Package Insert: Information for the Patient

Dutasteride Aurovitas 0.5 mg Soft Gelatin Capsules EFG

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 refer to 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 may 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.

Dutasteride 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. It 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. Dutasteride 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.

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

Do not take Dutasterida:

• if you are allergic to dutasteride, other 5-alpha reductase inhibitors,or any of the other ingredients in 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. It should not be taken by women, children, or adolescents.

Warnings and precautions

Consult your doctor before starting to take this medication.

• In some clinical studies, there was a higher number of 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 capsules of this medication because the active ingredient 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 sex.Dutasteride has been found in the semen of men taking this medication. 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 (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 this medication.Men taking dutasteride should have regular PSA monitoring.
• In a clinical study of men at increased risk of developing prostate cancer, men taking dutasteride had a higher frequency of a type of severe prostate cancer than those not taking it. The effect of dutasteride on these types of severe 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 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 this medication.

Taking Dutasterida 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 dutasteride, which may increase the risk of 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 the dose of this medication.

Taking Dutasterida with food and drinks

This medication 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 this medication. 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 dutasteride will affect your ability to drive and operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If you do not take dutasterida 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. The capsules of this medication 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 is of long duration. 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 this medication for the time your doctor has indicated.

If you take more Dutasterida 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 Dutasterida

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

Do not interrupt treatment with this medication without consulting your doctor first. It may take 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)
• lumps on the skin
• swelling of the eyelids, face, lips, arms, and legs.

You must contact your doctor immediatelyif you experience any of these symptoms andstop taking this medicine.

Common side effects

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

• inability to achieve or maintain an erection(impotence), which may continue after stopping this medicine
• decreased libido(sex drive), which may continue after stopping dutasteride
• difficulty with ejaculation,such as a decrease in the amount of semen released during sexual intercourse,which may continue after stopping this medicine
• breast swelling or tenderness(gynecomastia)
• dizziness, when taken with tamsulosin.

Uncommon side effects

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

• heart failure (the heart becomes less efficient at pumping blood around the body. This may cause symptoms such as difficulty breathing, excessive fatigue, 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:

• 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 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.

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

Composition of Dutasterida Aurovitas

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

The other components are:

• capsule content: glycerol monocaprilocaprato (type I) and butylhydroxytoluene (E321).
• capsule coating: gelatin, glycerol, titanium dioxide (E171) and iron oxide yellow (E172).

Appearance of the product and contents of the packaging

Dutasterida Aurovitas soft capsules are oblong, opaque, yellow in color, and contain an oily and yellowish liquid.

They are available in blisters, in packs of 30 and 90 capsules.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D,

28036 Madrid,

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmaceutica, S.A.

Rua João de Deus, n.o 19, Venda Nova, 2700-487

Amadora, Portugal

Last review date of this leaflet: October 2019

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