Avodart

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

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

1. What Avodart is and what it is 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 Avodart is and what it is 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 excessive production of a hormone called dihydrotestosterone.
The active substance in Avodart 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, more frequent urination, a slower urine flow, or a weak stream. Complete blockage of urine flow (acute urinary retention) may also occur. This situation requires immediate treatment. In some cases, surgery may be needed 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 relief of symptoms. Thus, it 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 symptoms of an enlarged prostate gland).

2. Important information before taking Avodart

When not to take Avodart

• 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 any of the above apply to you, do not take this medicine without first consulting your 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 Avodart, consult your doctor.

• Inform your doctor if you have liver disease. If you have liver disease, additional monitoring may be required during treatment with Avodart.
• Women, children, and adolescents must not handle damaged capsules of Avodart, because the active substance may be absorbed through the skin. In case of skin contact, the affected area should be washed immediately with soap and water.
• Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking Avodart. If your partner is pregnant or may be pregnant, avoid exposing her to contact with semen, as dutasteride may disrupt 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.
• Avodart affects the measurement of prostate-specific antigen (prostate-specific antigen – PSA), a test sometimes used to detect prostate cancer. Despite this, your doctor may still recommend this test to screen for prostate cancer. If you are undergoing PSA testing, you must inform your doctor that you are taking Avodart. Patients taking Avodart should have regular PSA tests.
• In a clinical trial involving patients at increased risk of prostate cancer, a higher incidence of high-grade prostate cancer was observed in patients taking Avodart compared to those not taking the medicine. The effect of Avodart on the risk of developing high-grade prostate cancer is not fully understood.
• Avodart may cause breast enlargement and tenderness. If these symptoms become bothersome or if lumps in the breast or nipple discharge occur, contact your doctor, as these may be signs of a serious condition such as breast cancer.

If you have any questions about the use of Avodart, contact your doctor or pharmacist.

Avodart with other medicines
Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take.
Some medicines taken together with Avodart may 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-blocker medicines (used to treat an enlarged prostate or high blood pressure).

Inform your doctor if you are taking any of these medicines. A dose adjustment of Avodart may be necessary.

Avodart with food, drink, and alcohol
Avodart may be taken with or without food.
Pregnancy, breastfeeding, and effects on fertility
Women who are pregnant (or may be pregnant) must not handle damaged capsules.
Dutasteride is absorbed through the skin and may disrupt 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 Avodart. If your partner is pregnant or may be pregnant, avoid exposing her to contact with semen.
It has been shown that Avodart 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.

Avodart contains soya lecithin
This medicine contains soya lecithin, which may contain soya oil. Do not use if you are known to be hypersensitive to peanuts or soya.

3. How to take Avodart
Always take Avodart exactly as your doctor or pharmacist has told you. Irregular use of the medicine may affect PSA monitoring. If in doubt, consult your doctor or pharmacist.

How much medicine to take

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

Taking more Avodart than prescribed
If you take more than the recommended dose, contact your doctor or pharmacist immediately.

If you miss a dose of Avodart
Do not take a double dose to make up for a missed capsule. Take the next capsule at your usual time.

Do not stop taking Avodart without your doctor’s advice
Do not stop taking Avodart unless your doctor tells you to. Improvement may require continued 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone 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 any of these symptoms occur, you should contact your doctor immediately and stop taking Avodart.
Common adverse effects
These effects may occur in no more than 1 in 10 men taking Avodart:

• inability to achieve or maintain an erection (impotence) – this effect may persist after stopping Avodart
• decreased sexual desire (libido) – this effect may persist after stopping Avodart
• problems with ejaculation, including reduced volume of semen during ejaculation – this effect may persist after stopping Avodart
• enlargement or tenderness of the breasts (gynaecomastia)
• dizziness when taken with tamsulosin.

Uncommon adverse effects
These effects may occur in no more than 1 in 100 men taking Avodart:

• heart failure (reduced heart function – symptoms may include breathlessness, extreme tiredness, and swelling in the ankles and lower limbs)
• hair loss (usually body hair) or hair growth.

Adverse effects with unknown frequency
Frequency cannot be estimated from the available data:

• depression,
• pain and swelling of the testicles.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Avodart
Keep this medicine out of 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 pack after: EXP. The expiry date refers to the last day of the stated month.
The abbreviation "Lot" refers to the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the packaging and other information

What Avodart contains
The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.
Other components of the medicine are:

• inside the capsule: mono- and di-glycerides of caprylic/capric acid and butylated hydroxytoluene (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, elongated soft capsule marked with the code GX CE2. The medicine is available in packs containing 10, 30, 50, 60 or 90 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
Poland
or
Aspen Bad Oldesloe GmbH
Industriestrasse 32-36
23843 Bad Oldesloe
Germany

This medicinal product is authorised 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, the Netherlands, United Kingdom
Avidart - Spain

For further information, please contact the representative of the Marketing Authorisation Holder.
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warszawa
Tel: +48 22 576 9000