TESTOSTERONE UNDECANOATE 40 MG CAPSULES
Active substance(s): TESTOSTERONE UNDECANOATE
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or your pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
- If you get any side effects talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.
This medicine is available using the above name but will be referred to as
Restandol Testocaps throughout the leaflet.
What is in this leaflet:
1. What Restandol Testocaps is and what it is used for
2. What you need to know before you take Restandol Testocaps
3. How to take Restandol Testocaps
4. Possible side effects
5. How to store Restandol Testocaps
6. Contents of the pack and other information
1. WHAT RESTANDOL TESTOCAPS IS AND WHAT IT IS USED FOR
Restandol Testocaps are soft oval glossy capsules which contain 40 mg of
testosterone undecanoate. The active substance, 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
Restandol Testocaps 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
impotence, infertility, low sex drive, tiredness, depressive moods, bone loss
caused by low hormone levels.
Restandol Testocaps 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RESTANDOL
- Do not take Restandol Testocaps: If you are allergic (hypersensitive) to
testosterone undecanoate or any of the ingredients of this medicine (listed
in section 6 “What Restandol Testocaps 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
Take special care with Restandol 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. 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).
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
The following blood checks should be carried out by your doctor before and
during the treatment: testosterone blood level, full blood count.
Medical check may also be necessary in some other conditions.
Tell your doctor if you have ever had, still have, or are suspected to
- 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
- blood clotting problems - thrombophilia (an abnormality of blood
coagulation that increases the risk of thrombosis – blood clots in blood
If you are suffering from severe heart, liver or kidney disease, treatment with
Restandol Testocaps may cause severe complications in the form of water
retention in your body sometimes accompanied by (congestive) heart
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
Also tell your doctor
- if you are taking anticoagulants (drugs to treat blood clots)
Your medication may need to be monitored more closely.
Children and adolescents
The safety and efficacy of this medicine has not been adequately
determined in children and adolescents.
Extra supervision by the doctor is necessary in the treatment of children
and adolescents since testosterone administration in general may cause
early sexual development and limits growth (see section 4 “Children and
Other medicines and Restandol Testocaps
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 Restandol Testocaps works or Restandol
Testocaps 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);
The following medicines may decrease the effect of Restandol Testocaps:
- antibiotics such as rifampicin
- anti-epileptic drugs such as barbiturates, carbamazepine,
dichloralphenazone, phenylbutazone, phenytoin and primidone.
The use of androgens like Restandol 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 Restandol Testocaps 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
Using Restandol Testocaps with food and drink
Food allows testosterone undecanoate, the active substance of this
medicine to be absorbed by your body.
Therefore, Restandol Testocaps must be taken with a normal meal
(see section 3).
Pregnancy, breast-feeding and fertility
Restandol Testocaps 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 Restandol 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.
Driving and using machines
As far as is known this medicine has no influence on driving or using
Important information about some of the ingredients of Restandol
This medicine contains:
Sunset yellow FCF (E110) which can cause allergic type reactions
including asthma. Allergy is more common in those people who are allergic
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 Restandol Testocaps can interfere with antidoping testing.
The misuse of this medicine to enhance ability in sports carries serious
health risks and is to be discouraged.
3. HOW TO TAKE RESTANDOL TESTOCAPS
Always take this medicine exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
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
You must take this medicine with a normal meal.
Swallow the capsules whole without chewing, using some water or
Depending on the dose prescribed for you, take the capsules as shown in
the table below.
No. of capsules to take
Smaller doses, taken less often, may be given if you are elderly.
Your doctor will have chosen the correct dose for you.
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 (see section 2 “Take special care
with Restandol Testocaps”).
If you take more Restandol Testocaps 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 Restandol Testocaps:
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.
Remember to always take Restandol Testocaps with food.
If you stop taking Restandol 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Restandol Testocaps can have side effects, although not
everybody gets them.
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
- 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.
Children and adolescents:
The following side effects have been reported in pre-pubertal children using
- early sexual development;
- penis enlargement;
- an increased frequency of erections;
- growth limitation (limited body height)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the
Yellow Card Scheme at: 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 RESTANDOL TESTOCAPS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the package, sachet
and blister. The expiry date refers to the last day of that month.
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
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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Restandol Testocaps contains
The active substance is: Testosterone undecanoate. Each capsule
contains 40 mg testosterone undecanoate equivalent to 25.3 mg
The other ingredients are:
- Capsule contents:
Castor oil and propylene glycol monolaurate (E477)
- Capsule shell ingredients:
Glycerin, Sunset Yellow FCF (E110) and gelatin
- Printing ink:
Opacode WB® white
- Auxiliary substances:
Medium-chain triglycerides and Lecithin
What Restandol Testocaps looks like and contents of the pack
Restandol Testocaps are soft oval glossy capsules, transparent, orange in
colour containing a yellow oily fill and are printed in white ORG and DV3.
A box of Restandol Testocaps contains either 3 or 6 sachets.
Each sachet contains a blister strip with 10 capsules.
PRODUCT LICENCE HOLDER AND MANUFACTURER
Manufactured by N.V. Organon, PO Box 20, 5340 BH Oss, The
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
Leaflet revision and issue date (Ref) 05.04.17
Restandol and Testocaps are trademarks of Merck Sharp & Dohme B.V.
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Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.