Medication Guide App

RESTANDOL 40MG

Active substance: TESTOSTERONE UNDECANOATE

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Read all of this leaflet carefully before you start taking this
medicine.
• 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. Do not pass it
on to others. It may harm them, even if their symptoms are
the same as yours.
• If any of the side effect gets serious or if you notice any
side effects not listed in this leaflet, please tell your doctor
or your pharmacist.
In this leaflet:
1. What Restandol Testocaps are and what are they used for
2. Before you take Restandol Testocaps
3. How to take Restandol Testocaps
4. Possible side effects
5. How to store Restandol Testocaps
6. Further information
1. What Restandol Testocaps are and what are they used for

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Testosterone undecanoate

40MG CAPSULES, SOFT

RESTANDOL ®
TESTOCAPS ™

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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. Before you take Restandol Testocaps
Do not take Restandol Testocaps
• If you are allergic (hypersensitive) to testosterone
undecanoate or any of the ingredients of Restandol Testocaps
• If you have prostate cancer
• If you have breast cancer
• If you have ever had liver cancer

Take special care with Restandol Testocaps:
Extra supervision by your doctor may sometimes be necessary;
particularly if you are elderly. In men over the age of 45, the
prostate gland will be investigated by digital rectal
examination (DRE) of the prostate and by determination of the
serum prostate-specific antigen (PSA) via blood tests.
➞Tell your doctor if you have ever had:
• heart disease
• kidney disease
• liver disease
• high blood pressure
• epilepsy
• migraine
• prostatic complaints, such as problems passing urine
• cancer of the lungs, kidney, breast or bones
➞Also tell your doctor
• if you are diabetic or
• if you are taking anticoagulants (drugs to treat blood clots)
Your medication may need to be monitored more closely.
Children and adolescents
Safety and efficacy have not been adequately determined in
children and adolescents.
Extra supervision by the doctor is necessary in the treatment
of young boys since male hormones may cause early sexual
development and delay growth.
Extra supervision by a doctor is also necessary in elderly men
since male hormones may increase the size of the prostate
gland. Furthermore, at regular intervals, blood tests will be
done to check the oxygen-carrying substance in your red
blood cells (hemoglobin).
In very rare cases the number of red blood cells will increase
too much leading to complications.
Taking other medicines
Other medicines may affect how Restandol Testocaps works or
Restandol Testocaps may affect how they work.
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.

Restandol Testocaps may also affect how drugs used to treat
diabetes and blood clots work.
Please tell your doctor or pharmacist if you are using (or intend
to use anti-diabetic, anti-clotting medicines, the hormone ACTH
or corticosteroids (used to treat various conditions such as
rheumatism, arthritis, allergic conditions and asthma): Restandol
Testocaps may increase the risk of water retention, especially if
your heart and liver are not working properly.
Restandol testocaps may also affect the results of some
laboratory tests (e.g. thyroid gland). Tell your doctor or laboratory
staff that you are using Restandol Testocaps.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.
Taking Restandol Testocaps with food and drink
Food allows testosterone undecanoate to be absorbed by your
body.
➞Therefore, Restandol Testocaps must be taken with a
normal meal.
Pregnancy and breast-feeding
Restandol Testocaps must not be taken during pregnancy or
when you are breast feeding.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
As far as is known Restandol Testocaps have no adverse
effect on alertness or concentration.
Important information about some of the ingredients of
Restandol Testocaps
The capsules also contain:
Glycerin which is harmful in high doses and may cause
headache, stomach upset or diarrhoea.
Sunset yellow (E110) which can cause allergic type reactions
including asthma. Allergy is more common in those people
who are allergic to aspirin.
3. How to take Restandol Testocaps
Always take Restandol Testocaps exactly as your doctor has
told you. You should check with your doctor or pharmacist if
you are not sure.

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Technical Info

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Adults
Usually, the dosage 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 Restandol Testocaps 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
Evening
1
0
1
1
2
1
2
2

Elderly
Smaller doses, taken less often, may be given if you are
elderly.
Your doctor will have chosen the correct dose for you.
Children
Restandol Testocaps should not be given to children who have
not reached puberty.
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 have any further questions on the use of the product,
ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Restandol Testocaps can have side effects,
although not everybody gets them.

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Mild side effects include:
• headache
• dizziness
• diarrhoea
Other side effects that may occur during testosterone therapy
are:
• rash
• nausea (feeling sick)
• yellowing of the skin or eyes
• increased or decreased sex drive
• depression
• nervousness
• mood disturbances
• muscle pain
• high blood pressure
• changes in the way your body processes fats
• increase in the number of red blood cells
• problems with your liver including liver tumours, though this
is rare.
• allergy to sunset yellow, a colour used in the capsules.

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6. Further information
What Restandol Testocaps contains
• The active substance is testosterone undecanoate, 40 mg
per capsule.
• The other ingredients are:
- castor oil,
- propylene glycol laurate (E477),
- gelatin,
- medium-chain triglycerides,
- lecithin and
- printing ink ‘Opacode WB white’.
- glycerin,
- Sunset Yellow (E110)
What Restandol Testocaps looks like and contents of the pack
The capsules are transparent and orange in colour. They are
oval in shape with a glossy, transparent, orange appearance.
They are filled with a yellow oil.
A box of Restandol Testocaps contains either 3 or 6 sachets.
Each sachet contains a blister strip with 10 capsules.
Marketing Authorisation Holder and Manufacturer

In men, enlargement of the breasts, growth of the prostate
gland, worsening of the early stage of prostate cancer,
difficulty passing urine, prolonged painful erection, decreased
amounts of ejaculation fluid and sperm.

Marketing Authorisation Holder:
Merck Sharp & Dohme Limited,
Hertford Road, Hoddesdon,
Hertfordshire, EN11 9BU, UK

In women, increase in facial or body hair, acne, no or lighter
periods and voice changes which may not return to normal.

Manufacturer:
N.V. Organon, Kloosterstraat 6
5349 AB Oss, The Netherlands

In children, early sexual development and delayed bone growth.
In a few patients stomach pain or discomfort have been
reported during the use of Restandol Testocaps.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
5. How to store Restandol Testocaps
Keep out of the reach and sight of children.
Do not use Restandol Testocaps after the expiry date stated on
the package, sachet and blister.
Do not store above 30 °C. Do not refrigerate or freeze.
Keep the blister in the outer carton. 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.

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)
Please be ready to give the following information:
Product name
Restandol Testocaps,

40 mg Capsules, Soft
Reference number 00025/0595
This is a service provided by the Royal National Institute of
Blind People.
This leaflet was last updated in July 2013

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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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