PACKAGE LEAFLET: INFORMATION FOR THE USER AVIDART®0.5MG SOFT CAPSULES

(dutasteride)

This product is available as the above name but will be

referred to as Avidart throughout this leaflet.

Please read this information leaflet carefully before you

start taking your 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.

In this leaflet:

1.    What Avidart is and what it’s used for

2.    Before you take Avidart

3.    How to take Avidart

4.    Possible side effects

5.    How to store Avidart

6.    Further information

Avidart 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. Avidart 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.

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

Do not take Avidart

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

other ingredients of Avidart.

•    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 Avidart

•    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 Avidart.

•    Women, children and adolescents must not handle leaking Avidart 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 Avidart. 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.

•    Avidart can affect 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 Avidart. Men taking Avidart should have their PSA tested regularly.

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

•    Avidart 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 Avidart.

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 Avidart 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 Avidart may need to be reduced.

Food and drink with Avidart

Avidart 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 Avidart. If your partner is or may be pregnant, you must avoid exposing her to your semen.

Avidart 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

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

Important information about some of the ingredients of Avidart

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.

Always take Avidart 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.

Avidart is a long term treatment.

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

If you take too much Avidart

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

If you forget to take Avidart

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

Don’t stop Avidart without advice

Don’t stop taking Avidart 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.

If you have any unwanted Avidart capsules, don’t dispose of them in waste water or household rubbish. Take them back to your pharmacist, who will dispose of them in a way that won’t harm the environment.

What Avidart contains

The active ingredient is: Dutasteride. Each soft capsule contains 0.5mg of the active ingredient dutasteride.

The other ingredients are: Each capsule also includes mono and diglycerides of caprylic/capric acid and butylated hydroxytoluene (E321) in the solution inside the capsule shell. The capsule shell contains gelatin, glycerol, titanium dioxide (E171), iron oxide yellow (E172), medium chain triglycerides and lecithin.

What Avidart looks like and contents of the pack

Oblong opaque yellow, gelatin capsules marked with 'GX CE2’ in grey and are available in packs of 30 capsules.

Manufacturer

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

Product Licence holder: G Pharma Ltd, Salford M50 2PU.

PL No: 16369/0040

Avidart 0.5mg Soft Capsules    30/01/2014

‘Avidart’ is a registered trademark of the GlaxoSmithKline Group of Companies.

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

Very rare 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 Avidart.

Common side effects

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

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

•    decreased sex drive (libido)

•    difficulty with ejaculation

•    breast enlargement or tenderness (gynecomastia)

•    dizziness when taken with tamsulosin.

Uncommon side effects

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

•    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

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.

Keep out of the sight and reach of children.

Don’t store Avidart above 30°C.

Don’t use Avidart after the expiry date which is stated on the carton or the foil blister strip. The expiry date refers to the last day of that month.