DUTAS 0.5 mg Miękkie kapsułki

Treść ulotki

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

Dutas 0.5 mg soft capsules

Dutasteride
Generic medicine

Read 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 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 Dutas is and what it is used for
• 2. What you need to know before you take 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 an enlarged prostate(benign prostatic hyperplasia) - an increase in the volume of the prostate gland, of non-cancerous origin, caused by the production of excessive amounts of a hormone called dihydrotestosterone.
Prostate enlargement can cause urinary problems over time, such as difficulty passing urine and the need to go to the bathroom frequently. It can also make the urine flow slower and weaker. If the enlargement is not treated, there is a risk of complete blockage of the urine flow (acute urinary retention) which requires immediate medical treatment. In some situations, surgery is necessary to remove the prostate gland or reduce its size. Dutasteride reduces the production of dihydrotestosterone, helping to decrease the volume of the prostate and alleviate the symptoms. This will reduce the risk of acute urinary retention and the need for surgery.
Dutas can also be used together with another medicine called tamsulosin (used to treat the symptoms of an enlarged prostate).

2. What you need to know before you take Dutas

DO NOT take Dutas:

• if you are allergic to dutasteride, 5-alpha-reductase inhibitors, soy, 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 apply to you, do not takethis medicine until you have checked
with your doctor.

This medicine is for men only. It should not be used by women,
children or adolescents.

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

• Make sure your doctor is aware of any liver problems you have. If you have had a liver disease, you may need additional checks during treatment with Dutas.
• Women, children and adolescentsshould avoid contact with broken Dutas capsules because the active ingredient can be absorbed through the skin. The affected areashould be washed immediatelywith water and soap if contact with the skin occurs.
• Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Dutas. If your partner is or may be pregnant, you should 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, volume and motility. This may reduce fertility.
• Dutas alters a blood test for measuring PSA( prostate-specific antigen) which is sometimes used to detect prostate cancer. Your doctor should be informed of this effect and may still be able to use this test to detect prostate cancer. If you are having a blood test for measuring PSA, tell your doctor that you are taking Dutas . Men taking dutasterideshould have regular PSA checks.
• In a clinical study conducted on men at increased risk of prostate cancer, men treated with dutasteride developed a severe form of prostate cancer moreoftenthan men not treated with dutasteride. The effect of dutasteride on this severe form of prostate cancer is unclear.
• Dutas may cause enlargement and tenderness of the breasts. If this effect causes you discomfort or if you notice the presence of breast lumpsor nipple discharge, you should inform your doctor of these changes as they could be signs of a serious illness, such as breast cancer.

If you have any doubts about taking Dutas, talk to your doctor or pharmacist.

Other medicines and Dutas
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Some medicines can 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).

Tell 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 those who may become pregnant) should avoid any
contact with broken capsules.Dutasteride is absorbed through the skin and can
impair the normal development of a male fetus. This risk is present
especially during the first 16 weeks of pregnancy. If a pregnant woman has come into contact with
dutasteride contact your doctorfor advice.

Use a condom during sexual intercourse. Dutasteride has been found in the semen of
men taking Dutas. If your partner is or may be pregnant, you should avoid exposing her to your semen.
Dutasteride has been shown to reduce sperm count, volume and motility. Therefore, it may reduce
male fertility.

Contact your doctorfor 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 use machines.

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

3. How to take Dutas

Take this medicine following exactly the instructions of your doctor, pharmacist or nurse. 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 a day. 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 more before experiencing an effect. Continue to take Dutas for as long as indicated by your doctor.

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

If you forget to take Dutas
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 Dutas without advice
Do not stop taking Dutas without first talking to your doctor. It may be
necessary to wait up to 6 months or more 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.
manifest.

Allergic reaction
The signs of an allergic reaction may include:

• skin rash(which may be itchy),
• urticaria (like the rash caused by nettles)
• swelling of eyelids, face, lips, arms or legs.

Contactyour doctor immediatelyif you experience any of these symptoms and stop
treatment with Dutas.
Common side effects
(may affect 1 in 10 men taking Dutas):

• inability to get or maintain an erection (impotence), *this may continue after stopping treatment with Dutas,
• decreased sexual drive (libido), this may also continue after stopping treatment with Dutas,
• difficulty ejaculating, such as a decrease in the amount of semen released during sexual activity, this may continue after stopping treatment with Dutas,
• enlargement or tenderness of the breasts (gynecomastia),
• dizziness when taken with tamsulosin.

Uncommon side effects
(may affect 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 ankles and legs);
• hair loss (generally loss of body hair) or growth of hair.

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

• depressed mood
• pain and swelling of the testicles.

If any side effect becomes serious or if you notice any side effect not
listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Dutas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister, after
EXP. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in 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 Dutas contains
The active ingredient is dutasteride.

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

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

Marketing Authorisation Holder
Pharmacare Srl
Via Marghera, 29
20149 Milan - Italy

Manufacturer:
Galenicum Health S.L.
Avda. Cornellá 144, 7º-1ª, Edificio Lekla
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
or
Pharmadox Healthcare, Ltd.
KW20A Kordin Industrial Park, Paola, PLA 3000, Malta