Leaflet: information for the user

Dutacap 0.5 mg soft capsules EFG

Dutasteride

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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 Dutacap is and what it is used for

2. What you need to know before you start taking Dutacap

3. How to take Dutacap

4. Possible side effects

5. Storage of Dutacap

6. Contents of the pack and additional information

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

Dutacap 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 can produce urinary problems such as difficulty in urinating and a need to urinate more frequently. It can 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. Dutacap 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.

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

Do not take Dutacap

- 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 think you are in any of these situations, do not take this 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 Dutacap.

- 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 checks during your treatment with Dutacap if you have any liver disease.

- Women, children, and adolescents should avoid contact with broken Dutacap capsules because the active ingredient can be absorbed through the skin. If there is any skin contact, the affected area should be washed immediately with 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, she should avoid exposure 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 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 Dutacap. Men taking Dutacap should have regular PSA checks.

- In a clinical study conducted in men at increased risk of developing prostate cancer, men taking dutasteride had more frequently, a type of severe prostate cancer than those not taking dutasteride. The effect of dutasteride on these types of severe prostate cancer is unclear.

- Dutacap may cause breast enlargement and tenderness. If this causes you discomfort, or if you notice lumps in your 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 pharmacist if you have any questions related to taking Dutacap.

Other medications and Dutacap

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 Dutacap, 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)

- other 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 Dutacap.

Taking Dutacap with food and drinks

Dutacap can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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.

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, she should avoid exposure to your semen.

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

Consult your doctor if 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.

Dutacap contains soy lecithin

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

FOLLOW EXACTLY THE ADMINISTRATION INSTRUCTIONS FOR THIS MEDICINE AS INDICATED BY YOUR DOCTOR OR PHARMACIST. IF YOU DO NOT TAKE Dutacap REGULARLY, THE CONTROL OF YOUR PSA LEVELS MAY BE AFFECTED. IN CASE OF DOUBT, ASK YOUR DOCTOR OR PHARMACIST.

What Dose Should You Take

- The recommended dose is one capsule (0.5 mg) once a day. 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.

- Dutacap treatment is long-term. Some men may experience rapid improvement in symptoms. However, others may need to take this medicine for up to 6 months or more before an effect begins to occur. Continue taking Dutacap for the time your doctor has indicated.

If You Take More Dutacap Than You Should

IF YOU HAVE TAKEN TOO MUCH Dutacap OR IF YOU HAVE ACCIDENTALLY INGESTED IT, CONSULT YOUR DOCTOR, PHARMACIST IMMEDIATELY OR CALL THE TOXICOLOGY INFORMATION SERVICE, PHONE 915620420, INDICATING THE MEDICINE AND THE AMOUNT TAKEN. IT IS RECOMMENDED TO BRING THE PACKAGE AND THE PACKAGE INSERT TO THE HEALTHCARE PROFESSIONAL.

If You Forget to Take Dutacap

DO NOT TAKE A DOUBLE DOSE TO COMPENSATE FOR THE FORGOTTEN DOSES. TAKE THE NEXT DOSE AT THE USUAL TIME.

Do Not Discontinue Dutacap Treatment

DO NOT DISCONTINUE Dutacap TREATMENT 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 MEDICINE, ASK YOUR DOCTOR OR PHARMACIST.

Like all medications, this medication may produce adverse effects, although not all people will 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 symptomsimmediately report them to yourdoctor andstop taking Dutacap.

Frequent Adverse Effects, may affect up to 1 in 10 men:

- inability to achieve or maintain an erection (impotence), which may continue after stopping Dutacap

- decreased sex drive (libido), which may continue after stopping Dutacap

- difficulty with ejaculation,such as a decrease in the amount of semen released during sexual intercourse,which may continue after stopping Dutacap

- breast swelling or tenderness (gynecomastia)

- dizziness, when taken with tamsulosina

Rare 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 body hair) or excessive hair growth.

Adverse Effects of Unknown Frequency, the frequency cannot be estimated from available data:

- depression.

- testicular pain and inflammation.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 Medicines 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, in the blister pack, or in the bottle 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 in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Dutacap

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 contents of the packaging

Soft capsules. Soft gelatin capsules, oblong, opaque, yellow in color, filled with a yellowish oily liquid, 14.7 ± 0.5 mm x 5.9 ± 0.2 mm in size, without markings.

They are available in: white opaque PVC/PVDC-Aluminum blister packs containing 30 or 90 capsules.

Only some package sizes may be marketed.

Marketing authorization holder

Galenicum Derma, S.L.U.

Ctra. N-1, Km 36

28750 - San Agustín del Guadalix

Madrid - Spain

Responsible for manufacturing:

Cyndea Pharma, S.L

Polígono Industrial Emiliano Revilla Sanz,

Avenida de Ágreda, 31 Olvega, 42110,

Soria, Spain

or

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid 82

28802 Alcalá de Henares

Madrid – Spain

or

Galenicum Health S.L.

Avda. Cornellá 144, 7º-1ª, Edificio Lekla

Esplugues de Llobregat

08950 Barcelona - Spain

Last review date of this leaflet: September 2019

Other sources of information

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