Dutas

Patient Information Leaflet: Information for the User

DUTAS 0.5 mg Soft Capsules

Dutasteride
Generic Medicine
Please read all of this leaflet carefully before you start 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 they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What DUTAS is and what it is used for

The active substance is dutasteride. It belongs to a group of medicines called 5-alpha-reductase inhibitors.
DUTAS is used to treat men with enlarged prostate (benign prostatic hyperplasia) – a non-cancerous increase in the size of the prostate gland caused by excessive production of a hormone called dihydrotestosterone.
An enlarged prostate can over time cause urinary problems, such as difficulty in passing urine and frequent need to urinate. It may also cause a slow and weak urine flow. If left untreated, there is a risk of a complete blockage of urine flow ( acute urinary retention ), which requires immediate medical treatment. In some cases, surgery may be needed to remove part of the prostate gland or to reduce its size. Dutasteride reduces the production of dihydrotestosterone, helping to decrease the size of the prostate and relieve symptoms. This will reduce the risk of acute urinary retention and the need for surgical intervention.
DUTAS may also be used in combination with another medicine called tamsulosin (used to treat symptoms of enlarged prostate).

2. What you need to know before taking DUTAS

DO NOT take DUTAS:

• if you are allergic to dutasteride, 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 you think any of these apply to you, do not take this medicine until you have checked with your doctor.
This medicine is intended for men only. It must not be used by women, children, or adolescents.

Warnings and precautions
Talk to your doctor or pharmacist before taking DUTAS.

• Make sure your doctor knows about any liver problems you have had. If you have previously suffered from liver disease, you may require additional monitoring during treatment with DUTAS.
• Women, children, and adolescents must avoid contact with broken DUTAS capsules, as the active ingredient can be absorbed through the skin. The affected area must be washed immediately with soap and water in case of skin contact.
• Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking DUTAS. If your partner is pregnant or could be pregnant, you must avoid exposing her to your semen, as dutasteride may impair the normal development of a male fetus. Dutasteride has been shown to reduce sperm count, semen volume, and sperm motility. This may reduce fertility.
• DUTAS affects a blood test measuring PSA (prostate-specific antigen) used to help detect prostate cancer. Your doctor must be informed of this effect and may still use this test to screen for prostate cancer. If you have a blood test to measure PSA, tell your doctor that you are taking DUTAS. Men taking dutasteride should have regular PSA monitoring.
• In a clinical study conducted in men at increased risk of prostate cancer, men treated with dutasteride developed a more aggressive form of prostate cancer more frequently than men not treated with dutasteride. The effect of dutasteride on this aggressive form of prostate cancer is not fully understood.
• DUTAS may cause breast enlargement and tenderness. If this side effect causes you discomfort, or if you notice breast lumps or nipple discharge, inform your doctor about these changes, as they could be signs of a serious condition, such as breast cancer.

If you have any doubts about taking DUTAS, contact your doctor or pharmacist.
Mood changes and depression
In patients treated with another medicine of the same therapeutic class (oral 5-alpha reductase inhibitors), depressive mood, depression, and, less frequently, suicidal thoughts have been reported.
If any of these symptoms occur, contact your doctor as soon as possible for further advice.

Other medicines and DUTAS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may interact with DUTAS and increase the risk 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).

Inform your doctor if you are taking any of these medicines. Your dose of DUTAS may need to be reduced.

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

Pregnancy, breastfeeding, and fertility
Pregnant women (or women who could be pregnant) must avoid any contact with broken capsules. Dutasteride can be absorbed through the skin and may impair the normal development of a male fetus. This risk is particularly present during the first 16 weeks of pregnancy. If a pregnant woman has been exposed to dutasteride, contact a doctor for advice.
Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking DUTAS. If your partner is pregnant or could be pregnant, you must avoid exposing her to your semen.
Dutasteride has been shown to reduce sperm count, semen volume, and sperm motility. Therefore, it may reduce male fertility.
Contact your doctor for advice if a pregnant woman comes into contact with dutasteride.

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

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

3. How to take DUTAS

Take this medicine exactly as your doctor, pharmacist, or nurse has told you.
If you do not take it regularly, monitoring of your PSA levels may be affected.
If you have any doubts, consult your doctor, pharmacist, or nurse.

Recommended dose

• The recommended dose is one capsule (0.5 mg) once daily. Swallow the capsule whole with water. Do not chew or open the capsule. Contact with the capsule contents may cause pain in the mouth or throat.
• DUTAS is a long-term treatment. Some men notice a rapid improvement in symptoms, while others may need to take DUTAS for 6 months or longer before an effect is seen. Continue taking DUTAS for as long as directed by your doctor.

If you take more DUTAS than you should
Contact your doctor or pharmacist for advice if you take too many capsules of DUTAS.

If you forget to take DUTAS
Do not take a double dose to make up for the forgotten dose. Take the next dose at your usual time.

Do not stop taking DUTAS without medical advice
Do not stop taking DUTAS without first talking to your doctor. It may take up to 6 months or longer to notice an effect.

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 cause itching),
• hives (similar to the rash caused by nettles),
• swelling of the eyelids, face, lips, arms or legs.

Contact your doctor immediately if you experience any of these symptoms and stop treatment with DUTAS.

Common side effects
(may affect up to 1 in 10 men taking DUTAS):

• inability to obtain or maintain an erection (impotence); *this may continue after stopping DUTAS;
• decreased sex drive (libido), which may continue even after stopping DUTAS;
• ejaculation disorders, such as reduced amount of semen released during sexual activity, which may continue after stopping DUTAS;
• breast enlargement or tenderness (gynecomastia);
• dizziness when taken together with tamsulosin.

Uncommon side effects
(may affect up to 1 in 100 men taking DUTAS):

• heart failure (the heart pumps blood around the body less efficiently; you may develop symptoms such as shortness of breath, extreme tiredness, and swelling of the ankles and legs);
• hair loss (generally loss of body hair) or excessive hair growth.

Frequency not known
(frequency cannot be estimated from the available data):

• depressed mood;
• pain and swelling of the testicles.

If any side effect becomes severe, or if you notice any side effect not listed in this leaflet, consult your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the following website:
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 DUTAS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister, after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep in the original packaging to protect the medicine from moisture.
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. Pack contents and other information

What DUTAS contains
The active substance is dutasteride.

• Each soft capsule contains 0.5 mg of dutasteride.
• The other components are:
• inside the capsule: propylene glycol monocaprylate (type I) and butylated hydroxytoluene (E321);
• capsule shell: gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), medium-chain triglycerides, soy lecithin (may contain soy oil) (E322), and purified water.

Description of the appearance of DUTAS and pack contents
DUTAS soft capsules are size 6, oblong, yellow, opaque soft gelatin capsules containing a yellowish oily liquid.
DUTAS is available in packs of 30 and 60 capsules.
Not all pack sizes may be marketed.
Dimensions of the soft capsules: 19 ± 0.8 mm x 6.9 ± 0.4 mm.

Marketing Authorization Holder
EBERLIFE FARMACEUTICI S.p.A.
Via G. Porzio snc
80143 Naples - Italy

Manufacturer:
Galenicum Health S.L.U.
Sant Gabriel, 50
Esplugues de Llobregat
08950 Barcelona - Spain
or
Cyndea Pharma, S.L
Polígono Industrial Emiliano Revilla Sanz,
Avenida de Ágreda, 31 Olvega, 42110
Soria, Spain
or
SAG MANUFACTURING, S.L.U
Crta. N-I, Km 36, San Agustin de Guadalix
Madrid, 28750
Spain