DUTASTERIDE ARISTO 0.5 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the User

Dutasteride Aristo 0.5 mg Soft Capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again. - If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

The active substance is dutasteride, which belongs to a group of medicines called 5-alpha reductase inhibitors.

Dutasteride Aristo is used in men to treat enlarged prostate(benign prostatic hyperplasia), a non-cancerous growth of the prostate caused by overproduction of a hormone called dihydrotestosterone.

As the prostate grows, it can cause urinary problems such as difficulty in the flow of urine and a need to urinate more frequently. It can also cause the stream of urine to be weaker and less forceful. If left untreated, benign prostatic hyperplasia can lead to a risk of the urine flow being completely blocked (acute urinary retention). This requires immediate medical treatment. In some cases, surgery may be necessary to reduce the size of the prostate or remove it. Dutasteride Aristo reduces the production of dihydrotestosterone, which helps to reduce the size of the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgery.

Dutasteride Aristo can also be used with another medicine called tamsulosin (used to treat symptoms of enlarged prostate).

2. What you need to know before you take Dutasteride Aristo

Do not take Dutasteride Aristo

• if you are allergic to dutasteride, other 5-alpha reductase inhibitors, soya, peanut, or 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.

Tell your doctorif you think you may have any of these conditions.

This medicine is for men only. Women, children, and adolescents must not take it.

Warnings and precautions

Talk to your doctor before taking Dutasteride Aristo.

• In some clinical studies, there were more patients taking dutasteride and another medicine called alpha-blocker, such as tamsulosin, who experienced heart failure compared to patients taking only dutasteride or only an alpha-blocker. Heart failure means that your heart does not pump blood as it should.
• Make sure your doctor knows if you have liver problems. You may need extra checks during your treatment with Dutasteride Aristo if you have any liver disease.
• Women, children, and adolescents must avoid contact with leaking Dutasteride Aristo capsules because the active ingredient can be absorbed through the skin. If there is any contact with the skin, the affected area must be washed immediately with water and soap.
• Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking dutasteride. If your partner is pregnant or thinks she may be pregnant, she must avoid exposure to your semen because dutasteride can affect the normal development of a male baby.

Dutasteride has been shown to decrease sperm count, sperm motility, and semen volume. This may reduce fertility.

• Dutasteride affects the blood test for PSA (prostate-specific antigen) used to detect prostate cancer. Your doctor may still use this test to detect prostate cancer, but must be aware of this effect. If you have a blood test for PSA, tell your doctor you are taking Dutasteride Aristo. Men taking Dutasteride Aristo should have regular PSA tests.

In a clinical study in men at high risk of prostate cancer, men taking dutasteride were more likely to have a type of prostate cancer called high-grade prostate cancer than those not taking dutasteride. The effect of dutasteride on these types of prostate cancer is not clear.

• Dutasteride Aristo may cause breast enlargement and breast tenderness. If this causes you discomfort, or if you notice lumps in your breast or nipple discharge, talk to your doctor, as these changes can be signs of a serious disease, such as breast cancer.
• Mood changes and depression. Depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with another medicine in the same therapeutic group (5-alpha reductase inhibitor) by mouth. If you experience any of these symptoms, contact your doctor for additional medical advice as soon as possible.

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

Taking Dutasteride Aristo with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Certain medicines may interact with Dutasteride Aristo, which may increase the risk of you experiencing side effects. Some of these medicines are:

• verapamil or diltiazem (for high blood pressure)
• ritonavir or indinavir (for AIDS)
• itraconazole or ketoconazole (for fungal infections)
• nefazodone (an antidepressant)
• other 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 of Dutasteride Aristo.

Taking Dutasteride Aristo with food and drink

Dutasteride Aristo can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Women must not take dutasteride.

Pregnant women (or women who may be pregnant) must avoid contact with leaking capsules. Dutasteride is absorbed through the skin and may affect the normal development of a male baby. This risk is especially important during the first 16 weeks of pregnancy. Talk to your doctor if a pregnant woman has been in contact with dutasteride.

Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking dutasteride. If your partner is pregnant or thinks she may be pregnant, she must avoid exposure to your semen.

Dutasteride has been shown to decrease sperm count, sperm motility, and semen volume. This may reduce fertility.

Driving and using machines

It is unlikely that dutasteride will affect your ability to drive or use machines.

Dutasteride Aristo contains soya lecithin

This medicine contains soya lecithin, which may contain soya oil. It must not be used in case of peanut or soya allergy.

3. How to take Dutasteride Aristo

Take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. If you do not take Dutasteride Aristo regularly, your PSA levels may be affected.

What dose should you take

• The recommended dose is one capsule (0.5 mg) once a day. The capsules should be swallowed whole, with water. Do not chew or open the capsules. Contact with the contents of the capsules can irritate your mouth or throat.
• Treatment with Dutasteride Aristo is long-term. Some men may experience rapid improvement in symptoms. However, others may need to take this medicine for 6 months or more before an effect is seen. Continue taking Dutasteride Aristo for as long as your doctor tells you.

If you take more Dutasteride Aristo than you should

If you have taken more than the recommended dose, contact your doctor, pharmacist, or poison control center immediately, stating the medicine and the amount taken.

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 the usual time.

If you stop taking Dutasteride Aristo

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

If you have any further questions on the use of this product, 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

Symptoms of an allergic reaction can include:

• skin rash (which may itch)
• hives
• swelling of the eyelids, face, lips, arms, and legs.

If you experience any of these symptoms, contact your doctor immediately and stop taking Dutasteride Aristo.

Common side effects

May affect up to 1 in 10 men:

• inability to get or keep an erection (impotence), *which may continue after stopping Dutasteride Aristo
• reduced sex drive (libido), *which may continue after stopping Dutasteride Aristo
• difficulty with ejaculation, *which may continue after stopping Dutasteride Aristo
• breast tenderness or enlargement (gynaecomastia)
• dizziness, when taken with tamsulosin

Uncommon side effects

May affect up to 1 in 100 men:

• heart failure (the heart becomes less efficient at pumping blood around the body. This can cause symptoms such as difficulty breathing, tiredness, and swelling in the ankles and legs).
• hair loss (usually from the body) or increased hair growth.

Rare side effects

Frequency cannot be estimated from the available data:

• depressed mood
• testicular pain and swelling.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 blister after EXP. The expiry date refers to the last day of the month shown.

Do not store above 30°C.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What is in Dutasteride Aristo

The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.

The other ingredients are:

• capsule content: glycerol monocaprylocaprate (type I), butylhydroxytoluene (E321).
• capsule shell: gelatina, glycerol, titanium dioxide (E171), yellow iron oxide (E172), medium-chain triglycerides, lecithin (may contain soya oil) (E322), and purified water.

Appearance and packaging

Soft, opaque, yellow capsules containing a yellowish oily liquid, size 19 ± 0.8 mm x 6.9 ± 0.4 mm. They are available in white opaque PVC/PVDC-Aluminum blister packs containing 30 and 90 capsules. Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Aristo Pharma Iberia S.L.

Calle Solana 26

28850 Torrejón de Ardoz-Madrid

Spain

Manufacturer:

Laboratorios Medicamentos Internacionales S.A.

Solana 26

28850 Torrejón de Ardoz (Madrid)

Spain

Or

SAG Manufacturing, S.L.U.

Ctra. N-I, Km 36

28750 San Agustín de Guadalix, Madrid

Spain

Date of last revision of this leaflet: September 2025