Dutafin

Package Leaflet: Information for the User

DUTAFIN, 0.5 mg, soft capsules
Dutasteride

Read the package 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 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, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is DUTAFIN and what is it used for

DUTAFIN is used in men with an enlarged prostate gland (benign prostatic hyperplasia) - a non-cancerous enlargement of the prostate gland caused by an excess of a hormone called dihydrotestosterone.
The active substance of the medicine is dutasteride, which belongs to a group of medicines called 5-alpha-reductase inhibitors.
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 may be necessary to remove or reduce the prostate gland. DUTAFIN 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.
DUTAFIN may also be used in combination with another medicine called tamsulosin (used to treat symptoms of enlarged prostate gland).

2. Important information before taking DUTAFIN

When not to take DUTAFIN

• 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 use in men only. It must not be taken by women, children, and adolescents.

Warnings and precautions

Before taking DUTAFIN, consult your doctor.

• Tell your doctor if you have liver disease.If you have had liver disease, you may need to have additional tests while taking DUTAFIN.
• Women, children, and adolescentsmust not handle damaged DUTAFIN capsules, as the active substance may be absorbed through the skin. If contact with the skin occurs, wash the affected area immediatelywith soap and water.
• Use a condom during sexual intercourse.Dutasteride has been found in the semen of men taking DUTAFIN. If your partner is pregnant or may become pregnant, you should avoid exposing her to your 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, which may lead to reduced fertility in men.
• DUTAFIN affects the measurement of prostate-specific antigen (PSA), which is sometimes performed to detect prostate cancer. Despite this, your doctor may still order this test to detect prostate cancer. If you are having a PSA test, you should tell your doctor that you are taking DUTAFIN. Patients taking DUTAFIN should have their PSA levels regularly checked.
• 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 cancerthan patients who did not take dutasteride. The impact of dutasteride on the risk of developing high-grade prostate cancer is not clear.
• DUTAFIN may cause breast enlargement and tenderness.If these symptoms become troublesome or if you notice breast lumpsor discharge from the nipple,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 DUTAFIN, contact your doctor or pharmacist.

DUTAFIN and other medicines

Tell your doctor about all the medicines you are taking, or have recently taken, and any medicines you plan to take.
Some medicines taken with DUTAFIN may interact with it and 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 any of these medicines. It may be necessary to reduce the dose of DUTAFIN.

Taking DUTAFIN with food and drink

The medicine 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 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 DUTAFIN. If your partner is pregnant or may become pregnant, you should avoid exposing her to your semen.
It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility, which may lead to reduced fertility in men.
➔ If a pregnant woman has been exposed to dutasteride, contact a doctor.

Driving and using machines

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

DUTAFIN contains soybean lecithin and propylene glycol

This medicine contains soybean lecithin, which may contain soybean oil. Do not take if you are allergic to peanuts or soy.
The medicine contains 299.46 mg of propylene glycol monocaprylate in each capsule.

3. How to take DUTAFIN

Always take this medicine exactly as your doctor has told you.
Irregular intake of the medicine may affect the monitored PSA levels.
If you are unsure, consult your doctor or pharmacist.

Recommended dose

The usual dose is one capsule (0.5 mg) taken once a day. The capsule should be swallowed whole, with water. Do not chew or open the capsules. Contact with the contents of the capsules can cause mouth or throat pain. The medicine can be taken with or without food.
DUTAFIN is intended for long-term use. Some men may experience relief from symptoms at the beginning of treatment. However, others may require taking DUTAFIN for 6 months or longer to see an improvement. You should take DUTAFIN for as long as your doctor recommends.

Taking more than the recommended dose of DUTAFIN

If you have taken more than the recommended dose of DUTAFIN, contact your doctor or pharmacist.

Missing a dose of DUTAFIN

Do not take a double dose to make up for a forgotten dose.
Take the next dose at the usual time and continue with the previous dosing schedule.

Stopping treatment with DUTAFIN

Do not stop taking DUTAFIN without consulting your doctor. To see an improvement, you may need to continue treatment for 6 months or longer.
➔ If you have any doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions

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

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

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

• heart failure (less efficient heart function, which may cause symptoms such as shortness of breath, extreme tiredness, and swelling in the ankles and legs)
• hair loss (usually body hair) or increased hair growth.

Frequency not known side effects(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 Drug Safety, 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.
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 DUTAFIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
The batch number is stated on the blister and carton.
Store in a temperature below 30°C.
Keep the blister in the outer carton in order to protect from light.
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 DUTAFIN 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) and propylene glycol monocaprylate, type II.
• capsule shell: gelatin, glycerol, titanium dioxide (E 171), saturated fatty acid triglycerides, soybean lecithin.

What DUTAFIN looks like and contents of the pack

DUTAFIN soft capsules are yellow, transparent, and have a size of approximately 16.5 x 5.6 mm.
The medicine is available in packs (transparent triple-layer blister (PVC/PE/PVDC/Aluminum)) of 10, 30, 50, 60, or 90 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

+pharma arzneimittel gmbh
Hafnerstrasse 211
8054 Graz
Austria

Manufacturer

Laboratorios León Farma, S.A.
C/La Vallina s/n, Polígono Industrial Navatejera
24193 Villaquilambre, León
Spain
Terapia SA
124 Fabricii Street
Cluj-Napoca 400632
Romania

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

Denmark:
Dutasterid Laboratorios Liconsa
Spain:
Dutasterida Tarbis 0,5 mg cápsulas blandas EFG
Romania:
ASIUM0, 5 mg capsule moi
Czech Republic:
Dutamon
Croatia:
Dutasterid Genericon
Finland:
Dutasteride Medical Valley
Slovakia:
Dutamon
Date of last revision of the leaflet:September 2024