Prospecto: information for the user

Dutasteride Krka 0.5 mg soft capsules EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Dutasteride Krka

3.How to take Dutasteride Krka

4.Possible adverse effects

1. Conservation of Dutasteride Krka

6.Contents of the package and additional information

Dutasterida Krka 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.

The active ingredient is dutasteride. It belongs to a group of medicines called 5 alpha reductase inhibitors.

As the prostate grows in size, it can cause urinary problems such as difficulty in urinating and a need to urinate more frequently. It can also cause a weaker and less forceful flow of urine. If benign prostatic hyperplasia is not treated, there is a risk of complete blockage of the flow of urine (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. Dutasterida Krka 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.

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

Do not take Dutasterida Krka

-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 severe 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, and adolescents should not take it.

Warnings and precautions

• 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 dutasterida Krka if you have any liver disease.
• Women, children, and adolescents should avoid contact with broken Dutasterida Krka capsules because the active ingredient 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 sex. Dutasterida Krka has been found in the semen of men taking dutasteride. If your partner is pregnant or thinks she may be, you should avoid exposing her 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.
• Dutasterida Krka 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 you should inform your doctor that you are taking this medication. Men taking dutasterida Krka should have regular PSA checks.
• In a clinical study conducted in men at increased risk of developing prostate cancer, men taking dutasterida Krka had a higher frequency of a type of severe prostate cancer than those not taking dutasteride. The effect of dutasterida Krka on these types of severe prostate cancer is unclear.
• Dutasterida Krka 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 pharmacistif you have any questions related to taking this Dutasterida Krka.

Children and adolescents

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

Other medications and Dutasterida Krka

Inform your doctor orpharmacistif you are taking, have taken recently, or may need to take any other medication.

Some medications may interact with dutasterida Krka and increase the risk of adverse effects. These medications 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 medications. You may need to reduce the dose of dutasterida Krka.

Dutasterida Krka with food and drinks

Dutasterida Krka can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Women who are pregnant (or may be) 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. Dutasterida Krka has been found in the semen of men taking dutasterida Krka. If your partner is pregnant or thinks she may be, you should avoid exposing her to your semen.

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

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

Driving and operating machinery

Dutasterida Krka is unlikely to affect your ability to drive and operate machinery.

Dutasterida Krka contains propylene glycol

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

Follow exactly the administration instructions for Dutasterida Krka indicated by your doctor or pharmacist.Dutasterida Krka..If you do not take dutasterida regularly, the control of 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 a day.Dutasterida Krkacapsules 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.Dutasterida Krkacapsules can be taken with or without food.

The 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 up to 6 months or more before a effect begins to occur. Continue taking Dutasterida Krka for the time your doctor has indicated.

Liver Insufficiency

Consult your doctor or pharmacist if you have liver problems (mild to moderate). Dutasterida Krka is not recommended for use in 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 Dutasterida Krka capsules.

If You Forget to Take Dutasterida Krka

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

If You Interrupt Treatment with Dutasterida Krka

Do not stop treatment with this medication without consulting your doctor first. You may need up to 6 months or more to notice an effect.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Allergic Reaction

The symptoms of an allergic reaction may 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.

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

• inability to achieve or maintain an erection (impotence), which may continue after stopping dutasterida.
• decreased libido, such as a decrease in the amount of semen released during sexual intercourse, which may continue after stopping dutasterida.
• difficulty with ejaculation, which may continue after stopping dutasterida.
• breast swelling or tenderness (gynecomastia).
• dizziness, when taken with tamsulosina.

Less Frequent(may affect up to 1 in 100 patients):

• 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 of the body) or excessive hair growth.

Frequency Not Known(the frequency cannot be estimated from the 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 theSpanish System for Pharmacovigilance of Medicines for Human Use Website:www.notificaram.es.>.Reporting adverse effects can help provide more information about 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 packaging or in the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

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

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Dutasteride Krka Composition

• The active ingredient is dutasteride.Each soft capsule contains 0.5 mg of dutasteride.
• The other components are:propylenglycol monocaprylate type IIand butylhydroxytoluene (E321) in the capsule content and gelatin, glycerol, titanium dioxide (E171) in the capsule coating. See section 2 “Dutasteride Krkacontains propylenglycol”

Appearance of the product and packaging contents

Dutasteride Krka soft capsules (capsules) are soft gelatin oval-shaped capsules (approximately 16.5 x 6.5 mm), light yellow in color, filled with transparent liquid.

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

Only some packaging sizes may be commercially marketed.

Marketing Authorization Holder

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

Responsible for manufacturing:

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 request more information about this medication by contacting 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 medication is authorized in the member states of the European Economic Area with the following names:

Denmark:Dutrys 0.5 mg

Germany:Dutascar 0.5 mg Soft Capsules

Spain:Dutasteride Krka 0.5 mg Soft Capsules EFG

France:Dutastéride Krka 0.5 mg Soft Capsule

Italy:Dutasteride Krka

Lithuania:ADUTRYO 0.5 mg Soft Capsules

Poland:Dutrys

Romania:DUTRYS 0.5 mg Soft Capsule

Slovenia:Adutryo 0.5 mg Soft Capsules

Slovakia:DUTRYS 0.5 mg

Last reviewed date of this leaflet: February 2021

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