Package Insert: Information for the Patient

Avidart 0.5 mg Soft Capsules

dutasteride

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

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

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

As the prostate grows in size, it may produce urinary problems such as difficulty in urinating and a need to urinate more frequently. It may also cause a smaller and weaker urine stream.

If benign prostatic hyperplasia is not treated, there is a risk of complete blockage of urine flow(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 to reduce the size of the prostate and alleviate symptoms. This reduces the risk of acute urinary retention and the need for surgery.

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

Do not take Avidart:

• if you are allergic to dutasteride, other 5-alpha reductase inhibitors, soy, peanutsor any of the other ingredients of this medication (listed in section 6)
• if you have a serious liver disease.

??If you think you are in any of these situations,do not takethis medication until you have consulted with your doctor.

This medication is only for men. Women, children, and adolescents should not take it.

Warnings and precautions

Consultyour doctor before starting to take 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 ingredient can be absorbed through the skin.If there is any skin contact,the affected areashould be washed immediatelywith water and soap.
• Use a condom during sex.Dutasteride has been found in the semen of men taking Avidart. If your partner is pregnant or may be pregnant, you should avoid exposing her to your semen because dutasteride may affect the normal development of the male fetus. Dutasteride has been shown to decrease sperm count, motility, and semen volume. This may reduce your fertility.
• Avidart affects PSA (prostate-specific antigen) blood teststhat are sometimes 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, inform your doctor that you are taking Avidart.Men taking Avidart should have regular PSA checks.
• In a clinical study in men at increased risk of prostate cancer, men taking Avidart hada higher frequency of a serious type of prostate cancerthan those not taking Avidart. The effect of Avidart on these serious types of prostate cancer is unclear.
• Avidart may cause breast enlargement and tenderness.If this causes you discomfort, or if you noticelumps in the breast or nipple dischargeconsult your doctor, as these changes may be signs of a serious disease, such as breast cancer.

??Consult your doctor or pharmacistif you have any questions about taking Avidart.

Taking Avidart with other medications

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

Certain medications may interact with Avidart, which may cause adverse effects. Some of these medications are:

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

??Inform your doctorif you are taking any of these medications. You may need to reduce your Avidart dose.

Taking Avidart with food and drinks

Avidart can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Women whoare pregnant (or may be pregnant) should avoid contact with broken capsules. Dutasteride can be absorbed through the skin and may affect the normal development of the male fetus. This risk is especially important in the first 16 weeks of pregnancy.

Use a condom during sex.Dutasteride has been found in the semen of men taking Avidart. If your partner is pregnant or may be pregnant, you should avoid exposing her to your semen.

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

??Consult your doctorif a pregnant woman has come into contact with dutasteride.

Driving and operating machinery

It is unlikely that Avidartwill affect your ability to drive and use machinery.

Avidart contains soy lecithin

This medication contains soy lecithin, so it may contain soy oil. Do not use this medication if you are allergic to peanuts or soy.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If you do not take Avidart regularly, the control of your PSA levels may be affected. In case of doubt, consult your doctor or pharmacist again.

What dose should you take

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

• The treatment with Avidart is of long duration. Some men may experience a rapid improvement in symptoms. However, others may need to continue treatment for up to 6 months or more before an effect begins to occur. Continue taking Avidart for the time your doctor has indicated.

If you take more Avidart than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 915620420, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Avidart

Do not take a double dose to compensate for the missed doses. Take the next dose at the usual time.

Do not interrupt treatment with Avidart

Do not interrupt treatment with Avidart without consulting your doctor first. You may need up to 6 months or more to notice an effect.

• If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Allergic reaction

The symptoms of an allergic reaction may include:

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

??Contact your doctorimmediatelyif you experience any of these symptoms andstop taking Avidart.

Common side effects

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

• inability to achieve or maintain an erection, which could continue after stopping Avidart
• decreased libido(sex drive), which could continue after stopping Avidart
• difficulty with ejaculation,such as a decrease in the amount of semen released during sexual intercourse,which could continue after stopping Avidart
• enlargement of the breasts and breast tenderness(gynecomastia)
• dizziness, when taken with tamsulosina.

Uncommon side effects

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

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

Side effects of unknown frequency

The frequency cannot be estimated from the available data:

• depression
• testicular pain and inflammation.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 86°F (30°C).

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Avidart

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

The other components are:

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

Appearance of the product and contents of the 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. Some pack sizes may not be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

GlaxoSmithKline, S.A.

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

28760 Tres Cantos (Madrid)

Manufacturer responsible:

DelpharmPoznan 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 medicinal product is authorized in the member states of the European Economic Area with 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, Slovak Republic, Slovenia, Sweden, Netherlands, United Kingdom

Avidart- Spain

Date of the last review of this leaflet:November 2017.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es