ANDRIOL TESTOCAPS
Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Patient Information leaflet
(PIL)
19-12-2013
Summary of Product characteristics
(SPC)
10-03-2020
Active ingredient:
TESTOSTERONE UNDECANOATE
Available from:
MSD PHARMA (SINGAPORE) PTE. LTD.
ATC code:
G03BA03
Dosage:
40 mg
Pharmaceutical form:
CAPSULE, LIQUID FILLED
Composition:
TESTOSTERONE UNDECANOATE 40 mg
Administration route:
ORAL
Prescription type:
Prescription Only
Manufactured by:
CATALENT FRANCE BEINHEIM SA
Authorization status:
ACTIVE
Authorization date:
1990-05-23
Patient Information leaflet
CCDS-MK3033-CP-112012
ANDRIOL TESTOCAPS
RA 141 CCDS 7 (ref 45.0)
Capsule
1. Name of the medicinal product
Andriol
®
Testocaps
®
40 mg capsules
2. Qualitative and quantitative composition
Andriol Testocaps contain testosterone undecanoate, a
fatty acid ester of the natural hormone testosterone.
Each capsule contains 40 mg testosterone undecanoate dissolved
in a mixture of castor oil and propylene
glycol laurate.
For excipients, see 6.1.
3. Pharmaceutical form
Capsules. Soft oval glossy capsules, transparent, orange
in colour, coded ORG DV3 containing a yellow oily
fill.
4. Clinical particulars
4.1 Therapeutic indications
In males: testosterone
replacement therapy for primary or secondary hypogonadal disorders, for example:
• after castration
• eunuchoidism
• hypopituitarism
• endocrine impotence
• certain types of infertility due to
spermatogenic disorders
• male climacteric symptoms such as decreased libido and decreased feeling of general well-being and
fitness
Moreover, in men testosterone therapy may be indicated in osteoporosis caused by androgen deficiency.
4.2 Posology and method of administration
Posology
In general, dosage should be adjusted according to the response of the individual patient.
Adult (including elderly)
Usually, an
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Summary of Product characteristics
S-CCDS-MK3033-CP-052017
ANDRIOL TESTOCAPS
Capsule
1. Name of the medicinal product
Andriol® Testocaps® 40 mg capsules
2. Qualitative and quantitative composition
Andriol Testocaps contain testosterone undecanoate, a fatty acid ester
of the natural hormone testosterone.
Each capsule contains 40 mg testosterone undecanoate dissolved in a
mixture of castor oil and propylene
glycol laurate.
For excipients, see 6.1.
3. Pharmaceutical form
Capsules
Soft oval glossy capsules, transparent, orange in colour, coded ORG
DV3 containing a yellow oily fill.
4. Clinical particulars
4.1 Therapeutic indications
In males: testosterone replacement therapy associated with primary or
secondary hypogonadal disorders,
(either congenital or acquired) when testosterone deficiency has been
confirmed by clinical features and
biochemical tests.
Examples of hypogonadal disorder are:
•
after castration
•
eunuchoidism
•
hypopituitarism
•
endocrine impotence
•
certain types of infertility due to spermatogenic disorders
•
male climacteric symptoms such as decreased libido and decreased
feeling of general well-being and
fitness
Moreover, in men testosterone therapy may be indicated in osteoporosis
caused by androgen deficiency.
4.2 Posology and method of administration
Posology:
In general, dosage should be adjusted according to the response of the
individual patient.
Adult (including elderly):
Usually, an initial dosage of 120–160 mg testosterone undecanoate
daily for 2–3 weeks is adequate,
followed by a maintenance dosage of 40–120 mg testosterone
undecanoate daily.
Pediatric population:
Safety and efficacy have not been adequately determined in children
and adolescents. Pre-pubertal children
treated with Andriol Testocaps should be treated with caution (see
section 4.4).
Method of administration:
Andriol Testocaps must be taken with a meal, with some fluid and
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 odd
number of capsules
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