Skip to Content

UK Edition. Click here for US version.

TESTOSTERONE PROPIONATE 100 MG/2 ML SOLUTION FOR INJECTION

Active substance(s): TESTOSTERONE PROPIONATE

View full screen / Print PDF » Download PDF ⇩
Transcript
VIRORMONE 100MG/2ML INJECTION
Testosterone Propionate
Package Leaflet:
INFORMATION FOR THE USER
Read all of this leaflet carefully before you start using this medicine.
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. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. WHAT VIRORMONE INJECTION IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE VIRORMONE INJECTION
3. HOW TO USE VIRORMONE INJECTION
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE VIRORMONE INJECTION
6. FURTHER INFORMATION
1. WHAT VIRORMONE INJECTION IS AND WHAT IT IS USED FOR
The name of your medicine is Virormone 100mg/2ml Injection. The active ingredient of Virormone
Injection is testosterone propionate (a form of the hormone testosterone which is produced
naturally by the body in both men and women). Each ampoule of Virormone Injection contains
100mg of testosterone propionate in 2ml of liquid.
Virormone Injection 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
It may also be prescribed in men to treat the following conditions :•


Delayed puberty
Testicles which have not dropped (undescended testicles)

It may also be prescribed in women to treat breast cancer after the menopause.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE VIRORMONE INJECTION
Do not use Virormone Injection if









you are a man suffering from cancer of the breast
you are a man suffering from cancer of the prostate
you suffer, or have suffered, from cancer of the liver
you are pregnant, or likely to become pregnant
you are breast feeding
you suffer from a disease of the kidney called nephrosis
you have been told by your doctor that you have high levels of calcium in your blood or in your
urine
you have an allergy to any of the ingredients of Virormone Injection

Tell your doctor if any of the above conditions apply to you, before you use Virormone Injection.
Take Special Care with Virormone Injection if








you have high blood pressure, if you suffer from heart failure or have other heart disease ·
you are diabetic
you have reduced liver function
you have reduced kidney function
you are epileptic
you suffer, or have suffered, from migraine
you have cancer affecting the bone
If you are suffering from severe heart, liver or kidney disease, treatment with Virormone
Injection may cause severe complications in the form of water retention in your body
sometimes accompanied by (congestive) heart failure.
The following blood checks should be carried out by your doctor before and during the
treatment: testosterone blood level, full blood count.
Tell your doctor if you have high blood pressure as testosterone may cause a rise in blood
pressure.
Check with your doctor if you are concerned about any of the above.

Children and Adolescents
Safety and efficacy have not been adequately determined in children and adolescents.
Taking other medicines
Please inform your doctor or pharmacist if you are taking, or have recently taken, any other
medicine - even those which your doctor has not prescribed for you, but which you may have bought
yourself without a prescription.
Before using Virormone Injection please check with your doctor if you are taking any of the
following:•


anticoagulants (medicines used to thin the blood, e.g. warfarin, acenocoumarol or phenindione)
medicines used to treat diabetes

Pregnancy and breast-feeding
Do not use Virormone Injection if you are pregnant or breast feeding.
Driving and using machines
It is not known whether Virormone Injection affects your ability to drive or operate machinery. Do
not drive or operate machinery if you feel sleepy after using Virormone Injection.
3. HOW TO USE VIRORMONE INJECTION
The injection will be given to you by a doctor or nurse. The number of injections given to you per day
or per week is called the ‘dose’. Depending on which condition you are being treated for, the doctor
will give the appropriate dose by injection into a muscle.
The most common dose for men with hypogonadism (failure to produce sperm or sex hormones) is
50mg of testosterone propionate given as an injection two or three times a week.
The most common dose for men with delayed puberty or with testicles which have not descended is
50mg of testosterone propionate given as an injection once a week.
The most common dose for women with breast cancer following the menopause is 100mg of
testosterone propionate given as an injection two or three times a week.
The correct dose will have been decided by your doctor. If you are not sure ask your doctor.
Elderly male patients may be prescribed lower doses.
If you think that you have missed a dose or have been given too much Virormone Injection
If you think that you have missed a dose or have been given too much Virormone Injection, please
tell a nurse or doctor.
During treatment of men with Virormone Injection, your doctor will carry out regular checks of your
prostate.
The results of some laboratory tests (such as tests for glucose tolerance or thyroid function) may be
affected by Virormone Injection. Tell your doctor that you are using Virormone Injection if you are
asked to take any laboratory tests.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Virormone Injection can cause side effects, although not everybody gets them.
Increase in red blood cell count, haematocrit (percentage of red blood cells in blood) and
haemoglobin (the component of red blood cells that carries oxygen), identified by periodic blood
tests, are common side effects (may affect up to 1 in 10 patients).
The following effects that can occur in men :Acne, hirsutism (abnormal growth of body hair), voice changes, loss of hair on the head.
Advanced sexual development in boys before puberty (increased number and duration of erections).
Reduction in sperm production, painful and unwanted erections, changes in libido (sexual desire).
Changes in sodium and calcium levels in the blood with fluid retention (swelling and weight increase
due to retained water in the body).
Headache, depression, stomach upset, nausea (feeling sick), enlarged breasts, anxiety, irritability,
nervousness, increased bone growth, weakness, a general sensation of prickling or burning, jaundice

(yellowing of the eyes or skin), muscle cramps, itchiness, pain in the joints, blood disorder affecting
red blood cells.
The following effects that can occur in women :Masculine features may develop in women on high doses.
Very rarely, cancer of the liver can occur in both men and women and prostate problems can occur
in men.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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/yellowcardBy reporting side effects you can help provide more information on
the safety of this medicine.
5. HOW TO STORE VIRORMONE INJECTION
Keep out of the reach and sight of children.
Store your medicine in the original package. Do not store above 25°C.
On the label you will find the letters “EXP” followed by some numbers. These numbers are the date
when the medicine is no longer fit for use. Do not use this medicine after this date.
Medicines should not be disposed of via waste water or household waste.
Ask your pharmacist how to dispose of medicines which you no longer require. These measures will
help to protect the environment.
6. FURTHER INFORMATION
What Virormone Injection contains
Each ampoule contains 100 mg of the active ingredient testosterone propionate in 2ml of liquid.
The ampoule also contains ethyl oleate.
What Virormone Injection looks like and contents of the pack
Virormone Injection is a sterile, pale yellow oily liquid. It is supplied in clear glass ampoules in packs
containing 10 ampoules.
Marketing Authorisation Holder
DHP Healthcare Ltd., Maidstone, Kent, ME15 9RS United Kingdom.
Manufacturer Recipharm Limited, Vale of Bardsley, Ashton-under-Lyne, OL7 9RR, United Kingdom
This leaflet was last revised in March 2015.

Expand view ⇕

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.

Hide