Leaflet: information for the user

Dutasteride Aristo 0.5 mg soft capsules EFG

Read this leaflet carefully before you start taking this medicine, because 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 the same symptoms as you, 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 Aristo is and what it is used for

2. What you need to know before starting to take Dutasteride Aristo

3. How to take Dutasteride Aristo

4. Possible side effects

5. Storage of Dutasteride Aristo

6. Contents of the pack and additional information

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

Dutasterida Aristo 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 blockage of the 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. Dutasterida Aristo 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.

Dutasterida Aristo may also be used with another medication, tamsulosin (used to treat symptoms of an enlarged prostate).

Do not take Dutasterida Aristo

-if you are allergic to dutasteride, other 5-alpha reductase inhibitors, soy, peanuts, or any of the other components of this medication (listed in section 6).

-if you have a serious liver disease.

- if you are a child or adolescent.

Inform your doctorif you think you are in any of these situations.

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

Warnings and precautions

Consult your doctor before starting to take Dutasterida Aristo.

-In some clinical studies, a higher number of patients taking dutasteride and another medication called an alpha blocker, such as tamsulosin, 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.

-Assure your doctor knows if you have liver problems.You may need additional monitoring during your treatment with Dutasterida Aristo if you have any liver disease.

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

-Use a condom during sexual intercourse.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 the PSA (prostate-specific antigen) blood test(prostate-specific antigen) that is 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 Dutasterida Aristo.Men taking Dutasterida Aristo should have regular PSA monitoring.

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

-Dutasterida Aristo 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 related to taking Dutasterida Aristo.

Taking Dutasterida Aristo with other medications

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

Certain medications may interact with Dutasterida Aristo, 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)
• other alpha blockerss(for enlarged prostate or high blood pressure).

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

Taking Dutasterida Aristo with food and drinks

Dutasterida Aristo can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Women should not take dutasteride.

Women who are pregnant (or 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.Consult your doctorif a pregnant woman has come into contact with dutasteride.

Use a condom during sexual intercourse.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.

Driving and operating machinery

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

Dutasterida Aristo contains soy lecithin

This medication contains soy lecithin, which may contain soy oil. It should not be used in cases of allergy to peanuts or soy.

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

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 break the capsules. Contact with the contents of the capsules may irritate your mouth or throat.
• The treatment with Dutasterida Aristo is long-term. Some men may experience rapid improvement in symptoms. However, others may need to take this medication for up to 6 months or more before an effect begins to occur. Continue taking Dutasterida Aristo for the time your doctor has indicated.

If you take more Dutasterida Aristo 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.

If you forgot to take Dutasterida Aristo

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

If you interrupt the treatment with Dutasterida Aristo

Do not interrupt the treatment with Dutasterida Aristo 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 medications, this medication may produce adverse effects, although not all people may experience them..

Allergic Reaction

The symptoms of an allergic reaction may include:

• skin rash(which may itch)
• skin bumps
• swelling of the eyelids, face, lips, arms, and legs.

If you experience any of these symptomscontact your doctor immediately andstop taking Dutasterida Aristo.

Frequent Adverse Effects

May affect up to 1 in 10 men:

• inability to achieve or maintain an erection(impotence), *which may continue after stopping Dutasterida Aristo
• decreased libido(sex drive), *which may continue after stopping Dutasterida Aristo
• difficulty with ejaculation, *which may continue after stopping Dutasterida Aristo
• breast swelling or tenderness(gynecomastia)
• dizziness, when taken with tamsulosina

Less Frequent Adverse Effects

May affect up to 1 in 100 men:

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

Adverse Effects of Unknown Frequency

The frequency cannot be estimated from available data:

- depressive mood

- testicular pain and inflammation.

Reporting Adverse Effects

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

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 or on the blister after CAD. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofDutasterida Aristo

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

The other components are:

- capsule content: glycerol monocaprilocaprato (type I), butylhydroxytoluene (E321).

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

Appearance of the product and contents of the packaging

Soft, opaque, yellow capsules made of soft gelatin containing an oily and yellowish liquid, measuring 19 ± 0.8 mm x 6.9 ± 0.4 mm. They are available in white, opaque PVC/PVDC-Aluminum blister packs containing 30 and 90 capsules. Some packaging sizes may only be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aristo Pharma Iberia S.L.

Solana 26 Street

28850 Torrejón de Ardoz-Madrid

Spain

Responsible for manufacturing:

Laboratorios Medicamentos Internacionales S.A.

Solana 26 Street

28850 Torrejón de Ardoz (Madrid)

Spain

Or

SAG Manufacturing, S.L.U.

Highway N-I, Km 36

28750 San Agustín de Guadalix, Madrid

Spain

Last review date of this leaflet: December 2016