Testavan

Package leaflet: Information for the patient

Testavan, 20 mg/g, transdermal gel
Testosteronum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Testavan is and what it is used for
2. Important information 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 naturally produced in the male body.
Testavan is used to supplement testosterone levels in adult men who do not produce sufficient amounts of natural testosterone, a condition known as hypogonadism. This medicine helps increase testosterone concentration to normal levels.

How testosterone works
Testosterone is naturally produced in the body by the testes.

• It helps in sperm production and in the development and maintenance of male characteristics such as low voice pitch and body hair.
• It is necessary for normal sexual function and libido.
• It also helps maintain muscle mass and strength.

What Testavan is used for
Testavan is used in men as testosterone replacement therapy for the treatment of various conditions resulting from testosterone deficiency (male hypogonadism). This should be confirmed by two separate measurements of testosterone levels and the presence of clinical symptoms such as:
impotence,
infertility,
reduced libido,
fatigue,
depressive moods,
loss of bone mass due to low hormone levels,
partial loss of secondary sexual characteristics, such as voice changes, changes in fat distribution,
and partial loss of facial and body hair.

2. Important information before using Testavan

Who can use Testavan

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

When not to use Testavan
if the patient is allergic to testosterone or any of the other ingredients of this medicine
(listed in section 6),
if the patient has been diagnosed with or is suspected of having prostate cancer,
if the patient has been diagnosed with or is suspected of having breast cancer (rare in men).

Warnings and precautions
Testosterone treatment may accelerate the growth of existing prostate cancer.
Before starting treatment with Testavan, the doctor will perform all necessary tests and will periodically monitor blood parameters and examine the prostate gland.
Before starting to use Testavan, discuss with your doctor if the patient has or has ever had in the past:

• difficulty urinating due to an enlarged prostate gland,
• bone cancer; the doctor will check the patient's blood calcium levels,
• high blood pressure or is taking medications for high blood pressure, as Testavan may increase blood pressure,
• severe heart, liver, or kidney disease, as the use of Testavan may lead to serious complications such as fluid retention, sometimes leading to (congestive) heart failure (fluid overload of the heart),
• ischemic heart disease (affecting blood flow to the heart),
• blood clotting disorders

• thrombophilia (abnormalities in blood coagulation increasing the risk of thrombosis - formation of blood clots in blood vessels)
• factors increasing the risk of venous blood clots: previous history of venous blood clots; smoking; obesity; cancer; immobility; family history of blood clots in the leg, lungs, or other organs at a young age (e.g., under 50 years); advanced patient age.
• How to recognize a blood clot: painful swelling of one leg or sudden skin discoloration (e.g., paleness, redness, or blueness), sudden unexplained shortness of breath, sudden unexplained cough possibly with coughing up blood, sudden chest pain, severe dizziness or vertigo, severe abdominal pain, sudden loss of vision. If any of these symptoms occur, seek immediate medical help.

• if the patient has epilepsy,
• if the patient suffers from migraine headaches,
• if the patient has breathing problems during sleep – these are more likely in patients who are overweight or have chronic lung disease.

If the patient has (or possibly has) any of the above conditions, consult a doctor or pharmacist before using Testavan – using this medicine may worsen these conditions.

If severe skin reactions occur at the site of Testavan application, consult the treating doctor. Discontinuation of Testavan treatment may be necessary.
The following blood tests should be ordered by the doctor before and during treatment:

• blood testosterone levels,
• complete blood count.

During and immediately after daily application of Testavan gel, do not apply moisturizers or sun protection products to the area where the gel has been applied.

How to prevent transferring Testavan to another person
Testavan can be transferred to others through direct skin-to-skin contact. This may increase testosterone levels in those individuals and may be dangerous. This can occur after a single contact, but may also develop gradually after repeated exposure to small amounts over time.

• This is particularly important for women and children – they normally have very low testosterone levels in their bodies.
• Pregnant women must not have any contact with Testavan. If the patient’s partner is pregnant, the patient must be cautious and protect her from any contact with the medicine and the application site.

To prevent transferring the gel from the patient’s skin to another person, the patient should:

• use the applicator instead of fingers to apply the medicine,
• wash hands immediately with soap and water if Testavan comes into contact with the hands,
• cover the application site with clothing immediately after the gel has dried,
• take a bath or shower, or wear clothing covering the application sites (e.g., a T-shirt) before engaging in direct skin-to-skin contact with another person.

To increase the safety of the patient’s partner, the patient should wash the application site with soap (e.g., during a shower) before sexual intercourse. If this is not possible, wear a T-shirt covering the application site during contact.

What to do if another person is exposed to Testavan
If another person touches the gel or has direct skin-to-skin contact with the area of skin where the gel has been applied, that person should wash the contacted skin areas immediately with soap and water. The longer the gel remains in contact with the skin before washing, the greater the risk that the person will absorb some testosterone.

If Testavan has been transferred to another person, monitor for any changes in the health or behavior of people around the patient. If anyone in the patient’s environment experiences any of the following symptoms, they should see their doctor:

• acne
• deepening of the voice
• increased facial or body hair growth
• changes in menstruation
• early sexual development, enlargement of genital organs, or changes in sexual behavior in children

Testavan and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. Testavan may affect the action of these medicines, and dosage adjustments may be required.

In particular, inform your doctor or pharmacist if you are taking:

• medicines that reduce blood clotting (anticoagulants) – Testavan may enhance the effect of these medicines,
• corticosteroids or any other medicines that may increase the production of these hormones. Corticosteroids and Testavan may cause fluid retention,
• insulin to maintain normal blood sugar levels (in diabetes); during treatment with Testavan, a reduction in insulin dose may be necessary.

If any of the above situations apply (or may apply) to the patient, consult a doctor or pharmacist before using Testavan.

Pregnancy, breastfeeding, and effects on fertility
Testavan is not indicated for use in pregnant or breastfeeding women.

If the patient’s partner is pregnant or becomes pregnant, the patient must follow the instructions above under the heading "How to prevent transferring Testavan to another person".

Pregnant women must avoid any direct skin contact with areas where Testavan has been applied to men. This medicine may harm the unborn child. In case of contact, the skin surface should be washed immediately with soap and water.

Breastfeeding women must avoid any direct skin contact with areas where Testavan has been applied to men.

Testavan may reversibly suppress sperm production.

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) in each 1.15 g dose of gel, equivalent to 468.40 mg/g (46.84% w/w). It may cause stinging on damaged skin.

3. How to use Testavan

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
What dose should be used

• The recommended starting dose of Testavan is 23 mg of testosterone (1 pump actuation) applied once daily at approximately the same time each day, preferably in the morning. Some patients may require a higher dose.
• The maximum recommended dose is 69 mg of testosterone per day (3 pump actuations).

Your doctor will determine the appropriate dose of Testavan for you, based on regular monitoring of:

• your blood testosterone levels
• your response to the medicine.

Consult your treating doctor if you feel the medicine's effect is too strong or too weak.

How to use this medicine
It is important that you read and follow the instructions for the correct use of Testavan.
Testavan is applied to the skin using the applicator. This is called "transdermal administration."

• The medicine passes through the skin into the body.

Apply the medicine only to clean, dry, and intact skin on the upper arms and shoulders.
Never apply Testavan to:

• the penis and testicles,
• cracked or damaged skin,
• open wounds, cuts, or skin irritations.

Items required for application:

• Testavan medicine applicator kit See Figure A.
• Box of single-use wipes.

Cap Applicator Pump head Dosing pump
Figure A
Note: Multi-packs contain containers with a cap on the pump head of each container.
Preparing the dosing pump for gel application – only the first time
Before using a new Testavan dosing pump, it must be primed. This is called
"pump priming."

• Disconnect the applicator from the dosing pump in case of a single pack, or remove the cap from the pump head in case of a multi-pack. See Figure B.

Figure B

• Prime the pump by pressing the pump head fully down over a wipe. Repeat this procedure until gel appears. See Figure C.

Figure C

• Do not use any gel expressed during pump priming, as this may not provide the correct dose.
• Dispose of the used wipe safely to prevent transfer of the gel to other persons, including children and pets.
• The Testavan applicator kit is now ready for use.

For daily dosing, follow steps 1–4
Step 1: Prepare for application of Testavan gel

• Select a clean, dry, undamaged area of skin on the upper arm and shoulder that can be covered with a short-sleeved undershirt. See Figure D.
• Apply Testavan gel only to the upper arms and shoulders.

Figure D

• Disconnect the applicator from the dosing pump. See Figure E.

Figure E

• Remove the applicator cap. See Figure F.

Figure F
Step 2: Applying Testavan gel

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

Figure G

• Use the applicator to evenly spread the gel on the skin of the upper arm and shoulder, taking care to avoid contact with the hands. See Figure H.
• Wipe off any spills with a wipe. Dispose of the used wipe safely to prevent transfer of the gel to other persons, including children and pets.

Figure H
Find the dose prescribed by your doctor in the table below.

Step 3: Cleaning the Testavan medication applicator

• After use, clean the applicator with a wipe. See Figure I.

Figure I

• Dispose of the used wipe according to safety precautions. Exercise caution to prevent accidental transfer of the gel to other individuals, including children and pets.
• REMEMBER to place the cap back onto the applicator and reattach the applicator to the dosing pump. See Figure J.

Figure J

• Store the medication safely and out of reach of children.

Step 4: After applying Testavan medication

• Wash hands immediately with soap and water if the gel has come into contact with the skin of the hands.
• Testavan gel is flammable before it dries. Wait until the Testavan gel has dried completely before lighting a cigarette or going near an open flame.
• Wait for the gel to dry before putting on clothes.
• Wear clothing that fully covers the areas where the gel was applied to prevent accidental transfer of the gel to other people.
• Wait at least 2 hours before taking a shower, swimming, or bathing.
• Wash the areas where the gel was applied with soap and water before any situation involving potential skin-to-skin contact with another person.

Using more than the recommended dose of Testavan medication
If more than the recommended dose of the medication is accidentally used, wash the gel application site immediately with soap and water.
Only use the amount of medication prescribed by your doctor. Symptoms such as irritability, nervousness, weight gain, and prolonged or frequent erections may indicate excessive use of the medication.

Missed dose of Testavan medication
Do not use a double dose to make up for a missed dose.

• If less than 12 hours remain before the next dose, skip the missed dose and take the next dose according to the regular schedule.
• If more than 12 hours remain before the next dose, take the missed dose. Continue treatment as normal the following day.

Stopping the use of Testavan medication
Before stopping the use of Testavan medication, discuss this with your doctor.
If you have any further doubts regarding the use of this medication, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Common (may occur in up to 1 in 10 patients):

• skin irritation at the site of gel application (including rash, erythema, dry skin, redness),
• high levels of fats (triglycerides) in the blood,
• increased blood pressure,
• increased levels of prostate-specific antigen (PSA). PSA is a protein produced by the prostate gland and may be used to detect prostate gland diseases,
• increased hematocrit (percentage of red blood cells in the blood), detected by periodic blood tests.

Uncommon (may occur in up to 1 in 100 patients):

• increased hemoglobin levels (component of red blood cells that carries oxygen), detected by periodic blood tests,
• headache.

Other known adverse reactions associated with testosterone treatment include:
acne, seborrhea, alopecia, sweating, excessive hair growth on the body, skin itching or tingling,
headache, dizziness, nausea, hot flushes, fluid retention (such as swelling of the ankles),
increased body weight, sleep apnea, shortness of breath, hypersensitivity reactions, malaise,
mood changes (such as aggression, hostility, nervousness, anxiety, depression), insomnia,
muscle pain or cramps, breast enlargement, increased number of red blood cells, decreased number of red blood cells, blood clots in blood vessels, jaundice (liver problems which may sometimes be associated with yellowing of the skin and whites of the eyes), abnormal liver function test results.
Changes in libido, increased erections, priapism (prolonged and painful erections), testicular disorders, reduced sperm count, difficulty urinating, changes in the prostate gland, prostate cancer (there is no convincing evidence that testosterone replacement therapy in men with hypogonadism causes prostate cancer; however, testosterone treatment should be avoided in men with diagnosed or suspected prostate cancer).
Long-term administration of testosterone may lead to changes in electrolyte levels and water content in the body.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, Phone: +48 22 49 21 301, Fax: +48 22 49 21 309,
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Testavan

Keep the medicine out of sight and reach of children.
There are no special storage temperature requirements for this medicine.
Do not use this medicine after the expiry date stated on the dispenser label and cardboard
package following the abbreviation EXP. The expiry date refers to the last day of the stated month.
The batch number is indicated after the word Lot.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

What Testavan contains
The active substance is testosterone.
The other ingredients are: 96% ethanol, propylene glycol, ethylene glycol monethyl ether,
carbomer 980, triethanolamine, disodium edetate, purified water.
One gram of gel contains 20 mg of testosterone. One pump actuation delivers 1.15 g of gel
(1.25 ml) containing 23 mg of testosterone.

What Testavan looks like and contents of the pack
Testavan is a homogeneous, slightly opalescent gel.
The following pack sizes with or without an applicator and hygienic cap are available:
Single pack containing 1 metering pump.
Multipacks containing 3 metering pumps.
One metering pump contains 85.5 g of Testavan gel and allows administration of 56 measured 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:
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 authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Testavan: Austria, Bulgaria, Denmark, Estonia, Finland, France, Spain, the Netherlands, Iceland,
Liechtenstein, Lithuania, Germany, Norway, Poland, Portugal, the Czech Republic,
Romania, Slovakia, Sweden, United Kingdom, Italy, United Kingdom (Northern Ireland)
Testarzon: Belgium, Croatia, Greece, Ireland, Luxembourg, Latvia, Slovenia, Hungary