Tostran 2 % Gel

Land: Sverige

Sprog: svensk

Kilde: Läkemedelsverket (Medical Products Agency)

Aktiv bestanddel:

testosteron

Tilgængelig fra:

2care4 ApS

ATC-kode:

G03BA03

INN (International Name):

testosterone

Dosering:

2 %

Lægemiddelform:

Gel

Sammensætning:

etanol, vattenfri Hjälpämne; propylenglykol Hjälpämne; testosteron 20 mg Aktiv substans; butylhydroxitoluen Hjälpämne

Recept type:

Receptbelagt

Autorisation status:

Avregistrerad

Autorisation dato:

2017-12-20

Indlægsseddel

PACKAGE LEAFLET:
INFORMATION FOR THE USER
TOSTREX 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 Tostrex is and what it is used for
2.
What you need to know before you use Tostrex
3.
How to use Tostrex
4.
Possible side effects
5.
How to store Tostrex
6.
Contents of the pack and other information
1.
WHAT TOSTREX IS AND WHAT IT IS USED FOR
The active substance, testosterone, is a male hormone, which is a type
of androgen.
Tostrex 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 TOSTREX
Tostrex 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 Tostrex. Tostrex 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 TOSTREX:
If you:
-
are allergic to testosterone or to 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 doct

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tostrex 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 Tostrex 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_
Tostrex 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 application site should be covered, preferably with
loose clothing. Hands should then be
washed with soap and water.
Each full depression of the canister piston delivers one half gr