tissue safely. It is important to try to avoid transfer to others, including children and pets.

• REMEMBER to replace the cap on the applicator and return the applicator to the pump. See Image J.

Image J

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

Step 4: After applying Testavan

• Wash your hands immediately with water and soap if they become stained with the gel.

• Testavan gel is flammable until it dries. Allow the Testavan gel to dry completely before smoking or approaching a flame.

• Allow the application site 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 hours before showering, swimming, or bathing.

• Wash the application site with water and soap before any situation in which direct skin-to-skin contact with another person may occur.

If you use more Testavan than you should

If you have accidentally applied too much medication, wash the application site with water and soap as soon as possible.

Use only the amount of medication prescribed by your doctor. 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 at 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Testavan

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

• If the next dose is due in less than 12 hours, do not apply the missed dose. Then apply the next dose as usual.
• If more than 12 hours remain until the next dose, apply the missed dose. Continue with your normal dosing schedule the following day.

If you stop using Testavan

Consult your doctor before stopping treatment with this medication.

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

4. Possible adverse effects

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

Frequent (may affect up to 1 in 10 people)

• Skin irritation at the site of gel application (including rash, dryness, and erythema).
• High levels of fats (triglycerides) in the blood.
• Hypertension.
• Increase in prostate-specific antigen (PSA). PSA is a protein produced by the prostate gland that can be used to detect prostate disease.
• Increase in hematocrit (percentage of red blood cells in the blood), identified through periodic blood tests.

Uncommon (may affect up to 1 in 100 people)

• Increase in 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 include:

acne, seborrhea, baldness, sweating, increased body hair growth, numbness or tingling of the skin, headache, dizziness, nausea, hot flushes, fluid retention (such as swelling of the ankles), weight gain, sleep apnea, dyspnea, hypersensitivity reactions, malaise/feeling unwell, mood changes (aggression, hostility, nervousness, anxiety, depression), insomnia, muscle pain or cramps, breast development, increased red blood cell count, decreased red blood cells, blood clots, jaundice (liver problems which may sometimes be associated with yellowing of the skin and whites of the eyes), abnormal liver function tests.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Testavan

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the dosing pump label and on the outer carton, after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Testavan

The active substance is testosterone.

The other excipients are: ethanol 96%, 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 actuation delivers 1.15 g of gel (1.25 ml), containing 23 mg of testosterone.

Appearance of the product and contents of the container

Testavan is a homogeneous, translucent to slightly opalescent gel.

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

Single pack containing 1 dosing pump

Multiple packs containing 3 dosing pumps

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

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

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

Manufacturer:

Copea Pharma Europe Limited,
Medici House, Unit 2,
Ashbourne Manufacturing Park, Ashbourne,
Co. Meath, A84 KH58,
Ireland

CAP Applicator:

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

This medicinal product is authorized in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:

Austria Testavan 20 mg/g transdermal gel; Belgium Testarzon 20 mg/g transdermale gel ; gel transdermique ; transdermales Gel; Bulgaria Testavan 20 mg/g трансдермален гел; Croatia Testarzon 20 mg/g transdermalni gel; Czech Republic Testavan; Denmark Testavan 20 mg/g transdermal gel; Estonia Testavan; Finland Testavan 20 mg/g transdermaaligeeli; France Testavan 20 mg/g gel transdermique; Germany Testavan 20 mg/g transdermales Gel; Greece Testarzon 20 mg/g διαδερμικό γέλη; Hungary Testarzon 20 mg/g transzdermális gél; Ireland Testarzon 20 mg/g transdermal gel; Iceland Testavan 20 mg/g hlaup til notkunar umhúð; Italy Testavan 20 mg/g gel transdermico; Latvia Testarzon 20 mg/g transdermalais gels; Liechtenstein Testavan 20 mg/g transdermales Gel; Lithuania Testavan 20 mg/g transderminis gelis; Luxembourg Testarzon 20 mg/g transdermale gel ; gel transdermique ; transdermales Gel; Netherlands Testavan 20 mg/g gel voor transdermaal gebruik; Norway Testavan 20 mg/g transdermalgel; Poland Testavan; Portugal Testavan 20 mg/g gel transdérmico; Romania Testavan 20 mg/g gel transdermic; Slovakia Testavan 20 mg/g transdermálny gél; Slovenia Testarzon 23 mg/pump transdermalni gel; Spain Testavan 20 mg/g gel transdérmico; Sweden Testavan 20 mg/g transdermal gel; United Kingdom Testavan 20 mg/g transdermal gel.

Date of the most recent revision of this leaflet: August 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/