Testogel 50mg Gel In Sachet

Document: leaflet MAH BRAND_PLPI 15184-1509 change

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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.aov.uk/vellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

Manufacturer and Licence Holder

Manufactured by Besins Manufacturing Belgium, Groot Bijgaardenstraat 128, 1620 Drogenbos, Belgium, and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 ORE.

15184/1509

Q How to store Testogel

• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN

• This medicinal product does not require any special storage conditions.

• Do not use this medicine after the expiry date shown on the sachet and carton label. The expiry date refers to the last day of that month.

• If your doctor tells you to stop using this medicine, return any unused medicine to your pharmacist (chemist) for safe disposal. Only keep this medicine, if your doctor tells you to.

• If your medicine becomes discoloured or show any other signs of deterioration, ask your pharmacist who will advise you what to do

• 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.

Testogel is a registered trademark of Besins Healthcare Luxembourg S.A.R.L.

Leaflet revision date: 09/02/15

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: 01527 505414 for help.

Q Further information

What Testogel contains

The active substance is testosterone.

Each sachet contains 50mg of testosterone in 5g of gel.

The other ingredients are carbopol 980, isopropyl myristate, ethanol 96%, sodium hydroxide and purified water.

What Testogel looks like

Testogel is a transparent or slightly opalescent, colourless gel in sachet. Each pack contains 30 sachets.

Testogel ®50mg gel in sachet

(testosterone)

Patient Information Leaflet

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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Your medicine is called Testogel 50mg gel in sachet and will be referred to as Testogel throughout the rest of this leaflet.

In this leaflet:

Q What Testogel is and what it is used for Q Before you use Testogel Q How to use Testogel Q Possible side effects Q How to store Testogel Q Further information

Q What Testogel is and what it is used for

This medicine contains testosterone, a male hormone produced naturally in the body. It is a hormone treatment in men used for problems related to testosterone deficiency as described in Section 2 (Take special care...).

Q Before you use Testogel Do not use Testogel

• If you are allergic to testosterone or to any of the ingredients of the gel,

• If you are suffering from prostate cancer,

• If you are suffering from breast cancer.

Take special care with Testogel

Before starting any treatment with Testogel, your testosterone deficiency must be clearly demonstrated by clinical signs (regression of masculine characteristics, reduced lean body mass, weakness or fatigue, reduced sexual desire/drive, inability to have/maintain an erection, etc.) and confirmed by laboratory tests carried out in the same laboratory.

Testogel is not recommended for:

• The treatment of male sterility or impotence,

• Children as no clinical information is available for boys under 18 years,

• By women because of possibly developing male characteristics.

Androgens may increase the risk of an enlarged prostate gland (benign prostatic hypertrophy) or prostate cancer. Regular examinations of the prostate gland before the beginning and during therapy should be performed to follow your doctor's recommendations.

If you are suffering from severe heart, liver or kidney disease, treatment with Testogel may cause severe complications in the form of water retention in your body sometimes accompanied by congestive heart failure (fluid overload in the heart).

Testosterone may cause a rise in blood pressure. Testogel should therefore be used with caution if you are suffering from high blood pressure.

Worsening of breathing problems during sleep have been reported during treatment with testosterone in some people, particularly those who are very overweight or are already suffering from breathing difficulties.

If you have cancer that affects your bones, you may develop increased levels of calcium in your blood or urine. Testogel may further affect these calcium levels. Your doctor may wish to check these calcium levels using blood tests during your treatment with Testogel.

If you receive testosterone replacement treatment over long periods of time you may develop an abnormal increase in the number of red blood cells in your blood (polycythaemia). You will need regular blood tests to check that this is not happening.

Testogel must be used with caution if you are suffering from epilepsy and/or from migraine as these conditions may be made worse.

In case of severe skin reactions, treatment should be reviewed and stopped if necessary.

The following may indicate you are taking too much of the product: irritability, nervousness, weight gain, frequent or prolonged erections. Report any of these to your doctor who will adjust the daily dose of Testogel.

Before starting treatment your doctor will perform a full examination. He/she will need to take blood samples on 2 visits to measure your levels of testosterone before you are given this medicine. You will have regular check-ups (at least once a year and twice a year if you are elderly or an at risk patient) during treatment.

Possible transfer of testosterone

During close and relatively long periods of skin contact testosterone may be transferred to another person unless you cover the treated area. This could cause your partner to show the signs of increased testosterone such as more hair on the face and body and a deepened voice. It may cause changes in the menstrual cycle of women. Wearing clothes covering the application area or showering before contact protects against such transfer.

The following precautions are recommended:

• wash your hands with soap and water after applying the gel,

• cover the application area with clothing once the gel has dried,

• take a shower before intimate contact.

If you believe testosterone has been transferred to another person (woman or child)

• wash the area of skin which may have been affected immediately with soap and water,

• report any signs such as acne or changes in the growth or pattern of hair on your body or face to your doctor.

To make sure no-one else is accidentally put at risk you should leave a long period of time between applying Testogel and making contact. You should also either wear a T-shirt during times of close contact to cover the area where Testogel has been applied or bathe or shower before making contact.

You should preferably wait at least 6 hours between applying the gel and taking a bath or shower. If you occasionally need to bathe or shower between 1 and 6 hours after applying the gel it should not significantly change the effects of your treatment

Taking or using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed, but particularly oral anticoagulants (used to thin the blood), insulin or corticosteroids. These particular medicines may lead to your dose of Testogel being adjusted.

Pregnancy and breast-feeding

Testogel is not to be used by pregnant or breast-feeding women.

Pregnant women must avoid any contact with the Testogel application sites. This medicine may cause the development of unwanted male characteristics in the developing baby. In the event of contact, as recommended above, wash the area of contact as soon as possible with soap and water.

If your partner becomes pregnant you must follow the advice regarding avoiding transfer of the testosterone gel.

Driving and using machines

Testogel has no influence on the ability to drive or use machines.

Sportsmen and women

The attention of sportsmen and women is drawn to the fact that this proprietary medicine contains an active substance (testosterone) which may produce a positive reaction in antidoping tests.

Q How to use Testogel This medicine is for use by adult men only.

Always use Testogel exactly as your doctor has told you. You should check with your doctor if you are not sure.

The recommended dose is 5g of gel (i.e. 50mg of testosterone) applied once daily at approximately the same time, preferably in the morning.

The daily dose may be adjusted by your doctor, on an individual patient basis, not exceeding 10 g of gel per day.

The gel must be gently spread onto clean, dry, healthy skin as a thin layer on the shoulders, arms or stomach.

After opening the sachet, the entire contents should be taken out of the sachet and applied immediately onto the skin. Allow the gel to dry for at least 3-5 minutes before dressing. Wash your hands with soap and water after applying.

Do not apply to the genital areas (penis and testes) as the high alcohol content may cause local irritation.

If you forget to use Testogel

Do not use a double dose to make up for a forgotten individual dose.

If you stop using Testogel

You should not stop therapy with Testogel unless told to do so by your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Q Possible side effects

Like all medicines, Testogel can cause side effects, although not everybody gets them:

Very common side effects may be experienced by 10 people in every 100

Because of the alcohol this medicine contains, frequent applications to the skin may cause irritation and skin dryness. Moreover, acne may occur.

Common side effects (between 1 and 10 people in every 100)

Testogel may cause headaches, hair loss, development of painful, tender or enlarged breasts, changes to your prostate gland, diarrhoea, dizziness, an increase in blood pressure, changes to your mood, changes in laboratory test results (increase in the number of red blood cells in the blood, lipids), skin hypersensitivity, stinging and loss of memory.

Other side effects have been observed during treatment with oral or injectable testosterone: weight gain, changes of the salt in the blood, muscular pain, nervousness, depression, hostility, breathing problem during sleep, yellowing of the skin (jaundice), changes in the results of tests that check how the liver is working, seborrhoea, sex drive changes, reduction in the number of sperm, frequent or prolonged erections, blockages that may make it difficult to pass urine, water retention, hypersensitivity reactions.

Ref: 1509/090215/1 /B

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