Leaflet: information for the user

Dutasteride VIR 0.5 mg soft capsules EFG

Read 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 are unsure, consult your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

• Consult your doctor, pharmacist or nurse if you experience any side effects, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Dutasteride VIR

3.How to take Dutasteride VIR

4.Possible side effects

5Storage of Dutasteride VIR

6.Contents of the pack and additional information

Dutasterida VIR is used in men to treat an enlarged prostate(benign prostatic hyperplasia),a non-cancerous growth of the prostate caused by excessive production of a hormone called dihydrotestosterone.

The active ingredient is dutasteride, which belongs to a group of medications called 5 alpha reductase inhibitors.

As the prostate enlarges, it may produce urinary problems such as difficulty in urinating and a need to urinate more frequently. It may also cause a smaller and weaker urine stream. If benign prostatic hyperplasia is not treated, there is a risk of complete urine flow blockage(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. Dutasterida VIR reduces dihydrotestosterone production, which helps to reduce prostate size and alleviate symptoms. This reduces the risk of acute urinary retention and the need for surgery.

Dutasterida VIR may also be used with another medication called tamsulosin (used to treat symptoms of an enlarged prostate).

Do not takeDutasteride VIR

-if you are allergic to dutasteride, other 5-alpha reductase inhibitors, soy, peanuts,or any of the other ingredients in this medication (listed in section 6).

-if you have a serious liver disease.

If you think you are in any of these situations,,do not takethis medication until you have consulted with your doctor.

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This medication is only for men. Women, children, or adolescents should not take it.

Warnings and precautions

Consult your doctor before starting Dutasteride VIR.

-Make sure your doctor knows if you have liver problems. You may need additional checks during your treatment with Dutasteride VIR if you have any liver disease..

- Women, children, and adolescentsshould avoid contact with broken Dutasteride VIR capsules because the active ingredient can be absorbed through the skin. If there is any skin contact,the affected area must be washed immediatelywith water and soap.

-Use a condom during sex.Dutasteride has been found in the semen of men taking Dutasteride. If your partner is pregnant or thinks she may be pregnant, you should avoid exposing her to your semen because dutasteride may affect the normal development of the male fetus.

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

-Dutasteride affects PSA serum analysis(prostate-specific antigen) that is sometimes used to detect prostate cancer. Your doctor may still use this test to detect prostate cancer, but they should 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 checks.

In a clinical study in men at increased risk of prostate cancer, men taking Dutasteride hada higher frequency of a serious type of prostate cancerthan those not taking Avidart. The effect of Dutasteride on these serious types of prostate cancer is unclear.

-Dutasteride may cause breast enlargement and tenderness. If this causes you discomfort, or if you noticelumps in the breast or nipple dischargeconsult your doctor, as these changes may be signs of a serious disease, such as breast cancer.

Consult your doctor or pharmacistif you have any questions about taking Dutasteride VIR.

Taking Dutasteride VIR with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication..

Certain medications may interact with Dutasteride VIR, which may cause adverse effects. Some of these medications are:

• verapamil or diltiazem(for high blood pressure)
• ritonavir or indinavir(for HIV/AIDS)
• itraconazole or ketoconazole(for fungal infections)
• nefazodone(an antidepressant)
• other alpha blockers(for enlarged prostate or high blood pressure).

Inform your doctorif you are taking any of these medications.You may need to reduce your Dutasteride VIR dose.

Taking Dutasteride VIR with food and drinks

Dutasteride VIR can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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Women who are pregnant (or may be pregnant) should avoid contact with broken Dutasteride VIR capsules. Dutasteride can be absorbed through the skin and may affect the normal development of the male fetus. This risk is especially important in the first 16 weeks of pregnancy.Use a condom during sex.Dutasteride has been found in the semen of men taking Dutasteride. If your partner is pregnant or thinks she may be pregnant, you should avoid exposing her to your semen.

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

Driving and operating machinery

It is unlikely that Dutasteride VIR will affect your ability to drive and operate machinery.

Dutasteride VIR contains soy lecithin

This medication contains soy lecithin, which may contain soy oil. It should not be used in cases of allergy to peanuts or soy.

Follow exactly the administration instructions for this medication as indicated by your doctor.If you do not take Dutasterida VIR regularly, the control of your PSA levels may be affected.In case of doubt, consult your doctor or pharmacist again.

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 break the capsules. Contact with the contents of the capsules may irritate your mouth or throat.
• The treatment with Dutasterida VIR is long-term. Some men may experience a rapid improvement in symptoms. However, others may need to take Dutasterida VIR for up to 6 months or more before an effect begins to occur. Continue taking Dutasterida VIR for the time your doctor has indicated.

If you take moreDutasterida VIRthan you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 915620420, indicating the medication and the amount ingested.

If you forgot to takeDutasterida VIR

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

Do not interrupt treatment withDutasterida VIR without consulting

Do not interrupt treatment with Dutasterida VIR without consulting your doctor first.You may need up to 6 months or more to notice an effect

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

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

Allergic reaction

The symptoms of an allergic reaction may include:

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

Contact your doctor immediately and stop taking DutasteridaVIR.

Common side effects

They may affect up to 1 in 10 men taking Dutasterida VIR:

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

Uncommon side effects

They may affect up to 1 in 100 men taking Dutasterida 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 inflammation in the ankles and legs).
• hair loss (usually from the body) or excessive hair growth.

Side effects of unknown frequency

The frequency cannot be estimated from the available data:

- depressive mood

- pain and inflammation of the testicles.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box or on the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofDutasterida VIR

The active ingredient is dutasteride.

Each soft capsule contains 0.5 mg of dutasteride.

The other components are:

- capsule content: glycerol monocaprilocaprato (type I), butylhydroxytoluene (E321).

- capsule coating: gelatin, glycerol, titanium dioxide (E171), iron oxide yellow (E172), triglycerides (medium-chain), soy lecithin (may contain soy oil) (E322) and purified water.

Appearance of the product and contents of the package

Dutasterida VIR soft capsules are size 6, oblong, opaque, yellow, soft gelatin capsules containing an oily and yellowish liquid.

Dutasterida VIR is available in packages of 10, 30, 50, 60, and 90 soft capsules.Only some package sizes may be marketed.

The dimensions of the soft capsule are: 19± 0.8 mmx 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 URTINSAII

28923 Alcorcón (Madrid)

Spain

Manufacturer:

Industria Química y Farmacéutica VIR, S.A.

C/Laguna 66-70,.Polígono Industrial URTINSAII

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

Pharmadox Healthcare, Ltd.

KW20A Kordin Industrial Park,

Paola , PLA 3000, Malta

SAG Manufacturing S.L.U

Autovía A-1, km.36

28750 San Agustín de Guadalix (Madrid)

Spain

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

Malta:Dutasterida Galenicum 0.5 mg soft capsules

Croatia:Duster 0.5 mg meke kapsule

Spain:Dutasterida VIR 0.5 mg soft capsules EFG

Italy:PRODIREXAN

Hungary:Dutasterida Galenicum 0.5 mg lágy kapszula

Germany:Dutasterida Galenicum 0.5 mg Weichkapseln

France:Dutasterida EVOLUGEN 0.5 mgcapsule molle

Finland:Dutasterida Galenicum 0.5 mg pehmeät kapselit

Romania:Dutasterida Galenicum 0.5 mg capsule moi

Czech Republic:Dutasterida Galenicum 0.5 mg me?kké tobolky

Slovakia:Dutamed 0.5 mg

Portugal:Dutasterida Galenicum 0.5 mg soft capsules

Date of the last review of this leaflet: