TESTAVAN 20 mg /G Transdermal Gel

Зміст інструкції

1. TESTAVAN 20 mg/g transdermal gel
   1. What is TESTAVAN and what is it 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

TESTAVAN 20 mg/g transdermal gel

testosterone

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is TESTAVAN and what is it used for

What is TESTAVAN
TESTAVAN is a clear gel that contains testosterone, a male hormone produced
naturally by the body.
TESTAVAN is used to replace testosterone in adult men when they do not produce
enough natural testosterone, this condition is called “hypogonadism”. The medicine
helps to bring your testosterone to normal levels.

What does testosterone do
Testosterone is produced naturally in the testicles.

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

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

• impotence
• infertility
• low sexual desire
• 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 hair on the face and body

2. What you need to know before using TESTAVAN

Who can use TESTAVAN

• Only men can 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 on which 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
Treatment with testosterone may accelerate the progression of pre-existing prostate cancer.
Your doctor will perform the necessary tests before using TESTAVAN and will perform check-up
visits performing periodic blood and prostate exams.
Talk to your doctor before using TESTAVAN if you have or have ever had any of the following
conditions:

• you have difficulty urinating (urinating) due to an enlarged prostate
• you have bone cancer, your doctor will check your calcium levels
• you have high blood pressure or are being treated for high blood pressure, as TESTAVAN may cause an increase in blood pressure
• you suffer from severe heart, liver or kidney disorders, as treatment with TESTAVAN may cause serious complications in terms of fluid retention sometimes accompanied by heart failure (congestion) (fluid overload in the heart)
• you suffer from ischemic heart disease (a condition that affects blood flow to the heart)
• blood clotting problems
• thrombophilia (an abnormality of blood coagulation that increases the risk of thrombosis - blood clots in blood vessels)
• factors that increase the risk of blood clots in the vein: previous blood clots in the vein; smoking; obesity; cancer; sedentary lifestyle; if a close relative has had a blood clot in the leg, lung, or other organs at a young age (e.g. under the age of 50); or with increasing age.
• How to recognize a blood clot: painful swelling of a leg or sudden change in skin color, e.g. becomes pale, red or blue, sudden shortness of breath, sudden unexplained cough with possible appearance of blood; or sudden chest pain, severe dizziness or vertigo, severe stomach pain, sudden loss of vision. Seek medical attention urgently if you experience any of these symptoms.
• you suffer from epilepsy
• you suffer from migraine
• you have breathing problems during sleep; these problems are more likely to occur if you are overweight or have long-standing lung problems. If any of the above conditions apply to you (or you are not sure), talk to your doctor or pharmacist before using TESTAVAN, the use of this medicine may worsen these conditions.

If you develop skin reactions on the skin where you have applied TESTAVAN, ask your doctor for advice again.
It may be necessary to stop treatment with TESTAVAN.
The following blood tests must be performed by the doctor before and/or during
treatment: blood levels of testosterone, complete blood count.
For those who play sports: the use of the drug without a therapeutic need constitutes doping
and may still result in a positive doping test.
When applying TESTAVAN daily, and immediately after, do not apply moisturizers or sunscreens to the area where you have put the gel.

How to prevent the transfer of TESTAVAN to other people
TESTAVAN can be transferred to others through direct skin contact. This can
cause an increase in testosterone levels in their body which may be dangerous.
This condition can result from a single contact, but can also develop gradually
through brief repeated contacts over time.

• This is particularly important for women and children who normally have low levels of testosterone in their bodies
• Pregnant women should not come into contact with TESTAVAN. If your partner is pregnant, she must be careful and protect herself from any contact with the drug and the area of application.

To prevent the gel from being transferred from your skin to someone else's, you should:

• use the applicator instead of your fingers to administer the medicine
• wash your hands immediately with soap and water if your hands come into contact with TESTAVAN
• cover the area where you have applied the gel with clothing, once the gel has dried
• take a bath or shower or wear clothes to cover the application site of the gel, before any situation where you anticipate direct skin contact with someone else.

To improve the safety of your partner, she should wash the area with soap, for example
during a shower, before having sexual intercourse or, if not possible, wear a
shirt that covers 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 have applied the gel, they should
wash the skin area with soap and water as soon as possible. The longer the gel is in contact
with the skin before washing, the more likely the person is to absorb
testosterone.
If TESTAVAN has been transferred to someone else, look for any changes in the body or
behavior of people close to you. If someone close to you presents any of the
following symptoms, they should consult a doctor:

• acne
• deepened voice
• growth of facial or body hair
• changes in the 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
take any other medicines, including medicines obtained without a prescription and
herbal products. TESTAVAN can affect the way these medicines
work and it may be necessary to adjust the dose.
In particular, tell your doctor or pharmacist if you are taking:

• medicines that thin the blood (called anticoagulants), TESTAVAN may increase the effects of these medicines
• corticosteroids or any other medicine that may increase the production of these hormones. Both corticosteroids and TESTAVAN can cause fluid retention
• insulin to control blood sugar levels (in diabetes); you may need to reduce your dose of insulin when you are being treated with TESTAVAN. If any of the above conditions apply to you (or you are not sure), consult your doctor or pharmacist before using TESTAVAN.

Pregnancy, breastfeeding and fertility
TESTAVAN is not indicated in pregnant or breastfeeding women.
If your partner is or becomes pregnant, you mustfollow the instructions in the “How
Pregnant women must avoid anycontact with the areas of application of
TESTAVAN by the man. This medicine can cause harm to the fetus. In case of contact, the area
should be washed as soon as possible with soap and water.
Breastfeeding women must avoid allcontact with the areas of application of
TESTAVAN by the man.
Sperm production may be reversibly suppressed with TESTAVAN.

TESTAVAN contains propylene glycol
This medicine contains propylene glycol which can 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 following the instructions of your doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.

Dosage to use

• The recommended initial dose of TESTAVAN is 23 mg of testosterone (one pump delivery) applied once a day at approximately the same time during the day, preferably in the morning, but some patients may require a higher dose.
• The maximum recommended dose is 69 mg of testosterone per day (three pump deliveries).

The correct dose of TESTAVAN that you need will be decided by your doctor and will be determined through regular monitoring of two parameters:

• testosterone levels in the blood
• the effectiveness of the medicine on you. Talk to your doctor if you feel that the effects of this medicine are too strong or too weak.

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

• to the penis and testicles
• to broken or damaged skin
• to open wounds, sores or irritations.

Devices needed

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

Cap Applicator Pump Head Pump

Image A
Note: the multiple pack has a cap on the head of each pump
Activating the gel pump – for first use only
Before using a newTESTAVAN pump, you need to prepare it for use.
This step is called “activating” the pump:

• Remove the applicator from the pump 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

• Prepare the pump by pressing the pump head all the way down onto a tissue. Repeat until gel appears. See Image C.
• Do not use the gel dispensed during activation as it may not be the correct dose.
• Safely dispose of the tissues used to avoid transfer to others including children or pets.
• Your TESTAVAN pump is now ready for use.

Image C
For daily dosage follow steps 1-4
Step 1: Preparing for the application of TESTAVAN gel

• Select a clean, dry and intact area of skin on the upper arm and shoulder covered by the short sleeve of a t-shirt. See Image D.
• Use TESTAVAN gel onlyon the upper arm and shoulder

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 facing towards the surface of the applicator.
• Press the pump head all the way down once. See Image G.

Image G

• Use the applicator to spread the gel evenly on the upper arm and shoulder, taking care that the gel does not come into contact with your hands. See Image H.
• Wipe away any spills with a tissue. Safely dispose of the tissues used to avoid transfer to others including children or pets.

Image H

Identify the doseprescribed by the doctor in the table below.

Step 3: Cleaning the TESTAVAN applicator

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

Image I

• Safely dispose of the tissue used. Be careful to prevent transfer to others, including children or pets.
• REMEMBERto put the cap on the applicator and put the applicator back on the pump. See Image J.

Image J

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

Step 4: After applying TESTAVAN

• Wash your hands immediately with water and soap if they have come into contact with the gel.
• TESTAVAN gel is flammable until it is dry. Allow TESTAVAN gel to dry before smoking or approaching 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 hoursbefore showering, swimming or bathing.
• Wash the application site with water and soap before any situation where skin contact from the application site with another person is likely.

If you use more TESTAVAN than you should
If you accidentally applied too much medicine, wash the application area with water and soap as soon as you realize it.
Use only the amount of medicine prescribed by your doctor. If you feel irritable, nervous, have gained weight, have erections that last a long time or frequently, these may be signs of over-use.

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

• If the next dose is due less than 12 hours away, do not apply the missed dose. Then take the next dose as usual.
• If the next dose is due more than 12 hours away, apply the dose you forgot. Continue as usual the next day.

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

4. Possible side effects

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

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• increased hemoglobin (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 apnea, shortness of breath, hypersensitivity reactions, feeling unwell/malaise, mood changes (such as 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 can sometimes be associated with yellowing of the skin and whites of the eyes), abnormal liver function tests. Changes in sexual orientation, 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 induces prostate cancer; however, testosterone therapy should be avoided in men with known or suspected prostate cancer). Prolonged administration of testosterone can cause changes in salt (electrolyte) and water levels in the body.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the pump label and
on the outer packaging after “Exp.”. The expiry date refers to the last day of that
month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What TESTAVAN contains
The active ingredient is testosterone.
The other ingredients are: 96% ethanol, propylene glycol (E 1520), diethylene glycol monoethyl ether, carbomer 980, trolamine, 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, from transparent to slightly opalescent.
The following packs are available with or without an applicator cap and hygienic cap:
Single pack containing 1 dosing pump.
Multipack containing 3 dosing pumps.
Each pump contains 85.5 g of TESTAVAN gel and is able to deliver 56 single doses.
Not all pack sizes may be marketed.

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 11-24109 Kiel
Germany

Applicator:
Ferring Pharmaceuticals A/S
Kay Fiskers Plads 11
2300 Copenhagen S
Denmark
This medicinal product is authorised in the Member States of the European Economic Area and
in the United Kingdom (Northern Ireland) under the following denominations:
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