DUTASTERIDE CINFA 0.5 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the User

dutasteride cinfa 0.5 mg soft capsules EFG

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is dutasteride cinfa and what is it used for
2. What you need to know before you take dutasteride cinfa
3. How to take dutasteride cinfa
4. Possible side effects
5. Storage of dutasteride cinfa
6. Contents of the pack and further information

1. What is dutasteride cinfa and what is it used for

dutasteride cinfa is used in men to treat the enlargement of the prostate(benign prostatic hyperplasia), a non-cancerous growth of the prostate caused by overproduction of a hormone called dihydrotestosterone.

The active substance is dutasteride. Dutasteride belongs to a group of medicines called 5-alpha reductase inhibitors.

As the prostate grows, it can cause urinary problems such as difficulty in the flow of urine and a need to urinate more frequently. It can also cause the urine stream to be weaker.

If benign prostatic hyperplasia is not treated, there is a risk that the flow of urine will be completely blocked (acute urinary retention). This requires immediate medical treatment. In some cases, surgery may be necessary to reduce the size of the prostate or to remove it. Dutasteride reduces the production of dihydrotestosterone, which helps to reduce the size of the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgery.

Dutasteride can also be used with another medicine called tamsulosin (used to treat the symptoms of an enlarged prostate).

2. What you need to know before you take dutasteride cinfa

Do not take dutasteride cinfa

• if you are allergic to dutasteride, to other 5-alpha reductase inhibitors, to soya, to peanutor to any of the other ingredients of this medicine (listed in section 6)
• if you have severe liver disease.
• This medicine contains soya oil. It should not be used in case of peanut or soya allergy.

If you think you may have any of these conditions, do not takethis medicine until you have consulted your doctor.

This medicine is for men only. It should not be taken by women, children or adolescents.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take dutasteride.

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

• Make sure your doctor knows if you have liver problems. You may need some additional checks during your treatment with dutasteride if you have any disease that affects your liver.
• Women, children and adolescentsshould avoid contact with dutasteride capsules that are leaking, because the active ingredient can be absorbed through the skin. If there is any contact with the skin, the affected area should be washed immediatelywith water and soap.
• Use a condom during sexual intercourseDutasteride has been found in the semen of men taking dutasteride. If your partner is pregnant or may be pregnant, she should avoid exposure to your semen because dutasteride may affect the normal development of a male baby. Dutasteride has been shown to decrease sperm count, sperm motility and semen volume. This may reduce your fertility.

• Dutasteride affects the blood test for PSA(prostate-specific antigen) which is sometimes used to detect prostate cancer. Your doctor may still use this test to detect prostate cancer, even though you should know about this effect. If you have a blood test for PSA, tell your doctor that you are taking dutasteride. Men taking dutasteride should have regular PSA tests.
• In a clinical study in men at high risk of prostate cancer, men taking dutasteride were more likely to have a higher grade of prostate cancer than those not taking dutasteride. The effect of dutasteride on these high-grade prostate cancers is not clear.
• Dutasteride may cause breast enlargement and breast tenderness.If this causes you discomfort, or if you notice breast lumps or nipple discharge, talk to your doctor, as these changes can be signs of a serious disease, such as breast cancer.
• Mood changes and depression. Depressed mood, depression and, less frequently, suicidal thoughts have been reported in patients treated with another medicine in the same therapeutic group (5-alpha reductase inhibitor) by mouth. If you experience any of these symptoms, contact your doctor for further medical advice as soon as possible.

Talk to your doctor or pharmacistif you have any questions about taking dutasteride.

Taking dutasteride cinfa with other medicines

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Certain medicines may interact with dutasteride, which may increase the risk of you experiencing side effects. Some of these medicines are:

• verapamil or diltiazem(for high blood pressure)
• ritonavir or indinavir(for AIDS)
• itraconazole or ketoconazole(for fungal infections)
• nefazodone(an antidepressant)
• alpha blockers(for an enlarged prostate or high blood pressure).

Tell your doctorif you are taking any of these medicines. It may be necessary to reduce the dose of dutasteride.

Taking dutasteride cinfa with food and drink

Dutasteride can be taken with or without food.

Pregnancy, breast-feeding and fertility

Pregnant women (or women who may be pregnant) should avoid contact with leaking capsules. Dutasteride is absorbed through the skin and may affect the normal development of a male baby. This risk is especially important during the first 16 weeks of pregnancy.

Use a condom during sexual intercourse.Dutasteride has been found in the semen of men taking dutasteride. If your partner is pregnant or may be pregnant, she should avoid exposure to your semen.

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

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

Driving and using machines

It is unlikely that dutasteride will affect your ability to drive or use machines.

3. How to take dutasteride cinfa

Follow exactly the instructions of your doctor or pharmacist. If you are 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.The capsules of dutasteride cinfa should be swallowed whole, with water. Do not chew or open the capsules. Contact with the contents of the capsules can irritate your mouth or throat.
• Treatment with dutasteride is long-term. Some men may experience rapid improvement in symptoms. However, others may need to continue treatment for 6 months or more before an effect is seen. Continue to take dutasteride for as long as your doctor has told you.

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 Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take dutasteride cinfa

Do not take a double dose to make up for forgotten doses. Take the next dose at the usual time.

If you stop taking dutasteride cinfa

Do not stop taking dutasteride without consulting your doctor first. It may take up to 6 months or more for you to notice an effect.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reaction

The symptoms of an allergic reaction can include:

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

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

Common side effects

These may affect up to 1 in 10 patients who take dutasteride:

• inability to achieve or maintain an erection (impotence), which may continue after stopping dutasteride
• reduced sex drive (libido), 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 enlargement (gynaecomastia)
• dizziness, when taken with tamsulosin

Uncommon side effects

These may affect up to 1 in 100 patients who take dutasteride:

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

Rare side effects

Frequency cannot be estimated from the available data:

• depression
• testicular pain and swelling.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of dutasteride cinfa

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

Do not store above 30°C.

Store in the original package to protect from moisture.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of dutasteride cinfa

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

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

Appearance of the product and pack contents

The soft gelatin capsules are size 6, oblong, opaque, yellow, containing a yellowish oily liquid.

They are available in packs of 30 and 90 capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

O

Cyndea Pharma, S.L.

Polígono Industrial Emiliano Revilla Sanz,

Avenida de Agreda 31

42110 Ólvega (Soria)

O

Galenicum Health, S.L.U

Sant Gabriel, 50,

Esplugues de Llobregat

08950 Barcelona (Spain)

O

Pharmadox Healthcare, Ltd.

KW20A Kordin Industrial Park, Paola,

PLA 3000, Malta

Date of last revision of this package leaflet:September 2025

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

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the package leaflet and carton with your mobile phone (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