DURITAL 0.5 MG Soft capsule

Зміст інструкції

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

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

1. What Durital is and what it is used for

The active ingredient 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 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.
Durital can also be used together with another medicine called tamsulosin (used to treat the 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, 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 Durital.

• Make sure your doctor is aware of any liver problems you have. If you have suffered from a liver disease, you may need additional checks during treatment with Durital.
• Women, children and adolescentsshould avoid contact with broken Durital 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 detected in the semen of men taking Durital. 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.
• Durital 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 to measure your PSA, tell your doctor that you are taking Durital. 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.
• Durital 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 tell your doctor about these changes as they may be signs of a serious illness, such as breast cancer.

If you have any doubts about taking Durital, contact your doctor or pharmacist.

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

Tell 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 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 detected in the semen of
men taking Durital. 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 Durital will affect your ability to drive or use machines.

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 following exactly the instructions of your doctor, pharmacist or nurse. If you do not take it regularly, the 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.
• Durital is a long-term treatment. Some men notice a rapid improvement in symptoms, while others may need to take Durital for 6 months or more before seeing an effect. Continue to take Durital for as long as indicated by your doctor.

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 a missed dose. Take the next dose at the usual time.

Do not stop taking Durital without advice
Do not stop taking Durital without first talking to your doctor. It may take 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.

Contact your doctor immediatelyif you experience any of these symptoms and stop
treatment with Durital .
Common side effects
(may affect 1 in 10 people taking Durital ):

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

Uncommon side effects
(may affect 1 in 100 people taking Durital )

• 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 hair growth.

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

• depressed mood
• pain and swelling of the testicles.

If any side effect gets serious, or if you notice any side effects 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 Durital

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 Durital 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 butylhydroxytoluene (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 Durital and contents of the pack
Durital soft capsules are size 6, oblong, yellow and opaque soft gelatin capsules containing
an oily and yellowish liquid.
Durital is available in packs of 30 and 60 capsules. Not all pack sizes may be
marketed.
The size of the soft capsules is: 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