DUTASTERIDE 0.5 MG Soft capsules

Зміст інструкції

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

[Dutasteride Aristo 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 or pharmacist.
• 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 or pharmacist. See section 4. Contents of this leaflet:
• 1. What Dutasteride Aristo is and what it is used for
• 2. What you need to know before you take Dutasteride Aristo
• 3. How to take Dutasteride Aristo
• 4. Possible side effects
• 5. How to store Dutasteride Aristo
• 6. Contents of the pack and other information

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

The active ingredient is dutasteride. It belongs to a class of drugs called 5-alpha reductase inhibitors.
Dutasteride Aristo is used to treat men with enlarged prostate (benign prostatic hyperplasia) - a non-cancerous increase in prostate volume, due to excessive production of a hormone called dihydrotestosterone.
If the prostate increases in volume, it can lead to urinary problems such as difficulty passing urine and
the need to urinate frequently. This can also result in a slower and weaker urine flow. If left untreated, there is a risk that the urine flow may become completely blocked (acute urinary retention). This requires immediate medical treatment. In some cases, surgery is necessary to remove or reduce the volume of the prostate. Dutasteride reduces the production of
dihydrotestosterone and this promotes a decrease in prostate volume and relieves symptoms. This reduces the
risk of acute urinary retention and the need for surgery.
Dutasteride Aristo can be used with another medicine called tamsulosin (used in the treatment
of symptoms of prostate enlargement).

2. What you need to know before taking Dutasteride Aristo

Do not take Dutasteride Aristo:

• if you are allergic to dutasteride, to other 5-alpha reductase inhibitors, to soy, to peanuts or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver disease;
• if you are a child or adolescent.

If any of the above situations apply to you, speak to your doctor.

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

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

• In some clinical studies, more patients taking dutasteride and another medicine called an alpha blocker such as tamsulosin, developed heart failure compared to patients treated with dutasteride alone or an alpha blocker alone. Heart failure means that the heart does not pump blood as well as it should.
• Make sure your doctor is aware of any liver problems you have.If you have had any liver disease, further checks may be needed while you are taking Dutasteride Aristo.
• Women, children and adolescentsshould avoid contact with broken Dutasteride Aristo capsules, because the active ingredient is absorbed through the skin. If contact with the skin occurs, wash the affected area immediatelywith soap and water.
• Use a condom during sexual intercourse.Dutasteride has been found in the semen of men treated with Dutasteride Aristo. If your partner is or may become pregnant, you should avoid exposing her to your semen as dutasteride may harm the normal development of a male child. Dutasteride has been shown to reduce sperm count, semen volume and sperm motility. This may decrease your fertility.
• Dutasteride Aristo affects a blood test for PSA(prostate-specific antigen), which is sometimes used to detect prostate cancer. Your doctor should be aware of this effect and may still prescribe the test to find out if you have prostate cancer. If you are to have a PSA test, tell your doctor that you are taking Dutasteride Aristo. Men who take dutasteride should have the PSA test regularly. In a clinical trial conducted on men at increased risk of prostate cancer, men taking dutasteride were more likely to develop a serious form of prostate cancer than men who were not taking dutasteride. The effect of dutasteride on this serious form of prostate cancer is unclear.
• Dutasteride Aristo may cause enlargement and tenderness of the breasts.If this becomes troublesome, or if you notice lumps in the breasts or nipple discharge, you should talk to your doctor about these changes as they may be signs of a serious condition, such as breast cancer.

Ask your doctor or pharmacist if you have any questions about taking Dutasteride Aristo.

Other medicines and Dutasteride Aristo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines can interact with Dutasteride Aristo and may increase the possibility 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 an enlarged prostate or high blood pressure).

Tell your doctor if you are taking any of these medicines. It may be necessary to reduce the dose you take of Dutasteride Aristo.

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

Pregnancy, breastfeeding and fertility
Women should not take Dutasteride Aristo

Women who are pregnant (or who may become pregnant) should not handle broken capsules.
Dutasteride is absorbed through the skin and can interfere with the normal development of a male child.
This is particularly risky during the first 16 weeks of pregnancy. Ask your doctor for advice if a pregnant woman has come into contact with dutasteride.

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

Driving and using machines
It is unlikely that Dutasteride Aristo will affect your ability to drive or operate machinery.

Dutasteride Aristo 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 Dutasteride Aristo

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist. If you do not take it regularly, the control of PSA levels may
be affected.
How much Dutasteride Aristo to take:
The recommended dose is one capsule (0.5 mg) to be taken once a day. Swallow the capsules whole with
water. Do not chew or open the capsules. Contact with the contents of the capsules may irritate the mouth or
throat.
Treatment with Dutasteride Aristo is long-term. Some individuals notice an early improvement in
symptoms. However, others may need to take Dutasteride Aristo for 6 months or more before it begins
to take effect. Continue to take Dutasteride Aristo for as long as your doctor tells you.

If you take more Dutasteride Aristo than you should
If you take more capsules of Dutasteride Aristo than prescribed, contact your doctor or pharmacist for
advice.

If you forget to take Dutasteride Aristo
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 Aristo
Do not stop taking Dutasteride Aristo without first consulting your doctor. It may be
necessary to wait 6 months or more before you notice an improvement.
If you have further questions on 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
The signs of allergic reactions may include:

• Skin rash (which may be itchy)
• Hives (like a nettle sting)
• Swelling of the eyelids, face, lips, arms or legs.

Contact your doctor immediately if you experience any of these symptoms and stop taking
Dutasteride Aristo.

Common side effects
These may affect up to 1 in 10 patients treated with Dutasteride Aristo:

• Inability to achieve or maintain an erection (impotence)*,
• Decreased sexual desire (libido)*,
• Difficulty with ejaculation*,
• Breast enlargement or tenderness (gynecomastia),
• Dizziness when taking tamsulosin..

*These symptoms may continue after you stop taking Dutasteride Aristo.

Uncommon side effects
These may affect up to 1 in 100 patients treated with Dutasteride Aristo:

• Heart failure (the heart becomes less efficient at pumping blood around the body. You may experience symptoms such as shortness of breath, extreme fatigue and swelling of the ankles and legs)
• Hair loss (usually from the body) or hair growth.

Side effects with unknown frequency
The frequency cannot be estimated on the basis of the available data:

• Depressed mood
• Pain and swelling of the testicles.

If you get any side effects that are severe, including those not listed in this leaflet, tell your
doctor or pharmacist.

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: www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dutasteride Aristo

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 package or on the blister, after “EXP”.
The expiry date refers to the last day of that month.
Do not store this medicine at a temperature above 30°C.
Store in the original package to protect 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. Package contents and other information

What Dutasteride Aristo contains

• The active ingredient is dutasteride.
• Each soft capsule contains 0.5 mg of dutasteride.
• The other ingredients are: o capsule core: glycerol monocaprylocaprate (Type I) and butylhydroxytoluene (E321). o capsule shell: gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), triglycerides (medium chain), lecithin (may contain soybean oil) (E322) and purified water.

Description of the appearance of Dutasteride Aristo and package contents
Dutasteride Aristo soft capsules are soft gelatin capsules, size 6, oblong, opaque, yellow in colour, containing an oily and yellowish liquid.
They are available in packs of 10, 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 and Manufacturer
Marketing Authorisation Holder:
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

Manufacturer:
Galenicum Health S.L.
Avda. Cornellá 144, 7º-1ª, Edificio Lekla
Esplugues de Llobregat
08950 Barcelona - Spain
Cyndea Pharma, S.L
Polígono Industrial Emiliano Revilla Sanz,
Avenida de Ágreda, 31 Olvega, 42110,
Soria, Spain
Pharmadox Healthcare, Ltd.
KW20A Kordin Industrial Park,
Paola, PLA 3000, Malta
This medicinal product is authorised in the Member States of the European Economic Area under the following
denominations:
Malta Dutasteride Aristo 0.5 mg soft capsules
Italy Dutasteride Aristo 0.5 mg soft capsules
Portugal Dutasterida Aristo 0.5 mg soft capsules