Dutasteride Aurovitas 0.5 mg soft capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dutasteride Aurovitas 0.5 mg soft capsules EFG

Read this entire leaflet carefully before you start taking this medicine, as 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, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Dutasteride 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.

The active substance is dutasteride. It belongs to a group of medicines known as 5-alpha reductase enzyme inhibitors.

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 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 reduce the size of the prostate or to remove it. Dutasteride reduces the production of dihydrotestosterone, helping to shrink the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgery.

Dutasteride 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 Aurovitas

Do not take Dutasteride:

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

If you think you are in any of these situations, do not take this medicine until you have consulted with your doctor.

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 this medicine.

• 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 it should.

• Make sure your doctor knows if you have liver problems. You may need additional monitoring during treatment with dutasteride if you have any condition affecting your liver.

• Women, children, and adolescents must avoid contact with broken capsules of this medicine because the active ingredient can be absorbed through the skin. If any contact with the skin occurs, 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 this medicine. If your partner is pregnant or suspects she may be pregnant, you must avoid exposing her to your semen, because dutasteride may affect the normal development of a male baby. Dutasteride has been shown to reduce sperm count, sperm motility, and semen volume. This may reduce your fertility.

• Dutasteride affects the serum PSA test (prostate-specific antigen), which is sometimes used to detect prostate cancer. Your doctor may still use this test to screen for prostate cancer, but must be aware of this effect. If you have a blood test for PSA, inform your doctor that you are taking this medicine. Men being treated with dutasteride should have regular PSA monitoring.

• In a clinical study conducted in men at increased risk of developing prostate cancer, men who took dutasteride developed a higher frequency of more serious types of prostate cancer than those who did not take it. The effect of dutasteride on these more serious types of prostate cancer is not clear.

• Dutasteride may cause breast enlargement and breast tenderness. If this causes you discomfort, or if you notice lumps in the breast or nipple discharge, consult your doctor, as these changes may be signs of a serious condition, 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 (oral 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 this medicine.

Taking Dutasteride with other medicines

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

Certain medicines may interact with dutasteride, 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)
• alpha blockers (for enlarged prostate or high blood pressure).

Inform your doctor if you are taking any of these medicines. A dose reduction of this medicine may be necessary.

Taking Dutasteride with food and drink

This medicine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnant women (or women who may be pregnant) must avoid contact with broken capsules. Dutasteride is absorbed through the skin and may affect the normal development of a male baby. This risk is particularly important during the first 16 weeks of pregnancy.

Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking this medicine. 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.

Talk to your doctor if a pregnant woman has been exposed to dutasteride.

Driving and using machines

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

3. How to take Dutasterida Aurovitas

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

What dose should you take

• The recommended dose is one capsule (0.5 mg) once daily. The capsules of this medicine should 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 dutasteride is long-term. Some men may experience rapid improvement in symptoms. However, others may need to continue treatment for up to 6 months or longer before an effect begins. Continue taking this medicine for as long as your doctor has instructed.

If you take more Dutasteride than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at 915620420, indicating the medicine and the amount ingested. You are advised to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Dutasteride

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

Do not stop treatment with Dutasteride

Do not stop treatment with this medicine 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 can cause adverse effects, although not everyone experiences 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.

You must immediately contact your doctor if you experience any of these symptoms and stop taking this medicine.

Frequent adverse effects

These may affect up to 1 in every 10 patients taking dutasteride:

• inability to achieve or maintain an erection (impotence), which may continue after stopping this medicine
• reduced sex drive (libido), which may continue after stopping dutasteride
• difficulty with ejaculation, such as a decrease in the amount of semen released during sexual intercourse, which may continue after stopping this medicine
• swelling or tenderness of the breast (gynecomastia)
• dizziness, when taken with tamsulosine.

Uncommon adverse effects

These may affect up to 1 in every 100 patients taking dutasteride:

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

Adverse effects of unknown frequency

Frequency cannot be estimated from the available data:

• depression
• pain and inflammation of the testicles.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dutasteride Aurovitas

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

Do not store above 30 °C.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a pharmacy’s SIGRE collection point. Ask your pharmacist how to properly discard medicines and containers you no longer need. This helps protect the environment.

6. Contents of the container and other information

Composition of Dutasteride Aurovitas

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

The other components are:

• capsule contents: glycerol monocaprylocaprate (type I) and butylated hydroxytoluene (E321).
• capsule shell: gelatin, glycerol, titanium dioxide (E171) and yellow iron oxide (E172).

Appearance of the product and contents of the container

Dutasteride Aurovitas soft capsules are oblong, opaque, yellow in colour, and contain a yellowish oily liquid.

They are available in blister packs, in pack sizes of 30 and 90 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D,

28036 Madrid,

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmaceutica, S.A.

Rua João de Deus, n.o 19, Venda Nova, 2700-487

Amadora, Portugal

Date of the most recent review of this leaflet: September 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es