Dutazir

Patient Information Leaflet: User Information

Dutazyr, 0.5 mg, Soft Capsules

Dutasteride

Read the leaflet carefully before taking the medicine, 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, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. 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 any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

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

1. What is Dutazyr and what is it used for

The active substance of the medicine is dutasteride, which belongs to a group of medicines called 5-alpha-reductase inhibitors.
Dutazyr 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.
Enlargement of the prostate gland can lead to problems with urination, such as difficulty urinating and frequent urination. There may also be 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 is necessary to remove or reduce the prostate gland. Dutasteride 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.
Dutazyr may also be used in combination with another medicine called tamsulosin (used to treat symptoms of enlarged prostate gland).

2. Important information before taking Dutazyr

When not to take Dutazyr

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

If any of the above statements apply to you, do not takethe medicine before consulting your doctor.
The medicine is for men only.It must not be taken by women, children, and adolescents.

Warnings and precautions

Before taking Dutazyr, consult your doctor.

• Tell your doctor if you have liver disease.If you have had any liver disease, you may need to have additional tests while taking Dutazyr.
• Women, children, and adolescentsmust not handle damaged Dutazyr capsules, as the active substance may be absorbed through the skin. If contact with the skin occurs, 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 dutasteride. If your partner is pregnant or may be pregnant, avoid exposing her to contact with semen, as dutasteride may affect the development of a male child. It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility. This may lead to reduced fertility.
• Dutazyr affects the measurement of PSA(prostate-specific antigen), which is sometimes performed to detect prostate cancer. Nevertheless, your doctor may still decide to perform this test to detect prostate cancer. If you are having a PSA test, you should tell your doctor that you are taking Dutazyr. Men taking Dutazyr should have their PSA levels checked regularly.
• In a clinical study of 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 impact of dutasteride on high-grade prostate cancer is not clear.
• Dutazyr may cause breast enlargement and tenderness.If these symptoms become troublesome or if you notice any lumps in your breasts, or discharge from your nipples, you should contact your doctor, as these may be signs of a serious condition, such as breast cancer.

If you have any questions about taking Dutazyr, contact your doctor or pharmacist.

Dutazyr and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, and about any medicines you plan to take.
Some medicines taken with Dutazyr may increase the risk of side 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-blockers(used to treat enlarged prostate gland or high blood pressure). Tell your doctorif you are taking these medicines. It may be necessary to reduce the dose of Dutazyr.

Dutazyr with food and drink

The medicine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnant women (or women who may be pregnant) must not handle damaged capsules.

Dutasteride is absorbed through the skin and may affect the development of a male child. 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 dutasteride. If your partner is pregnant or may 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 come into contact with dutasteride, contact your doctor.

Driving and using machines

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

Dutazyr contains soy lecithin

The medicine contains soy lecithin, which may contain soy oil. Do not take if you are allergic to peanuts or soy.

3. How to take Dutazyr

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

Dosage:

The recommended dose is one capsule (0.5 mg) taken once a day.

Treatment with Dutazyr is long-term. Some patients may experience relief from symptoms at the beginning of treatment. However, for others, it may take 6 months or longer to see an improvement. You should take Dutazyr for as long as your doctor recommends.

Method of administration:

Oral use.
Swallow the capsule whole with water. Do not chew or open the capsules. Contact with the contents of the capsules may cause mouth or throat pain.

Overdose:

If you take more than you should, contact your doctor or pharmacist.

Missed dose:

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

Stopping treatment:

Do not stop taking Dutazyr without discussing it with your doctor. To see an improvement, you may need to continue treatment for 6 months or longer.

If you have any further questions about taking Dutazyr, 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 may include:

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

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

Common side effects

May affect up to 1 in 10 people:

• erectile dysfunction (impotence), which may persist after stopping treatment with Dutazyr,
• decreased libido, which may persist after stopping treatment with Dutazyr,
• difficulty with ejaculation, including reduced semen volume, which may persist after stopping treatment with Dutazyr,
• breast tenderness or enlargement (gynecomastia),
• dizziness when taken with tamsulosin.

Uncommon side effects

May affect up to 1 in 100 people:

• heart failure (the heart is less efficient at pumping blood. Symptoms may include: shortness of breath, extreme tiredness, and swelling in the ankles and lower limbs),
• 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 any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dutazyr

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

Do not use this medicine after the expiry date stated on the carton and blister after: EXP. The expiry date refers to the last day of the month.
Do not store the medicine above 30°C.
Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Dutazyr contains

• The active substance is dutasteride.
• Each soft capsule contains 0.5 mg of dutasteride.
• The other ingredients are:
• inside the capsule: butylhydroxytoluene (E 321), glycerol monocaprylocaprate (type I)
• capsule shell: gelatin, glycerol, titanium dioxide (E 171), yellow iron oxide (E 172), medium-chain triglycerides, soy lecithin, purified water.

What Dutazyr looks like and contents of the pack

Dutazyr, soft gelatin capsules, opaque, yellow, elongated, filled with a yellowish oily liquid.
Dimensions of the soft capsules: 19 ± 0.8 mm x 6.9 ± 0.4 mm.
The medicine is available in packs of 30 or 60 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma Sp. z o.o.
Baletowa 30
02-867 Warsaw

Manufacturer

Galenicum Health, S.L.U.
Calle Sant Gabriel, 50
Esplugues de Llobregat
08950 Barcelona
Spain
Cyndea Pharma, S.L
Polígono Industrial Emiliano Revilla Sanz,
Avenida de Ágreda, 31 Olvega,
42110 Soria,
Spain
Pharmadox Healthcare, Ltd.
KW20A Kordin Industrial Park,
Paola , PLA 3000
Malta
SAG Manufacturing, S.L.U.
Ctra. N-I Km 36
28750 San Agustín de Guadalix, Madrid
Spain

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

Czech Republic
Dutasterid Aristo
Netherlands
Dutasteride Aristo 0.5 mg soft capsules
Germany
Dutasterid Aristo 0.5 mg soft capsules
Poland
Dutazyr
Portugal
Dutasterida Aristo 0.5 mg soft capsules
Italy
Dutasteride Aristo 0.5 mg soft capsules
Date of last revision of the leaflet:April 2023