Dutasteride Krka 0.5 mg soft capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dutasteride Krka 0.5 mg soft capsules EFG

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

• Keep this 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 other people, even if they have the same symptoms as you, because it may harm them.

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

Contents of the leaflet

1. What Dutasteride Krka is and what it is used for

2. What you need to know before taking Dutasteride Krka

3. How to take Dutasteride Krka

4. Possible side effects

5. How to store Dutasteride Krka

6. Contents of the pack and other information

1. What Dutasteride Krka is and what it is used for

Dutasteride Krka 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. It 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 left untreated, there is a risk that urine flow may become completely blocked (acute urinary retention), which requires immediate medical treatment. In some cases, surgery may be needed to reduce the size of the prostate or to remove it. Dutasteride Krka reduces the production of dihydrotestosterone, helping to shrink the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgery.

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

2. What you need to know before taking Dutasteride Krka

Do not take Dutasteride Krka

• if you are allergic to dutasteride, to other inhibitors of the enzyme 5-alpha reductase, to soy, to peanuts, or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver disease.
  • 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

• In some clinical studies, there was a higher number of patients taking dutasteride and another medicine 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 does not pump blood as well as it should.
• Make sure your doctor knows if you have any liver problems. You may need additional monitoring during treatment with Dutasteride Krka if you have any condition affecting your liver.
• Women, children, and adolescents must avoid contact with broken capsules of Dutasteride Krka because the active substance can be absorbed through the skin. If any contact with the skin occurs, the affected area should be washed immediately with water and soap.
• Use a condom during sexual intercourse. Dutasteride Krka 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 can 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 Krka affects the serum PSA (prostate-specific antigen) test, which is sometimes used to detect prostate cancer. Your doctor may still use this test to detect prostate cancer, but must be aware of this effect. If you have a blood test for PSA, inform your doctor that you are taking this medicine. Men taking Dutasteride Krka should have regular PSA monitoring.
• In a clinical study conducted in men at increased risk of developing prostate cancer, men who took Dutasteride Krka had a higher incidence of a type of more serious prostate cancer compared to those who did not take dutasteride. The effect of Dutasteride Krka on these more serious types of prostate cancer is not clear.
• Dutasteride Krka may cause breast enlargement and breast 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 condition, 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) taken orally. If you experience any of these symptoms, contact your doctor as soon as possible for further medical advice.

Consult your doctor or pharmacist if you have any questions regarding the use of Dutasteride Krka.

Children and adolescents

This medicine is for men only. Broken capsules must not be handled by women, children, or adolescents.

Other medicines and Dutasteride Krka

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Some medicines may interact with Dutasteride Krka and may increase the risk of adverse effects. These include:

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

Inform your doctor if you are taking any of these medicines. It may be necessary to reduce the dose of Dutasteride Krka.

Dutasteride Krka with food and drink

Dutasteride Krka can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Women who are pregnant (or might be pregnant) must avoid contact with broken capsules. Dutasteride is absorbed through the skin and can 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 Krka. 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

Dutasteride Krka is unlikely to affect your ability to drive or operate machinery.

Dutasteride Krka contains propylene glycol

This medicine contains 299.26 mg of propylene glycol in each soft capsule.

3. How to take Dutasterida Krka

Follow exactly the administration instructions for Dutasterida Krka provided by your doctor or pharmacist. If you do not take dutasteride regularly, your PSA levels may be affected. Consult your doctor or pharmacist if you have any doubts.

Recommended dose

The recommended dose is one capsule (0.5 mg) once daily. Dutasterida Krka capsules should be swallowed whole with water. Do not chew or open the capsules. Contact with the capsule contents may irritate your mouth or throat. The capsules may be taken with or without food.

Treatment with Dutasterida Krka is long-term. Some men may experience rapid symptom improvement. However, others may need to continue taking Dutasterida Krka for up to 6 months or longer before an effect begins. Continue taking Dutasterida Krka for as long as your doctor has instructed.

Hepatic impairment

Consult your doctor or pharmacist if you have hepatic problems (mild to moderate). Use of Dutasterida Krka is not recommended in patients with severe liver disease (see section "Do not take Dutasterida Krka").

If you take more Dutasterida Krka than you should

Contact your doctor or pharmacist if you take too many Dutasterida Krka capsules.

If you forget to take Dutasterida Krka

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

If you stop taking Dutasterida Krka

Do not stop treatment with this medicine 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 will experience them.

Allergic reaction

Symptoms of an allergic reaction may include:

• Skin rash (which may be itchy).
• Hives.
• Swelling of the eyelids, face, lips, arms, and legs.

You should contact your doctor immediately if you experience any of these symptoms and stop taking Dutasteride Krka.

Frequent (may affect up to 1 in 10 people):

• Inability to achieve or maintain an erection (impotence), which may continue after stopping dutasteride.
• Decreased sex drive (libido), such as a reduction in the amount of semen released during sexual intercourse, which may continue after stopping dutasteride.
• Difficulty in ejaculation, which may continue after stopping dutasteride.
• Swelling or tenderness of the breast (gynecomastia).
• Dizziness, when taken with tamsulosin.

Uncommon (may affect up to 1 in 100 people):

• 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 of the body) or hair growth.

Frequency not known (frequency cannot be estimated from the available data):

• Depression.
• Pain and inflammation of the testicles.

Reporting of adverse effects

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

5. Storage of Dutasteride Krka

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

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

Do not store above 30°C.

Keep the blister inside the outer cardboard carton to protect it from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Dutasteride Krka

• The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.
• The other components are: propylene glycol monocaprylate type II and butylated hydroxytoluene (E321) in the capsule contents, and gelatin, glycerol, titanium dioxide (E171) in the capsule shell. See section 2 “Dutasteride Krka contains propylene glycol”.

Nature of the product and pack contents

Dutasteride Krka soft capsules (capsules) are oblong soft gelatin capsules (approximately 16.5 x 6.5 mm), light yellow in color, filled with clear liquid.

Dutasteride Krka is available in packs of 10, 30, 50, 60 and 90 soft capsules in triple blister (PVC/PE/PVDC)/transparent aluminum.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer(s):

Laboratorios LEÓN FARMA, S.A., C/La Vallina, s/n, Polígono Industrial Navatejera, 24193 Villaquilambre (León), SPAIN

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, SPAIN.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark: Dutrys 0.5 mg

Germany: Dutascar 0.5 mg Weichkapseln

Spain: Dutasterida Krka 0.5 mg cápsulas blandas EFG

France: Dutastéride Krka 0.5 mg capsule molle

Italy: Dutasteride Krka

Lithuania: ADUTRYO 0.5 mg minkštosios kapsules

Poland: Dutrys

Romania: DUTRYS 0.5 mg capsule moi

Slovenia: Adutryo 0.5 mg mehke kapsule

Slovakia: DUTRYS 0.5 mg

Date of the most recent revision of this leaflet: December 2025

Detailed and up-to-date 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/