AVODART <0.5 MG Soft capsule

Зміст інструкції

1. Avodart 0,5 mg soft capsules
   1. What is Avodart and what is it 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

Avodart 0,5 mg soft capsules

Dutasteride

Read this leaflet carefully before taking this medicine as 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 pass it on to others even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 to treat men with enlarged prostate( hyperplasia

prostatica benigna) - a non-cancerous increase in prostate volume, due to excessive production of a hormone called dihydrotestosterone.
The active ingredient is dutasteride. It belongs to a class of drugs called 5-alpha reductase inhibitors.
If the prostate increases in volume, it can lead to urinary problems such as difficulty passing urine and
the need to urinate frequently. This can also result in a slower and weaker urine flow.
If left untreated, there is a risk that the urine flow may become completely blocked ( acute urinary retention). This requires immediate medical treatment. In some cases, surgery is necessary to remove or reduce the volume of the prostate. Avodart reduces the production of dihydrotestosterone
and this promotes a decrease in prostate volume and relieves symptoms. This reduces the risk of acute urinary retention
and the need for surgery.
Avodart can be used with another medicine called tamsulosin (used in the treatment of
symptoms of prostate enlargement).

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 peanutsor to any of the other ingredients of this medicine (listed in section 6).
• if you have a severe liver disease.If you think any of these applies to you, do not takethis medicine without first consulting your doctor. This medicine is only intended for men. It should not be taken by women, children or adolescents.

Warnings and precautions
Talk to your doctor before taking Avodart.

Make sure your doctor is aware of any liver problems you have.If you have had any
liver disease, further checks may be necessary while you are taking Avodart.

Women, children and adolescentsshould avoid contact with broken Avodart capsules, because the
active ingredient is absorbed through the skin. If contact occurs with the skin, wash
the affected area immediatelywith water and soap.

Use a condom during sexual intercourse.Dutasteride has been found in the semen of
men treated with Avodart. If your partner is or could become pregnant, she should avoid exposure to your
semen as dutasteride may affect the normal development of a male child. Dutasteride has been shown to reduce sperm count, semen volume and
sperm motility. This may decrease your fertility.

Avodart affects a blood test for PSA( prostate-specific antigen), which is
used in some cases to detect prostate cancer. Your doctor should be aware of this effect and may still prescribe the test to find out if you have prostate
cancer. If you are going to have a PSA test, tell your doctor that you are taking Avodart.
Men taking Avodart should have their PSA tested regularly.
In a clinical study conducted on men at increased risk of prostate cancer, men who
were taking Avodart had more frequently a severe form of prostate cancer
than men who were not taking Avodart. The effect of Avodart on this severe form of
prostate cancer is unclear.

Avodart can cause breast enlargement and tenderness. If this becomes concerning, or if
you notice the presence of breast lumpsor nipple discharge, you should talk to your doctor about
these changes as they may be signs of a serious condition, such as breast cancer.

Ask your doctor or pharmacistif 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 can interact with Avodart and may increase the possibility of side
effects. These medicines 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 an enlarged prostate or high blood pressure). Tell your doctorif you are taking any of these medicines. It may be necessary to reduce the dose of Avodart you are taking.

Avodart with food and drink
Avodart can be taken with or without food.

Pregnancy, breastfeeding and fertility
Women who are pregnant or who may become pregnant should not handle broken capsules.The
dutasteride is absorbed through the skin and can interfere with the normal development of a male child.
This is particularly risky in 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, she should avoid contact with your
semen.
Avodart has been shown to reduce sperm count, semen volume and sperm motility. Therefore, male fertility may decrease.

Ask your doctor for adviceif a pregnant woman has come into contact with 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 soy oil. If you are allergic to peanuts or
soy, do not use this medicine.

3. How to take Avodart

Always take Avodart exactly as your doctor or pharmacist has told you. If you do not take it regularly, your PSA levels check may be affected. If you have any doubts, ask your doctor or pharmacist.

How much Avodart to take

• The recommended dose is one capsule (0.5 mg) to be taken once a day.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 notice an early improvement in symptoms. However, others may need to take Avodart for 6 months or more before it starts to take effect. Continue to take 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 a missed dose. Take the next dose at the 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 more
before you notice an improvement.

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

4. Possible side effects

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

• skin rash(which may be itchy)
• urticaria
• swelling of the eyelids, face, lips, arms or legs. Contact your doctor immediatelyif 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), this may continue after you
have stopped taking Avodart
decreased sexual drive (libido), this may continue after you have stopped taking
Avodart
difficulty ejaculating, such as a decrease in the amount of semen released during sexual
intercourse, this 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. You may have
symptoms such as shortness of breath, extreme tiredness and swelling of the ankles and legs)
hair loss (usually from the body) or hair growth.

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through 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 at a temperature higher than 30°C.
Do not use this medicine after the expiry date which is stated on the pack or on the foil of the
blisters. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 ingredient is dutasteride.Each soft capsule contains 0.5 mg of dutasteride.
The other ingredients are:

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

Description of Avodart and contents of the pack
Avodart soft capsules are soft gelatin capsules, opaque, yellow in colour, oblong in shape, with imprinted
GX CE2. They are available in packs of 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 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