TOSTRAN

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TESTOSTERONE

Available from:

Kyowa Kirin Ltd

ATC code:

G03BA03

INN (International Name):

TESTOSTERONE

Dosage:

2 %w/w

Pharmaceutical form:

Gel

Prescription type:

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

Therapeutic area:

testosterone

Authorization status:

Marketed

Authorization date:

2006-08-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TOSTRAN 2% GEL
Testosterone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 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 Tostran is and what it is used for
2.
What you need to know before you use Tostran
3.
How to use Tostran
4.
Possible side effects
5.
How to store Tostran
6.
Contents of the pack and other information
1.
WHAT TOSTRAN IS AND WHAT IT IS USED FOR
The active substance, testosterone, is a male hormone, which is a type
of androgen.
Tostran 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
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TOSTRAN
Tostran must only be used if hypogonadism has been confirmed by your
doctor, based on your
symptoms and laboratory tests. Other reasons for your symptoms must
have been excluded by your
doctor prior to the start of treatment.
Only men can use Tostran. Tostran has not been tested in males less
than 18 years of age, and there is
limited experience of treating men older than 65 years of age.
DO NOT USE TOSTRAN:
If you:
-
are allergic to testosterone or any of the other ingredients of this
medicine (listed in section 6.)
-
have or are suspected of having cancer of the breast or prostate
If any of these applies to you, tell your doctor or pharmacis

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tostran 2% Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of gel contains 20 mg testosterone.
One press of the canister piston delivers 0.5 g of gel containing 10
mg
testosterone.
Excipient(s) with known effect:
One gram of gel contains 1 mg butylhydroxytoluene.
One gram of gel contains 350 mg propylene glycol.
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Gel.
Clear, colourless to slightly yellow gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Testosterone replacement therapy for male hypogonadism when
testosterone deficiency has been confirmed by clinical
features and biochemical tests. (see Section 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and Elderly Men_
The recommended starting dose of Tostran is 3 g gel (60 mg of
testosterone) applied once daily at approximately the
same time each morning. Dose titration should be based on both serum
testosterone levels and the existence of clinical
signs and symptoms related to androgen deficiency.
It
should be taken into account
that
physiological
testosterone
levels decline with increasing age.
The daily dose should not exceed 4 g of gel (80 mg testosterone).
_Paediatric Population_
Tostran is not indicated for use in children and has not been
clinically evaluated in males under 18 years of age.
_Method of administration_
For cutaneous use
The dose can be applied to the abdomen (entire dose over an area of at
least 10 by 30 cm), or to BOTH inner thighs (one
half of the dose over an area of at least 10 by 15 cm for each inner
thigh). Daily rotation between the abdomen and
inner thighs is recommended to minimise application site reactions.
The gel should be applied to clean, dry, intact skin. It should be
rubbed in gently with one finger until dry, then the
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