DUTASTERIDE VIR 0.5 mg SOFT CAPSULES

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, you may need to read it again.
• 1. If you have any further questions, ask your doctor, pharmacist, or nurse.

• 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 experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

5 Storage of Dutasteride VIR

1. Contents of the pack and further information

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

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

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

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. If benign prostatic hyperplasia is not treated, there is a risk that the flow of urine will be 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 VIR reduces the production of dihydrotestosterone, which helps to reduce the size of the prostate and alleviate the symptoms. This reduces the risk of acute urinary retention and the need for surgery.

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

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

Do not takeDutasteride VIR

• if you are allergic to dutasteride, to other 5-alpha reductase inhibitors, to soy, 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 may have any of these conditions, do not takethis medicine until you have consulted your doctor.

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This medicine is for men only. It must not be taken by women, children, or adolescents.

Warnings and precautions

Talk to your doctor before starting to take Dutasteride VIR.

• Make sure your doctor knows if you have liver problems. You may need additional monitoring during your treatment with Dutasteride VIR if you have any liver disease.
• Women, children, and adolescents must avoid contact with broken Dutasteride VIR capsules because the active substance can be absorbed through the skin. If there is any contact with the skin, 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 may become pregnant, she should avoid exposure to your semen because dutasteride may 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 should be aware of this effect. If you have a blood test for PSA, tell your doctor that you are taking Dutasteride. Men treated with Dutasteride VIR should have regular PSA checks.

In a clinical study in men at increased risk of prostate cancer, men who took Dutasteride presented with more frequent, severe prostate cancerthan those who did not take Avidart. The effect of Dutasteride on these severe types of prostate cancer is unclear.

• Dutasteride may cause breast enlargement and pain on palpation. If this causes discomfort, or if you notice lumps in the breast or nipple discharge, consult your doctor, as these changes can be signs of a serious disease, such as breast cancer.

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

TakingDutasteride VIRwith 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 VIR, 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 VIR.

TakingDutasteride VIRwith food and drink

Dutasteride VIR can be taken with or without food.

Pregnancy, breast-feeding, and fertility

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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 especially 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 may become pregnant, she should 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 VIR will affect your ability to drive or use machines.

Dutasteride VIR contains soy lecithin

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

3. How to take Dutasteride VIR

Follow exactly the instructions of administration of this medicine given by your doctor. If you do not take Dutasteride 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 open the capsules. Contact with the contents of the capsules can irritate your mouth or throat.
• Treatment with Dutasteride VIR is long-term. Some men may experience rapid improvement in symptoms. However, others may need to take Dutasteride VIR for 6 months or more before an effect is seen. Continue to take Dutasteride VIR for the period your doctor has prescribed.

If you take moreDutasteride VIRthan you should

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

If you forget to takeDutasteride VIR

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

Do not stop takingDutasteride VIRwithout consulting

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

If you have any further questions on the use of this medicine, 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)
• skin lumps (like hives)
• swelling of the eyelids, face, lips, arms, and legs.

Contact yourdoctor immediatelyand stop taking Dutasteride VIR.

Common side effects

May affect up to 1 in 10 men who take Dutasteride VIR:

• inability to achieve or maintain an erection (impotence), *which could continue after stopping Dutasteride VIR
• reduced sex drive (libido), *which could continue after stopping Dutasteride VIR
• difficulty with ejaculation, *which could continue after stopping Dutasteride VIR
• breast tenderness or enlargement (gynaecomastia)
• dizziness, when taken with tamsulosin

Uncommon side effects

May affect up to 1 in 100 men who take Dutasteride VIR:

• heart failure (the heart becomes less efficient at pumping blood around the body. This could cause symptoms such as difficulty breathing, excessive 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:

• depression
• testicular pain and swelling.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side 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 which is stated on the carton or blister after EXP. The expiry date is 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 further information

Composition ofDutasteride VIR

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: 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 pack

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. Not all pack sizes may be marketed.

The dimensions of the soft capsule are: 19 ± 0.8 mm x 6.9 ± 0.4 mm.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 medicine is authorised in the Member States of the European Economic Area under the following names:

Malta:Dutasteride Galenicum 0.5 mg soft capsules

Croatia:Duster 0.5 mg soft capsules

Spain:Dutasterida VIR 0.5 mg soft capsules EFG

Italy:PRODIREXAN

Hungary:Dutasterida Galenicum 0.5 mg soft capsules

Germany:Dutasterida Galenicum 0.5 mg soft capsules

France:Dutasterida EVOLUGEN 0.5 mg soft capsules

Finland:Dutasterida Galenicum 0.5 mg soft capsules

Romania:Dutasterida Galenicum 0.5 mg soft capsules

Czech Republic:Dutasterida Galenicum 0.5 mg soft capsules

Slovakia:Dutamed 0.5 mg

Portugal:Dutasterida Galenicum 0.5 mg soft capsules

Date of last revision of this leaflet: