Package leaflet: Information for the patient

Dutrys, 0.5 mg, soft capsules
Dutasteridum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Dutrys is and what it is used for
Important information before taking Dutrys
How to take Dutrys
Possible side effects
How to store Dutrys
Contents of the pack and other information

1. What Dutrys is and what it is 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 in this medicine is dutasteride, which belongs to a group of medicines known as 5-alpha reductase inhibitors.
An enlarged prostate gland may lead to problems with urination, such as difficulty passing urine and increased frequency of urination. There may also be reduced urine flow and a weak urine stream. If left untreated, complete blockage of urine flow may occur (acute urinary retention). This condition requires immediate treatment. In some cases, surgery may be needed to remove or reduce the size of the prostate gland. Dutrys reduces the production of dihydrotestosterone, leading to a reduction in the size of the prostate gland and relief of symptoms. Thus, it reduces the likelihood of acute urinary retention and the need for surgical intervention.
Dutrys may also be used in combination with another medicine called tamsulosin (used to treat symptoms of an enlarged prostate gland).

2. Important information before using Dutrys

When not to use Dutrys

if the patient is allergic to dutasteride, other 5-alpha reductase inhibitors, soya, peanuts, or any of the other ingredients of this medicine (listed in section 6),
if the patient has severe liver disease.
If any of the above apply to the patient, do not take this medicine without first consulting a doctor.

Dutrys is intended for use in men only. It must not be used in women, children, or adolescents.
Warnings and precautions

Before starting to take Dutrys, discuss this with your doctor or pharmacist.

In some clinical studies, heart failure occurred more frequently in patients taking dutasteride together with a medicine belonging to a group called alpha-adrenergic receptor antagonists (such as tamsulosin) than in patients taking dutasteride alone or the alpha-adrenergic antagonist alone. Heart failure means the heart does not pump blood properly.
Inform your doctor if you have liver disease. If you have liver disease, additional tests may be required during treatment with Dutrys.
Women, children, and adolescents must not touch damaged capsules of Dutrys, as the active substance may be absorbed through the skin. In case of skin contact, wash the affected area immediately with soap and water.
Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking Dutrys. If your partner is pregnant or could be pregnant, avoid exposing her to contact with semen, because dutasteride may impair the development of a male fetus. It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility. This may lead to reduced fertility.
Dutrys affects the measurement of prostate-specific antigen (PSA) levels, which is sometimes performed to detect prostate cancer. Despite this, your doctor may deliberately order this test to screen for prostate cancer. If you are undergoing PSA testing, inform your doctor that you are taking Dutrys. Patients taking Dutrys should have their PSA levels monitored regularly.
In a clinical study involving patients at increased risk of prostate cancer, a more severe form of prostate cancer was diagnosed more frequently in patients taking dutasteride than in those not taking dutasteride. The effect of dutasteride on the potential to cause high-grade prostate cancer is not clear.
Dutrys may cause breast enlargement and tenderness. If these symptoms become bothersome, or if lumps in the breast or nipple discharge occur, contact your doctor, as these 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 taking another medicine from the same therapeutic group (5-alpha reductase inhibitor) orally. If any of these symptoms occur, seek immediate medical advice from your doctor.
If you have any questions about using Dutrys, contact your doctor or pharmacist.
Children and adolescents
This medicine is intended for men only. Women, children, and adolescents must not touch damaged capsules.
Dutrys and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Some medicines taken together with Dutrys may increase the likelihood of adverse effects. These 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-blocker medicines (used to treat enlarged prostate or high blood pressure).

Inform your doctor if you are taking any of these medicines. A reduced dose of Dutrys may be necessary.
Dutrys with food and drink
This medicine can be taken with or without food.
Pregnancy, breastfeeding, and effects on fertility
Women who are pregnant (or who could be pregnant) must not touch damaged capsules. Dutasteride is absorbed through the skin and may impair the development of a male fetus. The risk is particularly high during the first 16 weeks of pregnancy.
Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking Dutrys. If your partner is pregnant or could be pregnant, avoid exposing her to contact with semen.
It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility. This may lead to reduced fertility in men.
If a pregnant woman has been exposed to dutasteride, contact a doctor immediately.
Driving and operating machinery
It is unlikely that dutasteride will affect the ability to drive or operate machinery.
Dutrys contains propylene glycol
This medicine contains 299.46 mg of propylene glycol in each soft capsule.

3. How to use Dutrys

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.
Irregular use of this medicine may affect PSA level monitoring.

Recommended dose

The recommended dose of Dutrys is one capsule (0.5 mg) taken once daily. The capsule should be swallowed whole with water. The capsule must not be chewed or opened. Contact with the capsule contents may cause oral cavity pain or throat pain. The capsule may be taken with or without food.
Treatment with Dutrys is long-term. Some patients may experience symptom relief early in treatment. However, others may require treatment with Dutrys for 6 months or longer to achieve improvement. Dutrys should be used for as long as directed by the physician.

Liver function disorders
In case of liver function disorders (mild to moderate), consult a physician or pharmacist. Dutrys should not be used in patients with severe liver function disorders (see section "When not to use Dutrys").

Overdose of Dutrys
If more than the recommended dose of Dutrys has been taken, consult a physician or pharmacist immediately.

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

Discontinuation of Dutrys
Do not discontinue treatment with Dutrys unless instructed by the physician. Treatment for 6 months or longer may be necessary to achieve improvement.

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

4. Possible adverse reactions
Like all medicines, this medicine may cause adverse reactions, although not everyone experiences them.

Allergic reaction
Symptoms of an allergic reaction may include:

skin rash (which may be itchy),
urticaria,
swelling of the eyelids, face, lips, hands, or feet.

If any of these symptoms occur, contact a physician immediately and discontinue use of Dutrys.

Common adverse reactions (may occur in up to 1 in 10 men):

inability to achieve or maintain an erection (impotence); this effect may persist after discontinuation of Dutrys,
decreased sexual desire (libido); this effect may persist after discontinuation of Dutrys,
ejaculation disorders, including reduced semen volume during ejaculation; this effect may persist after discontinuation of Dutrys,
enlargement or tenderness of the breasts (gynecomastia),
dizziness when used concomitantly with tamsulosin.

Uncommon adverse reactions (may occur in up to 1 in 100 men):

heart failure (reduced cardiac efficiency—possible symptoms include shortness of breath, extreme fatigue, and swelling in the ankles and lower limbs),
hair loss (usually body hair) or hair growth.

Adverse reactions of unknown frequency (frequency cannot be estimated from available data):

depression,
testicular pain and swelling.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a physician or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Dutrys

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
The batch number is indicated on the packaging after the abbreviation "Lot".
Do not store above 30°C.
Keep the blisters in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the packaging 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, gelatin soft capsules (capsules), approximately 16.5 x 6.5 mm in size,
filled with a clear liquid.
Pack sizes: 10, 30, 50, 60 and 90 soft capsules in blister packs within a cardboard carton.
Not all pack sizes may be marketed.
Marketing Authorisation 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, S.A., c/La Vallina, s/n, Polígono Industrial Navatejera, 24193
Villaquilambre, León, Spain
For further information on the product names in other European Economic Area countries, please contact the representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Tel. 22 57 37 500