Testogel 50mg/5g transdermal gel sachets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Testosterone

Available from:

Besins Healthcare (UK) Ltd

ATC code:

G03BA03

INN (International Name):

Testosterone

Dosage:

50mg

Pharmaceutical form:

Transdermal gel

Administration route:

Transdermal

Class:

Schedule 4 (CD Anab)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06040200; GTIN: 5016703008590

Patient Information leaflet

TESTOGEL® 50 MG, GEL IN SACHET
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 TESTOGEL
®
is and what it is used for
2.
What you need to know before you use TESTOGEL
®
3.
How to use TESTOGEL
®
4.
Possible side effects
5.
How to store TESTOGEL
®
6.
Content of the pack and other information
1.
WHAT TESTOGEL
® IS AND WHAT IT IS USED FOR
This medicine contains testosterone, a male hormone produced naturally
in the body.
TESTOGEL
®
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,
- regression of masculine characteristics,
- reduced lean body mass,
- inability to have/maintain an erection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TESTOGEL
®
DO NOT USE TESTOGEL
®
- If you are allergic to testosterone or to any of the ingredients of
this medicine. (listed in
section 6),
- If you are suffering from prostate cancer,
- If you are suffering from breast cancer.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using TESTOGEL
®:
-
if you are suffering from epilepsy and/or from migraine, as these
conditions may be made
worse
-
if you have high blood pressure or if
you are treated for high blood pressure, as
testosterone may cause a rise in blood pressure
-
if you are

Summary of Product characteristics

OBJECT 1
TESTOGEL
Summary of Product Characteristics Updated 12-Dec-2017 | Besins
Healthcare (UK) Ltd
1. Name of the medicinal product
TESTOGEL 50 mg, gel in sachet
2. Qualitative and quantitative composition
One sachet of 5 g contains 50 mg of testosterone.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gel in sachet.
Transparent or slightly opalescent, colourless gel in sachet.
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 4.4 Special
warnings and precautions for use).
4.2 Posology and method of administration
Cutaneous use.
_Adult and Elderly men_
The recommended dose is 5 g of gel (i.e. 50 mg of testosterone)
applied once daily at about the same
time, preferably in the morning. The daily dose should be adjusted by
the doctor depending on the clinical
or laboratory response in individual patients, not exceeding 10 g of
gel per day. The adjustment of
posology should be achieved by 2.5 g of gel steps.
The application should be administered by the patient himself, onto
clean, dry, healthy skin over both
shoulders, or both arms or abdomen.
After opening the sachets, the total contents must be extracted from
the sachet and applied immediately
onto the skin. The gel has just to be simply spread on the skin gently
as a thin layer. It is not necessary to
rub it on the skin. Allow drying for at least 3-5 minutes before
dressing. Wash hands with soap and water
after applications.
Do not apply to the genital areas as the high alcohol content may
cause local irritation.
Steady state plasma testosterone concentrations are reached
approximately on the 2
nd
day of treatment by
Testogel. In order to adjust the testosterone dose, serum testosterone
concentrations must be measured in
the morning before application from the 3
rd
day on after starting treatment (one week seems reasonable).
The dose may be reduced if the plasma testosterone concentrat