Andriol Testocaps

Testosterone Undecanoate

Consumer Medicine Information

This leaflet answers some common questions about Andriol Testocaps. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighted the risks of you taking Andriol Testocaps against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

The name of your medicine is Andriol Testocaps.

Andriol Testocaps is used in adult men for testosterone replacement to treat various health problems caused by a lack of testosterone (male hypogonadism). Your doctor will confirm this by blood testosterone measurements and also clinical symptoms such as inability to get or maintain an erection (impotence), infertility, low sex drive, tiredness, depressive moods, or bone loss caused by low hormone levels.

Each capsule contains 40 mg of the active ingredient called testosterone undecanoate. Testosterone undecanoate is turned into testosterone by your body. Testosterone is a natural male hormone known as an androgen, a type of sex hormone necessary for the normal sexual development of males.

In men testosterone is produced by the testicles. It is necessary for the normal growth, development and function of the male sex organs and for secondary male sex characteristics. It is necessary for the growth of body hair, the development of bones and muscles, and it stimulates the production of red blood cells. It also makes men’s voices deepen.

Because of problems with the pituitary or testis, the production of testosterone by the body decreases.

Men may suffer from complaints such as depression, loss of motivation or concentration, and loss of sexual desire. Andriol Testocaps can relieve these complaints. It can also relieve these symptoms in men who have had their testis removed. Relief of symptoms usually starts within a few days, but optimal results are obtained after weeks to months of treatment.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

A doctor’s prescription is required to obtain this medicine.

Do not use Andriol Testocaps if

you have or have had a tumour of your prostate or breast or are suspected to have one of these tumours.

you have or have had severe kidney disease

you are allergic to testosterone undecanoate or any of the ingredients listed under Product Description, at the end of this leaflet.

Do not use Andriol Testocaps if the packaging is torn or shows signs of tampering.

Andriol Testocaps may not be suitable for you if you suffer from certain medical conditions.

Tell your doctor or pharmacist before you start using this medicine if you ever had, still have, or are suspected to have (particularly if you are elderly):

heart disease, high blood pressure or blood vessel problems

Diabetes mellitus, Kidney disease

Kidney or lung cancer;

Liver disease;

Breast cancer which has spread to the bones;

Epilepsy

Migraine, headaches

Psychiatric or emotional illness

Prostatic complaints, such as problems with passing urine.

Any unusual or allergic reactions to androgens or anabolic steroids

Factors that increase your risk for blood clots in a vein i.e. 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 (below the age of 50); or as you get older.

Sleep apnoea (temporarily stopping breathing during your sleep), this may get worse if you are using testosterone-containing products. Let your doctor know if you are worried about this. Extra supervision by your doctor may be necessary in case you are overweight or suffer from chronic lung disease.

Tell your doctor if

you are on a special diet, e.g. low salt, lower sugar and you are taking any other medicines.

you have or have ever had too much cholesterol or other fatty substances in the blood.

you have been treated with other sex hormones recently.

Caution:

During long-term treatment with Andriol Testocaps regular medical checks, including prostate examination, are recommended.

Children and adolescents:

The safety and efficacy of this medicine has not been adequately determined in children and adolescents.

Extra supervision by a doctor is necessary in the treatment of young boys and adolescents since testosterone administration in general may cause early sexual development and limits growth.

Elderly people:

There is limited experience on the safety and efficacy of the use of Andriol Testocaps in patients over 65 years of age.

Please tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines – even those not prescribed that you buy from your pharmacy, supermarket or healthfood shop.

Other medicines may influence the effects of Andriol Testocaps, or Andriol Testocaps may affect other medicines.

Therefore you must tell your doctor or pharmacist if you are taking (or intend to take) other medicines such as:-

Barbiturates, (medicines for epilepsy or sleeplessness)

Ciclosporin

Insulin and/or other medicines to control your blood sugar levels (antidiabetic drugs)*

Medicines to reduce the clotting of your blood (anti-coagulants)*

* The use of androgens like Andriol Testocaps may lead to a reduction of the doses of these medicines.

Also tell your doctor or pharmacist if you are using or about to use

the hormone ACTH or corticosteroids (used to treat various conditions such as rheumatism, arthritis, allergic conditions and asthma).

The use of androgens like Andriol Testocaps may increase the risk of water retention especially if your heart and liver are not working properly.

Andriol Testocaps may interfere with some laboratory tests (e.g for glucose tolerance, thyroid function and clotting factors).

Therefore you must tell your doctor or the laboratory staff performing the tests that you are using this medicine.

Andriol Testocaps are not intended for use in female patients. Therefore this medicine must not be taken by women who are pregnant or think that they are pregnant, or by women who are breast-feeding.

In men, treatment with Andriol Testocaps can lead to fertility disorders by repressing sperm formation.

If you are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

This medicine contains Sunset Yellow FCF which may cause allergic reactions.

If you are a patient who participates in competitions governed by the World Anti-Doping Agency (WADA), then you should consult the WADA-code before using this medicine as Andriol Testocaps can interfere with anti-doping testing.

The misuse of this medicine to enhance ability in sports carries serious health risks and is to be discouraged.

Drug abuse and dependence:

Always take this medicine exactly as your doctor or pharmacist has told you.

Abuse of testosterone, especially if you take too much of this medicine alone or with other anabolic androgenic steroids, can cause serious health problems to your heart and blood vessels (that can lead to death), mental health and/or the liver. Individuals who have abused testosterone may become dependent and may experience withdrawal symptoms when the dosage changes significantly or is stopped immediately. You should not abuse this medicine alone or with other anabolic androgenic steroids because it carries serious health risks. (See “Side Effects.”)

Take Andriol Testocaps exactly as directed by your doctor. You should also read the instructions on the label of your medicine. If you are not sure how to take Andriol Testocaps, ask your doctor or pharmacist.

Take the capsules daily, as directed by your doctor. Andriol Testocaps are to be swallowed after the morning and evening meal.

Swallow the capsules whole with some water or other drink. Do not chew them.

If you are taking an uneven number of capsules, the larger dose should be taken in the morning.

Food allows testosterone undecanoate, the active substance of this medicine, to be taken up by your body. Therefore, Andriol Testocaps must be taken with a meal.

If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist immediately.

Use in children and adolescents:

The safety and efficacy of this medicine have not been adequately determined in children and adolescents. Pre-pubertal children using this medicine will be monitored by your doctor

If you forget to take a capsule, take it as soon as you remember. If you do not remember to take the dose until the next dose is due, then just take one dose, do not double up.

It is not a medical emergency if someone has taken several capsules at once. However, you should consult a doctor, or the Australian Poisons Information Centre (telephone 131 126) or the New Zealand National Poisons Centre (telephone 0800 POISON or 0800 764 766) if you think you or anyone else may have taken too much Andriol Testocaps. Symptoms that may arise are nausea and vomiting and oily bowel motions. The oily substance in the capsule may cause diarrhoea.

If you stop taking Andriol Testocaps:

When treatment with this medicine is stopped, complaints such as those experienced before treatment may re-occur within a few weeks.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Stop taking Andriol Testocaps if you develop jaundice (yellowing of the eyes or skin).

Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

Take special care with Andriol Testocaps

Treatment with male hormones like testosterone may increase the size of the prostate gland, especially in elderly men. Therefore your doctor will examine your prostate gland at regular intervals by digital rectal examination (DRE) and blood tests for prostate-specific antigen (PSA).

Additionally, at regular intervals, blood tests will be done to check the oxygen-carrying substance in your red blood cells (haemoglobin). In very rare cases the number of red blood cells will increase too much leading to complications.

Your doctor will measure testosterone blood levels before and during your treatment. Based on the blood test results, your doctor may adjust the dose of Andriol Testocaps.

Medical checks may also be necessary in some other conditions.

If you are unsure of any of the aspects of this product, please discuss with your doctor or pharmacist.

Do not give Andriol Testocaps to anyone else, even if they have the same condition as you. Remember that your doctor has prescribed this medicine only for you.

Do not stop taking your medicine or lower the dosage without checking with your doctor.

Ability to drive or operate machinery

As far as is known, this medicine has no influence on driving and using machines.

Andriol Testocaps are generally well tolerated.

Tell your doctor or pharmacist if you notice any of the following and they worry you.

In general side effects which are reported with testosterone therapy include:

stomach or bowel complaints: oily bowel motions, abdominal or stomach pain, black, tarry or light coloured stools or dark coloured urine, vomiting, nausea, diarrhoea

acne, itching (pruritus) skin irritation: pimply spotty rash, hives

sleeplessness, chills, generalised tingling, unusual tiredness

headache, anxiety, mental depression, excitation, confusion, dizziness, nervousness, mood alterations

muscle pain (myalgia)

prolonged abnormal, painful irreversible erection, inflamed testis, bladder irritability

sexual dysfunction, changes in sexual desire, disturbed sperm formation

Feminization (gynecomastia)

prostatic growth to a size representative for the concerned age group

high blood pressure (hypertension)

blood disorders, increase in the number of red blood cells (the cells which carry the oxygen in your blood),

increase in percentage of red blood cells relative to the total blood volume (haematocrit);

increased concentration of the red blood cell component that carries oxygen (haemoglobin);

increased levels of a blood marker which is associated with prostate cancer (PSA increased)

changes in cholesterol levels (changes in lipid metabolism)

shortness of breath

fluid retention in the tissues, usually marked by swelling of ankles, feet or lower legs (oedema)

breast enlargement

increased growth of a small prostate cancer which had not been detected yet (progression of a sub-clinical prostatic cancer)

changes in liver function tests

weight gain

blood clot in the deep vein (venous thromboembolism)

These symptoms usually go away when treatment is stopped for a short while. Your doctor will then probably advise you to start at a lower dosage.

In a few patients diarrhoea and stomach pain or discomfort have been reported during the use of this medicine.

Drug abuse and dependence:

Abuse of this medicine can cause serious health problems, especially if you take too much testosterone alone or with other androgenic anabolic steroids.

Some of these health problems include significant side effects on the heart and blood vessels (that can lead to death), mental health and/or the liver. (See “Before you use Andriol Testocaps”).

Children and adolescents:

The following side effects have been reported in pre-pubertal children using androgens:

early sexual development;

penis enlargement;

an increased frequency of erections;

growth limitation (limited body height)

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Store Andriol Testocaps below 30°C. Do not refrigerate or freeze. Store in the original package and keep the blister in the outer carton in order to protect from light.

Keep this medicine out of reach and sight of children

Do not use this medicine after the expiry date stated on the carton or label after the term “Expiry date”. The expiry date refers to the last day of that month.

Return any unused medicine to your pharmacist.

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 to protect the environment.

Andriol Testocaps packs are available in 3, 6# or 12 sachets, each containing a blister pack with 10 capsules. Andriol Testocaps capsules are soft oval, glossy, transparent orange coloured capsules marked with ORG DV3 printed in white. They contain a yellow oil.

# commercially available pack.

Each Andriol Testocap capsule consists of 40 mg of testosterone undecanoate (equivalent to 25.3 mg testosterone) in hydrogenated castor oil and propylene glycol monolaurate. The capsule shells contain the following inactive ingredients: gelatin, glycerol, medium chain triglycerides, lecithin, sunset yellow FCF and printed with Opacode WB water based monogramming ink NSP-78-18022 White.

If you have any further questions or require the full prescribing information for this medicine, please consult your doctor or pharmacist.

Andriol Testocaps is supplied:

 

In Australia by:

Merck Sharp & Dohme (Australia) Pty Limited

Level 1 Building A, 26 Talavera Road, Macquarie Park, NSW 2113

Australia

 

In New Zealand by:

Merck Sharp & Dohme (New Zealand) Ltd

PO Box 99 851

Newmarket

Auckland 1149

New Zealand

Australian Registration Number:

AUST R 92904

 

This leaflet was prepared in

October 2020. 

S-CCPPI-MK3033-CP-052017