DUTASTERIDE KRKA 0.5 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the User

Dutasterida 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 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 leaflet. See section 4.

Contents of the pack

1. What is Dutasterida Krka and what is it used for
2. What you need to know before you take Dutasterida Krka
3. How to take Dutasterida Krka
4. Possible side effects
   1. Storage of Dutasterida Krka

1. Contents of the pack and other information

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

Dutasterida Krka is used in men to treat an 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 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 flow of urine 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. Dutasterida Krka 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.

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

2. What you need to know before you take Dutasterida Krka

Do not take Dutasterida Krka

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

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

Warnings and precautions

• 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 Krka if you have any liver disease.
• Women, children, and adolescents should avoid contact with leaking capsules of Dutasterida Krka because the active substance can be absorbed through the skin. If there is any contact with the skin, the affected area should 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 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 fertility.
• Dutasterida Krka affects the blood test for PSA (prostate-specific antigen) used to detect prostate cancer. Your doctor may still use this test to detect prostate cancer, but should be aware of this effect. If you have a blood test for PSA, tell your doctor that you are taking this medicine. Men taking Dutasterida Krka should have regular PSA tests.
• In a clinical study in men at high risk of prostate cancer, men who took dutasteride Krka were more likely to have a high-grade prostate cancer than those who did not take dutasteride. The effect of dutasteride Krka on these high-grade prostate cancers is not clear.
• Dutasterida Krka may cause breast enlargement and breast tenderness. If this causes you discomfort, or if you notice lumps or nipple discharge, consult your doctor, as these changes can be signs of a serious disease, such as breast cancer.

Consult your doctor or pharmacist if you have any questions about taking Dutasterida Krka.

Children and adolescents

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

Other medicines and Dutasterida Krka

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

Some medicines may interact with dutasteride Krka and increase the risk of side 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).

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

Dutasterida Krka with food and drink

Dutasterida Krka 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 Krka. 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 fertility.

Consult your doctor if a pregnant woman has been in contact with dutasteride.

Driving and using machines

Dutasterida Krka is unlikely to affect your ability to drive or use machines.

Dutasterida Krka contains propylene glycol

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

3. How to take Dutasterida Krka

Take Dutasterida Krka exactly as your doctor or pharmacist has told you. If you do not take dutasteride regularly, the control of your PSA levels may be affected. Consult your doctor or pharmacist if you have any questions.

Recommended dose

The recommended dose is one capsule (0.5 mg) once a day. The capsules of Dutasterida Krka 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. The capsules can be taken with or without food.

Treatment with Dutasterida Krka is long-term. Some men may experience rapid improvement in symptoms. However, others may need to continue taking Dutasterida Krka for 6 months or more before an effect is seen. Continue taking Dutasterida Krka for as long as your doctor has told you.

Liver failure

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

If you take more Dutasterida Krka than you should

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

If you forget to take Dutasterida Krka

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

If you stop taking Dutasterida Krka

Do not stop taking this medicine without consulting your doctor first. It may take up to 6 months or more to see an effect.

If you have any further questions on the use of this product, 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

Symptoms of an allergic reaction can include:

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

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

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

• inability to achieve or maintain an erection (impotence), which may continue after stopping dutasteride.
• reduced sex drive (libido), such as a decrease in the amount of semen released during sex, which may continue after stopping dutasteride.
• difficulty ejaculating, which may continue after stopping dutasteride.
• breast tenderness or enlargement (gynaecomastia).
• 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 from the body) or increased hair growth.

Frequency not known(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 leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dutasterida Krka

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

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

Do not store above 30°C.

Keep the blister in the outer carton in order to protect from light.

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 other information

Composition of Dutasterida Krka

• The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.
• The other ingredients are: propylene glycol monocaprylate type II and butylhydroxytoluene (E321) in the capsule content and gelatin, glycerol, titanium dioxide (E171) in the capsule shell. See section 2 "Dutasterida Krka contains propylene glycol"

Appearance and packaging

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

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

Not all pack sizes may be marketed.

Marketing authorisation holder

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

Manufacturer

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

You can ask for more information about this medicine from the local representative of the marketing authorisation holder:

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

This medicine is authorised 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 soft capsules EFG

France:Dutastéride Krka 0.5 mg capsule molle

Italy:Dutasteride Krka

Lithuania:ADUTRYO 0.5 mg minkštosios kapsulės

Poland:Dutrys

Romania:DUTRYS 0.5 mg capsule moi

Slovenia:Adutryo 0.5 mg mehke kapsule

Slovakia:DUTRYS 0.5 mg

Date of last revision of this leaflet: February 2021

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