Testavan

Patient Information Leaflet: Information for the User

TESTAVAN 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist (see section 4).

Contents of this leaflet:

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 transparent gel containing testosterone, a male hormone naturally produced by the body.
TESTAVAN is used to replace testosterone in adult men who do not produce sufficient natural testosterone. This condition is called "hypogonadism". The medicine helps bring your testosterone levels back to normal.

What testosterone does
Testosterone is naturally produced in the testes.

• It promotes sperm production and the development and maintenance of male characteristics, such as a deep voice and body hair.
• It is necessary for normal sexual function and libido.
• It helps maintain muscle mass and strength.

What TESTAVAN is used for
TESTAVAN is used in men for testosterone replacement therapy to treat various health problems caused by testosterone deficiency (male hypogonadism).
This condition must be confirmed by two separate blood measurements of testosterone and must also include clinical signs and symptoms such as:

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

2. What you should know before using TESTAVAN

Who can use TESTAVAN

• Only men may use TESTAVAN.
• Men under the age of 18 must not use this medicine.
• Women of any age must not use this medicine.
• 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 to 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 pre-existing prostate cancer.
Your doctor will perform the necessary tests before you start using TESTAVAN and will schedule regular follow-up visits, including periodic blood and prostate examinations.
Contact your doctor before using TESTAVAN if you have or have ever had any of the following conditions:

• difficulty urinating due to an enlarged prostate
• bone cancer; your doctor will monitor your calcium levels
• high blood pressure or are being treated for high blood pressure, as TESTAVAN may cause an increase in blood pressure
• severe heart, liver, or kidney disease, as treatment with TESTAVAN may lead to serious complications such as fluid retention, sometimes associated with congestive heart failure (fluid overload in the heart)
• ischemic heart disease (a condition affecting blood supply to the heart)
• blood clotting disorders
• thrombophilia (a blood coagulation 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 organs 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; sudden chest pain; severe dizziness or lightheadedness; severe stomach pain; sudden loss of vision. Seek immediate medical attention if any of these symptoms occur.
• epilepsy
• migraine
• breathing problems during sleep; these are more likely if you are overweight or have long-standing lung disease. If any of the above conditions apply to you (or you are unsure), consult your doctor or pharmacist before using TESTAVAN, as use of this medicine may worsen these conditions.

If you develop skin reactions at the site where you applied TESTAVAN, consult your doctor again. It may be necessary to discontinue treatment with TESTAVAN.
The following blood tests should be performed by your doctor before and/or during treatment: testosterone blood levels and complete blood count.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
When applying TESTAVAN daily and immediately afterwards, do not apply moisturizers or sunscreen to the area where you applied the gel.

How to prevent transfer of TESTAVAN to others
TESTAVAN can be transferred to others through direct skin-to-skin contact. This may cause increased testosterone levels in their bodies, which can be dangerous. This condition may result from a single contact or may develop gradually through repeated brief 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, you must take care to protect her from any contact with the medicine and the application site.

To prevent the gel from transferring from your skin to someone else’s, you must:

• use the applicator instead of your fingers to apply the medicine
• wash your hands immediately with soap and water if they come into contact with TESTAVAN
• cover the area where you applied the gel with clothing once the gel has dried
• bathe or shower, or wear clothing to cover the application site (e.g., a shirt), before any situation involving direct skin-to-skin contact with another person.

To improve the safety of your partner, wash the application area with soap (e.g., during a shower) before sexual intercourse, or if this is not possible, wear a shirt covering the application site at the time of contact.

What to do if someone else is exposed to TESTAVAN
If someone touches the gel or has close contact with the skin where you applied the gel, they should wash the affected skin area with soap and water as soon as possible. The longer the gel remains in contact with the skin before washing, the greater the likelihood that testosterone will be absorbed.
If TESTAVAN has been transferred to someone else, watch for any physical or behavioral changes in people close to you. If anyone close to you experiences any of the following symptoms, they should consult a doctor:

• acne
• deepening of the voice
• increased facial or body hair growth
• changes in menstrual cycle
• early puberty, genital enlargement, or changes in sexual behavior in children.

Other medicines and TESTAVAN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines and herbal products. TESTAVAN may affect how these medicines work, and it may be necessary to adjust the dose.
In particular, inform your doctor or pharmacist if you are taking:

• blood-thinning medicines (called anticoagulants); TESTAVAN may enhance the effects of these medicines
• corticosteroids or any other medicine that may increase the production of these hormones; both corticosteroids and TESTAVAN may cause fluid retention
• insulin to control blood sugar levels (in diabetes); you may need to reduce your insulin dose when being treated with TESTAVAN. If any of the above conditions apply to you (or you are unsure), consult your doctor or pharmacist before using TESTAVAN.

Pregnancy, breastfeeding, and fertility
TESTAVAN is not indicated for use in pregnant or breastfeeding women.
If your partner is or becomes pregnant, you must follow the instructions provided in the section “How to prevent transfer of TESTAVAN to others” in this patient information leaflet.
Pregnant women must avoid any contact with the areas where TESTAVAN has been applied on a man. This medicine may harm the unborn baby. In case of contact, the area should be washed immediately with soap and water.
Breastfeeding women must avoid all contact with the areas where TESTAVAN has been applied on a man.
Sperm production may be reversibly suppressed with TESTAVAN.

TESTAVAN contains propylene glycol
This medicine contains propylene glycol, which may cause skin irritation.

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

3. How to use TESTAVAN

Use this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Dosage

• 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. However, 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, based on regular monitoring of two parameters:

• testosterone levels in the blood
• the effectiveness of the medicine in you. Speak with your doctor if you feel the effects of this medicine are too strong or too weak.

How to use this medicine
It is important to read and follow these instructions on how to correctly use
TESTAVAN.
Apply TESTAVAN to the skin using the applicator. This method is called
"transdermal use," meaning the medicine passes through your skin into your body.
Apply the medicine only to clean, dry, healthy, and intact skin on the shoulders and upper arms.
Never apply TESTAVAN:

• on the penis or testicles
• on damaged or irritated skin
• on open sores, wounds, or areas with irritation.

Required devices

• TESTAVAN gel pump kit. See image A.
• Box of tissues.

Cap Applicator Pump head Pump
Image A
Note: In the multi-pack, a cap is present on the head of each pump
Priming the gel pump – for first use only
Before using a new TESTAVAN pump, you must prepare it for use.
This step is called "priming" the pump:

• Remove the applicator from the pump in case of single pack, or remove the cap from the pump in case of multi-pack. See image B.

Image B

• Prime the pump by pressing the pump head fully down onto a tissue. Repeat until gel appears. See image C.

Image C

• Do not use the gel dispensed during priming, as it may not provide the correct dose.
• Safely dispose of the tissues used to avoid transfer to other people, including children or pets.
• Your TESTAVAN pump is now ready for use.

For daily dosing, follow steps 1–4
Step 1: Preparing for application of TESTAVAN gel

• Select a clean, dry, and intact area of skin on the upper arm and shoulder, an area covered by the short sleeve of a T-shirt. See image D.
• Use TESTAVAN gel only on the upper arms and shoulders.

Image D

• Remove the applicator from the pump. See image E.

Image E

• Remove the cap from the applicator. See image F.

Image F
Step 2: Applying TESTAVAN gel

• Hold the pump with the nozzle directed toward the surface of the applicator.
• Press the pump head down once fully. See image G.

Image G

• Use the applicator to spread the gel evenly over the upper arm and shoulder, taking care to avoid contact of the gel with your hands. See image H.
• Wipe any spillage with a tissue. Safely dispose of the used tissues to prevent transfer to other people, including children or pets.

Image H
Identify the dose prescribed by your doctor in the table below.

Step 3: Cleaning the TESTAVAN applicator

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

Image I

• Dispose of the used tissue safely. Take care to prevent transfer to other people, including children or pets.
• REMEMBER to replace the cap on the applicator and return the applicator to the pump. See image J.

Image J

• Store the product in a safe place out of the reach of children.

Step 4: After applying TESTAVAN

• Wash your hands immediately with soap and water if they have come into contact with the gel.
• TESTAVAN gel is flammable until dry. Allow TESTAVAN gel to dry completely before smoking or going near open flames.
• Allow the application site to dry completely before dressing.
• Always wear clothing that covers the application site to prevent accidental transfer of the product to others.
• Wait at least 2 hours before showering, swimming, or taking a bath.
• Wash the application site with soap and water before any situation in which skin-to-skin contact at the application site with another person is likely.

If you use more TESTAVAN than you should
If you accidentally apply too much medicine, wash the application area with soap and water as soon as you notice.
Use only the amount of medicine prescribed by your doctor. If you feel irritable, nervous, gain weight, or have prolonged or frequent erections, these may be signs of excessive use.

If you forget to use TESTAVAN
If you miss a dose, do not apply a double dose to make up for the missed dose.

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

If you stop using TESTAVAN
Talk to your doctor before stopping treatment with this medicine.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Common (may affect up to 1 in 10 people)

• skin irritation at the site where the gel was applied (including rash, dryness and redness)
• high levels of fats (triglycerides) in the blood
• increased blood pressure
• increase in Prostate-Specific Antigen (PSA). PSA is a protein produced by the prostate gland, which can be used to detect prostate disease
• increase in haematocrit (percentage of red blood cells in the blood), identified by periodic blood tests.

Uncommon (may affect up to 1 in 100 people)

• increase in haemoglobin (the component of red blood cells that carries oxygen), identified by periodic blood tests
• headache.

Other side effects observed during treatment with testosterone include: acne, seborrhoea, baldness, sweating, increased body hair growth, itching or numbness of the skin, headache, dizziness, nausea, hot flushes, fluid retention (such as swelling of the ankles), weight gain, sleep apnoea, shortness of breath, hypersensitivity reactions, feeling unwell/malaise, mood changes (such as aggression, hostility, nervousness, anxiety, depression), insomnia, muscle pain or cramps, breast development, increase in red blood cell count, decrease in 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 sexual interest, increased erection, priapism (prolonged and painful erections), testicular dysfunction, reduced sperm count, difficulty urinating, changes in the prostate gland, prostate cancer (there is no convincing evidence that testosterone replacement therapy in hypogonadal men causes prostate cancer; however, testosterone therapy should be avoided in men with known or suspected prostate cancer).
Prolonged administration of testosterone may cause changes in the levels of salts (electrolytes) and water in the body.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 pump label and on the outer carton after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TESTAVAN contains
The active substance is testosterone.
The other ingredients are: 96% ethanol, propylene glycol (E 1520), diethylene glycol monoethyl ether, carbomer 980, triethanolamine, disodium edetate, purified water.
One gram of gel contains 20 mg of testosterone. One pump activation releases 1.15 g of gel (1.25 ml) containing 23 mg of testosterone.

Description of the appearance of TESTAVAN and contents of the pack
TESTAVAN is a homogeneous gel, transparent to slightly opalescent.
The following packs are available with or without an applicator cap and hygienic cover:
Single pack containing 1 dosing pump.
Multiple pack containing 3 dosing pumps.
Each pump contains 85.5 g of TESTAVAN gel and is capable of delivering 56 single doses.
It is possible that not all pack sizes are commercially available.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
The Simple Pharma Company Limited
Ground Floor, 71 Lower Baggot St, Dublin D02 P593, Ireland

Manufacturer:
Ferring GmbH
Wittland 11-24, 24109 Kiel
Germany

Applicator:
Ferring Pharmaceuticals A/S
Kay Fiskers Plads 11
2300 Copenhagen S
Denmark

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Iceland, Italy, Liechtenstein, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, United Kingdom (Northern Ireland) – Testavan
Belgium, Croatia, Greece, Hungary, Ireland, Latvia, Luxembourg, Slovenia – Testarzon