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PRO-VIRON

Active substance(s): MESTEROLONE

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In this leaflet:
1. What Pro-Viron is and what it is used for
2. Before you take Pro-Viron
3. How to take Pro-Viron
4. Possible side effects
5. How to store Pro-Viron
6. Further information

Read all of this leaflet carefully before you start
taking this medicine.
R Keep this leaflet. You may need to read it again.
R If you have any further questions, ask your
doctor or pharmacist.
R This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.
R 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.

Mesterolone

Pro-Viron®
25mg tablet

Package Leaflet: Information
for the user

Take special care with Pro-Viron:
R You will have regular examinations of the
prostate while taking Pro-Viron to rule out the
possibility of prostate cancer. This is because
Pro-Viron may increase the growth rate of this
type of cancer.

Do not take Pro-Viron if:
R you are allergic (hypersensitive) to mesterolone
or any of the other ingredients of Pro-Viron (see
Section 6: Further Information)
R you have prostate cancer
R you have (or have had) a liver tumour.

2. Before you take Pro-Viron

What is Pro-Viron used for?
R Pro-Viron is used in men who do not naturally
produce enough androgens (male hormones).
R It is also used in men who are infertile due to
low levels of male hormones (caused by
hypogonadism, inadequate functioning of the
testes).

What is Pro-Viron?
Pro-Viron is a medicine containing mesterolone.
It is a form of androgen (male hormone) therapy.

1. What Pro-Viron is and what it is used for


Packaging Technology Berlin dy
page 1
Bayer Pharma AG
client: 0086
item-no.: 84365718
PZ: 2597F-4
code-no.: 600
name: LF-Pro-Viron 25MG TAB
country: GB/-/BPH
colors: Black
version: 26.11.2014/03
approval:
dimension: 160 x 297 mm

Please turn over

R Using hormones, such as the one in Pro-Viron,
has rarely been linked to benign
(non-malignant) liver tumours. Very rarely, using
hormones has been associated with some forms
of liver cancer (malignant liver tumours). Liver
tumours may lead to bleeding in the abdomen,
which can be life-threatening. If you have any
new “stomach” discomfort or pain that does
not go away quickly, you must tell your
doctor straight away.
R Pro-Viron is not suitable for body-building,
increasing muscles in healthy men or for
increasing other physical ability.
R Pro-Viron should be taken by men only.
Taking or using other medicines
Please tell your doctor if you are taking or have
recently taken any other medicines, including
medicines obtained without a prescription.
Driving and using machines
Taking Pro-Viron is not thought to have any effect
on driving or using machines.
Important information about some of the
ingredients in Pro-Viron
R If you have been told by your doctor that you
cannot tolerate or digest some sugars, tell your
doctor before you start taking Pro-Viron. This is
because it contains lactose (a type of sugar).
R Pro-Viron contains methyl and propyl parabens
which may cause allergic reactions (possibly
delayed).

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Like all medicines, Pro-Viron can cause side effects,
although not everybody gets them.
R Discomfort or pain in your “stomach”
(abdomen)
If you get pain or discomfort in your “stomach” or
abdomen that does not go away quickly, tell your

4. Possible side effects

Always take Pro-Viron exactly as your doctor has
told you. Ask your doctor or pharmacist if you are
not sure.
R The usual amount is one tablet, taken 3 or 4
times a day.
R Swallow the tablet whole with a drink of water.
After you have taken Pro-Viron for a few months,
your doctor may decide to reduce the number of
tablets you need to take each day.
If you take more Pro-Viron than you should
Talk to your doctor who will tell you what you need
to do. There have been no reports of serious illness
from taking too much Pro-Viron.
If you forget to take Pro-Viron
Do not take a double dose to make up for a
forgotten tablet. When you remember, take the next
dose and continue with the tablets as normal.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

3. How to take Pro-Viron

R Keep this medicine out of the sight and reach of
children.
R Do not use Pro-Viron after the expiry date which
is stated on the box after the letters ‘EXP’. The
expiry date refers to the last day of that month.
R Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

5. How to store Pro-Viron

doctor straight away. (See Section 2: Before you
take Pro-Viron).
R Frequent erections or erections that do not go
away
If you get unusually frequent erections or erections
that do not easily go away, tell your doctor. Your
doctor may ask you to stop taking Pro-Viron in
order to avoid injury to your penis.
Talk to your doctor if you notice any change in
your health or general sense of well-being when
taking Pro-Viron.
Reporting of side effects
If you get any side effects, talk to your doctor. This
includes any possible side effects not listed in this
leaflet. You can also report side effects directly via
the Yellow Card Scheme at: www.mhra.gov.uk/
yellowcard. By reporting side effects you can help
provide more information on the safety of this
medicine.

6. Further Information

84365718

Packaging Technology Berlin dy
page 2
Bayer Pharma AG
client: 0086
item-no.: 84365718
PZ: 2597F-4
code-no.: 600
name: LF-Pro-Viron 25MG TAB
country: GB/-/BPH
colors: Black
version: 26.11.2014/03
approval:
dimension: 160 x 297 mm

What Pro-Viron contains
R The active substance is mesterolone.
Each tablet contains 25mg of mesterolone.
R The other ingredients are lactose, maize starch,
povidone (E1201), methylparaben (E218),
propylparaben (E216) and magnesium stearate
(E572).
What Pro-Viron looks like and contents of the
pack
Each pack of Pro-Viron contains 3 strips of 10 white
tablets.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA United Kingdom
Manufacturer:
Bayer Pharma AG
Berlin
Germany
or
Bayer Weimar GmbH &Co KG
Weimar
Germany
This leaflet was last revised: November 2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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