Restandol 40mg Testocaps

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Testosterone undecanoate

Available from:

Organon Pharma (UK) Ltd

ATC code:

G03BA03

INN (International Name):

Testosterone undecanoate

Dosage:

40mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

Schedule 4 (CD Anab)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06040200; GTIN: 5013257001824 5013257001831

Patient Information leaflet

RESTANDOL
® TESTOCAPS
TM
40MG CAPSULES, SOFT
TESTOSTERONE UNDECANOATE
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 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

Summary of Product characteristics

OBJECT 1
RESTANDOL TESTOCAPS 40 MG CAPSULE, SOFT
Summary of Product Characteristics Updated 15-Dec-2016 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
Restandol
®
Testocaps
TM
40 mg capsule.
2. Qualitative and quantitative composition
Each capsule contains Testosterone Undecanoate 40.0 mg which is
equivalent to 25.3 mg testosterone.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule
Soft oval, glossy capsules, transparent, orange in colour, with a
yellow oily fill.
4. Clinical particulars
4.1 Therapeutic indications
Clinical Indications
Testosterone replacement therapy for male hypogonadism, when
testosterone deficiency has been
confirmed by clinical features and biochemical tests.
Examples of hypogonadal disorder are:
after castration;
eunuchoidism;
hypopituitarism;
endocrine impotence;
male climacteric symptoms like decreased libido and decreased mental
and physical activity;
certain types of infertility due to disorders of spermatogenesis
Testosterone therapy may also be indicated in osteoporosis due to
androgenic deficiency.
4.2 Posology and method of administration
Posology
In general, the dose should be adjusted according to the response of
the individual patient.
Adults
The initial dosage required will usually be 120-160 mg daily for 2-3
weeks. Subsequent dosage (40-120
mg daily) should be based on the clinical effect obtained during the
first weeks of therapy.
Elderly Patients
It should be noted that smaller and less frequent doses may achieve
the same response.
Paediatric population
Safety and efficacy has not been determined in children and
adolescents. Pre-pubertal children treated
with Restandol Testocaps should be treated with caution (see section
4.4).
METHOD OFADMINISTRATION
Oral.
To ensure absorption, Restandol Testocaps must be taken with a normal
meal, if necessary with a little
fluid, and be swallowed whole without chewing. It is preferable that
half of the daily dose be taken in the
morning and the other half in the evening. If an uneven number of