Package leaflet: Information for the user

Adadut, 0.5 mg, soft capsules
Dutasteride
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Adadut is and what it is used for
Important information before taking Adadut
How to take Adadut
Possible side effects
How to store Adadut
Contents of the pack and other information

1. What Adadut is and what it is used for

Adadut is used in men with an enlarged prostate gland (benign prostatic hyperplasia) – a non-cancerous enlargement of the prostate 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 may lead to problems with urination, such as difficulty passing urine, increased frequency of urination, reduced flow of urine, or a weak urine stream. If left untreated, complete blockage of urine flow may occur (acute urinary retention). This condition requires immediate treatment. In some cases, surgery may be needed to remove or reduce the size of the prostate. Adadut reduces the production of dihydrotestosterone, resulting in a smaller prostate and relief of symptoms. Therefore, it reduces the likelihood of acute urinary retention and the need for surgical intervention.
Adadut may also be used in combination with another medicine called tamsulosin (used to treat symptoms of an enlarged prostate).

2. Important information before taking Adadut

When not to use Adadut:

if the patient is allergic to dutasteride, other 5α-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 you think any of the above applies to you, do not take this medicine until you have consulted your doctor.

This medicine is intended for men only. Do not use in women, children or adolescents.

Warnings and precautions
Before starting Adadut, discuss this with your doctor.

Inform your doctor if the patient has liver disease. If the patient develops liver disease, additional tests may be required during treatment with Adadut.
Women, children and adolescents must not handle damaged capsules of Adadut, because the active substance may be absorbed through the skin. In case of skin contact, wash the contaminated area immediately with soap and water.
Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking dutasteride. If your partner is pregnant or may be pregnant, avoid exposing her to contact with semen, because dutasteride may impair the development of a male fetus. It has been shown that dutasteride may reduce sperm count, semen volume and sperm motility. This may lead to reduced fertility.
Adadut affects the measurement of prostate-specific antigen (PSA) levels, which is sometimes performed to detect prostate cancer. Despite this, your doctor may deliberately order this test to screen for prostate cancer. If the patient undergoes PSA testing, inform the doctor about taking Adadut. Men taking Adadut should have their PSA levels monitored regularly.
In a clinical study involving patients with an increased risk of prostate cancer, a more severe form of prostate cancer was diagnosed more frequently in patients taking dutasteride than in those not taking dutasteride. The effect of dutasteride on aggressive prostate cancer is not clear.
Adadut may cause breast enlargement and tenderness. If this becomes bothersome, or if the patient notices lumps in the breasts or nipple discharge, these changes should be discussed with the doctor, as they may indicate a serious condition, such as breast cancer.

If you have any questions about the use of Adadut, contact your doctor or pharmacist.
Children and adolescents
This medicine is intended for men only. Women, children and adolescents should not come into contact with damaged capsules.
Adadut with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Some medicines may interact with Adadut and 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-blocker medicines (used to treat benign prostatic hyperplasia or high blood pressure).

Inform your doctor if you are taking any of these medicines. A dose reduction of Adadut may be necessary.
Taking Adadut with food and drink
Adadut can be taken with or without food.
Pregnancy, breastfeeding and effects on fertility
Women who are pregnant (or who may become 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.
Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking Adadut. 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 been exposed to dutasteride, contact a doctor immediately.
Driving and operating machinery
It is unlikely that Adadut will affect the ability to drive or operate machinery.
Adadut contains soy lecithin and propylene glycol
This medicine contains soy lecithin (may contain soybean oil). This medicine should not be used by people allergic to peanuts or soy.
This medicine contains 299.46 mg of propylene glycol monocaprylate in each capsule.
Mood changes and depression
In patients taking another medicine from the same therapeutic class (5-alpha reductase inhibitor) orally, depressive mood, depression and, rarely, suicidal thoughts have been reported. If any of these symptoms occur, seek immediate medical advice from your doctor.

3. How to use Adadut

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult the
doctor or pharmacist.
Irregular use of this medicine may affect monitored PSA levels.
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 cavity pain or sore throat.
Adadut is intended for long-term use. Some men may experience symptom relief early in treatment. However, others may require treatment with Adadut for 6 months or longer to achieve improvement. Adadut should be used for as long as directed by the doctor.
Taking more Adadut than recommended
If more than the recommended dose of Adadut capsules is taken, consult a doctor or pharmacist immediately.
If you miss a dose of Adadut
Do not take a double dose to make up for a missed dose.
Take the next dose at the usual time and continue as before.
Stopping Adadut
Do not stop taking Adadut unless instructed by the doctor. 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 will experience them.
Allergic reactions
Symptoms of an allergic reaction may include:

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

If any of these symptoms occur, stop taking Adadut immediately and contact your doctor without delay.
Common adverse reactions (may occur in up to 1 out of 10 men):

inability to achieve or maintain an erection (impotence), which may persist after discontinuation of Adadut,
decreased sexual desire (libido), which may persist after discontinuation of Adadut,
difficulties with ejaculation, such as reduced volume of semen released during sexual intercourse, which may persist after discontinuation of Adadut,
enlargement or tenderness of the breasts (gynaecomastia),
dizziness when used concomitantly with tamsulosin.

Uncommon adverse reactions (may occur in up to 1 out of 100 men):

heart failure (reduced heart function; possible symptoms include shortness of breath, extreme fatigue, and swelling in the ankles and lower limbs);
hair loss (usually body hair) or hair growth.

Frequency not known (cannot be estimated from 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, pharmacist or nurse. Adverse reactions can also be reported directly to the Department for Monitoring Adverse Drug Reactions at 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 Adadut

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or on the foil blister pack.
The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Keep the blister in the outer cardboard package to protect from light.
Medicines must 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 Adadut contains

The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.
Other components are:
- Inside the capsule: butylhydroxytoluene (E 321) and propylene glycol monocaprylate, Type II.
- Capsule shell contains: gelatin, glycerol, titanium dioxide (E171), medium-chain triglycerides, and soya lecithin.

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

Marketing Authorisation Holder
For further information, please contact the local representative of the Marketing Authorisation Holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturer:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland
Laboratorios León Farma, S.A.
C/La Vallina s/n, Poligono Industrial Navatejera
24193 Villaquilambre, León
Spain
Genericon Pharma Gesellschaft m.b.H.
Hafnerstrasse 211
8054 Graz
Austria