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DHP TESTOS Ing PIL V9_Layout 1 30/03/2015 16:07 Page 1

4. POSSIBLE SIDE EFFECTS

Like all medicines, Testosterone 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.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE TESTOSTERONE 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 Testosterone Injection contains

Each ampoule contains 100 mg of the active ingredient testosterone propionate in 2 ml of liquid.

The ampoule also contains ethyl oleate.

What Testosterone Injection looks like and contents of the pack

Testosterone Injection is a sterile, pale yellow oily liquid. It is supplied in dear glass ampoules in packs containing 10 ampoules.

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/yellowcard.

Marketing Authorisation Holder

DHP Healthcare Ltd.,

Maidstone, Kent, ME15 9RS United Kingdom Manufacturer

Recipharm Limited,Vle of Bardsley, Ashton-under-Lyne, OL7 9RR,

United Kingdom

This leaflet was prepared in March 2015.

1. WHAT TESTOSTERONE INJECTION IS AND WHAT IT IS USED FOR

The name of your medicine is Testosterone Propionate 100 mg/2 ml Solution for Injection and is referred to as 'Testosterone Injection' in this leaflet.

The active ingredient ofTestosterone 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 Testosterone Injection contains 100 mg of testosterone propionate in 2 ml of liquid.

Testosterone 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

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 TESTOSTERONE INJECTION

Do not use Testosterone 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 ofTestosterone Injection

Tell your doctor if any of the above conditions apply to you, before you use Testosterone Injection.

Take Special Care with Testosterone 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 Testosterone 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 Testosterone 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 Testosterone Injection if you are pregnant or breast feeding.

Driving and using machines

It is not known whether Testosterone Injection affects your ability to drive or operate machinery. Do not drive or operate machinery if you feel sleepy after using Testosterone Injection.

3. HOW TO USE TESTOSTERONE INJECTION

The most common dose for men with hypogonadism (failure to produce sperm or sex hormones) is 50 mg 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 50 mg of testosterone propionate given as an injection once a week.

The most common dose for women with breast cancer following the menopause is 100 mg 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 Testosterone Injection

If you think that you have missed a dose or have been given too much Testosterone Injection, please tell a nurse or doctor.

During treatment of men with Testosterone 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 Testosterone Injection. Tell your doctor that you are using Testosterone Injection if you are asked to take any laboratory tests.