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Avodart 0.5mg Soft Capsules

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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.

S1695 LEAFLET Avodart 20140722

PACKAGE LEAFLET: INFORMATION FOR THE USER

AVODART 0.5mg SOFT CAPSULES (dutasteride)

Your medicine is known as Avodart 0.5mg Soft Capsules but will be referred to as Avodart throughout the following leaflet.

In this leaflet:

1. What Avodart is and what it's used for

2. Before you take Avodart

3. How to take Avodart

4. Possible side effects

5. How to store Avodart

6. Further information

1. WHAT AVODART IS AND WHAT IT’S USED FOR

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

The active ingredient is dutasteride. It 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 of the prostate gland. Avodart lowers the production of dihydrotestosterone, which helps to shrink the prostate and relieve the symptoms. This will reduce the risk of acute urinary retention and the need for surgery.

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

2. BEFORE YOU TAKE AVODART

Do not take Avodart

• if you’re allergic (hypersensitive) to dutasteride, other 5-alpha reductase inhibitors, soya, peanut or to any of the

other ingredients of Avodart

• if you have a severe liver disease.

^ Tell your doctor if you think any of these apply to you.

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

Take special care with Avodart

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

• Make sure your doctor knows about liver problems. If you have had any illness affecting your liver, you may need some additional check-ups while you are taking Avodart.

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

• Use a condom during sexual intercourse.

Dutasteride has been found in the semen of men taking Avodart. If your 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.

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

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

• Avodart may cause breast enlargement and tenderness. If this becomes troublesome, or if you 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.

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

Taking other medicines

Tell your doctor if you’re taking, or have recently taken, any other medicines. This includes any medicines you've bought without a prescription.

Some medicines can react with Avodart and may make it more likely that you'll have side effects. These medicines include:

• verapamil or diltiazem (for high blood pressure)

• ritonavir or indinavir (for HIV)

• itraconazole or ketaconazole (for fungal infections)

• nefazodone (an antidepressant)

• alpha-blockers (for enlarged prostate or high blood pressure). ^ Tell your doctor if you are taking any of these medicines. Your

dose of Avodart may need to be reduced.

Food and drink with Avodart

Avodart can be taken with or without food.

Pregnancy and breast-feeding

Women who are pregnant (or may be) must not handle 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 Avodart. If your partner is or may be pregnant, you must avoid exposing her to your semen.

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

^ Contact your doctor for advice if a pregnant woman has come into contact with dutasteride.

Driving and using machines

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

Important information about some of the ingredients of Avodart

This medicine contains lecithin from soya, which may contain soya oil. If you are allergic to peanut or soya, do not use this medicinal product.

3. HOW TO TAKE AVODART

Always take Avodart exactly as your doctor has told you to. 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.

How much to take

The usual 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 of the capsules may make your mouth or throat sore.

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

If you take too much Avodart

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

If you forget to take Avodart

Don't take extra capsules to make up for a missed dose. Just take your next dose at the usual time.

Don’t stop Avodart without advice

Don't stop taking Avodart 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 product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Avodart 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.

^ Contact your doctor immediately if you get any of these symptoms, and stop using Avodart.

Common side effects

These may affect up to 1 in 10 men taking Avodart:

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

• decreased sex drive (libido), this may continue after you stop taking Avodart

• difficulty with ejaculation, this may continue after you stop taking Avodart

• breast enlargement or tenderness (gynecomastia)

• dizziness when taken with tamsulosin.

Uncommon side effects

These may affect up to 1 in 100 men taking Avodart:

• 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 Not known side effects

The frequency cannot be estimated from the available data:

• depressed mood

• pain and swelling in your testicles

^ 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.

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.

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

5. HOW TO STORE AVODART

• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

• Do not store above 30°C.

• If your doctor stops your treatment, take any leftover capsules back to the pharmacy for safe disposal.

• Do not use after the expiry date printed on the carton label or blister strip. Take any capsules which are out of date back to the pharmacy.

• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell 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.

6. FURTHER INFORMATION

What Avodart contains

Each soft capsule contains 0.5mg of the active ingredient

dutasteride.

The other ingredients are:

• inside the capsule: mono and diglycerides of caprylic/capric acid and butylated hydroxytoluene (E321).

• capsule shell: gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), triglycerides (medium chain), lecithin.

What Avodart looks like and contents of the pack

• Avodart soft capsules are yellow, oblong, opaque capsules marked with GX CE2.

• Avodart capsules are available as blister packs of 30 capsules.

Product Licence holder

Procured from within the EU and repackaged by the Product

Licence holder: S&M Medical Ltd, Chemilines House, Alperton

Lane, Wembley, HA0 1 DX.

Manufacturer

This product is manufactured by either of the below manufacturers-

• GlaxoSmithKline Pharmaceuticals S.A., Ul. Grunwaldzka 189, 60-322 Poznan, Poland.

• Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, 23843 Bad Oldesloe, Germany

| POM | PL No: 19488/1695 Leaflet revision date: 22 July 2014

Avodart is a registered trade mark of GlaxoSmithKline group of companies.

S1695 LEAFLET Avodart 20140722

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.

S1695 LEAFLET Dutasteride 20140722

PACKAGE LEAFLET: INFORMATION FOR THE USER DUTASTERIDE 0.5mg SOFT CAPSULES

Your medicine is known as Dutasteride 0.5mg Soft Capsules but will be referred to as Dutasteride throughout the following leaflet.

In this leaflet:

1. What Dutasteride Capsules are and what they are used for

2. Before you take Dutasteride Capsules

3. How to take Dutasteride Capsules

4. Possible side effects

5. How to store Dutasteride Capsules

6. Further information

1. WHAT DUTASTERIDE CAPSULES ARE AND WHAT THEY ARE USED FOR

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

The active ingredient is Dutasteride. It 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 of the prostate gland. Dutasteride Capsules lower the production of dihydrotestosterone, which helps to shrink the prostate and relieve the symptoms. This will reduce the risk of acute urinary retention and the need for surgery.

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

2. BEFORE YOU TAKE DUTASTERIDE CAPSULES

Do not take Dutasteride Capsules

• if you’re allergic (hypersensitive) to Dutasteride Capsules, other 5-alpha reductase inhibitors, soya, peanut or to any of

the other ingredients of Dutasteride Capsules

• if you have a severe liver disease.

^ Tell your doctor if you think any of these apply to you.

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

Take special care with Dutasteride Capsules

• Make sure your doctor knows about liver problems. If you

have had any illness affecting your liver, you may need some additional check-ups while you are taking Dutasteride Capsules.

• 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 if there is any contact with the skin.

• Use a condom during sexual intercourse.

Dutasteride Capsules has been found in the semen of men taking Dutasteride Capsules. If your partner is or may be pregnant, you must avoid exposing her to your semen as Dutasteride Capsules 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 Capsules affects a blood test for PSA (prostate-specific antigen), which is sometimes used to detect prostate cancer.

Your doctor should be aware of this effect and can still use the test to detect prostate cancer. If you are having a blood test for PSA, tell your doctor that you are taking Dutasteride Capsules. Men taking Dutasteride Capsules should have their PSA tested regularly.

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

• Dutasteride Capsules may cause breast enlargement and tenderness. If this becomes troublesome, or if you 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.

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

Taking other medicines

Tell your doctor if you’re taking, or have recently taken, any other medicines. This includes any medicines you've bought without a prescription.

Some medicines can react with Dutasteride Capsules and may make it more likely that you'll have side effects. These medicines include:

• verapamil or diltiazem (for high blood pressure)

• ritonavir or indinavir (for HIV)

• itraconazole or ketaconazole (for fungal infections)

• nefazodone (an antidepressant)

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

^ Tell your doctor if you are taking any of these medicines. Your dose of Dutasteride Capsules may need to be reduced.

Food and drink with Dutasteride Capsules

Dutasteride Capsules can be taken with or without food.

Pregnancy and breast-feeding

Use a condom during sexual intercourse.

Dutasteride has been found in the semen of men taking Dutasteride Capsules. If your partner is or may be pregnant, you must avoid exposing her to your semen.

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

^ Contact your doctor for advice if a pregnant woman has come into contact with Dutasteride Capsules.

Driving and using machines

Dutasteride Capsules are unlikely to affect your ability to drive or operate machinery.

Important information about some of the ingredients of Dutasteride Capsules

This medicine contains lecithin from soya, which may contain soya oil. If you are allergic to peanut or soya, do not use this medicinal product.

3. HOW TO TAKE DUTASTERIDE CAPSULES

Always take Dutasteride Capsules exactly as your doctor has told you to. 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.

How much to take

The usual 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 of the capsules may make your mouth or throat sore.

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

If you take too much Dutasteride Capsules

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

If you forget to take Dutasteride Capsules

Don't take extra capsules to make up for a missed dose. Just take your next dose at the usual time.

Don’t stop Dutasteride Capsules without advice Don't stop taking Dutasteride Capsules 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 product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Dutasteride Capsules 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.

^ Contact your doctor immediately if you get any of these symptoms, and stop using Dutasteride Capsules.

Common side effects

These may affect up to 1 in 10 men taking Dutasteride Capsules:

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

• decreased sex drive (libido), this may continue after you stop taking Dutasteride Capsules

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