Patient Information Leaflet

Duagen 0.5 mg Soft Capsules

Dutasteride
Please read this entire 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Duagen is and what it is used for
What you need to know before taking Duagen
How to take Duagen
Possible side effects
How to store Duagen
Contents of the pack and other information

1. What Duagen is and what it is used for

Duagen is used to treat men with an enlarged prostate (benign prostatic hyperplasia) – a non-malignant enlargement of the prostate gland 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 gland enlarges, it can lead to urinary problems such as difficulty in passing urine and the need to urinate frequently. This may also result in a weaker and slower urine flow. If left untreated, there is a risk that urine flow becomes completely blocked (acute urinary retention). This condition requires immediate medical treatment. In some cases, surgery may be necessary to remove or reduce the size of the prostate. Duagen 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.
Duagen may be used together with another medicine called tamsulosin (used to treat symptoms of an enlarged prostate).

2. What you need to know before taking Duagen

Do not take Duagen

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 Duagen.
Make sure your doctor is aware of any liver problems you may have. If you have ever had any liver disease, additional monitoring may be required while you are taking Duagen.
Women, children, and adolescents must avoid contact with damaged Duagen capsules, because the active ingredient can be absorbed through the skin. In case of skin contact, wash the affected area immediately with soap and water.
Use a condom during sexual intercourse. Dutasteride has been found in the semen of men being treated with Duagen. If your partner is or could be pregnant, you must avoid exposing her to your semen, as dutasteride may impair 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.
Duagen 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 are due to have a PSA test, inform your doctor that you are taking Duagen. Men taking Duagen should have regular PSA tests.
In a clinical study conducted in men at increased risk of prostate cancer, men taking Duagen developed a higher incidence of high-grade prostate cancer compared to men not taking Duagen. The effect of Duagen on this high-grade form of prostate cancer is not clear.
Duagen 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 Duagen.

Other medicines and Duagen
Inform your doctor if you are currently taking, have recently taken, or might take any other medicines.
Some medicines may interact with Duagen 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). Inform your doctor if you are taking any of these medicines. It may be necessary to reduce your dose of Duagen.

Duagen with food and drink
Duagen may be taken with or without food.

Pregnancy, breastfeeding and fertility
Pregnant women or women who may be 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 Duagen. If your partner is pregnant or could be pregnant, you must avoid exposing her to your semen.
Duagen 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 Duagen will affect your ability to drive or operate machinery.

Duagen 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 Duagen

Take Duagen exactly as directed 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 Duagen 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 Duagen is long-term. Some individuals may notice an early improvement in symptoms. However, others may need to take Duagen for 6 months or longer before it starts to work. Continue taking 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 the missed dose. Take the next dose at your usual time.
Do not stop Duagen without medical advice
Do not stop taking Duagen without first consulting your doctor. It may take 6 months or longer before you notice an improvement.
If you have 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:

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 Duagen.

Common side effects
These may affect up to 1 in 10 patients treated with Duagen:
inability to achieve or maintain an erection (impotence), which may continue after stopping Duagen
decreased sexual desire (libido), which may continue after stopping Duagen

ejaculation disorders, such as a reduced amount of semen released during sexual intercourse, which may continue after stopping Duagen
breast enlargement or tenderness (gynecomastia)
dizziness with tamsulosin intake.

Uncommon side effects
These may affect up to 1 in 100 patients treated with Duagen:
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 body hair (usually from the body) or excessive hair growth.

Side effects with 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 Duagen

Keep this medicine out of the sight and reach of children.
Do not store Duagen 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 medicines 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 Duagen 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 butylated hydroxytoluene (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 Duagen and contents of the pack
Duagen soft capsules are opaque, yellow, oval soft gelatin capsules, marked 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
Italy

Manufacturer:
GlaxoSmithKline Pharmaceuticals S.A.
Ul. Grunwaldzka 189
60-322 Poznan
Poland

This medicinal product is authorised in the European Economic Area Member States under the following names:
Duagen – Greece, Italy, Portugal, Sweden