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Testosterone Undecanoate soft gel capsule
What is this medicine?
Testosterone Undecanoate is turned into testosterone by your body. Testosterone is a natural male hormone known as an androgen. It is produced in the body by both men and women. Testosterone Undecanoate is used in adult men for testosterone replacement to treat various health problems caused by a lack of testosterone (male hypogonadism).
Testosterone Undecanoate are used if your body does not make enough testosterone of its own, for example:
- impotence caused by hormonal disorders
- after castration or a similar problem called eunuchoidism
- decreased sex drive and decreased mental and physical activity
- certain types of infertility because you don’t make enough sperm
- it may also be used to treat a type of bone disease (osteoporosis) caused
by having too little testosterone
What should I tell my health care provider before I take this medicine?
The following medicines may decrease the effect of Testosterone Undecanoate:
- antibiotics such as rifampicin
- anti-epileptic drugs such as barbiturates, carbamazepine,
- dichloralphenazone, phenylbutazone, phenytoin and primidone.
The use of androgens like Testosterone Undecanoate 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 Testosterone Undecanoate may increase the risk of water retention, especially if your heart and liver are not working properly.
Androgens may also affect the results of some laboratory tests (e.g. thyroid gland). Therefore you must tell your doctor or the laboratory staff performing the tests that you are using this medicine.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Do not take Testosterone Undecanoate:
- If you are allergic (hypersensitive) to testosterone undecanoate or any of the ingredients of this medicine (listed in section 6 “What Testosterone Undecanoate contain”).
- If you have or have had a tumour of your prostate or breast or are suspected to have one of these tumours.
- If you have ever had liver cancer
Tell your doctor if you have ever had, still have, or are suspected to have:
- breast cancer which has spread to the bones
- kidney or lung cancer
- heart disease
- kidney disease
- liver disease
- high blood pressure
- diabetes mellitus
- migraine, headaches
- prostatic complaints, such as problems passing urine
If you are suffering from severe heart, liver or kidney disease, treatment with Testosterone Undecanoate may cause severe complications in the form of water retention in your body sometimes accompanied by (congestive) heart failure.
Tell your doctor if you have high blood pressure or if you are treated for high blood pressure as testosterone may cause a raise in blood pressure.
If you have sleep apnea (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.
Also tell your doctor
- if you are taking anticoagulants (drugs to treat blood clots)
Using Testosterone Undecanoate with food and drink
Food allows testosterone undecanoate, the active substance of this medicine to be absorbed by your body.
Therefore, Testosterone Undecanoate must be taken with a normal meal.
Pregnancy, breast-feeding and fertility
Testosterone Undecanoate are not for use in women, 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 Testosterone Undecanoate 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.
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 Testosterone Undecanoate can interfere with antidoping testing.
The misuse of this medicine to enhance ability in sports carries serious health risks and is to be discouraged.
How should I take this medicine?
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Take special care with Testosterone Undecanoate
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. In men over the age of 45, the prostate gland will be investigated by digital rectal examination (DRE) and blood tests for prostate-specific antigen (PSA).
The recommended dose is 3–4 capsules daily during the first 2–3 weeks, followed by a gradual decrease to 1–3 capsules daily. Look at the label on the pack to see how many capsules your doctor would like you to take each day.
The following blood checks should be carried out by your doctor before and during the treatment: testosterone blood level, full blood count.
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.
You must take this medicine with a normal meal.
Swallow the capsules whole without chewing, using some water or other fluid.
Children and adolescents
The safety and efficacy of this medicine has not been adequately determined in children and adolescents.
Smaller doses, taken less often, may be given if you are elderly. Your doctor will have chosen the correct dose for you.
What may interact with this medicine?
Please tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines-even those not prescribed.
Other medicines may affect how Testosterone Undecanoate works or RTestosterone Undecanoate may affect how they work. Therefore you must tell your doctor or pharmacist if you are using or are about to use:
- insulin and/or other medicines to control your blood sugar levels;
- medicines to reduce the clotting of your blood (anti-coagulants);
If you take more Testosterone Undecanoate than you should:
If you have taken several capsules at once, there is no need for great concern, however you should tell your doctor. The castor oil in the capsule may cause diarrhoea.
If you forgot to take Testosterone Undecanoate:
If you miss the morning dose and it is more than 2 hours after breakfast, wait until lunch-time and then take the dose. If you miss the evening dose, and its more than 2 hours after dinner, don’t take the missed dose. Take the next morning dose as normal.
What side effects may I notice from this medicine?
Common (may affect upto 1 in 10 people)
- increase in red blood cell count (the cells which carry the oxygen in your blood); hematocrit (percentage of red blood cells in blood) and haemoglobin (the component of red blood cells that carries oxygen), identified by periodic blood tests.
Not known (cannot be estimated from available data)
- itching (pruritus)
- nausea (feeling sick)
- problems with your liver including liver tumours, though this is rare
- changes in the way your body processes fats
- mood alterations
- muscle pain
- fluid retention in the tissues, usually marked by the swelling of ankles or
- high blood pressure
- increased or decreased sex drive
- prolonged painful erection
- decreased amounts of ejaculation fluid and sperm
- enlargement of the breasts
- growth of the prostate gland
- increased levels of a blood marker which is associated with prostate
- cancer (PSA)
- worsening of the early stage of prostate cancer
- yellowing of the skin or eyes
- difficulty passing urine
- allergy to sunset yellow, a colour used in the capsules.
- electrolyte changes (sodium, potassium, calcium, inorganic phosphate
- and water retention)
- no sperm count
In a few patients diarrhoea, stomach pain or discomfort have been reported during the use of this medicine.
Where can I keep my medicine?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the package and blister.
Do not store above 30 °C.
Do not refrigerate or freeze.
Store in the original package and keep the blister in the outer carton.
If the capsules become discoloured or show signs of any other deterioration, you should seek the advice of your pharmacist who will advise you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.