Testavan 20 mg / g transdermal gel – patient leaflet, side effects, dosage

What Testavan is used for

Testavan is used in men for testosterone

replacement to treat various health problems

caused by a lack of testosterone (male

hypogonadism). This should be by two

separate blood testosterone measurements and

also include clinical signs and symptoms such as:

• impotence
• infertility
• low sex drive
• tiredness
• depressive moods
• bone loss caused by low hormone level

• partial loss of secondary sex characteristics,

  such as changes in your voice, changes in the

  fat distribution and partial loss of face and

  body hair

2. What you need to know before

you use Testavan

Who can use Testavan

• Only men can use Testavan.

• Young men under the age of 18 years should not

  use this medicine.

• This medicine should not be used by females of

  any age.

• Do not allow women (especially women that are

  pregnant or breast-feeding) or children to come

  into contact with Testavan gel or 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 are suspected of having prostate

  cancer

• if you have or are suspected of having breast

  cancer (a rare condition for men)

Warnings and precautions

Testosterone treatment can speed up the progress

of pre-existing prostate cancer. Your doctor will do

the necessary tests before you can use Testavan

and do follow-up checks by carrying out periodic

blood tests and prostate examinations.

Talk to your doctor before using Testavan, if you

have or ever had any of the following:

• you have in passing water (urinating)

  due to an enlarged prostate gland

• you have bone cancer, your doctor will check

  your calcium levels

• you have high blood pressure, or if you are

  treated for high blood pressure, as Testavan

  may cause a rise in blood pressure

• you have severe heart, liver or kidney disease,

  as treatment with Testavan may cause severe

  complications in the form of water retention in

  your body sometimes accompanied by

  (congestive) heart failure overload in the

  heart)

• you have ischaemic heart disease (which affects

  the supply of blood to the heart)

•

• you have epilepsy
• you have migraines

• you have breathing when you sleep -

  these are more likely to happen if you are

  overweight or have long term lung problems

If any of the above apply to you (or you are not

sure), talk to your doctor or pharmacist before using

Testavan, using this medicine may make these

conditions worse.

If you develop reactions on your skin where you

applied the Testavan, go back to your doctor to seek

advice. It may be necessary to stop the treatment

with Testavan.

The following blood checks should be carried out

by your doctor before and/or during the treatment:

testosterone blood levels, full blood count.

At the time of, and just afte

During repeated or prolonged periods of physical

contact, this medicine may be transferred to

another person. This may cause side-effects such

as growth of facial or body hair, deepening of the

voice or changes in the menstrual cycle of women,

or accelerated height, genital enlargement, and

early puberty (including development of pubic hair)

in children. Wearing clothes covering the applica-

tion area or washing the application area before

contact may reduce this risk.

r, the daily application of

Testavan, do not apply moisturisers or sunscreen

products to the area where you have put the gel

How to prevent transfer of Testavan to someone else

• This is especially important for women and children, they normally only have low levels of testosterone in their bodies.
• Pregnant women must not come into contact with Testavan. If your partner is pregnant you must be careful and protect her from any contact with the medicine and the application area.

To stop the gel being transferred from your skin to someone else, you should:

• use the applicator to apply the medicine rather than your
• wash your hands with water and soap straight away if you do get any Testavan on your hands • cover where you have put the gel with clothing, once the gel has dried
• have a bath or shower, or wear clothing to cover the gel application site (such as a T-shirt), before having close skin-to-skin contact with anyone blood clotting problems

• thrombophilia (an abnormality of blood

  coagulation that increases the risk of thrombosis,

  blood clots in blood vessels)

• factors that increase your risk for blood clots

  in a vein: previous blood clots in a vein;

  smoking; obesity; cancer; immobility; if one of

  your immediate family has had a blood clot in

  the leg, lung or other organ at a young age (e.g.

  below the age of about 50); or as you get older.

• how to recognise a blood clot: painful swelling

  of one leg or sudden change in colour of the

  skin e.g. turning pale, red or blue, sudden

  breathlessness, sudden unexplained cough

  which may bring up blood; or sudden chest

  pain, severe light headedness or dizziness,

  severe pain in your stomach, sudden loss of

  vision. Seek urgent medical attention if you

  experience one of these symptoms.

  Additional care should be taken by patients using this product who may be in close physical contact with children as testosterone may pass through clothing. Please make sure you follow the applica-tion technique (see section 3 of this leaflet) when in physical contact with children, including covering the application site with clean clothing once the gel has dried. Additionally, please wash the application site with soap once the recommended time period (at least 2 hours) has passed and cover again with clean clothing before physical contact with children.

  In order to improve the safety of your partner you should wash the area with soap for instance during a shower before having sexual intercourse or, if not possible, wear a T-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 skin-to-skin contact where you have put the gel, they should wash their area of skin with soap and water as soon as possible. The longer that the gel is in contact with the skin before washing, the greater the that the person will absorb some testosterone.

  If Testavan has been transferred to someone else, then look out for any changes in the body or you gets any of the following signs, they should see their doctor:

• acne • deepening of the voice
• growth of facial or body hair
• changes in their monthly period
• early puberty, genital enlargement or changes in level of sexual behaviour of children

Other medicines and Testavan

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This includes medicines obtained without a prescription and herbal medicines. Testavan may affect how these medicines work and you may need to have your doses adjusted.

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

• medicines to thin your blood (anti-coagulants) -

  Testavan may increase the effects of these drugs. • corticosteroids or any other medicines that may increase the production of these hormones. Both corticosteroids and Testavan may cause your body to hold on more water.

• insulin to control your blood sugar levels (in diabetes); you may need to reduce your dose of insulin when you are in treatment with Testavan.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Testavan.

Pregnancy, breast-feeding and fertility

Testavan is not intended for use by pregnant or breast-feeding women.

If your partner is or becomes pregnant, you must follow the advice above under the heading ‘How to prevent transfer of Testavan to someone else’.

Pregnant women must avoid any skin contact with Testavan application sites in men. This medicine may cause damage to the unborn baby. In the event of contact, the area should be washed as soon as possible with soap and water.

Breast-feeding women must avoid any contact with Testavan application sites in men.

Sperm production may be reversibly suppressed with Testavan.

Testavan contains propylene glycol

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

3. How to use Testavan

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How much to use

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

The correct dose of Testavan that you need will be decided by your doctor, they will do this by measuring two things regularly:

• the levels of testosterone in your blood • how well the medicine is working for you

Talk to your doctor if you feel that the effects of the medicine is too strong or too weak.

Using this medicine

It is important that you read and follow these directions on how to use Testavan properly.

Apply Testavan on your skin using the applicator. This is called “trans-dermal use”, the medicine goes through your skin into your body.

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

Never apply Testavan to:

• your penis and testicles
• to skin that is broken or damaged
• open sores, wounds or irritations

Supplies you will need

• Testavan gel pump kit. See Picture A. • Box of tissues.

  Picture A

Priming your gel pump – first time only

Before using a new Testavan pump, you need to get it ready to use. This is called “priming” the pump: •

Testavan contains ethanol

This medicine contains 538.70 mg alcohol (ethanol) in each 1.15 g dose which is equivalent to 468.40 mg/g (46.84 %w/w). It may cause burning sensation on damaged skin.

Note: Multipacks contain a lid on top of each pump head

Take off the applicator from the pump in the case of the single pack or take off the lid from the pump in the case of the multipack - See Picture B.

chance

behaviour of people close to you. If anyone close to For daily dosing follow steps 1-4 Step 1: Preparing to apply your Testavan gel

• Select a clean, dry, normal healthy area of the

  skin on the upper arm and shoulder that would be covered by a short sleeve t-shirt. See Picture D. • Use Testavan gel only on the upper arm and

shoulder.

Picture D

• Take off the applicator from the pump See Picture E.

  Picture E

• Take off the lid from the applicator See Picture F.

  Picture F Step 2: Applying your Testavan gel

• Hold the pump with the nozzle facing the

  applicator surface.

• Press the pump head all the way down once.

See Picture G.

Picture G

• Use the applicator to spread the gel evenly

  across one upper arm and shoulder, making sure not to get any gel on your hands. See Picture

  H.

• Clean up any spills with a tissue. Safely throw

away used tissues to prevent transfer to others including children or pets.

Picture H

Find your dose as prescribed by your doctor in the table below.

Step 3: Cleaning your Testavan applicator

• After use, clean the applicator with a tissue.

See Picture I.

Picture I

• Safely throw away used tissue. Becareful to

  prevent transfer to others including children or pets.

• REMEMBER to put the lid back on the

applicator and put the applicator back on the pump. See Picture J.

Picture J

• Store the product safely and out of reach of

  children.

  Step 4: After applying your Testavan

  • Wash your hands with soap and water straight away, if you got gel on them.

  • Testavan gel is until dry. Let the

    Testavan gel dry before smoking or going near an open

  • Let the application site dry completely before getting dressed.
  • Wear clothing that covers the application site at all times to prevent accidental transfer to others.

  • Wait at least 2 hours before showering,

    swimming or bathing.

  • Wash the application site with soap and water before any situation where skin-to-skin contact of the application site with another person is likely.

If you use more Testavan than you should

If you have applied too much medicine by mistake, wash the application area with soap and water as soon as you realise.

Only use the amount of medicine prescribed by your doctor. If you feel irritable, nervous, gain weight, get long lasting or frequent erections, these may be signs that you are using too much.

If you forget to use Testavan

Do not use a double dose to make up for a forgotten dose.

• If your next dose is less than 12 hours away, do not take the missed dose. Then take your next dose as normal.
• If it is more than 12 hours until your next dose, take the dose that you have missed. Continue as normal the following day.

If you stop using Testavan

Talk to your doctor before you stop taking this medicine.

If you have any further questions on 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 Prostatic Antigen (PSA). PSA is a protein produced by the prostate, which can be used to detect prostate disease
• increased haematocrit (percentage of red blood cells in blood), by periodic blood tests

Uncommon (may affect up to 1 in 100 people)

• Increased haemoglobin (the component of red blood cells that carries oxygen), by periodic blood tests
• Headache

Other known undesirable effects associated with testosterone treatment include:

acne, seborrhoea, baldness, sweating, increased body hair growth, skin tickling or numbness, headache, dizziness, nausea, hot

retention (such as swelling of ankles), weight gain, sleep apnoea, shortness of breath, hypersensitivity reactions, feeling sick/unwell, changes to your mood (such as aggression, hostility, nervousness, anxiety, depression), sleeplessness, muscular pain or cramp, development of breasts, increase in red blood cell count, decrease in red blood cells, blood clots, jaundice (liver problems which sometimes may be associated with yellowing of the skin and the whites of the eyes), abnormal liver function tests. Sex drive changes, erection increased, priapism (prolonged and painful erections), testis disorder, reduced number of sperm, passing urine, changes to your prostate gland, prostate cancer (there is no convincing evidence that testosterone replacement in hypogonadal men induces prostate cancer; however, testosterone therapy is to be avoided in men already known or thought to have prostate cancer).

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this You can also report side effects directly via Yellow Card scheme, Website: www.mhra.gov.uk/yellowcard. 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 the outer carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Testavan contains

The active substance is testosterone.

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

One gram of gel contains 20 mg testosterone. Each pump press delivers 1.15 g gel (1.25 ml) containing 23 mg of testosterone.

What Testavan looks like and contents of the pack

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

The Simple Pharma Company UK Limited Suite 3, 4th Floor, 1 Duchess Street,

London,W1W 6AN, United Kingdom

Testavan 20 mg/g transdermal gel - PL 54460/0002

Manufactured by:

Copea Pharma Europe Ltd, Medici House, Unit 2, Ashbourne Manufacturing Park,

Ashbourne, Co. Meath, A84 KH58, Ireland

CAP applicator:

This leaflet was last revised in

May 2025. Picture C

• Do not use any gel from priming because it might not be the right dose.

• Safely throw away the used tissues to prevent

  transferring to others including children or pets. • Your Testavan pump is now ready to use.

  TESTAVAN is a trademark of Simple Pharma I Ltd © 2021.

  Testavan is a homogenous, translucent to slightly opalescent gel.

  The following pack sizes are available with or without a cap applicator and hygiene lid:

  Single packs containing 1 metering pump Multipacks containing 3 metering pumps

  Each pump contains 85.5 g Testavan gel and is capable of dispensing 56 metered doses.

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

  Once the gel has dried, cover the application site with clean clothing (such as a t-shirt)

  Before close physical contact with another person (adult or child), wash the application site with soap and water once the recommended time period (at least 2 hours) has passed and cover again with clean clothing

•

•

Picture B

• Prime the pump by pressing the pump head

  all the way down over a tissue. Repeat until gel appears. See Picture C.