Dutasteride Vir 0.5 mg soft capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dutasteride VIR 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, as you may need to read it again.

  1. 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. It may harm them.

  • If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if these adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Dutasteride VIR is and what it is used for
2. What you need to know before taking Dutasteride VIR
3. How to take Dutasteride VIR
4. Possible side effects

5 Storage of Dutasteride VIR

1. Contents of the pack and other information

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

Dutasteride VIR 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, which 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 urine flow 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 VIR reduces the production of dihydrotestosterone, helping to shrink the size of the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgery.

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

2. What you need to know before taking Dutasteride VIR

Do not take Dutasteride VIR

• if you are allergic to dutasteride, to other 5-alpha reductase enzyme inhibitors, 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 think you are in any of these situations, do not take this medicine until you have consulted your doctor.

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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 VIR.

• Make sure your doctor knows if you have any liver problems. You may need additional monitoring during treatment with Dutasteride VIR if you have a condition affecting your liver.
• Women, children, and adolescents must avoid contact with crushed or opened Dutasteride VIR capsules, as the active ingredient can be absorbed through the skin. If skin contact 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 may 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 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 Dutasteride. Men taking Dutasteride VIR should have regular PSA monitoring.

In a clinical study conducted in men at increased risk of developing prostate cancer, men who took dutasteride were found to have a higher frequency of high-grade prostate cancer than those who did not take Avidart. The effect of dutasteride on these high-grade types of prostate cancer is not clear.

• Dutasteride may cause breast enlargement and breast tenderness. If you experience discomfort, or 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.

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

Taking Dutasteride VIR 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 VIR, 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).

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

Taking Dutasteride VIR with food and drink

Dutasteride VIR can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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Pregnant women (or those who may be pregnant) must avoid contact with crushed capsules. Dutasteride is absorbed through the skin and may affect the normal development of a male fetus. 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 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 VIR will affect your ability to drive or operate machinery.

Dutasteride VIR 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.

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 class (oral 5-alpha-reductase inhibitor). If you experience any of these symptoms, contact your doctor as soon as possible for further medical advice.

3. How to take Dutasterida VIR

Follow exactly the instructions for use of this medicine as given by your doctor. If you do not take Dutasterida VIR regularly, the 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 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 Dutasterida VIR is long-term. Some men may experience rapid symptom improvement. However, others may need to take Dutasterida VIR for up to 6 months or longer before an effect begins. Continue taking Dutasterida VIR for as long as your doctor has instructed.

If you take more Dutasterida VIR than you should

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

If you forget to take Dutasterida VIR

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

Do not stop treatment with Dutasterida VIR without consulting

Do not interrupt treatment with Dutasterida VIR 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 will experience them.

Allergic reaction

Symptoms of an allergic reaction may include:

• skin rash (which may be itchy)
• bumps on the skin (such as hives)
• swelling of the eyelids, face, lips, arms and legs.

Contact your doctor immediately and stop taking Dutasteride VIR.

Frequent adverse effects

May affect up to 1 in every 10 men taking Dutasteride VIR:

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

Uncommon adverse effects

May affect up to 1 in every 100 men taking Dutasteride VIR:

• 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 inflammation of the testicles.

Reporting of adverse effects

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

5. Storage of Dutasteride VIR

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 a pharmacy's SIGRE collection point. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and other information

Composition of Dutasteride VIR

The active substance is dutasteride.

Each soft capsule contains 0.5 mg of dutasteride.

The other components are:

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

Appearance of the product and contents of the container

Dutasteride VIR soft capsules are size 6, oblong, opaque, yellow, soft gelatin capsules containing a yellowish oily liquid.

Dutasteride VIR is available in packs of 10, 30, 50, 60 and 90 capsules. Only certain pack sizes may be marketed.

Dimensions of the soft capsule: 19 ± 0.8 mm x 6.9 ± 0.4 mm.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Industria Química y Farmacéutica VIR, S.A.

C/Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Manufacturer:

Industria Química y Farmacéutica VIR, S.A.

C/Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

Spain

Cyndea Pharma, S.L

Polígono Industrial Emiliano Revilla Sanz,

Avenida de Ágreda, 31 Olvega, 42110,

Soria, Spain

SAG Manufacturing S.L.U

Autovía A-1, km.36

28750 San Agustín de Guadalix (Madrid)

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Malta: Dutasteride Galenicum 0.5 mg soft capsules

Croatia: Duster 0.5 mg meke kapsule

Spain: Dutasteride VIR 0.5 mg soft capsules EFG

Italy: PRODIREXAN

Hungary: Dutasteride Galenicum 0.5 mg lágy kapszula

Germany: Dutasteride Galenicum 0.5 mg Weichkapseln

France: Dutasteride EVOLUGEN 0.5 mg capsule molle

Finland: Dutasteride Galenicum 0.5 mg pehmeät kapselit

Romania: Dutasteride Galenicum 0.5 mg capsule moi

Czech Republic: Dutasteride Galenicum 0.5 mg měkké tobolky

Slovakia: Dutamed 0.5 mg

Portugal: Dutasteride Galenicum 0.5 mg cápsulas moles

Date of the most recent revision of this leaflet: October 2025