Package leaflet: Information for the user

Durital 0.5 mg soft capsules

Dutasteride
Generic medicine
Please read all of this leaflet carefully before you take 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Durital is and what it is used for

The active substance is dutasteride. It belongs to a group of medicines called 5-alpha-reductase inhibitors.
Durital is used to treat men with enlarged prostate (benign prostatic hyperplasia) – an increase in the size of the prostate gland of non-cancerous origin, caused by excessive production of a hormone called dihydrotestosterone.
Enlargement of the prostate can over time lead to urinary problems, such as difficulty in passing urine and the need to urinate frequently. In addition, it can make the urine stream slower and weaker. If the enlargement is not treated, there is a risk of complete blockage of urine flow ( acute urinary retention ), which requires immediate medical treatment. In some cases, surgery may be necessary to remove the prostate gland or 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.
Durital 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 Durital

DO NOT take Durital:

if you are allergic to dutasteride, 5-alpha-reductase inhibitors, soy, 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 these apply to you, do not take this medicine until you have
consulted 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 Durital.

Make sure your doctor is aware of any liver problems you may have. If you have previously suffered from liver disease, you may require additional monitoring during treatment with Durital.
Women, children and adolescents must avoid contact with damaged Durital capsules, as the active substance 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 Durital. If your partner is or could be pregnant, you must avoid exposing her to your semen, since dutasteride may impair the normal development of a male fetus. It has been shown that dutasteride reduces sperm count, volume and motility. This may reduce fertility.
Durital alters a blood test used to measure PSA (prostate-specific antigen), which is sometimes used to detect prostate cancer. Your doctor must be informed of this effect and may still use this test to detect prostate cancer. If you undergo a blood test to measure PSA, inform your doctor that you are taking Durital. Men taking dutasteride must undergo regular PSA monitoring.
In a clinical study conducted in men at increased risk of prostate cancer, men treated with dutasteride developed a more serious form of prostate cancer more frequently than men not treated with dutasteride. The effect of dutasteride on this serious form of prostate cancer is not clear.
Durital may cause breast enlargement and tenderness. If this effect causes you discomfort, or if you notice breast nodules or nipple discharge, you must 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 Durital, contact your doctor or pharmacist.
Mood changes and depression
In patients treated with another medicine in 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 Durital
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines may interact with Durital 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 Durital may need to be reduced.
Durital with food and drink
Durital can be taken with or without food.
Pregnancy, breastfeeding and fertility
Pregnant women (or women who might be pregnant) must avoid any contact with damaged 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 your doctor for advice.
Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking Durital. If your partner is or could be pregnant, you must avoid exposing her to your semen.
It has been shown that dutasteride reduces sperm count, volume and 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 Durital will affect your ability to drive or use machinery.
Durital 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 Durital

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.
Durital is a long-term treatment. Some men notice an improvement in symptoms quickly, while others may need to take Durital for 6 months or longer before experiencing an effect. Continue taking Durital for as long as your doctor has instructed.

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

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

Do not stop taking Durital without medical advice
Do not stop taking Durital 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 Durital.

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

inability to get or maintain an erection (impotence); this may continue after stopping Durital,
decreased sex drive (libido); this may also continue after stopping Durital,
ejaculation problems, such as reduced amount of semen released during sexual activity; this may continue after stopping Durital,
breast enlargement or tenderness (gynaecomastia),
dizziness when taken together with tamsulosin.

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

heart failure (the heart pumps blood around the body less effectively; 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 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 effects not listed in this leaflet, talk to your doctor or pharmacist.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the 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 Durital

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 pack, following
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. Package contents and other information

What Durital 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 soybean oil) (E322), and purified water.

Description of the appearance of Durital and contents of the pack
Durital soft capsules are size 6, oblong, yellow, opaque soft gelatin capsules containing a yellowish oily liquid.
Durital 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
Pharmacare Srl
Via Marghera, 29
20149 Milan - 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