This page is intended for patients who have been prescribed Testogel 16.2 mg/g gel

Frequently asked questions on testosterone deficiency and
Testogel (testosterone) 16.2 mg/g gel

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

intended for patients who have been prescribed Testogel 16.2 mg/g gel

Frequently asked questions on testosterone deficiency and
Testogel (testosterone) 16.2 mg/g gel

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

Intended for patients prescribed Testogel 16.2mg/g gel

Frequently asked questions on testosterone deficiency and Testogel (testosterone) 16.2 mg/g gel

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

Questions about testosterone

What is testosterone?

Testosterone is a hormone that is produced naturally by the testicles. It is important for both your physical and emotional well-being. It is responsible for many things in the body including maintaining muscle and bone mass, the production of sperm, and the desire to have sex1.

Why do I need testosterone?

Testosterone is essential for developing and maintaining characteristics in men such as:

  • Sex drive and sexual function
  • Muscle mass and strength
  • Bone strength
  • Mood and energy levels1

What is a normal testosterone level?

Although levels vary, testosterone levels higher than 12 nmol/L or free testosterone level high than 0.225 nmol/L is usually considered healthy and doesn’t require treatment.1

Questions about testosterone deficiency

What is testosterone deficiency?

It is normal for our body to make less testosterone as we age but when testosterone levels fall below the normal range, it can lead to some unwanted symptoms. This condition is known as “testosterone deficiency” or “TD”.1

As men get older testosterone levels often decline naturally; however, in men with testosterone deficiency the decreased levels of testosterone are associated with clinical symptoms that affect their overall health and enjoyment of life in a variety of different ways.

Who experiences testosterone deficiency?

The overall prevalence of TD has been shown to be 2.1% in men 40 to 79 years old.1 The chances of having testosterone deficiency are higher when men have certain other conditions such as2:

  • Obesity
  • Type 2 diabetes
  • Hyperlipidaemia
  • Hypertension
  • Chronic opioid use
  • Moderate to severe chronic obstructive pulmonary disease (COPD)

How could testosterone deficiency affect my life?

Testosterone deficiency may impact many areas of a man’s life with symptoms including3:

  • Mood and energy levels
  • Sexual dysfunction (problems with erections)
  • Depressed mood and low satisfaction with life
  • Decreased energy, motivation, initiative and self-confidence
  • Less muscle mass, weaker bones and increased body fat

Questions about Testogel 16.2 mg/g gel

This section is not a substitute for the patient information leaflet contained in the pack that you should read for further information.

What is Testogel 16.2 mg/g gel used for?

This medicine contains testosterone, a male hormone produced naturally in the body. Testogel 16.2 mg/g is used in adult men for testosterone replacement to treat various health problems caused by a lack of testosterone (male hypogonadism). This should be confirmed by two separate blood testosterone measurements and also include clinical symptoms such as:4

  • Impotence
  • Infertility
  • Low sex drive
  • Tiredness
  • Depressive moods
  • Bone loss caused by low hormone levels

How long does Testogel 16.2 mg/g gel take to work?

You can expect some symptoms to improve within 3 months. Other symptoms may take longer to improve.

The maximum effect of treatment on symptom alleviation is often seen between 6-12 months.5

Your doctor will monitor your progress to ensure you are receiving the right treatment and dose, so make sure you continue to visit your doctor regularly.

Does Testogel 16.2 mg/g gel have any side effects?

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

Common side effects (may affect up to 1 in 10 people)4

Testogel 16.2 mg/g gel may cause changes to your mood including:

  • Mood swings, anger or aggression
  • Impatience
  • Sleeplessness
  • Abnormal dreams
  • Increased sex drive

Testogel 16.2 mg/g gel may cause skin reactions including:

  • Acne
  • Hair loss
  • Dry skin
  • Skin irritation
  • Hair colour changes
  • Rash
  • Sensitive skin

Other common side effect include increase in red blood cell count, haematocrit (percentage of red blood cells in blood) and haemoglobin (the component of red blood cells that carries oxygen), identified by periodic blood tests. Changes to the prostate gland (including increased blood levels of a protein called prostate specific antigen that is produced by the prostate).

Uncommon side effects (may affect up to 1 in 100 people)

Testogel 16.2 mg/g gel may cause an increase in blood pressure, flushing, inflammation of the veins, diarrhoea, bloated stomach, pain in the mouth, development of breasts, tender nipples, pain in the testicles, fluid retention.

Other side effects that have been observed during treatment with Testogel 16.2 mg/g gel include tiredness, depression, anxiety, headache, dizziness, tingling skin, blood clots, difficulty breathing, feeling sick, sweating, abnormal body hair growth, muscle or bone pain, difficulty passing urine, reduced number of sperm, muscle weakness, feeling unwell, weight gain.

Because of the alcohol this medicine contains, frequent applications to the skin may cause irritation and skin dryness.

For full information about the possible side effects, contraindications and information you need to know before you use Testogel 16.2 mg/g gel, please read the Patient Information Leaflet.

Who should not use Testogel 16.2 mg/g gel?

Do not use Testogel 16.2 mg/g gel if:4,6

  • You have or are suspected of having prostate cancer
  • You have or are suspected of having breast cancer
  • You are allergic to testosterone or any of the other ingredients of this medicine

Testogel 16.2 mg/g gel is not recommended for:

  • The treatment of male sterility or impotence
  • Children, as no clinical information is available for boys under 18 years

Testogel 16.2 mg/g gel is not meant for use in women and must not be used in women who are or may become pregnant or are breastfeeding due to possibly virilising effects. Testogel 16.2 mg/g gel may harm the unborn or breastfeeding baby. Women who are pregnant or may become pregnant should avoid contact with the area of skin where Testogel 16.2 mg/g gel has been applied.

You should use Testogel 16.2 mg/g gel with caution if:

  • You have or are at risk of an enlarged prostate gland (benign prostatic hypertrophy – regular examinations of the prostate gland before the beginning and during therapy should be performed to follow your doctor’s recommendations
  • You are suffering from severe heart, liver or kidney disease – treatment with Testogel 16.2 mg/g gel may cause severe complications in the form of water retention in your body, sometimes accompanied by congestive heart failure (fluid overload in the heart)
  • You have high blood pressure or if you are treated for high blood pressure – testosterone may cause a rise in blood pressure
  • You are suffering from epilepsy and/or from migraine as these conditions may worsen
  • You have diabetes – testosterone treatment may affect your response to insulin and your diabetes medication might need adjustment
  • You have thrombophilia as there have been reports of thrombotic events in these patients during testosterone therapy
  • You have cancer that affects your bones, which can increase your risk of hypercalcaemia or hypercalciuria (high calcium levels in the blood or urine), as Testogel 16.2 mg/g may further affect these levels

The attention of sportsmen and women is drawn to the fact that this proprietary medicine contains an active substance (testosterone) that may produce a positive result in doping control tests.

Talk to your doctor before taking this medicine if you have any of the above conditions.

For full information about the possible side effects, contraindications and information you need to know before you use Testogel 16.2 mg/g gel, please read the Patient Information Leaflet.

Should I take Testogel 16.2 mg/g gel if I'm taking other medications?

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. When Testogel 16.2 mg/g gel is used with certain other medicines, they can affect each other. Especially tell your doctor if you take:4

  • Insulin
  • Corticosteroids
  • Medicines that decrease blood clotting

Testogel 16.2 mg/g gel may have an effect on how these medications work, so be sure to tell your doctor if you are taking these or any other medications.

For full information about the possible side effects, contraindications and information you need to know before you use Testogel 16.2 mg/g gel, please read the Patient Information Leaflet.

Using Testogel 16.2 mg/g gel

How much should I use?

The recommended dose is two pump actuations of gel (i.e. 40.5 mg of testosterone) applied once daily at about the same time, preferably in the morning. But your Doctor may recommend a different dose to this.4

1 pump actuation of Testogel = 1.25 g of gel = 20.25 mg of testosterone.

Your doctor will tell you how many times to press the plunger to get the correct dose for you.

How do I prepare the Testogel 16.2 mg/g gel pump?

Testogel 16.2 mg/g gel comes in a pump specifically designed to deliver a consistent amount of testosterone gel each time you press down the plunger.

Setting up your Testogel 16.2 mg/g gel4

Follow these steps when you use your pump for the first time:

1. Remove the cap from the canister to reveal the plunger

2. Press the plunger down 3 times, collecting the gel on a tissue.

3. Do not use the gel released and safely discard it in a rubbish bin.

Your pump is now ready to use. You won’t need to perform these steps again.

How do I use Testogel 16.2 mg/g gel?

3 simple steps to follow each day:4, 6

Apply

  • Apply the gel approximately at the same time every morning onto clean, dry, healthy skin as a thin layer on both shoulders and upper arms
  • Do not apply to the upper chest, or genitals or abdomen.
  • Do not rub in

Wash

  • Wash hands with soap and water after applying gel
  • It seems preferable to observe at least 2 hours between gel application and bathing or showering.

Cover

  • Testogel 16.2 mg/g gel dries within 3-5 minutes
  • After it dries the area should be covered with clothing

If someone else comes into contact with the application site, they should wash their skin with soap and water as soon as possible.

Where should I apply Testogel 16.2 mg/g gel?

Testogel 16.2 mg/g gel is not meant for use in women.

Apply Testogel 16.2 mg/g gel only to areas that will be covered by a short-sleeve T-shirt, as shown in the shaded areas in the illustration. These areas are your shoulders and upper arms. Do not apply Testogel 16.2 mg/g gel to any other areas of your body, such as your stomach area (abdomen), penis, scrotum, chest, armpits (axillae), or knees.4

2 application sites

Why do I need to use Testogel 16.2 mg/g gel every day?

Hypogonadism, sometimes known as low testosterone or testosterone deficiency, due to certain medical conditions requires ongoing treatment, so you must use Testogel 16.2 mg/g gel daily, as prescribed by your doctor. If you stop, your testosterone levels may fall back to previous levels in 3 or 4 days.4

What precautions should I take when using Testogel 16.2 mg/g gel?

Transfer risk:4, 6

During close and relatively long periods of skin contact testosterone may be transferred to another person unless you cover the treated area. This could cause your partner to show the signs of increased testosterone.

The following precautions are recommended:

  • Wash your hands with soap and water after applying the gel
  • Cover the application area with clothing once the gel has dried
  • Wait at least 2 hours between applying the gel and taking a bath or shower – if you occasionally need to bath or shower between 2 and 6 hours after applying the gel it should not significantly change the effects of your treatment
  • Take a shower and wash the application area with soap before sexual intercourse – if not possible, wear a T-shirt that covers the application site at time of contact
  • Wear a T-shirt that covers the application site when in contact with children in order to avoid the risk of transferring the gel to the child’s skin

Can I swim or shower after using Testogel 16.2 mg/g gel?

Patients should wait at least 2 hours after applying Testogel 16.2 mg/g gel before showering or swimming. Ideally leave at least 6 hours between gel application and bathing or showering. Occasional baths or showers taken between 2 and 6 hours after application of the gel should not significantly influence the treatment outcome.4

What if someone else is exposed to Testogel 16.2 mg/g gel?

If you believe testosterone has been transferred to another person (woman or child):4

  • Wash the area of skin which may have been affected immediately with soap and water
  • Report any signs such as acne or changes in the growth or pattern of hair on their body or face to your doctor.

What if I miss a dose/application?

Do not use a double dose to make up for a forgotten individual dose. Apply the next dose at the usual time.6

How do I store my Testogel 16.2 mg/g gel?

Keep your Testogel 16.2 mg/g gel in a safe place to protect it. Store Testogel 16.2 mg/g gel at room temperature. Keep it away from children. When it is time to throw away the pump, safely throw away used Testogel 16.2 mg/g gel in household trash. Be careful to prevent accidental exposure of children or pets. Keep Testogel 16.2 mg/g gel away from fire.6

Can I take Testogel 16.2 mg/g in my carry-on luggage when travelling?

You’re allowed to carry essential medicines of more than 100 ml in your hand luggage, but you need supporting documentation from a relevant medical professional (e.g. a letter from your doctor or a copy of your prescription). The same applies for gel packs.7

Airport staff might need to open the containers to screen the liquids at the security point. The label only indicates 88 g but we would recommend either putting the medicine in the hold luggage or carrying it separately from other liquids with a letter from your doctor or a copy of your prescription, because the volume of the gel in the pump is approximately 100 ml.

At security, you must present all liquid, aerosol and gel medication for inspection. Following x-ray screening, security officers may also need to carry out additional checks on these items. As with taking any medicine abroad, we would also recommend you check the requirements of the country you are visiting. Visit the gov.uk website (https://www.gov.uk/hand-luggage-restrictions/essential-medicines-and-medical-equipment) for more details.

References

  1. Hackett, G. et al (2017) British Society for Sexual Medicine Guidelines on Adult Testosterone Deficiency, With Statements for UK Practice. J Sex Med. 14 1504-1523.
  2. Khera M et al. J Sex Med 2016; 13: 1787-1804
  3. McBride, J. et al (2016) Testosterone Deficiency in the Aging Male. Ther Adv Urol. Vol. 8(1) 47–60.
  4. Testogel 16.2mg/g Summary of Product Characteristics July 2018
  5. Onset of effects of testosterone treatment and time span until maximum effects are achieved, Farid Saad et al. European Journal of endocrinology, 2011.
  6. Testogel 16.2mg/g patient information leaflet
  7. https://www.gov.uk/hand-luggage-restrictions/essential-medicines-and-medical-equipment

This page is intended for patients who have been prescribed Testogel 16.2 mg/g gel

intended for patients who have been prescribed Testogel 16.2 mg/g gel

© 2018 BESINS HEALTHCARE LTD. TES/2019/032 Date of Preparation May 2019.

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