TEVA UK Ref: 231-30-12345-A LEA DUTASTERIDE 0.5mg SOFT CAPS TUK Version: 8    19 MAY 2014

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DUTASTERIDE 0.5 mg SOFT CAPSULES

PACKAGE LEAFLET: INFORMATION FORTHE USER

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    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 only. Do not pass it on to others. It may harm them, even iftheir signs of illness are the same as yours.

•    If you get any side effects, talkto your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET:

1.    What Dutasteride is and what it is used for

2.    What you need to know before you take Dutasteride

3.    How to take Dutasteride

4.    Possible side effects

5.    How to store Dutasteride

6.    Contents of the pack and other information

Pharma code 123 (EXAMPLE CODE)

First bar is 105mm from the top edge of the leaflet.

What Dutasteride is and what it is used for

Iml Dutasteride is used to treat men with an enlarged prostate (benign prostatic hyperplasia)- a non-cancerous growth ofthe prostate gland, caused by producing too much of a hormone called dihydrotestosterone.

The active ingredient is dutasteride. Dutasteride belongs to a group of medicines called 5-alpha reductase inhibitors.

As the prostate grows, it can lead to urinary problems, such as difficulty in passing urine and a need to go to the toilet frequently. It can also cause the flow of the urine to be slower and less forceful. If left untreated, there is a risk that your urine flow will be completely blocked (acute urinary retention).This requires immediate medical treatment. In some situations surgery is necessary to remove or reduce the size ofthe prostate gland. Dutasteride lowersthe production of dihydrotestosterone, which helps to shrinkthe prostate and relieve the symptoms.This will reduce the risk of acute urinary retention and the need for surgery.

Dutasteride may also be used with another medicine called tamsulosin (used to treat the symptoms of an enlarged prostate).

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What you need to know before you take Dutasteride

Do not take Dutasteride

•    If you are allergic to dutasteride, 5-alpha reductase inhibitors or any ofthe other ingredients ofthis medicine (listed in section 6)

•    Ifyouhaveasevereliverdisease.

Inform your doctor if you think any of these apply to you.

This medicine is for men only. It must not be used by women, children or adolescents.

Warnings and precautions

Talkto your doctor or pharmacist before taking Dutasteride.

Take special care with Dutasteride

• In some clinical studies, more patients taking dutasteride and another medicine called an alpha-blocker, like tamsulosin experienced heart failure than patients taking only dutasteride or only an alpha blocker. Heart failure means your heart does not pump blood as well as it should.

•    Your doctor must be aware about your liver problems before using this medicine. Ifyou have had any illness affecting your liver, you may need regular monitoring while you are taking Dutasteride.

•    Women, children and adolescents must not handle leaking Dutasteride capsules, because the active ingredient can be absorbed through the skin. Wash the affected area immediately with soap and water ifthere is any contact with the skin.

•    Use a condom during sexual intercourse.

Dutasteride has been found in the semen of men taking Dutasteride. Ifyour partner is or may be pregnant, you must avoid exposing her to your semen as dutasteride may affect the normal development of a male baby. Dutasteride has been shown to decrease sperm count, semen volume and sperm motility.This could reduce your fertility.

•    Dutasteride affects a blood test for PSA (prostate-specific antigen), which is sometimes used to detect prostate cancer. Your doctor should be aware ofthis effect and can still use the test to detect prostate cancer. Ifyou are having a blood test for PSA, tell your doctor that you are taking Dutasteride. Men taking Dutasteride should have their PSA tested regularly.

•    Dutasteride may cause breast enlargement and tenderness. If this becomes troublesome or ifyou notice breast lumps or nipple discharge you

should talk to your doctor about these changes as these may be signs of a serious condition, such as breast cancer.

•    Ina clinical study of men at increased risk of prostrate cancer, men taking dutasteride had a serious form of prostrate cancer more often than men who did not take dutasteride.The effect of dutasteride on this serious form of prostrate cancer is not clear.

Contact your doctor or pharmacist if you have any questions about taking Dutasteride.

Other medicines and Dutasteride

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, as these can interact with Dutasteride and increase the risk of side effects. Your dose of Dutasteride may need to be reduced.These medicines include:

•    verapamil or diltiazem (for high blood pressure)

•    ritonavirorindinavir(forHIV)

•    itraconazole or ketaconazole (for fungal infections)

•    nefazodone (an antidepressant)

•    alpha-blockers (for enlarged prostate or high blood pressure).

Dutasteride with food and drink

Dutasteride can be taken with or without food.

Pregnancy, breast-feeding and fertility

Women who are pregnant (or may be) must avoid any contact with leaking capsules. Dutasteride is absorbed through the skin and can affect the normal development of a male baby.This is a particular risk in the first 16 weeks of pregnancy.

Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Dutasteride. Ifyour partner is or may be pregnant, you must avoid exposing her to your semen.

Dutasteride has been shown to reduce sperm count, semen volume and sperm movement.Therefore male fertility may be reduced.

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Contact your doctor immediately if a pregnant woman has come into contact with dutasteride.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Dutasteride is unlikely to affect your ability to drive or operate machinery.

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How to take Dutasteride

Always take this medicine exactly as your doctor or pharmacist has told you. If you do not take it regularly the monitoring of your PSA levels may be affected. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one capsule (0.5 mg) taken once a day. Swallow the capsules whole with water. Do not chew or break open the capsule. Contact with the contents ofthe capsules may make your mouth or throat sore.

Dutasteride is a long term treatment. Some men notice an early improvement in their symptoms. However, others may need to take Dutasteride for 6 months or more before it begins to have an effect. Keep taking Dutasteride for as long as your doctor tells you.

If you take more Dutasteride than you should

Contact your doctor or pharmacist for advice if you take too many Dutasteride capsules.

If you forget to take Dutasteride

Do not take a double dose to make up for a forgotten capsule. Just take your next dose at the usual time and then continue as earlier.

If you stop taking Dutasteride

Don't stop taking Dutasteride without talking to your doctor first it may take up to 6 months or more for you to notice an effect.

If you have any further questions on the use of this medicine, askyour doctor or pharmacist.

^ Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reaction

The signs of allergic reactions can include:

•    skin rash (which can be itchy)

•    hives (like a nettle rash)

•    swelling of the eyelids, face, lips, arms or legs.

Stop using Dutasteride and contact your doctor immediately ifyou get any ofthese symptoms.

Common: (may affect up to 1 in 10 men)

•    impotence (not able to achieve or maintain an erection) this may continue after you stop taking Dutasteride

•    decreased sex drive (libido) this may continue afteryou stop taking Dutasteride

•    difficulty with ejaculation this may continue after you stop taking Dutasteride

•    breast enlargement or tenderness (gynecomastia)

•    dizziness when taken with tamsulosin.

Uncommon: (may affect up to 1 in 100 men)

•    heart failure (heart becomes less efficient at pumping blood around the body. You may have symptoms such as shortness of breath, extreme tiredness and swelling in your ankles and legs).

•    hair loss (usually from the body) or hair growth.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard

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

^5 How to store Dutasteride

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer carton and blister after EXRThe expiry date refers to the last day ofthat month.

Do not store above 30°C. Store in the original package in order to protect from light.

Do not use this medicine if you notice visible signs of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.These measures will help to protect the environment.

Contents of the pack and other information

What Dutasteride contains

•    The active substance is dutasteride

•    Each soft capsule contains 0.5 mg of dutasteride

•    The other ingredients are butylhydroxytoluene (E321) and glycerol monocaprylocaprate, medium chain triglycerides, liquid paraffin, purified water

•    The capsule shell contains gelatin (160 Bloom), glycerol (E422), titanium dioxide (El71) and yellow Iron Oxide (E172).

What Dutasteride looks like and contents of the pack

Dutasteride 0.5 mg soft capsules are size 6, oblong, yellow, opaque capsules filled with a clear to yellow solution, without printing.

They are available in packs of 10, 28, 30, 50, 60, 90 and 100.

10 (blisters of:2x5 capsules,

1x10 capsules)/carton 28 (blisters of:2x14 capsules,

4x7 capsules, 7x4 capsules)/carton 30 (blisters of: 3x10 capsules,

6x5 capsules)/carton 50 (blisters of:5x10 capsules,

10x5 capsules)/carton 60 (blisters of:6x10 capsules,

12x5 capsules)/carton 90 (blisters of:9x10 capsules,

18x5 capsules) /carton

100 (blisters of: 10 x 10 capsules,

5x20 capsules)/carton

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Teva UK Limited, Eastbourne, BN22 9AG,

United Kingdom

This leaflet was last revised in 10/2013.

PL 00289/1824

Not known: (frequency cannot be estimated from the available data)

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•    painandswellinginyourtesticles

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