Package leaflet: Information for the patient

[Dutasteride Aristo 0.5 mg soft capsules]

Dutasteride
Generic 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 others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

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

The active substance is dutasteride. It belongs to a class of medicines called 5-alpha reductase inhibitors.
Dutasteride Aristo is used to treat men with an enlarged prostate (benign prostatic hyperplasia) – a non-malignant increase in prostate size caused by excessive production of a hormone called dihydrotestosterone.
If the prostate enlarges, it can lead to urinary problems such as difficulty in passing urine and the need to urinate frequently. This may also cause the urine stream to become slower and weaker. If left untreated, there is a risk that urine flow may become completely blocked (acute urinary retention), which requires immediate medical treatment. In some cases, surgery may be needed to remove or reduce the size of the prostate. Dutasteride reduces the production of dihydrotestosterone, thereby helping to decrease prostate volume and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgical intervention.
Dutasteride Aristo may be used together 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 with your doctor.
This medicine is intended for men only. It must 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 together with another medicine called an alpha blocker such as tamsulosin developed heart failure compared to patients treated only with dutasteride or only with an alpha blocker. 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 may have. If you have had any liver disease, additional monitoring may be necessary while you are taking Dutasteride Aristo.
Women, children, and adolescents must avoid contact with Dutasteride Aristo capsules that are not intact, because the active substance can be absorbed through the skin. In case of skin contact, wash the affected area immediately with water and soap.
Use a condom during sexual intercourse. Dutasteride has been found in the semen of men being treated with Dutasteride Aristo. If your partner is or could be pregnant, you must avoid exposing her to your semen, as dutasteride may interfere with the normal development of a male fetus. It has been shown that dutasteride reduces 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 order the test to check whether you have prostate cancer. If you are due to have a PSA test, inform your doctor that you are taking Dutasteride Aristo. Men taking dutasteride should have regular PSA tests. In a clinical study conducted in men at increased risk of prostate cancer, men taking dutasteride had a higher incidence of aggressive forms of prostate cancer compared to men not taking dutasteride. The effect of dutasteride on this aggressive form of prostate cancer is not fully understood.
Dutasteride Aristo may cause breast enlargement and tenderness. If this becomes bothersome, or if you notice breast lumps or nipple discharge, speak to your doctor about these changes, as they may be signs of a serious condition, such as breast cancer.

Ask your doctor or pharmacist for advice if you have any questions about taking Dutasteride Aristo.
Other medicines and Dutasteride Aristo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
Some medicines may interact with Dutasteride Aristo and increase the likelihood of
side effects. These medicines include:

Verapamil or diltiazem (for hypertension)
Ritonavir or indinavir (for HIV)
Itraconazole or ketoconazole (for fungal infections)
Nefazodone (an antidepressant)
Alpha blockers (for enlarged prostate or hypertension).

Inform your doctor if you are taking any of these medicines. It may be necessary to reduce the dose of
Dutasteride Aristo that you take.
Dutasteride Aristo with food and drink
Dutasteride Aristo can be taken with or without food.
Pregnancy, breastfeeding and fertility
Women must not take Dutasteride Aristo.
Pregnant women (or women who may become pregnant) must not handle damaged capsules.
Dutasteride is absorbed through the skin and may interfere with the normal development of a male
fetus. This is particularly risky during the first 16 weeks of pregnancy. Consult your doctor if a pregnant
woman has been exposed to 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 could be pregnant, you must avoid exposing her 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 use machinery.
Dutasteride Aristo contains soya lecithin
This medicine contains soya lecithin, which may contain soya oil. If you are allergic to peanuts or soya, do not use this medicine.

3. How to take Dutasteride Aristo

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist. If you do not take it regularly, monitoring of PSA levels may be affected.

How much Dutasteride Aristo to take:
The recommended dose is one capsule (0.5 mg) taken once daily. 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 may notice an early improvement in symptoms. However, others may need to take Dutasteride Aristo for 6 months or longer before it starts to work. Continue taking Dutasteride Aristo for as long as your doctor tells you to.

If you take more Dutasteride Aristo than you should
If you take more Dutasteride Aristo capsules 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 forgotten dose. Take the next dose at your usual time.

If you stop taking Dutasteride Aristo
Do not stop taking Dutasteride Aristo without first consulting your doctor. It may take 6 months or longer before you notice an improvement.

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 be itchy)
Hives (similar to nettle rash)
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 people treated with Dutasteride Aristo:

Inability to achieve or maintain an erection (impotence)*,
Decreased sexual desire (libido)*,
Ejaculation disorders*,
Enlargement or tenderness of the breast (gynecomastia),
Dizziness when taking tamsulosin.

*These symptoms may continue after you have stopped taking Dutasteride Aristo.
Uncommon side effects
These may affect up to 1 in 100 people treated with Dutasteride Aristo:

Heart failure (the heart becomes less efficient at pumping blood around the body. Symptoms may include breathlessness, extreme tiredness and swelling of the ankles and legs)
Hair loss (usually from the body) or hair growth.

Side effects with unknown frequency
Frequency cannot be estimated from the available data:

Depressed mood
Pain and swelling of the testicles.

If you experience any serious side effect, including those not listed in this leaflet, consult 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 or pharmacist. You can also report side effects directly via 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 carton or on the blister packs, after “EXP”.
The expiry date refers to the last day of that month.
Do not store this medicine above 30°C.
Keep in the original packaging to protect 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 Dutasteride Aristo contains

The active substance is dutasteride.
Each soft capsule contains 0.5 mg of dutasteride.
The other components are:
o Capsule core: glycerol monocaprylocaprate (type I) and butylated hydroxytoluene (E321).
o Capsule coating: gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), medium-chain triglycerides, lecithin (may contain soybean oil) (E322), and purified water.

Description of the appearance of Dutasteride Aristo and contents of the pack
Dutasteride Aristo soft capsules are soft gelatin capsules, size 6, oblong, opaque, yellow in colour, containing a yellowish oily liquid.
They are available in packs containing 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

Manufacturers:
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 names:
Malta Dutasteride Aristo 0.5 mg soft capsules
Italy Dutasteride Aristo 0.5 mg soft capsules
Portugal Dutasterida Aristo 0.5 mg soft capsules