ANDRIOL TESTOCAPS testosterone undecanoate 40mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

testosterone undecanoate, Quantity: 40 mg

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

Pharmaceutical form:

Capsule, soft

Composition:

Excipient Ingredients: propylene glycol monolaurate; hydrogenated castor oil; medium chain triglycerides; Gelatin; sunset yellow FCF; lecithin; glycerol; titanium dioxide; propylene glycol; ethyl acetate; isopropyl alcohol; purified water; ethanol; strong ammonia solution; polyvinyl acetate phthalate; macrogol 400

Administration route:

Oral

Units in package:

120 capsules, 60 capsules, 30 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Androgen replacement therapy for confirmed testosterone deficiency in males, when testosterone deficiency has been confirmed by clinical features and biochemical tests.

Product summary:

Visual Identification: Intact soft oval (No. 6) glossy transparent, orange coloured capsule containing a clear yellow oily fill. The capsules are marked ORG DV3 in white ink.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2003-07-16

Patient Information leaflet

ANDRIOL
® TESTOCAPS
®
A
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R
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O
L
®
T
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T
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®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ANDRIOL TESTOCAPS?
Andriol Testocaps contains the active ingredient Testosterone
Undecanoate. Andriol Testocaps is used in adult men for testosterone
replacement to treat various health problems caused by lack of
testosterone.
For more information, see Section 1. Why am I using Andriol Testocaps?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ANDRIOL TESTOCAPS?
Do not use if you have ever had an allergic reaction to Andriol
Testocaps or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Andriol Testocaps? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Andriol Testocaps and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ANDRIOL TESTOCAPS?
•
Take the capsules daily, as directed by your doctor. Andriol Testocaps
are to be swallowed after the morning and evening meal.
•
Swallow the capsules whole with some water or other drink. Do not chew
them.
More instructions can be found in Section 4. How do I use Andriol
Testocaps? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ANDRIOL TESTOCAPS?
THINGS YOU
SHOULD DO
•
Stop taking Andriol Testocaps if you develop jaundice (yellowing of
the eyes or skin).
•
Keep your appointments with your doctor to regularly examine your
prostate gland.
•
Keep your appointments with your doctor to do blood tests to check
your red blood cells (haemoglobin)
and testosterone blood levels
THINGS YOU
SHOULD NOT DO
•
Do not give Andriol Testocaps to anyone else, even if they have th

Summary of Product characteristics

Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION
Andriol
®
Testocaps
®
(testosterone undecanoate) soft capsule
1
NAME OF THE MEDICINE
Testosterone undecanoate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 40.0 mg testosterone undecanoate, which is
equivalent to 25.3 mg
testosterone.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Soft oval glossy, transparent orange coloured gelatin capsules,
containing a clear yellow oil
fill. The capsules are encoded with a white imprint marked ORG DV3.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Androgen replacement therapy for confirmed testosterone deficiency in
males, when
testosterone deficiency has been confirmed by clinical features and
biochemical tests.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULTS INCLUDING ELDERLY
Andriol Testocaps must be taken orally with the morning and evening
meal.
The capsules should be taken with some fluid and swallowed whole
without chewing.
If an uneven number of capsules are to be taken, the greater dose
should be taken in the
morning.
The dosage of Andriol Testocaps should be determined by the physician
according to the
severity of the symptoms.
The initial dose is usually 120-160 mg/day for 2-3 weeks.
Subsequent dosage (40-120 mg/day) should be based on the clinical
effect obtained in the
first weeks of therapy.
Responses to dosage should be more closely monitored in those patients
referred to under
Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE.
In general, the dose should be adjusted according to the response of
the individual patient.
PAEDIATRIC 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.
Page 2 of 13
4.3
C
ONTRAINDICATIONS
•
Like any androgen therapy testosterone undecanoate is contraindicated
in male patients
with known or suspected carcinoma of the prostate gland or breast.
•
Patients with nephrosis or nephrotic phase of