DUTASTERIDE AUROBINDO

Package leaflet: Information for the user

Dutasteride Aurobindo 0.5 mg soft capsules

Equivalent medicine
Please read this leaflet carefully before taking 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult 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 taking 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 Dutasteride Aurobindo is and what it is used for

Dutasteride Aurobindo is used to treat men with an enlarged prostate (benign prostatic hyperplasia) – a non-cancerous increase in the size of the prostate gland caused by the overproduction of a hormone called dihydrotestosterone.
The active substance of this medicine is dutasteride. It belongs to a group of medicines known as 5-alpha-reductase inhibitors.
An enlarged prostate can over time cause urinary problems, such as difficulty in passing urine and the need to urinate frequently.
It may also result in a slower and weaker urinary stream. If left untreated, there is a risk of complete blockage of urine flow ( acute urinary retention ), which requires immediate medical treatment. In some cases, surgery may be needed to remove the prostate gland or reduce its size. Dutasteride Aurobindo 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.
Dutasteride Aurobindo may also be used in combination with another medicine called tamsulosin (used to treat symptoms of an enlarged prostate).

2. What you should know before taking Dutasteride Aurobindo

Do not take Dutasteride Aurobindo

• if you are allergic to dutasteride, to other 5-alpha-reductase inhibitors, 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 situations 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 Dutasteride Aurobindo.

• 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 Dutasteride Aurobindo.
• Women, children, and adolescents must avoid contact with damaged Dutasteride Aurobindo 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 Dutasteride Aurobindo. If your partner is or could be pregnant, you must avoid exposing her to your semen, as dutasteride may impair the normal development of a male fetus. It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility. This could reduce fertility.
• Dutasteride Aurobindo affects a blood test measuring PSA (prostate-specific antigen), which is sometimes used to detect prostate cancer. Your doctor should be informed of this effect and may still use this test to screen for prostate cancer. If you undergo a blood test to measure PSA, inform your doctor that you are taking Dutasteride Aurobindo. Men taking Dutasteride Aurobindo must undergo regular PSA monitoring.
• In a clinical study conducted in men at increased risk of prostate cancer, men treated with Dutasteride Aurobindo developed a more aggressive form of prostate cancer more frequently than men not treated with Dutasteride Aurobindo. The effect of Dutasteride Aurobindo on this aggressive form of prostate cancer is not fully understood.
• Dutasteride Aurobindo may cause breast enlargement and tenderness. If this effect causes you discomfort, or if you notice breast lumps or nipple discharge, inform your doctor of these changes, as they could be signs of a serious condition, such as breast cancer.

Ask your doctor or pharmacist if you have any questions about taking Dutasteride Aurobindo.
Other medicines and Dutasteride Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may 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).

Inform your doctor if you are taking any of these medicines. It may be necessary to reduce your dose of Dutasteride Aurobindo.
Dutasteride Aurobindo with food and drinks
Dutasteride Aurobindo can be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnant women (or women who may be pregnant) must avoid any contact with damaged capsules.
Dutasteride is absorbed through the skin and may impair the normal development of a male fetus. This risk is particularly relevant 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 could be pregnant, you must 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 doctor if a pregnant woman has been exposed to dutasteride.
Driving and using machines
It is unlikely that Dutasteride Aurobindo will affect your ability to drive or operate machinery.

3. How to take Dutasteride Aurobindo

Take this medicine exactly as directed by your doctor or pharmacist. If you do not take it regularly, monitoring 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 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.
• Dutasteride Aurobindo is a long-term treatment. Some men notice a rapid improvement in symptoms, while others may need to take Dutasteride Aurobindo for 6 months or longer before experiencing an effect. Continue taking Dutasteride Aurobindo for as long as your doctor recommends.

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

If you forget to take Dutasteride Aurobindo
Do not take a double dose to make up for the missed dose. Take the next dose at your 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 longer to notice an effect.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Allergic reaction
Signs of allergic reactions may include:

• rash (which may cause itching);
• hives;
• 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 achieve or maintain an erection (impotence); this may continue after stopping treatment with Dutasteride Aurobindo;
• decreased sex drive (libido); this may continue after stopping treatment with Dutasteride Aurobindo;
• problems with ejaculation; this may continue after stopping treatment with Dutasteride Aurobindo;
• enlargement or tenderness of the breast (gynecomastia);
• dizziness when taken together 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 the ankles and legs);
• loss of body hair (usually from the body) or hair growth.

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the label, pack, blister, or bottle after EXP. The expiry date refers to the last day of that month.
Store below 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 no longer in use. This will help protect the environment.

6. Package contents and other information

What Dutasteride Aurobindo contains

• The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.
• The other components are: Capsule contents: 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 Aurobindo and contents of the pack
Soft capsules.
Dark yellow, oblong, size “6” soft gelatin capsules containing a colourless to pale yellow clear viscous oil.
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, Uxbridge HA4 6QD, United Kingdom
Arrow Génériques - 26 avenue Tony Garnier, 69007 Lyon, France
This medicinal product is authorised in the Member States of the European Economic Area under the
following names:
Belgium: Dutasteride AB 0.5 mg soft capsules
France: Dutastéride Arrow Lab 0.5 mg, capsules molles
Italy: Dutasteride Aurobindo
Netherlands: Dutasteride Aurobindo 0.5 mg, zachte capsules
Portugal: Dutasterida Generis
Romania: Dutasteridă Aurobindo 0.5 mg capsule moi
Spain: Dutasterida Aurobindo 0.5 mg cápsulas blandas EFG
United Kingdom: Dutasteride 0.5 mg soft capsules