Dutasteride Aristo 0.5 mg soft capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dutasteride Aristo 0.5 mg soft capsules EFG

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

• Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Dutasteride Aristo is 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. Contents of the pack and other information

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

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

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

As the prostate enlarges, it may cause urinary problems such as difficulty in passing urine and a need to urinate more frequently. It may also cause the urine stream to become weaker and less forceful. If benign prostatic hyperplasia is not treated, there is a risk that the flow of urine may become 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 to remove it. Dutasteride Aristo reduces the production of dihydrotestosterone, helping to shrink the size of the prostate and relieve symptoms. This will reduce the risk of acute urinary retention and the need for surgery.

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

2. What you need to know before taking Dutasteride Aristo

Do not take Dutasteride Aristo

• if you are allergic to dutasteride, to other inhibitors of the enzyme 5-alpha reductase, to soya, 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.

Tell your doctor if you think you are in any of these situations.

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

Warnings and precautions

Talk to your doctor before starting to take Dutasteride Aristo.

• In some clinical studies, there was a higher number of patients taking dutasteride and another medicine called an 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 well as it should.
• Make sure your doctor knows if you have liver problems. You may need additional monitoring during treatment with Dutasteride Aristo if you have a condition affecting your liver.
• Women, children, and adolescents must avoid contact with broken capsules of Dutasteride Aristo because the active ingredient can be absorbed through the skin. If any contact with the skin occurs, the affected area should 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 suspects she may be pregnant, you must avoid exposing her to your semen because dutasteride can affect the normal development of a male fetus.

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

• Dutasteride affects the serum PSA (prostate-specific antigen) test, which is sometimes 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, inform your doctor that you are taking Dutasteride Aristo. Men taking Dutasteride Aristo should have regular PSA monitoring.

In a clinical study conducted in men at increased risk of developing prostate cancer, men who took dutasteride developed more frequently a type of high-grade prostate cancer than men who did not take dutasteride. The effect of dutasteride on these high-grade types of prostate cancer is not clear.

• Dutasteride Aristo may cause breast enlargement and tenderness. If this causes discomfort, or if you notice lumps in the breast or nipple discharge, consult your doctor, as these changes may 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 oral medicine in the same therapeutic group (5-alpha reductase inhibitor). If you experience any of these symptoms, contact your doctor for 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 need to take any other medicines.

Certain medicines may interact with Dutasteride Aristo, increasing the risk of adverse 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 doctor if 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 broken capsules. Dutasteride is absorbed through the skin and can affect the normal development of a male fetus. This risk is particularly important 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. If your partner is pregnant or suspects she may be pregnant, you must avoid exposing her to your semen.

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

Driving and using machines

It is unlikely that dutasteride will affect your ability to drive or operate machinery.

Dutasteride Aristo contains soya lecithin

This medicine contains soya lecithin, which may contain soya oil. It must not be used if you are allergic to peanuts or soya.

3. How to take Dutasterida Aristo

Follow exactly the instructions for using this medicine given by your doctor. If you are in any doubt, consult your doctor or pharmacist again. If you do not take Dutasterida Aristo regularly, the monitoring of your PSA levels may be affected.

What dose should you take

• The recommended dose is one capsule (0.5 mg) once daily. The capsules must be swallowed whole with water. Do not chew or open the capsules. Contact with the capsule contents may irritate your mouth or throat.
• Treatment with Dutasterida Aristo is long-term. Some men may experience a rapid improvement in symptoms. However, others may need to take this medicine for up to 6 months or longer before an effect begins. Continue taking Dutasterida Aristo for as long as your doctor has instructed.

If you take more Dutasterida Aristo than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 915620420, indicating the medicine and the amount ingested.

If you forget to take Dutasterida Aristo

Do not take a double dose to make up for missed doses. Take the next dose at your usual time.

If you stop taking Dutasterida Aristo

Do not stop treatment with Dutasterida Aristo without first consulting your doctor. It may take up to 6 months or longer before you notice an effect.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Allergic reaction

Symptoms of an allergic reaction may include:

• rash (which may be itchy)
• lumps on the skin
• 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.

Frequent adverse effects

May affect up to 1 in every 10 men:

• inability to achieve or maintain an erection (impotence), *which may continue after stopping Dutasteride Aristo
• decreased sex drive (libido), *which may continue after stopping Dutasteride Aristo
• difficulty with ejaculation, *which may continue after stopping Dutasteride Aristo
• swelling or tenderness of the breast (gynaecomastia)
• dizziness, when taken with tamsulosin

Uncommon adverse effects

May affect up to 1 in every 100 men:

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

Adverse effects of unknown frequency

Frequency cannot be estimated from the available data:

• depressive mood
• pain and swelling of the testicles.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dutasterida Aristo

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton or blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Dutasteride Aristo

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

The other components are:

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

Appearance of the medicine and contents of the container

Yellow, opaque, soft gelatin capsules containing a yellowish oily liquid, size 19 ± 0.8 mm x 6.9 ± 0.4 mm. Available in white opaque PVC/PVDC-Aluminum blister packs containing 30 and 90 capsules. Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aristo Pharma Iberia S.L.

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 the most recent revision of this leaflet: September 2025