Dutazyr

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not give it to others. This 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, pharmacist, or nurse. See section 4.

Leaflet contents:

1. What Dutazyr is and what it is 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 Dutazyr is and what it is used for
The active substance in this 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.
An enlarged prostate can lead to problems with urination, such as difficulty urinating, increased frequency
of urination, reduced urine flow, and weak urine stream. Complete blockage of urine flow (acute urinary
retention) may also occur. This condition requires immediate treatment. In some cases, surgery may be
needed to remove or reduce the size of the prostate gland. Dutasteride reduces the production of
dihydrotestosterone, which leads 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.
Dutazyr may also be used in combination with another medicine called tamsulosin (used to treat
symptoms of an enlarged prostate).

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 apply to you, do not take this medicine before consulting your doctor.
This medicine is intended for men only. It must not be used in women, children, or adolescents.

Warnings and precautions
Before taking Dutazyr, consult your doctor.

• Inform your doctor if you have liver disease. If you have any liver condition, additional tests may be required during treatment with Dutazyr.
• Women, children, and adolescents must not touch damaged capsules of Dutazyr, 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 this medicine. If your partner is pregnant or may become pregnant, avoid exposing her to semen, as 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.
• Dutazyr affects the measurement of PSA (prostate-specific antigen), which is sometimes tested to detect prostate cancer. Despite this, your doctor may intentionally order this test to screen for prostate cancer. If you are having a PSA test, you must inform your doctor that you are taking Dutazyr. Men taking Dutazyr should have their PSA levels monitored regularly.
• In a clinical study involving patients at increased risk of prostate cancer, patients taking dutasteride were diagnosed with high-grade prostate cancer more frequently than those not taking dutasteride. The effect of dutasteride on high-grade prostate cancer is not fully understood.
• Dutazyr may cause breast enlargement and tenderness. If these symptoms become bothersome, or if you notice lumps in the breast or nipple discharge, consult your doctor, as these may be signs of a serious condition such as breast cancer.

Mood changes and depression
Depressed mood, depression, and, rarely, suicidal thoughts have been reported in patients taking another
oral medicine from the same therapeutic group (a 5-alpha-reductase inhibitor). If any of these symptoms
occur, seek immediate medical advice from your doctor.
For any questions about the use of Dutazyr, please contact your doctor or pharmacist.

Dutazyr and other medicines
Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take.
Some medicines taken together with Dutazyr may increase the risk 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 an enlarged prostate or high blood pressure). Inform your doctor if you are taking any of these medicines. A dose adjustment of Dutazyr may be necessary.

Dutazyr with food and drink
This medicine may be taken with or without food.
Pregnancy, breastfeeding, and effects on fertility
Pregnant women (or women who may become 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
this medicine. If your partner is pregnant or may become pregnant, avoid exposing her to 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, consult a doctor immediately.
Driving and operating machinery
It is unlikely that Dutazyr will affect your ability to drive or operate machinery.
Dutazyr contains soya lecithin
This medicine contains lecithin derived from soy, which may contain soy oil. Do not use if you have a known hypersensitivity to peanuts or soy.

3. How to take Dutazyr
Always take this medicine exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. Irregular use of the medicine may affect monitored PSA levels.

Dosage:
The recommended dose is one capsule (0.5 mg) taken once daily.
Treatment with Dutazyr is long-term. Some patients may experience symptom relief early in treatment. However, in others, treatment with Dutazyr for 6 months or longer may be required to achieve improvement. Continue taking 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 capsule. Contact with the capsule contents may cause mouth or throat irritation.

Taking more Dutazyr than prescribed
If you take more than the recommended dose, consult your doctor or pharmacist immediately.

If you miss a dose of Dutazyr
Do not take a double dose to make up for a missed capsule. Take the next capsule at your usual time.

Stopping Dutazyr
Do not stop taking Dutazyr without discussing it with your doctor. Continuing 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 doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Allergic reaction
Symptoms of allergic reactions 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 your doctor immediately
and discontinue use of Dutazyr.
Common adverse reactions
May occur in fewer than 1 in 10 patients:

• inability to achieve or maintain an erection (impotence); this symptom may persist after discontinuation of Dutazyr,
• reduced sexual desire (libido); this symptom may persist after discontinuation of Dutazyr,
• difficulties with ejaculation, including reduced volume of semen during ejaculation; this symptom may persist after discontinuation of Dutazyr,
• enlargement or tenderness of the breasts (gynaecomastia),
• dizziness when used concomitantly with tamsulosin.

Uncommon adverse reactions
May occur in fewer than 1 in 100 patients:

• heart failure (the heart is less efficient at pumping blood; 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 the available data:

• depression,
• testicular pain and swelling.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 outer carton and on the blister pack after: EXP. The expiry date refers to the last day of the stated month.
Do not store Dutazyr above 30 °C.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via the sewage system 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

What Dutazyr contains

• The active substance is dutasteride.
• Each soft capsule contains 0.5 mg of dutasteride.
• Other ingredients are:
  • Inside the capsule: butylated hydroxytoluene (E 321), glyceryl monooctanoate/caprylocaprate (type I)
  • Capsule shell: gelatin, glycerol, titanium dioxide (E 171), yellow iron oxide (E 172), medium-chain triglycerides, soybean lecithin, purified water.

What Dutazyr looks like and contents of the pack
Dutazyr is a soft, opaque, yellow, elongated gelatin capsule filled with a yellowish oily liquid.

Dimensions of soft capsules: 19 ± 0.8 mm x 6.9 ± 0.4 mm.
The medicine is available in packs containing 30 or 60 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa Street 30
02-867 Warsaw, Poland

Manufacturers
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 authorised in the European Economic Area under the following names:
Czech Republic: Dutasterid Aristo
Netherlands: Dutasteride Aristo 0.5 mg zachte capsules
Germany: Dutasterid Aristo 0.5 mg Weichkapseln
Poland: Dutazyr
Portugal: Dutasterida Aristo 0.5 mg cápsulas moles
Italy: Dutasteride Aristo 0.5 mg capsula molli