Adadut

Package Leaflet: Information for the User

Adadut, 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 or pharmacist.
• 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 or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Adadut and what is it used for

Adadut 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 of Adadut 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. Adadut reduces the production of dihydrotestosterone, which reduces the size of the prostate gland and alleviates symptoms. It therefore 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 enlarged prostate gland).

2. Important information before taking Adadut

When not to take Adadut:

• 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 you think any of the above applies to you, do not take this medicine until you have consulted your doctor.

• This medicine is for use in men only. It should not be taken by women, children, or adolescents.

Warnings and precautions

Before taking Adadut, discuss it with 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 Adadut.
• Women, children, and adolescents should not handle damaged Adadut capsules, as the active substance may be absorbed through the skin. If contact occurs with the skin, wash the affected area with soap and water immediately.
• Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking dutasteride. If your partner is pregnant or may become pregnant, avoid exposing her to contact with 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.
• Adadut affects the measurement of prostate-specific antigen (PSA) levels, 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, tell your doctor that you are taking Adadut. Men taking Adadut should have their PSA levels checked regularly.
• In a clinical study of patients at high risk of prostate cancer, patients taking dutasteride were more likely to be diagnosed with high-grade prostate cancer than patients who did not take dutasteride. The effect of dutasteride on high-grade prostate cancer is not clear.
• Adadut may cause breast enlargement and tenderness. If this becomes troublesome or you notice lumps in your breasts or discharge from your nipples, you should discuss these changes with your doctor, as they may be signs of a serious condition, such as breast cancer.

If you have any questions about taking Adadut, ask your doctor or pharmacist.

Children and adolescents

This medicine is for use in men only. Women, children, and adolescents should not handle damaged Adadut capsules.

Adadut and other medicines

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

Taking Adadut with food and drink

Adadut can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnant women (or women who may become pregnant) should not handle damaged Adadut 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 Adadut. If your partner is pregnant or may become pregnant, avoid exposing her to contact with 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 come into contact with dutasteride, she should consult her doctor immediately.

Driving and using machines

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

Adadut contains soy lecithin and propylene glycol

This medicine contains soy lecithin (may contain soybean oil). This medicine should not be taken by people who are allergic to peanuts or soy.
This medicine contains 299.46 mg of propylene glycol monocaprylate in each capsule.

3. How to take Adadut

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Irregular intake of Adadut may affect monitored PSA levels.

Recommended dose

The usual dose is one capsule (0.5 mg) taken once a day. The capsule should be swallowed whole, with water. The capsule should not be chewed or opened. Contact with the contents of the capsule may cause mouth or throat pain.
Adadut is intended for long-term use. Some men may experience relief from symptoms at the beginning of treatment. However, others may require taking Adadut for 6 months or longer to see an improvement. You should take Adadut for as long as your doctor recommends.

Taking more than the recommended dose of Adadut

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

Missing a dose of Adadut

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 Adadut

Do not stop taking Adadut without talking to your doctor. To see an improvement, you may need to continue treatment for 6 months or longer.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Allergic reactions

Symptoms 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, stop taking Adadut and contact your doctor immediately.
Common side effects(may affect up to 1 in 10 men):

• erectile dysfunction (impotence), which may persist after stopping Adadut,
• decreased libido, which may persist after stopping Adadut,
• difficulty with ejaculation, such as reduced semen volume, which may persist after stopping Adadut,
• breast tenderness or enlargement (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(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, pharmacist, or nurse. You can also report side effects directly to the Department of Medicines Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
phone: +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 Adadut

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 carton or blister after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original package 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 Adadut 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 contains: gelatin, glycerol, titanium dioxide (E171), medium-chain triglycerides, soy lecithin.

What Adadut looks like and contents of the pack

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

Marketing authorization holder and manufacturer

For further information, contact your local representative of the marketing authorization holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
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

Date of last revision of the leaflet: 06.2024