Dutafin

Package leaflet: Information for the user

DUTAFIN, 0.5 mg, soft capsules
Dutasteridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What DUTAFIN is and what it is 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 DUTAFIN is and what it is 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 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 a reduced flow of urine and a weak urine stream. If left untreated, complete blockage of urine flow may occur (acute urinary retention). This situation requires immediate treatment. In some cases, surgery may be needed to remove or reduce the size of the prostate gland. DUTAFIN reduces the production of dihydrotestosterone, resulting in a reduction of the prostate gland size and relief of symptoms. Therefore, it 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 an enlarged prostate gland).

2. Important information before using DUTAFIN

When not to use DUTAFIN

• if the patient is allergic to dutasteride, other 5-alpha-reductase inhibitors, soy, 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 DUTAFIN before consulting a doctor.
This medicine is intended for use in men only. It must not be used in women, children, or adolescents.

Warnings and precautions

Before taking DUTAFIN, consult your doctor.

• Inform your doctor if the patient has liver disease. If the patient has liver disease, additional tests may be required during treatment with DUTAFIN.
• Women, children, and adolescents must not handle damaged DUTAFIN capsules, as the active substance may be absorbed through the skin. In case of skin contact, the contaminated area should be washed immediately with soap and water.
• Condoms should be used during sexual intercourse. Dutasteride has been detected in the semen of men taking DUTAFIN. If the partner is pregnant or may be pregnant, exposure to semen should be avoided, 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.
• DUTAFIN affects the measurement of prostate-specific antigen (PSA) levels, which is sometimes performed to detect prostate cancer. Despite this, your doctor may intentionally order this test to screen for prostate cancer. If the patient undergoes PSA testing, the patient should inform the doctor about taking DUTAFIN. Patients taking DUTAFIN should have their PSA levels monitored regularly.
• In a clinical study involving patients with an increased risk of prostate cancer, a higher incidence of high-grade prostate cancer was observed in patients taking dutasteride compared to those not taking dutasteride. The effect of dutasteride on the potential to cause high-grade prostate cancer is not fully understood.
• DUTAFIN may cause breast enlargement and tenderness. If these symptoms become bothersome, or if lumps in the breast or nipple discharge occur, contact a doctor, as these may be signs of a serious condition such as breast cancer.

➔ If you have any questions about using DUTAFIN, contact your doctor or pharmacist.

DUTAFIN and other medicines

Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Some medicines taken together with DUTAFIN may interact with this medicine and 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-blocking agents (used to treat benign prostatic hyperplasia or high blood pressure)

➔ Inform your doctor if the patient is taking any of these medicines. A dose reduction of DUTAFIN may be necessary.

Taking DUTAFIN with food and drink

DUTAFIN can be taken with or without food.

Pregnancy, breastfeeding, and effects on fertility

Women who are pregnant (or who may be pregnant) must not handle 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.

Condoms should be used during sexual intercourse. Dutasteride has been detected in the semen of men taking DUTAFIN. If the partner is pregnant or may be pregnant, exposure to semen should be avoided.

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.

DUTAFIN contains soy lecithin and propylene glycol

This medicine contains soy lecithin, which may contain soybean oil. Do not use if the patient has a known hypersensitivity to peanuts or soy.

The medicine contains 299.46 mg of propylene glycol monocaprylate in each capsule.

Mood changes and depression

In patients taking orally another medicine from the same therapeutic class (5-alpha-reductase inhibitor), depressive mood, depression, and rarely suicidal thoughts have been reported. If any of these symptoms occur, seek immediate medical advice from a doctor.

3. How to use DUTAFIN

This medicine should always be taken exactly as prescribed by your doctor. Taking the medicine irregularly may affect monitored PSA levels. If in doubt, consult your doctor or pharmacist.

Recommended dose
The usual dose is one capsule (0.5 mg) taken once daily. The capsule should be swallowed whole with water. Do not chew or open the capsule. Contact with the capsule contents may cause oral pain or sore throat. DUTAFIN can be taken with or without food.

DUTAFIN is intended for long-term use. Some men may experience symptom relief early in treatment. However, others may require 6 months or longer of treatment with DUTAFIN to achieve improvement. Continue taking DUTAFIN for as long as your doctor recommends.

Taking more DUTAFIN than recommended
If you take more DUTAFIN capsules than recommended, consult your doctor or pharmacist immediately.

Missed dose of DUTAFIN
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time and continue following the prescribed dosing schedule.

Stopping DUTAFIN treatment
Do not stop taking DUTAFIN unless advised by your doctor. Improvement may require continuing treatment for 6 months or longer.

➔ If you have any doubts about how to use 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 reactions
Symptoms of an allergic reaction may include:

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

➔ If any of these symptoms occur, contact your doctor immediately and discontinue use of DUTAFIN.
Common adverse reactions (may occur in not more than 1 in 10 men)

• inability to achieve or maintain an erection (impotence), which may persist after discontinuation of DUTAFIN
• decreased sexual desire (libido), which may persist after discontinuation of DUTAFIN
• ejaculation disorders, including reduced volume of semen during ejaculation, which may persist after discontinuation of DUTAFIN
• enlargement or tenderness of the breasts (gynaecomastia)
• dizziness when used with tamsulosin

Uncommon adverse reactions (may occur in not more than 1 in 100 men)

• heart failure (reduced cardiac performance; 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 with unknown frequency (cannot be estimated from available data)

• depression
• pain and swelling of the testicles

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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.: +48 22 49 21 301, fax: +48 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 DUTAFIN

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard box,
following the abbreviation "EXP". The expiry date refers to the last day of the stated month.
The word "Lot" on the blister and the cardboard box indicates the batch number of the medicinal product.
Store below 30°C.
Keep the blister in the outer cardboard packaging 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 in use. 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.
• Other ingredients are:
• inside the capsule: butylhydroxytoluene (E 321) and propylene glycol monocaprylate, type II
• capsule shell: gelatin, glycerol, titanium dioxide (E 171), medium-chain triglycerides, soybean lecithin

What DUTAFIN looks like and contents of the pack
DUTAFIN soft capsules are elongated, soft gelatin capsules (approx. 16.5 x 5.6 mm) of light yellow colour, filled with a clear liquid.
The medicine is available in packs (transparent three-layer blisters (PVC/PE/PVDC/Aluminium)) containing 10, 30, 50, 60 or 90 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
Denmark: Dutasterid Laboratorios Liconsa
Spain: Dutasterida Tarbis 0.5 mg cápsulas blandas EFG
Romania: ASIUM 0.5 mg capsule moi
Czech Republic: Dutamon
Croatia: Dutasterid Genericon
Finland: Dutasteride Medical Valley
Slovakia: Dutamon