AVODART

Patient Information Leaflet

Avodart 0.5 mg Soft Capsules

Dutasteride
Please read 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Avodart is and what it is used for
2. What you need to know 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 to treat men with an enlarged prostate ( benign prostatic hyperplasia ) – a non-malignant increase in prostate size caused by excessive production of a hormone called dihydrotestosterone.
The active substance is dutasteride. It belongs to a class of medicines known as 5-alpha reductase inhibitors.
When the prostate enlarges, it can cause urinary problems such as difficulty in passing urine and the need to urinate frequently. This may also result in a weaker and less forceful urine stream. If left untreated, there is a risk that urine flow may become completely blocked ( acute urinary retention ). This requires immediate medical treatment. In some cases, surgery may be needed to remove or reduce the size of the prostate. Avodart reduces the production of dihydrotestosterone, thereby helping to decrease prostate volume and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgical intervention.
Avodart may be used in combination with another medicine called tamsulosin (used to treat symptoms of an enlarged prostate).

2. What you need to know before taking Avodart

Do not take Avodart

• if you are allergic to dutasteride, to other 5-alpha reductase inhibitors, to soy, to peanuts, or to 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 apply to you, do not take this medicine without first consulting your doctor. This medicine is intended for men only. It must not be taken by women, children, or adolescents.

Warnings and precautions
Talk to your doctor before taking Avodart.
Make sure your doctor knows about any liver problems you have. If you have had any liver disease, you may require additional monitoring while taking Avodart.
Women, children, and adolescents must avoid contact with damaged Avodart capsules, as the active ingredient can be absorbed through the skin. If skin contact 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 or could be pregnant, you must avoid exposing her to your semen, as dutasteride may interfere with the normal development of a male fetus. It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility. This may reduce your fertility.
Avodart affects a blood test for PSA (prostate-specific antigen), which is sometimes used to detect prostate cancer. Your doctor should be aware of this effect and may still recommend the test to check for prostate cancer. If you need to have a PSA test, inform your doctor that you are taking Avodart. Men taking Avodart should have regular PSA tests.
In a clinical study conducted in men at increased risk of prostate cancer, men taking Avodart were found to have a higher incidence of high-grade prostate cancer compared to men not taking Avodart. The effect of Avodart on this high-grade form of prostate cancer is not clear.
Avodart may cause breast enlargement and tenderness. If this becomes bothersome, or if you notice breast lumps or nipple discharge, you should discuss these changes with your doctor, as they may be signs of a serious condition, such as breast cancer.
Ask your doctor or pharmacist if you have any questions about taking Avodart.

Other medicines and Avodart
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Some medicines may interact with Avodart and increase the risk of side effects. These include:

• verapamil or diltiazem (for high blood pressure)
• ritonavir or indinavir (for HIV)
• itraconazole or ketoconazole (for fungal infections)
• nefazodone (an antidepressant)
• alpha-blockers (for enlarged prostate or high blood pressure). Tell your doctor if you are taking any of these medicines. Your dose of Avodart may need to be reduced.

Avodart with food and drink
Avodart 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 can be absorbed through the skin and may interfere with the normal development of a male fetus. This is particularly risky 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 could be pregnant, you must avoid exposing her to your semen.
Avodart has been shown to reduce sperm count, semen volume, and sperm motility. Therefore, male fertility may be reduced.
Consult your doctor if a pregnant woman has been exposed to dutasteride.

Driving and using machines
It is unlikely that Avodart will affect your ability to drive or operate machinery.

Avodart contains soy lecithin
This medicine contains soy lecithin, which may contain soybean oil. If you are allergic to peanuts or soy, do not use this medicine.

3. How to take Avodart

Take Avodart exactly as instructed by your doctor or pharmacist. If you do not
take it regularly, monitoring of PSA levels may be affected. If you have any doubts, consult your doctor or
pharmacist.
How much Avodart to take

• The recommended dose is one capsule (0.5 mg) taken once daily. Swallow the capsules whole with water. Do not chew or open the capsules. Contact with the capsule contents may irritate the mouth or throat.
• Treatment with Avodart is long-term. Some people may notice an early improvement in symptoms. However, others may need to take Avodart for 6 months or longer before it starts to work. Continue taking Avodart for as long as your doctor tells you to.

If you take more Avodart than you should
If you take more Avodart capsules than prescribed, contact your doctor or pharmacist for advice.
If you forget to take Avodart
Do not take a double dose to make up for the missed dose. Take the next dose at your usual time.
Do not stop taking Avodart without medical advice
Do not stop taking Avodart without first consulting your doctor. It may take 6 months or longer before you notice an improvement.
If you have further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Allergic reaction
Signs of allergic reactions may include:

• skin rash (which may be itchy)
• hives
• swelling of the eyelids, face, lips, arms or legs. Contact your doctor immediately if you experience any of these symptoms and stop taking Avodart.

Common side effects
These may affect up to 1 in 10 patients treated with Avodart:
inability to achieve or maintain an erection (impotence), which may continue after you have
stopped taking Avodart
decreased sexual desire (libido), which may continue after you have stopped taking
Avodart
ejaculation disorders, such as a reduced amount of semen released during sexual intercourse, which may continue after you have stopped taking Avodart
breast enlargement or tenderness (gynecomastia)
dizziness when taking tamsulosin.

Uncommon side effects
These may affect up to 1 in 100 patients treated with Avodart:
heart failure (the heart becomes less efficient at pumping blood around the body. Symptoms may include shortness of breath, extreme tiredness, and swelling of the ankles and legs)
loss of hair (usually from the body) or hair growth.

Side effects of unknown frequency
Frequency cannot be estimated from the available data:
depression
pain and swelling of the testicles.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Avodart

Keep this 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 or on the aluminium foil of the blister packs.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. 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 components are:

• capsule core: mono- and diglycerides of caprylic/capric acid and butylhydroxytoluene (E321).
• capsule coating: gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), medium-chain triglycerides, lecithin (may contain soybean oil).

Description of the appearance of Avodart and contents of the pack
Avodart soft capsules are opaque, yellow, elongated gelatin capsules imprinted with GX CE2. They are available in packs containing 10, 30, 50, 60 and 90 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline S.p.A.
Via A. Fleming, 2
Verona
Manufacturer:
GlaxoSmithKline Pharmaceuticals S.A.
Ul. Grunwaldzka 189
60-322 Poznan
Poland
or
Aspen Bad Oldesloe GmbH
Industriestrasse 32-36
23843 Bad Oldesloe
Germany
This medicinal product is authorised in the European Economic Area countries 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
This leaflet was last updated on: