Leaflet: information for the user

Dutasteride 0.5 mg soft capsules EFG

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to yours, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Dutasteride Pensa is and what it is used for

2.What you need to know before you start taking Dutasteride Pensa

3.How to take Dutasteride Pensa

4.Possible side effects

5.Storage of Dutasteride Pensa

6.Contents of the pack and additional information

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

Dutasterida Pensa 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.

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 urine flow blockage(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. Dutasterida Pensa reduces dihydrotestosterone production, which helps to reduce prostate size and alleviate symptoms. This reduces the risk of acute urinary retention and the need for surgery.

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

Do not take Dutasterida Pensa:

-ifyou 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 severe 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, or adolescents should not take it.

Warnings and precautions

Consult your doctor before starting to take Dutasterida Pensa.

- In some clinical studies, there were more patients taking dutasteride and another medication called an alpha blocker, such as tamsulosin, who experienced heart failure compared to patients taking only dutasteride or only an alpha blocker. Heart failure means that your heart is not pumping blood as it should.

-Make sure your doctor knows if you have liver problems. You may need additional monitoring during your treatment with dutasteride if you have any liver disease.

-Women, children, and adolescentsshould avoid contact with broken dutasteride capsules because the active ingredient can be absorbed through the skin. If there is any skin contact,the affected area must be washed immediatelywith water and soap.

-Use a condom during sex. Dutasteride has been found in the semen of men taking dutasteride. If your partner is pregnant or thinks she 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.

-Dutasteride affects PSA blood tests(prostate-specific antigen) that are sometimes used to detect prostate cancer. Your doctor may still use this test to detect prostate cancer, but they should know about this effect. If you have a blood test for PSA, inform your doctor that you are taking dutasteride.Men taking dutasteride should have regular PSA checks.

- In a clinical study conducted in men at increased risk of developing prostate cancer, men taking dutasteride hada higher frequency of a serious type of prostate cancerthan those not taking dutasteride. The effect of dutasteride on these serious types of prostate cancer is unclear.

-Dutasteride may cause breast enlargement and tenderness. If this causes you discomfort, or if you noticelumps in the breast or nipple discharge, consult 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 Dutasterida Pensa.

Taking Dutasterida Pensa with other medications

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

Do not take Dutasterida Pensa with these medications:

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

Certain medications may interact with Dutasterida Pensa, which may increase the risk of side 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)

Inform your doctorif you are taking any of these medications. You may need to reduce the dose of Dutasterida Pensa.

Taking Dutasterida Pensa with food and drinks

Dutasterida Pensa can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnant women (or those who may be pregnant) should avoid contact with broken capsules. Dutasteride is 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 dutasteride. If your partner is pregnant or thinks she may be pregnant, you should avoid exposing her to your semen.

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

Consult your doctorif a pregnant woman has been in contact with dutasteride.

Driving and operating machinery

It is unlikely that Dutasterida Pensa will affect your ability to drive and operate machinery.

Dutasterida Pensa 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 Dutasterida Pensa as indicated by your doctor or pharmacist.If you do not take Dutasterida Pensa regularly, the control of your PSA levels may be affected. Consult your doctor or pharmacist if you have any doubts.

What dose to take

• The recommended dose is one capsule (0.5 mg) once a day.Dutasterida Pensa 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 treatmentwith Dutasterida Pensa is long-term. Some men may experience 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 Dutasterida Pensa for the time your doctor has indicated.

If you take more Dutasterida Pensa than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist immediately, or call the Toxicological Information Service, phone 915620420, indicating the medication and the amount ingested.

If you forgot to take Dutasterida Pensa

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 Dutasterida Pensa

Do not interrupt treatment with Dutasterida Pensa 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(like nettle rash)
• swelling of the eyelids, face, lips, arms, and legs.

You should contact your doctor immediatelyif you experience any of these symptoms andstop taking Dutasterida Pensa.

Common side effects

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

• inability to achieveor maintain an erection(impotence), which could continue after stopping dutasterida
• decreased libido(sex drive), which could continue after stopping dutasterida
• difficulty with ejaculation, which could continue after stopping dutasterida
• breast swelling or tenderness(gynecomastia)
• dizziness,when taken with tamsulosina.

Less common side effects

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

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

Side effects of unknown frequency

The frequency cannot be estimated from the available data:

• depressive mood
• testicular pain and inflammation.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

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

Do not store above 86°F (30°C). Store in the original packaging to protect it from humidity.

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

Do not use this medication after the expiration date that appears on the box and on the blister after CAD. 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 containers and unused medications at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of containers and unused medications if you are unsure.By doing so, you will help protect the environment.

Composition of Dutasterida Pensa

Theactive principleis dutasteride. Each soft capsule contains 0.5 mg of dutasteride.

Theothercomponents are:

• Content of the capsule: monocaprilocaprato of glycerol (type I) and butylhydroxytoluene (E321).

• Capsule coating: gelatin, glycerol, titanium dioxide (E171), iron oxide yellow (E172), triglycerides (medium chain), lecithin (may contain soy oil) (E322) and purified water.

Appearance of the product and content of the container

Dutasterida Pensa soft capsules are opaque, oblong, yellow in color, and soft gelatin containing a yellow oily liquid.

Dutasterida Pensa is available in blisters of 30 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

Galenicum Health S.L.U.

San Gabriel, 50

Esplugues de Llobregat

08950 Barcelona - Spain

or

Cyndea Pharma, S.L

Polígono Industrial Emiliano Revilla Sanz,

Avenida de Ágreda, 31 Olvega, 42110,

Soria, Spain

or

Pharmadox Healthcare, Ltd.

KW20A Kordin Industrial Park,

Paola, PLA 3000, Malta

or

SAG Manufacturing, S.L.U.

Ctra. N-I, Km 36

28750 San Agustín de Guadalix

Madrid, Spain

Last review date of thisleaflet: August 2016

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/