Dutasteride CINFA 0.5 mg soft capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

dutasteride cinfa 0.5 mg soft capsules EFG

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

dutasteride cinfa is used in men to treat enlarged 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 known as 5-alpha reductase enzyme inhibitors.

As the prostate enlarges, it may cause urinary problems such as difficulty in urine flow and a need to urinate more frequently. It may also cause the urine stream to become weaker and less forceful.

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

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

2. What you need to know before taking dutasteride cinfa

Do not take dutasteride cinfa

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

If you think you are in any of these situations, do not take this medicine until you have consulted your doctor.

This medicine is for men only. Women, children, and adolescents must not take it.

Warnings and precautions

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

• In some clinical studies, a higher number of patients taking dutasteride and another medicine 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 does not pump blood as well as it should.

• Make sure your doctor knows if you have liver problems. You may need additional monitoring during treatment with dutasteride if you have a condition affecting your liver.

• Women, children, and adolescents should avoid contact with broken dutasteride capsules because the active ingredient can be absorbed through the skin. If contact occurs, the affected area must be washed immediately with 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 suspects she might be pregnant, you must avoid exposing her to your semen because dutasteride may affect the normal development of a male baby. Dutasteride has been shown to reduce sperm count, sperm motility, and semen volume. This may reduce your fertility.

• Dutasteride affects the PSA blood test (prostate-specific antigen), which is sometimes used to detect prostate cancer. Your doctor may still use this test to screen for prostate cancer, but must 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 in men at increased risk of developing prostate cancer, men taking dutasteride were found to have a higher frequency of more serious types of prostate cancer than those not taking dutasteride. The effect of dutasteride on these more serious types of prostate cancer is not clear.

• Dutasteride may cause breast enlargement and tenderness. If this causes discomfort, or if you notice lumps in the breast or nipple discharge, consult your doctor, as these changes may be signs of a serious illness, 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 (oral 5-alpha-reductase inhibitor). If you experience any of these symptoms, contact your doctor for further medical advice as soon as possible.

Talk to your doctor or pharmacist if 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 need to take any other medicines.

Certain medicines may interact with dutasteride, increasing the risk of adverse 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 enlarged prostate or high blood pressure).

Tell your doctor if you are taking any of these medicines. A dose reduction of dutasteride may be necessary.

Taking dutasteride cinfa with food and drink

Dutasteride can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnant women (or women who may be pregnant) must avoid contact with broken capsules. Dutasteride is absorbed through the skin and may affect the normal development of a male baby. This risk is particularly 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 suspects she might be pregnant, you must avoid exposing her to your semen.

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

Consult your doctor if a pregnant woman has been exposed to dutasteride.

Driving and using machines

It is unlikely that dutasteride will affect your ability to drive or operate machinery.

3. How to take dutasterida cinfa

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. If you do not take dutasteride regularly, your PSA levels may be affected.

What dose should you take

• The recommended dose is one capsule (0.5 mg) once daily. Dutasterida cinfa capsules must be swallowed whole with water. Do not chew or open the capsules. Contact with the capsule contents may irritate your mouth or throat.
• Treatment with dutasteride is long-term. Some men may experience rapid symptom improvement. However, others may need to continue treatment for up to 6 months or longer before an effect begins. Continue taking dutasteride for as long as your doctor has instructed.

If you take more dutasterida cinfa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take dutasterida cinfa

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

If you stop taking dutasterida cinfa

Do not stop treatment with dutasteride without first consulting your doctor. It may take up to 6 months or longer before an effect is noticed.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Allergic reaction

Symptoms of an allergic reaction may include:

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

You must immediately contact your doctor if you experience any of these symptoms and stop taking dutasteride.

Frequent adverse effects

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

• inability to achieve or maintain an erection (impotence), which may continue after stopping dutasteride
• decreased 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
• swelling or tenderness of the breast (gynecomastia)
• dizziness, when taken with tamsulosine

Uncommon adverse effects

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

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

Adverse effects with unknown frequency

Cannot be estimated from the available data:

• depression
• pain and inflammation of the testicles.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of dutasteride cinfa

Keep this medicine out of sight and reach of children.

Do not store above 30 °C.

Store in the original packaging to protect from moisture.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of dutasteride cinfa

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

• The other components are:

• Capsule contents: glycerol monocaprylocaprate (type I), butylhydroxytoluene (E321).

• Capsule shell: 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 container

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

Available in packs of 30 and 90 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

Or

Cyndea Pharma, S.L.

Polígono Industrial Emiliano Revilla Sanz,

Avenida de Agreda 31

42110 Ólvega (Soria)

Or

Galenicum Health, S.L.U.

Sant Gabriel, 50,

Esplugues de Llobregat

08950 Barcelona (Spain)

Or

SAG Manufacturing, S.L.U.

Ctra. N-I, Km 36, 28750, San Agustín de Guadalix. Madrid, Spain

Date of the most recent review of this leaflet: September 2025

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

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80595/P_80595.html

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