Testogel 16.2mg/g gel

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:

16.2mg/1gram

Pharmaceutical form:

Transdermal gel

Administration route:

Transdermal

Class:

Schedule 4 (CD Anab)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06040200; GTIN: 5060385020074

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TESTOGEL
® 16.2 MG/G 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 TESTOGEL
®
16.2 mg/g is and what it is used for
2.
What do you need to know before you use TESTOGEL
®
16.2 mg/g
3.
How to use TESTOGEL
®
16.2 mg/g
4.
Possible side effects
5.
How to store TESTOGEL
®
16.2 mg/g
6.
Contents of the pack and other information
1.
WHAT TESTOGEL
® 16.2 MG/G IS AND WHAT IT IS USED FOR
This medicine contains testosterone, a male hormone produced naturally
in the body.
TESTOGEL
®
16.2 mg/g 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 TESTOGEL
® 16.2 MG/G
DO NOT USE TESTOGEL
® 16.2 MG/G
-
if you have or are suspected of having prostate cancer
-
if you have or are suspected of having breast cancer
-
if you are allergic to testosterone or any of the other ingredients of
this medicine (listed in
section 6)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using TESTOGEL
®
16.2 mg/g.
Before starting any treatment with TESTOGEL
®
16.2 mg/g, your testosterone deficiency must be
clearly demonstrated by clinical signs (regression of masculine
characteristics,

Summary of Product characteristics

OBJECT 1
TESTOGEL 16.2MG/G GEL
Summary of Product Characteristics Updated 23-Jan-2018 | Besins
Healthcare (UK) Ltd
1. Name of the medicinal product
TESTOGEL 16.2 mg/g gel
2. Qualitative and quantitative composition
One gram of gel contains 16.2 mg testosterone. One pump actuation
delivers 1.25 g of gel containing
20.25 mg of testosterone.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gel
Transparent or slightly opalescent, colourless gel.
4. Clinical particulars
4.1 Therapeutic indications
TESTOGEL 16.2 mg/g is indicated in adults as 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
Transdermal use.
_Adult and elderly men_
The recommended dose is two pump actuations of gel (_i.e._ 40.5 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 four pump
actuations or 81 mg testosterone per day. The adjustment of posology
should be achieved by increments
of one pump actuation of gel.
The dose should be titrated based on the pre-dose morning testosterone
blood levels. Steady state blood
testosterone levels are reached usually by the second day of treatment
with TESTOGEL 16.2 mg/g. In
order to evaluate the need to adjust the testosterone dosage, blood
testosterone levels should be measured
in the morning before application of the product, after the steady
state is reached. Testosterone blood
levels should be assessed periodically. The dose may be reduced if the
testosterone blood levels are raised
above the desired level. If the levels are low, the dosage may be
increased stepwise, to a daily
administration of 81 mg of testosterone (four actuations of gel) per
day.
Therapy should be discontinued if the blood testosterone levels
consistently