RESTANDOL 40MG

Active substance: TESTOSTERONE UNDECANOATE

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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 yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any
possible side effects not listed in this 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 women.
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 Testocaps
• 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).

Testosterone undecanoate

XXXXX/XXXXXX-X

RESTANDOL ®
TESTOCAPS ™

40MG CAPSULES, SOFT

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.
Medical check may also be necessary in some other conditions.
➞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
• epilepsy
• migraine, headaches
• prostatic complaints, such as problems passing urine
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)
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 adolescents”).
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.
Laboratory tests:
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.
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 machines.
Important information about some of the ingredients of Restandol Testocaps
This medicine contains
Sunset yellow (E110) which can cause allergic type reactions including asthma.
Allergy is more common in those people who are allergic to aspirin.
Improper use
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 anti-doping 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.
Adults
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.

You must take this medicine with a normal meal.
Swallow the capsules whole without chewing, using some water or other fluid.
Depending on the dose prescribed for you, take the capsules as shown in the table
below.
Prescribed
daily dose
1
2
3
4

No. of capsules to take
Morning
1
1
2
2

Evening
0
1
1
2

Elderly
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:
Don’t worry.
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.
• Mild side effects include:
• diarrhoea
Other side effects that may occur during testosterone therapy are:
• itching (pruritus)
• acne
• nausea (feeling sick)
• problems with your liver including liver tumours, though this is rare
• changes in the way your body processes fats
• depression
• nervousness
• mood alterations
• muscle pain
• fluid retention in the tissues, usually marked by the swelling of ankles or feet
• high blood pressure
• increase in the number of red blood cells
• 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 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
androgens:
• early sexual development;
• penis enlargement;
• an increased frequency of erections;
• growth limitation (limited body height)

Please be ready to give the following information:
Product name
Restandol Testocaps,
40 mg Capsules, Soft
Reference number PL 00025/0595
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last updated in May 2014

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 national reporting system listed below:
United Kingdom
Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.
Malta
ADR Reporting, The Medicines Authority, Post-Licensing Directorate, 203 Level 3,
Rue D’Argens
GŻR-1368 Gżira, Website: www.medicinesauthority.gov.mt,
e-mail: postlicensing.medicinesauthority@gov.mt
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, after the term “exp” (expiry date). 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.
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.
6. Contents of the pack and other information
What Restandol Testocaps contain
The active substance is: Testosterone undecanoate, 40 mg which is equivalent to
25.3 mg testosterone.
The other ingredients are:
• Capsule contents:
Castor oil and propylene glycol laurate (E477)
• Capsule shell ingredients:
Glycerin, Sunset Yellow (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.
A box of Restandol Testocaps contains either 3 or 6 sachets. Each sachet contains
a blister strip with 10 capsules.
If you have any further questions or require the full prescribing information for this
medicine, please consult your doctor or pharmacist.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Merck Sharp & Dohme Limited,
Hertford Road, Hoddesdon,
Hertfordshire, EN11 9BU, UK
Manufacturer:
N.V. Organon, Kloosterstraat 6
5349 AB Oss, The Netherlands
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Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please
call, free of charge:
0800 198 5000 (UK only)

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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.

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