Package leaflet: Information for the user

Findarts, 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. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to other people. 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 or pharmacist. See section 4.

Leaflet contents:

What Findarts is and what it is used for
Before you take Findarts
How to take Findarts
Possible side effects
How to store Findarts
Contents of the pack and other information

1. What Findarts is and what it is used for

Findarts is used to treat 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 the need to urinate frequently. There may also be a weaker and less forceful urine flow. If left untreated, there is a risk that urine flow will become completely blocked (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.
Findarts reduces the production of dihydrotestosterone, which leads to a reduction in the size of the prostate gland and relief of symptoms. Therefore, it reduces the likelihood of acute urinary retention and the need for surgical intervention.
Findarts 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 Findarts

When not to use Findarts

if the patient is allergic to dutasteride, other 5-alpha reductase inhibitors, 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 conditions apply to the patient, do not take this medicine
until the patient has consulted a doctor.
This medicine is intended for men only. Women, children, and adolescents must not take it.

Warnings and precautions
Before starting Findarts, consult a doctor or pharmacist.

Inform the doctor if the patient has liver disease. If the patient has any liver condition, additional tests may be required during treatment with Findarts.
Women, children, and adolescents must not touch damaged capsules of Findarts, because 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.
A condom must be used during sexual intercourse. Dutasteride has been detected in the semen of men taking Findarts. 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.
Findarts affects the measurement of prostate-specific antigen (PSA) levels, which is sometimes performed to detect prostate cancer. Despite this, the 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 Findarts. Patients taking Findarts 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 Findarts than in those not taking Findarts. The effect of Findarts on the risk of developing high-grade prostate cancer is not clear.
Findarts may cause breast enlargement and tenderness. If these symptoms become bothersome, or if lumps in the breast or nipple discharge occur, consult a 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 medicine from the same therapeutic class (5-alpha reductase inhibitor) orally. If any of these symptoms occur, seek immediate medical advice from a doctor.
Contact a doctor or pharmacist if you have any questions about using Findarts.

Findarts and other medicines
Tell the 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 Findarts 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-blocking agents (used to treat benign prostatic hyperplasia or high blood pressure). Inform the doctor if any of these medicines are being used. A dose reduction of Findarts may be necessary.

Findarts with food and drink
This medicine can be taken with or without food.

Pregnancy, breastfeeding, and effect on fertility
Women must not take Findarts.
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.
A condom must be used during sexual intercourse. Dutasteride has been detected in the semen of men taking Findarts. If the partner is pregnant or may be pregnant, exposure to semen should be avoided.
It has been shown that Findarts 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.

3. How to take Findarts

Findarts should always be taken exactly as directed by your doctor or pharmacist. Taking the medicine irregularly may affect PSA level monitoring. If in doubt, contact your doctor or pharmacist.
How much medicine to take

The recommended dose of Findarts 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 pain in the mouth or throat.
Treatment with Findarts is long-term. Some patients may experience symptom relief early in treatment. However, others may require treatment with Findarts for 6 months or longer to achieve improvement. Continue taking Findarts for as long as your doctor recommends.

Taking more Findarts than recommended
If you take more Findarts than recommended, contact your doctor or pharmacist immediately.
If you miss a dose of Findarts
Do not take a double dose to make up for a missed capsule. Take the next capsule at your usual time.
Stopping treatment with Findarts
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
Do not stop taking Findarts unless your doctor tells you to. Improvement may require continuing treatment for 6 months or longer.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Allergic reaction
Symptoms of an allergic reaction may include:

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

You should contact your doctor immediately if any of these symptoms occur and
stop taking Findarts.

Common adverse reactions (may affect up to 1 in 10 men taking Findarts):

difficulty in achieving or maintaining an erection (impotence), which may persist after stopping Findarts
reduced sex drive (libido), which may persist after stopping Findarts
problems with ejaculation, including reduced volume of semen during ejaculation, which may persist after stopping Findarts
enlargement or tenderness of the breasts (gynaecomastia)
dizziness when taken with tamsulosin.

Uncommon adverse reactions (may affect up to 1 in 100 men taking Findarts):

heart failure (the heart becomes less efficient at pumping blood around the body. Symptoms may include breathlessness, extreme tiredness and swelling around the ankles and lower limbs)
hair loss (usually body hair) or hair growth.

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

depression
pain and swelling of the testicles.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor 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 can 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 Findarts

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, carton, blister, or bottle after: EXP. The expiry date refers to the last day of the stated month.
Store below 30°C.
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 Findarts contains

The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.
Other ingredients are:
Capsule contents: glycerol monooctanoate (type I) and butylated hydroxytoluene (E 321).
Capsule shell: gelatin, glycerol, titanium dioxide (E 171), yellow iron oxide (E 172), and medium-chain triglycerides.

What Findarts looks like and contents of the pack
Soft capsule.
Dull yellow, opaque, elongated, soft gelatin capsule of size '6', containing a clear, colourless to pale yellow sticky oil. Size is approximately 18.4 x 6.4 mm.
Findarts capsules are available in blister packs.
Pack sizes:
Blister packs: 30, 90 and 120 capsules
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, lokal 27
01-909 Warsaw
Poland
Manufacturer/Importer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
This medicinal product is authorised in the European Economic Area member states under the following names:
Poland: Findarts