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Avodart 0.5mg Soft Capsules/Dutasteride 0.5mg Soft Capsules

(Dutasteride)

This product is available using any of the above names but will be referred to as Avodart throughout the following:

Patient Information Leaflet

Please read this information leaflet carefully before you start taking your medicine. It contains all the information you should need to know. If you have any further questions or are not sure about anything, ask your doctor or pharmacist. Please keep this leaflet in a safe place, you may need to refer to it again.

This leaflet contains the following information about Avodart:

•    1. About your medicine

•    2. Why you need to take this medicine

•    3. Before you take your medicine

•    4. How to take your medicine

•    5. What to do if an overdose is taken

•    6. What to do if you miss a dose

•    7. After taking your medicine

•    8. Storing your medicine

1.    ABOUT YOUR MEDICINE:

Your medicine is called Avodart. Each Avodart Soft Capsule contains 0.5mg of the active ingredient Dutasteride.

Avodart also contain some inactive ingredients. The solution inside the capsule shell contains mono and diglycerides of caprylic/capric acid and butylated hydroxytoluene (E321). The capsule shell contains gelatin, glycerol, titanium dioxide (E171), iron oxide yellow (E172), triglycerides, lecithin and red iron oxide (E172) as the colourant, polyvinyl acetate phthalate, propylene glycol and polyethylene glycol.

Avodart are oblong opaque, yellow, soft gelatin capsules printed with GX CE2 on one side in red ink and are available in packs of 30 capsules.

Dutasteride belongs to a group of medicines called 5-alpha reductase inhibitors. |POM|

PL 10383/1740 Avodart 0.5mg Soft Capsules/Dutasteride 0.5mg Soft Capsules

This product is manufactured by RP Scherer 74, Rue Principale, 67930 Beinheim France and is procured from within the EU and repackaged by the Product Licence holder: Primecrown Ltd., 28, Sarum Complex, Uxbridge, Middlesex UB8 2RZ.

2.    WHY YOU NEED TO TAKE THIS MEDICINE:

Avodart which are used to treat men who have a condition known as benign prostatic hyperplasia (BPH).

BPH is a condition in which the prostate gland, which is near the bladder, becomes large enough to squeeze the urine tube making it more difficult for you to pass urine. When this happens you may have some or all of the following symptoms:

•    Difficulty in passing urine/water

•    An interrupted weak flow of urine

•    Frequent passing of urine especially at night

•    A feeling that you must urinate (or pass water) straight away

•    A feeling that you cannot empty your bladder completely

•    If not treated, BPH can lead to an increased risk of complete inability to pass

urine (known as acute urinary retention or AUR)

•    Leaking and dribbling of urine.

How Avodart works

Prostate growth is caused by a hormone called dihydrotestosterone (DHT), which is present in blood. Avodart lowers the production of this hormone, leading to reduction in size of the prostate in most men. In order to treat your symptoms and control your BPH effectively, it is important that you continue to take Avodart for as long as your doctor prescribes it, even if you do not feel an immediate benefit. Some patients

show early improvements in symptoms, but most men may need to take Avodart for up to 6 months to see if it helps. Avodart works best when taken long term.

3.    BEFORE YOU TAKE YOUR MEDICINE:

This medicine is for men only and should not be taken or handled by women, children or adolescents.

You should NOT take Avodart if you:

•    Have ever had an allergic reaction (for example, a rash, itching or shortness of

breath) to Avodart, dutasteride or any of the other ingredients in Avodart,

listed at the beginning of this leaflet or to any other 5-alpha reductase inhibitor.

•    Have a serious liver disease.

If you have any type of liver disease, even if it is not serious, please discuss this with your doctor before you take Avodart. The solution from the capsule may be absorbed through the skin, so it is important to thoroughly wash your hands with soap and water if you have handled any capsules which are punctured or leaking.

Avoiding contact between Avodart and pregnant women

Your semen may contain small amounts of the active ingredient in Avodart which could affect the normal development of a male baby. Therefore, if your partner is or may be pregnant, you must avoid exposing her to your semen, for example by wearing a condom during sex.

If a pregnant woman comes into contact with the active ingredient in Avodart (for example by handling broken capsules or by unprotected sex), please consult a doctor.

Driving and using machines

Based on how dutasteride works, treatment with dutasteride would not be expected to interfere with the ability to drive or operate machinery.

Important information about ingredients of Avodart

These capsules contain glycerol, which can in high doses cause headache, stomach upset and diarrhoea. They also contain butylated hydroxytoluene, which can cause irritation to the eyes, skin and mucous membranes if punctured capsules are handled.

Taking Avodart with other medicines

Avodart does not usually interfere with other medicines. However, you should tell your doctor if you are taking any medication including herbal remedies or dietary supplements you may have bought yourself.

4.    HOW TO TAKE YOUR MEDICINE:

You must take your Avodart capsules in the way your doctor has told you to.

The label on your pack should tell you how many capsules to take and how often to take them. If the label doesn't say or if you are not sure, ask your doctor or pharmacist.

•    The usual dosage is one capsule (0.5mg) to be taken once a day.

•    The capsules should be swallowed whole (do not chew), with water and can be taken with or without food.

•    In order to treat your symptoms and control your BPH effectively, it is important that you continue to take Avodart as long as your doctor prescribes it for you, even if you do not feel an immediate benefit. Some patients show early improvement in symptoms, but you may need to take Avodart for up to six months to see if it helps. You must continue to take your medicine as your symptoms improve. Do not stop taking your medicine unless your doctor tells you to stop.

5.    WHAT TO DO IF AN OVERDOSE IS TAKEN:

If you take too many Avodart capsules, ask your doctor what to do IMMEDIATELY or contact your nearest accident and emergency department.

6.    WHAT TO DO IF YOU MISS A DOSE:

If you forget to take a dose just carry on with the next one as usual. Do not take any extra capsules to make up for doses you may have forgotten.

7.    AFTER TAKING YOUR MEDICINE:

As with all medicines, some people may have an allergic reaction to Avodart. STOP taking the medicine and tell your doctor IMMEDIATELY if you experience any of the following severe allergy symptoms after taking Avodart.

•    Sudden wheezing, tightness of the chest or throat, or difficulty breathing

•    Swollen eyelids, face, lips, tongue or other part of the body

•    Lumpy skin rash or ‘hives' (like a nettle rash) or blistering of the skin, especially if this is widespread or if you get a sore mouth or eyes, itchiness or fever.

Although they are rare, these symptoms could be serious.

Like any medicine, Avodart can have side effects, however, these are uncommon and do not affect most men.

The following have been reported:

•    Impotence (not able to achieve or maintain an erection)

•    Decrease in libido (decreased desire to have sex or a reduced sex drive)

•    Changes or problems with ejaculation, such as decrease in amount of semen released during sex or a decreased sperm count.

•    Breast swelling or tenderness.

If any of these symptoms occur you do not have to stop taking your medicine but you should seek advice from your doctor. If you have any other symptoms that you do not understand, tell your pharmacist or doctor.

8.    STORING YOUR MEDICINE:

•    Do not store Avodart above 30°C.

•    Do not use Avodart after the expiry date printed on the carton or the foil blister strip.

KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN

•    If you have any Avodart left after completing your course of treatment, please

return them to your pharmacist for a safe disposal.

If your doctor tells you to stop taking Avodart, please take them back to the pharmacist for safe disposal. Only keep the capsules if your doctor tells you to. If the capsules become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist.

Remember

This medicine has been prescribed for YOU. Never give it to women, children, adolescents or other men, as it may harm them even if their symptoms are the same as yours.

Further information

In addition to taking Avodart, the following changes to your habits may also help improve your urinary symptoms.

•    drink less fluid before going to bed

•    avoid drinking coffee and/or alcohol

This leaflet does not tell you all about your medicine. If you have any questions or are not sure about anything then ask your doctor or pharmacist.

Leaflet Date: 14.02.2008.

JO/Reg/Avodart 0.5mg Soft Capsules/New App/1740/14.02.08 Page 3