AVODART 0.5 mg Capsules

Contents of the leaflet

1. Patient Information Leaflet: User Information
2. Avodart, 0.5 mg, soft capsules
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
3. What is Avodart and what is it used for
4. Important information before taking Avodart
   1. When not to take Avodart
   2. Warnings and precautions
   3. Avodart and other medicines
   4. Avodart with food, drink, and alcohol
   5. Pregnancy, breastfeeding, and fertility
   6. Pregnant women (or women who may become pregnant) must not handle damaged capsules.
   7. Driving and using machines
   8. Avodart contains soy lecithin
5. How to take Avodart
   1. How much to take
   2. If you take more Avodart than you should
   3. If you forget to take Avodart
   4. Do not stop taking Avodart without consulting your doctor
   5. If you have any further questions on the use of this product, ask your doctor or pharmacist.
6. Possible side effects
   1. Like all medicines, Avodart can cause side effects, although not everybody gets them.
   2. Allergic reaction
   3. Common side effects
   4. Uncommon side effects
   5. Rare side effects
   6. Reporting side effects
7. How to store Avodart
8. Contents of the pack and other information
   1. What Avodart contains
   2. What Avodart looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet: January 2025

Patient Information Leaflet: User Information

Avodart, 0.5 mg, soft capsules

Dutasteride

Read the 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 any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

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

1. What is Avodart and what is it used for

Avodart 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.
An enlarged prostate gland can cause problems with urination, such as difficulty urinating and frequent urination. It can also cause 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 size of the prostate gland. Avodart 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.
Avodart may also be used in combination with another medicine called tamsulosin (used to treat the symptoms of an enlarged prostate gland).

2. Important information before taking Avodart

When not to take Avodart

• or any of the other ingredients of this medicine (listed in section 6).

If any of the above applies to you, do not takethe medicine before consulting your doctor.
The medicine is for men only.It must not be taken by women, children, or adolescents.

Warnings and precautions

Before taking Avodart, 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 Avodart.
• Women, children, and adolescentsmust not handle damaged Avodart capsules, as the active substance may be absorbed through the skin. If contact with the skin occurs, wash the affected area immediately with soap and water.
• Use a condom during sexual intercourse.Dutasteride has been found in the semen of men taking Avodart. If your partner is pregnant or may become pregnant, avoid exposing her to your semen, as dutasteride may affect the development of a male child. It has been shown that Avodart reduces sperm count, semen volume, and sperm motility, which may reduce fertility in men.
• Avodart affects the measurement of prostate-specific antigen (PSA), which is sometimes carried out to detect prostate cancer. Despite this, your doctor may still decide to perform this test to detect prostate cancer. If you are having a PSA test, tell your doctor that you are taking Avodart. Men taking Avodart should be regularly tested for PSA levels.

Avodart and other medicines

Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Certain medicines taken with Avodart may 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 an 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 Avodart.

Avodart with food, drink, and alcohol

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 Avodart. If your partner is pregnant or may become pregnant, avoid exposing her to your semen.
It has been shown that Avodart reduces sperm count, semen volume, and sperm motility, which may reduce fertility in men.
If a pregnant woman has come into contact with dutasteride, consult a doctor.

Driving and using machines

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

Avodart contains soy lecithin

The medicine contains soy lecithin, which may contain soybean oil. Do not take if you are allergic to peanuts or soy.

3. How to take Avodart

Always take Avodart exactly as your doctor or pharmacist has told you.Irregular intake of the medicine may affect the monitoring of PSA levels. If you are in doubt, consult your doctor or pharmacist.

How much to take

• The recommended dose of Avodart is one capsule (0.5 mg) taken once a day.Swallow the capsule whole with water. Do not chew or open the capsules. Contact with the contents of the capsules may cause mouth or throat pain.
• Treatment with Avodart is long-term. Some patients may experience an improvement in symptoms at the beginning of treatment. However, others may require treatment with Avodart for 6 months or longer to see an improvement. Continue to take Avodart for as long as your doctor recommends.

If you take more Avodart than you should

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

If you forget to take Avodart

Do not take a double dose to make up for a forgotten capsule. Take the next capsule at the usual time.

Do not stop taking Avodart without consulting your doctor

Do not stop taking Avodart unless your doctor tells you to. To see an improvement, you may need to continue treatment for 6 months or longer.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Allergic reaction

Symptoms of an allergic reaction may include:

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

If you experience any of these symptoms, contact your doctor immediately and stop taking Avodart.

Common side effects

These symptoms may occur in more than 1 in 10 men taking Avodart:

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

Uncommon side effects

These symptoms may occur in less than 1 in 100 men taking Avodart:

• heart failure (reduced heart function - symptoms may include shortness of breath, extreme tiredness, and swelling in the ankles and legs)
• hair loss (usually body hair) or increased hair growth.

Rare side effects

The frequency of these symptoms cannot be estimated from the available data:

• depression,
• testicular pain and swelling.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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 Avodart

Keep the medicine out of the sight and reach of children.
Do not store Avodart above 30°C.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
The batch number is the product's batch number.
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 Avodart contains

The active substance is dutasteride.Each soft capsule contains 0.5 mg of dutasteride.
The other ingredients are:

• inside the capsule: mono- and diglycerides of caprylic/capric acid and butylhydroxytoluene (E 321)
• capsule shell: gelatin, glycerol, titanium dioxide (E 171), yellow iron oxide (E 172), medium-chain triglycerides, lecithin (may contain soybean oil).

What Avodart looks like and contents of the pack

Avodart is a yellow, opaque, soft capsule, marked with GX CE2. The medicine is available in packs of 10, 30, 50, 60, or 90 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland

Manufacturer

Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań
or
Aspen Bad Oldesloe GmbH
Industriestrasse 32-36
23843 Bad Oldesloe
Germany

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

Avodart -Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden, Netherlands, United Kingdom
Avidart -Spain
For more information, contact the representative of the marketing authorization holder.
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
Tel: +48 22 576 9000

Date of last revision of the leaflet: January 2025