Dutris

Package Leaflet: Information for the Patient

Dutrys, 0.5 mg, Soft Capsules
dutasteride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication 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, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Dutrys and what is it used for
• 2. Important information before taking Dutrys
• 3. How to take Dutrys
• 4. Possible side effects
• 5. How to store Dutrys
• 6. Contents of the pack and other information

1. What is Dutrys and what is it used for

Dutrys is used in men with an enlarged prostate gland (benign prostatic hyperplasia) - a non-cancerous enlargement of the prostate gland caused by excessive production of a hormone called dihydrotestosterone.
The active substance of the medication is dutasteride, which belongs to a group of medications called 5-alpha reductase inhibitors.
Enlargement of the prostate gland can lead to problems with urination, such as difficulty urinating and frequent urination. It can also cause a decrease in urine flow and a weak urine stream. If left untreated, it can lead to complete blockage of urine flow (acute urinary retention). This situation requires immediate treatment. In some cases, surgical intervention may be necessary to remove or reduce the size of the prostate gland. Dutrys reduces the production of dihydrotestosterone, which leads to a reduction in the size of the prostate gland and alleviation of symptoms. It therefore reduces the likelihood of acute urinary retention and the need for surgical intervention.
Dutrys can also be used in combination with another medication called tamsulosin (used to treat symptoms of an enlarged prostate gland).

2. Important information before taking Dutrys

When not to take Dutrys

• if you are allergic to dutasteride, other 5-alpha reductase inhibitors, soy, peanuts, or any of the other ingredients of this medication (listed in section 6),
• if you have severe liver disease. If any of the above applies to you, do not take the medication before consulting your doctor.

This medication is for use in men only. It must not be taken by women, children, or adolescents.

Warnings and precautions

Before taking Dutrys, discuss it with your doctor or pharmacist.

• In some clinical trials, an increased risk of heart failure was observed in patients taking dutasteride in combination with a medication called an alpha-adrenergic receptor antagonist (such as tamsulosin), compared to patients taking dutasteride or an alpha-adrenergic receptor antagonist alone.
• Heart failure means that the heart is not pumping blood as well as it should.
• Tell your doctor if you have liver disease. If you have liver disease, you may need to have additional tests while taking Dutrys.
• Women, children, and adolescents must not handle damaged Dutrys capsules, as the active substance may be absorbed through the skin. If contact occurs with the skin, wash the affected area immediately with soap and water.
• Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Dutrys. If your partner is pregnant or may become pregnant, avoid exposing her to contact with semen, as dutasteride may affect the development of a male fetus. Dutasteride has been shown to decrease sperm count, semen volume, and sperm motility, which may reduce fertility in men.
• Dutrys affects the measurement of prostate-specific antigen (PSA), which is sometimes performed to detect prostate cancer. However, your doctor may still decide to perform this test to detect prostate cancer. If you are having a PSA test, tell your doctor that you are taking Dutrys. Patients taking Dutrys should have their PSA levels checked regularly.
• In a clinical trial involving patients with an increased risk of prostate cancer, patients taking dutasteride were more likely to be diagnosed with high-grade prostate cancer than patients who did not take dutasteride. The effect of dutasteride on the risk of developing high-grade prostate cancer is not clear.
• Dutrys may cause breast enlargement or tenderness. If these symptoms become troublesome or if you notice lumps in your breasts or discharge from your nipples, contact your doctor, as these may be signs of a serious condition such as breast cancer. If you have any questions about taking Dutrys, contact your doctor or pharmacist.

Dutrys and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Some medications taken with Dutrys may increase the risk of side effects. These medications include:

• verapamil or diltiazem (used to treat high blood pressure),
• ritonavir or indinavir (used to treat HIV infection),
• itraconazole or ketoconazole (used to treat fungal infections),
• nefazodone (used to treat depression),
• alpha-blockers (used to treat an enlarged prostate gland or high blood pressure).

Tell your doctor if you are taking any of these medications. Your doctor may need to reduce your dose of Dutrys.

Dutrys with food and drink

The medication can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnant women (or women who may become pregnant) must not handle damaged capsules. Dutasteride is absorbed through the skin and may affect the development of a male fetus. There is a special risk during the first 16 weeks of pregnancy.
Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Dutrys. If your partner is pregnant or may become pregnant, avoid exposing her to contact with semen.
Dutasteride has been shown to decrease sperm count, semen volume, and sperm motility, which may reduce fertility in men.
If a pregnant woman has come into contact with dutasteride, she should contact her doctor.

Driving and using machines

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

Dutrys contains propylene glycol

This medication contains 299.46 mg of propylene glycol in each soft capsule.

3. How to take Dutrys

Always take this medication exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Irregular intake of the medication may affect the monitoring of PSA levels.

Recommended dose

• The recommended dose of Dutrys is one capsule (0.5 mg) taken once daily. The capsule should be swallowed whole with water. Do not chew or open the capsules. Contact with the contents of the capsules may cause mouth or throat pain.
• Treatment with Dutrys is long-term. Some patients may experience an improvement in symptoms at the beginning of treatment. However, others may require treatment with Dutrys for 6 months or longer. You should continue to take Dutrys for as long as your doctor recommends.

Liver function disorders

If you have liver function disorders (mild to moderate), contact your doctor or pharmacist. Do not take the medication if you have severe liver function disorders (see section "When not to take Dutrys").

Overdose

If you take more than the recommended dose, contact your doctor or pharmacist.

Missed dose

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

Stopping treatment

Do not stop taking Dutrys without consulting your doctor. To achieve an improvement, it may be necessary to continue treatment for 6 months or longer.
If you have any further questions about taking this medication, ask your doctor or pharmacist.
4.

Possible side effects

Like all medications, Dutrys can cause side effects, although not everybody gets them.

Allergic reaction

Symptoms of an allergic reaction may include:

• skin rash (which may be itchy),
• hives,
• swelling of the eyelids, face, lips, hands, and feet.

If you experience any of these symptoms, contact your doctor immediately and stop taking Dutrys.

Common side effects (may affect up to 1 in 10 men):

• impotence (inability to achieve or maintain an erection), which may persist after stopping treatment with Dutrys,
• decreased libido (sex drive), which may persist after stopping treatment with Dutrys,
• difficulty with ejaculation, including reduced semen volume, which may persist after stopping treatment with Dutrys,
• breast tenderness or enlargement (gynecomastia),
• dizziness when taken with tamsulosin.

Uncommon side effects (may affect up to 1 in 100 men):

• heart failure (less efficient heart function - possible symptoms include shortness of breath, extreme tiredness, and swelling in the ankles and legs),
• hair loss (usually body hair) or increased hair growth.

Rare side effects (frequency cannot be estimated from the available data):

• depression,
• testicular pain and swelling.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to store Dutrys

Keep the medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month stated.
The batch number is stated on the packaging after "Lot".
Do not store above 30°C.
Store the blisters in the original packaging to protect from light.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Dutrys contains

• The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.
• The other ingredients are: propylene glycol monocaprylate, type II, butylhydroxytoluene (E 321) inside the capsule, and gelatin, glycerol, titanium dioxide (E 171) in the capsule shell. See section 2: "Dutrys contains propylene glycol".

What Dutrys looks like and contents of the pack

Light yellow, elongated, soft gelatin capsules, approximately 16.5 x 6.5 mm in size, filled with a clear liquid.
Packaging:10, 30, 50, 60, and 90 soft capsules in blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Laboratorios León Farma, SA, c/La Vallina, s/n, Polígono Industrial Navatejera, 24193 Villaquilambre, León, Spain
To obtain more detailed information on the names of medicinal products in other EU member states, contact the representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500

Date of last revision of the leaflet: 01.01.2025