Package Leaflet: Information for the User

dutasteride cinfa 0.5 mg soft capsules EFG

Read this leaflet carefully before you start to take 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.

dutasteride cinfa 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. Dutasteride belongs to a group of medications known as 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.

Unless treated, benign prostatic hyperplasia may lead to a 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 dihydrotestosterone production, which helps to reduce prostate size 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 dutasteride cinfa

• if you are allergic to dutasteride, other 5-alpha reductase inhibitors, soy, peanutsoranyof the other components of this medication (listed in section 6)
• if you have a serious liver disease.
• This medication contains soy oil. It should not be used in case of an allergy to peanuts or soy.

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 or pharmacist before starting to take dutasteride.

• 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 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 sexDutasteride 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 he or she should be aware of 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 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 severe prostate cancer than men not taking dutasteride. 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 related to taking dutasteride.

Taking dutasteride cinfa with other medications

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

Certain medications may interact with dutasteride, which may cause you to experience 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 dutasteride.

Taking dutasteride cinfa with food and drinks

Dutasteride can be taken with or without food.

Pregnancy, breastfeeding, and fertilityand 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 dutasteride will affect your ability to drive and use machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.If you do not take dutasteride 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.Dutasteride cinfa 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 dutasteride is long-term. 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 dutasteride for the time your doctor has indicated.

If you take more dutasteride cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take dutasteride cinfa

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 dutasteride cinfa

Do not stop treatment with dutasteride 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)
• lumps on the skin
• swelling of the eyelids, face, lips, arms, and legs.

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

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 dutasteride
• 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 dutasteride
• breast tenderness or swelling(gynecomastia)
• dizziness, when taken with tamsulosin

Uncommon side effects

These may affect up to 1 in 100patientstaking 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

Cannot be estimated from 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.

Store in the original packaging to protect it from moisture.

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

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointof 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.

Dutasteride Cinfa Composition

• The active ingredient is dutasteride.Each soft capsule contains 0.5 mg of dutasteride.
• The other components are:

• Capsule content: monocaprilocaprato glycerol (type I), butylhydroxytoluene (E321).
• Capsule coating: gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), medium-chain triglycerides, lecithin (may contain soybean oil) (E322) and purified water.

Appearance of the product and packaging contents

The soft gelatin capsules are size 6, oblong, opaque, yellow in color, containing an oily and yellowish liquid.

They are available in packs of 30 and 90 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Responsible Manufacturer

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Or

Cyndea Pharma, S.L.

Emiliano Revilla Sanz Industrial Estate,

Agreda Avenue 31

42110 Ólvega (Soria)

Or

Galenicum Health, S.L.U

Sant Gabriel, 50,

Esplugues de Llobregat

08950 Barcelona (Spain)

Or

Pharmadox Healthcare, Ltd.

KW20A Kordin Industrial Park, Paola,

PLA 3000, Malta

Last review date of this leaflet:May 2019

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/80595/P_80595.html

QR code to:https://cima.aemps.es/cima/dochtml/p/80595/P_80595.html