AVIDART 0.5 mg SOFT CAPSULES

1. What Avidart is and what it is used for

Avidart is used in men to treat the enlargement of the prostate (benign prostatic hyperplasia),a non-cancerous growth of the prostate caused by overproduction of a hormone called dihydrotestosterone.

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

As the prostate grows, it can cause urinary problems such as difficulty in the flow of urine and a need to urinate more frequently. It can also cause the urine stream to be weaker and less forceful.

If benign prostatic hyperplasia is not treated, there is a risk that the flow of urine will be completely blocked (acute urinary retention).This requires immediate medical treatment. In some cases, surgery may be necessary to reduce the size of the prostate or remove it. Avidart reduces the production of dihydrotestosterone, which helps reduce the size of the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgery.

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

2. What you need to know before you take Avidart

Do not take Avidart:

• if you are allergic to dutasteride, other 5-alpha reductase inhibitors, soya, peanutor any of the other ingredients of this medicine (listed in section 6)
• if you have severe liver disease.

If you think you may have any of these conditions, do not takethis medicine until you have consulted your doctor.

This medicine is for men only.Women, children, and adolescents must not take it.

Warnings and precautions

Talk to your doctor before taking Avidart.

• Make sure your doctor knows if you have liver problems.You may need additional checks during your treatment with Avidart if you have any liver disease.
• Women, children, and adolescentsshould avoid contact with broken Avidart capsules because the active substance can be absorbed through the skin. If there is any contact with the skin, the affected areashould be washed immediatelywith water and soap.
• Use a condom during sexual intercourse.Dutasteride has been found in the semen of men taking Avidart. If your partner is pregnant or may become pregnant, she should avoid exposure to your semen because dutasteride may affect the normal development of a male baby. Dutasteride has been shown to decrease sperm count, sperm motility, and semen volume. This may reduce fertility.
• Avidart affects the blood test for PSA (prostate-specific antigen)used to detect prostate cancer. Your doctor may still use this test to detect prostate cancer, but they should be aware of this effect. If you have a blood test for PSA, tell your doctor that you are taking Avidart. Men taking Avidart should have regular PSA tests.
• In a clinical study in men at increased risk of prostate cancer, men who took Avidart were more likely to have a type of prostate cancer called high-grade prostate cancerthan those who did not take Avidart. The effect of Avidart on these types of prostate cancer is not clear.
• Avidart may cause breast enlargement and breast tenderness.If this causes you discomfort or if you notice breast lumps or nipple discharge, talk to your doctor, as these changes can be signs of a serious disease, such as breast cancer.

Talk to your doctor or pharmacistif you have any questions about taking Avidart.

Taking Avidart with other medicines

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Some medicines may interact with Avidart, which can increase the risk of side effects. These include:

• verapamil or diltiazem(for high blood pressure)
• ritonavir or indinavir(for HIV)
• itraconazole or ketoconazole(for fungal infections)
• nefazodone(an antidepressant)
• alpha-blockers(for an enlarged prostate or high blood pressure).

Tell your doctorif you are taking any of these medicines. Your doctor may need to reduce the dose of Avidart.

Taking Avidart with food and drink

Avidart can be taken with or without food.

Pregnancy, breast-feeding, and fertility

Pregnant women (or women who may become pregnant) should avoid contact with broken capsules.Dutasteride is absorbed through the skin and may affect the normal development of a male baby. This risk is especially important during 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 pregnant or may become pregnant, she should avoid exposure to your semen.

Avidart has been shown to decrease sperm count, sperm motility, and semen volume. This may reduce fertility.

Talk to your doctorif a pregnant woman has come into contact with dutasteride.

Driving and using machines

Avidart is unlikely to affect your ability to drive or use machines.

Avidart contains soya lecithin

This medicine contains soya lecithin, which may contain soya oil. Do not use this medicine if you are allergic to peanut or soya.

3. How to take Avidart

Take this medicine exactly as your doctor or pharmacist has told you.If you do not take Avidart regularly, the control of your PSA levels may be affected. If you are in doubt, talk to your doctor or pharmacist again.

What dose should you take

• The recommended dose is one capsule (0.5 mg) once a day.The capsules should be swallowed whole with water. Do not chew or open the capsules. Contact with the contents of the capsules can irritate your mouth or throat.

• Treatment with Avidart is long-term. Some men may experience rapid improvement in symptoms. However, others may need to continue treatment for 6 months or more before an effect is seen. Continue taking Avidart for as long as your doctor has told you.

If you take more Avidart than you should

If you have taken too much Avidart, talk to your doctor, pharmacist, or call the Toxicology Information Service (telephone 915620420), stating the medicine and the amount taken. You should take the packaging and the leaflet with you to the doctor or hospital.

If you forget to take Avidart

Do not take a double dose to make up for forgotten doses. Take the next dose at the usual time.

Do not stop taking Avidart

Do not stop taking Avidart without talking to your doctor first. It may take 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, this medicine can cause side effects, although not everybody gets them.

Allergic reaction

Symptoms of an allergic reaction can include:

• skin rash(which may itch)
• hives(like nettle rash)
• swelling of the eyelids, face, lips, arms, or legs.

Talk to your doctor immediatelyif you get any of these symptoms and stop taking Avidart.

Common side effects

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

• inability to get or keep an erection (impotence), which may continue after stopping Avidart
• decreased sex drive (libido), which may continue after stopping Avidart
• difficulty ejaculating, such as a decrease in the amount of semen released during sex, which may continue after stopping Avidart
• breast enlargement and breast tenderness (gynaecomastia)
• dizziness, when taken with tamsulosin.

Uncommon side effects

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

• heart failure (the heart becomes less efficient at pumping blood around the body. This can cause symptoms such as difficulty breathing, tiredness, and swelling in the ankles and legs)
• hair loss (usually from the body) or increased hair growth.

Rare side effects

The frequency cannot be estimated from the available data:

• depression
• testicular pain and swelling.

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 Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Avidart

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

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.

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 protect the environment.

6. Contents of the pack and further information

What Avidart contains

The active substance is dutasteride.Each soft capsule contains 0.5 mg of dutasteride.

The other ingredients are:

• capsule content: mono- and diglycerides of capric/caprylic acid and butylhydroxytoluene (E321)
• capsule shell: gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), medium-chain triglycerides, and lecithin (may contain soya oil).

Appearance and packaging

Avidart soft capsules are oblong, opaque, yellow, soft gelatin capsules, engraved with GX CE2. They are available in packs of 10, 30, 50, 60, and 90 capsules. Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Manufacturer:

Delpharm Poznan Spólka Akcyjna

ul. Grunwaldzka 189

60-322 Poznan

Poland

or

Aspen Bad Oldesloe GmbH

Industriestrasse 32-36

23843 Bad Oldesloe

Germany

Local representative:

Casen Recordati, S.L.

Autovía de Logroño, Km 13,300

50180 Utebo (Zaragoza)

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Avodart- Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden, Netherlands, United Kingdom

Avidart- Spain

Date of last revision of this leaflet:November 2017

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es