Restandol Testocaps 40 mg soft capsules

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

TESTOSTERONE UNDECANOATE

Доступна с:

Merck Sharp & Dohme Ireland (Human Health) Limited

код АТС:

G03BA; G03BA03

ИНН (Международная Имя):

TESTOSTERONE UNDECANOATE

дозировка:

40 milligram(s)

Фармацевтическая форма:

Capsule, soft

Тип рецепта:

Product subject to prescription which may not be renewed (A)

Терапевтические области:

3-oxoandrosten (4) derivatives; testosterone

Статус Авторизация:

Not marketed

Дата Авторизация:

1978-11-24

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE USER
Restandol
®
Testocaps
™
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 further questions, please 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.
See section 4.
WHAT IS IN THIS LEAFLET:
1.
WHAT RESTANDOL TESTOCAPS ARE AND WHAT THEY ARE 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 ARE AND WHAT THEY ARE USED FOR
Restandol Testocaps are soft oval glossy capsules which contain 40mg
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.
In men testosterone is produced by the testicles. It is necessary for
the normal growth,
development and function of the male sex organs and for secondary male
sex characteristics.
It is necessary for the growth of body hair, the development of bones
and muscles, the
distribution of fat, and it stimulates the production of red blood
cells. It also makes men’s
voices deepen.
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.
It may also be used t

Характеристики продукта

Health Products Regulatory Authority
19 February 2020
CRN009JG5
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Restandol Testocaps 40 mg soft capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 40.0 mg of testosterone undecanoate, which is
equivalent to 25.3 mg testosterone.
Excipients with known effect: Includes 0.07mg Sunset Yellow (E110) per
capsule and propylene glycol monolaurate.
This medicine contains 117.2 mg propylene glycol monolaurate in each
capsule. This quantity corresponds to 34.5 mg
propylene glycol which is equivalent to 0.5 mg/kg.
Restandol Testocaps may contain trace amounts of soya lecithin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Soft capsule. (Short term capsule)
Soft oval glossy capsule, transparent, orange in colour, with a yellow
oily fill, with imprint ‘Org DV3’ in white.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Testosterone replacement therapy for male hypogonadism, when
testosterone deificiency has been confirmed by clinical
features and biochemical tests. In osteoporosis due to androgen
deficiency in males.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Initiation of testosterone therapy and its overall direction should
only be carried out by specialists.
Testosterone therapy should only be used in male hypogonadism in which
testosterone levels have been demonstrated to be
low.
POSOLOGY:
_ _
In general, the dose should be adjusted according to the response of
the individual patient.
Should be used only if hypogonadism (hyper- and hypogonadotrophic) has
been demonstrated, and if other aetiology,
responsible for the symptoms, has been excluded before treatment is
started. Testosterone insufficiency should be clearly
demonstrated by clinical features (regression of secondary sexual
characteristics, change in body composition, asthenia,
reduced libido, erectile dysfunction etc.) and confirmed by 2 separate
blood testosterone measurements.
Dosage
Adults (incl. elderly):
The initial dosage require