DUTASTERIDE 0.5 mg Soft capsules

Зміст інструкції

1. Dutasteride Aurobindo 0.5 mg soft capsules
   1. What is Dutasteride Aurobindo and what it is used for
   2. What you need to know before taking Dutasteride Aurobindo
   3. How to take Dutasteride Aurobindo
   4. Possible side effects
   5. How to store Dutasteride Aurobindo
   6. Package contents and other information

Dutasteride Aurobindo 0.5 mg soft capsules

Generic medicine

Read this 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 or pharmacist.
• 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 could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Dutasteride Aurobindo and what it is used for

Dutasteride Aurobindo is used to treat men suffering from an enlargement of the
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.
The active ingredient of this medicine is dutasteride. It belongs to a group of medicines called 5-alpha-
reductase inhibitors.
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 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 Aurobindo 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.
Dutasteride Aurobindo can also be used together with another medicine called tamsulosin (used
to treat the symptoms of prostate enlargement).

2. What you need to know before taking Dutasteride Aurobindo

Do not take Dutasteride Aurobindo

• if you are allergic to dutasteride, to other 5-alpha-reductase inhibitorsor 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 takethis medicine until you have checked with your doctor.

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

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

• 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 Dutasteride Aurobindo.
• Women, children and adolescentsshould avoid contact with broken Dutasteride Aurobindo capsules because the active ingredient can be absorbed through the skin. The affected area should be washed immediatelywith water and soap if contact occurs.
• Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking Dutasteride Aurobindo. 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, semen volume and sperm motility. This may reduce fertility.
• Dutasteride Aurobindo alters a blood test for measuring 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 are having a blood test for measuring PSA, tell your doctor that you are taking Dutasteride Aurobindo. Men taking DutasterideAurobindo should have periodic PSA checks.
• In a clinical study conducted on men at increased risk of prostate cancer, men treated with Dutasteride Aurobindo developed a more serious form of prostate cancer moreoftenthan men not treated with Dutasteride Aurobindo. The effect of Dutasteride Aurobindo on this serious form of prostate cancer is unclear.
• Dutasteride Aurobindo may cause enlargement and tenderness of the breasts. If this effect causes you discomfort or if you notice lumps in the breasts or nipple discharge, you should inform your doctor of these changes as they may be signs of a serious illness, such as breast cancer.

Ask your doctor or pharmacistif you have any questions about taking Dutasteride Aurobindo.

Other medicines and Dutasteride Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Some medicines can interact with Dutasteride Aurobindo 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 doctorif you are taking any of these medicines. It may be necessary to reduce the dose you take of
Dutasteride Aurobindo.

Dutasteride Aurobindo with food and drink
Dutasteride Aurobindo can be taken with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
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 especially present during the first 16 weeks of pregnancy.

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

Contact your doctorif a pregnant woman has come into contact with dutasteride.

Driving and using machines
It is unlikely that Dutasteride Aurobindo will affect your ability to drive or use machines.

3. How to take Dutasteride Aurobindo

Take this medicine following exactly the instructions of your doctor or pharmacist. If you do not take it regularly, the control of PSA levels may be affected. If you have any doubts, consult your doctor or pharmacist.

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.
• Dutasteride Aurobindo is a long-term treatment. Some men quickly notice an improvement in symptoms, while others may need to take Dutasteride Aurobindo for 6 months or more before experiencing an effect. Continue to take Dutasteride Aurobindo for as long as indicated by your doctor.

If you take more Dutasteride Aurobindothan you should
Contact your doctor or pharmacist for advice if you take too many capsules of Dutasteride Aurobindo.

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

If you stop taking Dutasteride Aurobindo
Do not stop taking Dutasteride Aurobindo without first talking to your doctor. It may take up to 6 months or more to notice an effect.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reaction
The signs of an allergic reaction may include:

• skin rash(which may be itchy);
• urticaria;
• swelling of eyelids, face, lips, arms or legs.

Common side effects(may affect up to 1 in 10 men treated with Dutasteride Aurobindo):

• inability to get or maintain an erection (impotence), this may continue after stopping Dutasteride Aurobindo;
• decreased sexual drive (libido), this may continue after stopping Dutasteride Aurobindo;
• difficulty with ejaculation, this may continue after stopping Dutasteride Aurobindo;
• breast enlargement or tenderness (gynecomastia);
• dizziness when taken with tamsulosin.

Uncommon side effects(may affect up to 1 in 100 men treated with Dutasteride
Aurobindo):

• 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 (usually from the body) or hair growth.

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

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at http://www.aifa.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 Dutasteride Aurobindo

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 label, the carton, the blister or the
bottle after EXP. The expiry date refers to the last day of that month.
Store at a temperature below 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 the
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Dutasteride Aurobindo contains

• The active ingredient is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.
• The other ingredients are: Capsule content: propylene glycol monocaprylate (Type I) and butylated hydroxytoluene (E321).

Capsule shell: gelatin, glycerol, titanium dioxide (E171) and yellow iron oxide (E172).

Description of the appearance of Dutasteride Aurobindoand package contents
Soft capsules.
Dark yellow, oblong, size “6” soft gelatin capsules, containing a viscous oil
ranging from colorless to pale yellow.
Dutasteride Aurobindo capsules are available in blister packs and in HDPE bottles.

Pack sizes:

Blister packs: 10, 30, 50, 60 and 90 capsules.
HDPE bottles: 500 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) s.r.l. – Via San Giuseppe, 102 – 21047 Saronno (VA)

Manufacturer:
APL Swift Services (Malta) Limited - HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000,
Malta
Milpharm Limited - Ares Block, Odyssey Business Park, West End Road, uislip HA4 6QD, United Kingdom
Arrow Génériques- Lyon 26 avenue Tony Garnier, 69007 Lyon, France

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Belgium: Dutasteride AB 0.5 mg soft capsules
France: Dutastéride Arrow Lab 0.5 mg, soft capsules
Italy: Dutasteride Aurobindo
Netherlands: Dutasteride Aurobindo 0.5 mg, soft capsules
Portugal: Dutasterida Generis
Romania: Dutasteridă Aurobindo 0.5 mg soft capsules
Spain: Dutasterida Aurobindo 0.5 mg soft capsules EFG
United Kingdom: Dutasteride 0.5 mg soft capsules