DUAGEN 0.5 MG Soft capsules

Зміст інструкції

1. Duagen 0.5 mg soft capsules
   1. What is Duagen and what is it used for
   2. What you need to know before taking Duagen
   3. How to take Duagen
   4. Possible side effects
   5. How to store Duagen
   6. Contents of the pack and other information

Duagen 0.5 mg soft capsules

Dutasteride

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 pass it on to others even if they have the same symptoms as you, because 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 Duagen is and what it is used for
• 2. What you need to know before you take Duagen
• 3. How to take Duagen
• 4. Possible side effects
• 5. How to store Duagen
• 6. Contents of the pack and other information

1. What is Duagen and what is it used for

Duagen is used to treat male subjects with enlarged prostate( hyperplasia

prostate benign) - a non-malignant 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 will be 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. Duagen 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.
Duagen 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 Duagen

Do not take Duagen

• if you are allergic to dutasteride, toother 5-alpha reductase inhibitors, to soy, to peanutsor to any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver disease.If you think any of these situations apply 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
Consult your doctor before taking Duagen.

Make sureyour doctor is informedabout any liver problems you have.If you have had any
liver disease, further checks may be necessary while you are taking Duagen.

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

Usea condom during sexual intercourse.Dutasteride has been found in the semen of
men treated with Duagen. If your partner is or could become pregnant, she must avoid exposure to your
semen as dutasteride may impair 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.

Duagen affects a blood test for PSA( prostate-specific antigen), which is
used in some cases to detect the presence of 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 to undergo a PSA test, inform your doctor that you are taking Duagen. Men who take Duagen should have the PSA test regularly.
In a clinical study conducted on men at increased risk of prostate cancer, men who
were taking Duagen had more frequently a severe form of prostate cancer
compared to men who were not taking Duagen. The effect of Duagen on this severe form of prostate cancer is unclear.

Duagen 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 Duagen.

Other medicines and Duagen
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Some medicines can interact with Duagen 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 enlarged prostate or high blood pressure). Tell your doctorif you are taking any of these medicines. It may be necessary to reduce the dose you take of Duagen.

Duagen with food and drink
Duagen 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 who were taking Duagen. If your partner is pregnant or may become pregnant, she should avoid contact with your semen.
Duagen 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 Duagen will affect your ability to drive or use machines.

Duagen 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 Duagen

Take Duagen following the instructions of your doctor or pharmacist exactly.If you do not take it
regularly, the control of your PSA levels may be affected. If you have any doubts, ask your doctor or
pharmacist.

How much Duagen to take

• The recommended dose is one capsule (0.5 mg) to be taken once a day.Swallow the capsules whole with some water. Do not chew or open the capsules. Contact with the capsule contents may irritate your mouth or throat.
• Treatment with Duagen is long-term. Some individuals notice an early improvement in symptoms. However, others may need to take Duagen for 6 months or more before it begins to take effect. Continue to take Duagen for as long as your doctor tells you to.

If you take more Duagen than you should
If you take more Duagen capsules than prescribed, contact your doctor or pharmacist for advice.

If you forget to take Duagen
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 Duagen without medical advice
Do not stop taking Duagen without first consulting your doctor. It may take 6 months or more
before you notice an improvement.

If you have any further questions about 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)
• hives
• swelling of the eyelids, face, lips, arms or legs. Contact your doctor immediatelyif you experience any of these symptoms and stop taking Duagen.

Common side effects

These may affect up to 1 in 10 people treated with Duagen:
inability to achieve or maintain an erection (impotence),this may continue after you
stop taking Duagen
decreased sexual drive (libido), this may continue after you stop taking
Duagen

• difficulty ejaculating, such as a decrease in the amount of semen released during sexual intercourse, this may continue after you stop taking Duagen
• breast enlargement or tenderness (gynecomastia)
• dizziness when taking tamsulosin.

Uncommon side effects

These may affect up to 1 in 100 people treated with Duagen:
heart failure (the heart becomes less efficient at pumping blood around the body. You may experience
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 Duagen

Keep this medicine out of the sight and reach of children.
Do not store Duagen at a temperature above 30°C.
Do not use this medicine after the expiry date which is stated on the package 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 eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

• capsule filling: 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 Duagen and contents of the pack
Duagen 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

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

Duagen -Greece, Italy, Portugal, Sweden