Dutasteride Viatris 0.5 mg soft capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dutasteride Viatris 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. 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Dutasteride Viatris 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 Viatris 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.

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 Viatris reduces the production of dihydrotestosterone, thereby helping to shrink the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgery.

Dutasteride Viatris 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 starting to take Dutasteride Viatris

Do not take Dutasteride Viatris

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

If you think you fall into any of these categories, do not take this medicine until you have consulted 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 Dutasteride Viatris.

• In some clinical studies, a higher number of patients taking dutasteride together with another medicine called an alpha blocker, such as tamsulosin, experienced heart failure compared to patients taking only dutasteride or only an alpha blocker. Heart failure means that your heart does not pump blood properly. - Make sure your doctor knows if you have liver problems. You may need additional monitoring during treatment with Dutasteride Viatris if you have a condition affecting your liver.

• Women, children, and adolescents should avoid contact with broken capsules of Dutasteride Viatris because the active ingredient can be absorbed through the skin. If skin contact occurs, the affected area should be washed immediately with soap and water.
• 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 might 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 Viatris. Men taking Dutasteride Viatris should have regular PSA monitoring.

In a clinical study conducted in men at increased risk of developing prostate cancer, men who took dutasteride were more likely to develop a more aggressive type of prostate cancer than those who did not take dutasteride. The effect of dutasteride on these aggressive types of prostate cancer is not fully understood.

• Dutasteride Viatris may cause breast enlargement and breast 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 condition, such as breast cancer.

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

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

Taking Dutasteride Viatris 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 Viatris, 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 Viatris.

Taking Dutasteride Viatris with food and drink

Dutasteride Viatris can be taken with or without food.

Pregnancy, breastfeeding and fertility

Pregnant women (or women who might be pregnant) must avoid contact with broken 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 might 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 use of machines

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

Dutasteride Viatris 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 Dutasteride Viatris

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again. If you do not take Dutasteride Viatris regularly, monitoring of your PSA levels may be affected.

What dose to 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 Dutasteride Viatris 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 Dutasteride Viatris for as long as your doctor has instructed.

If you take more Dutasteride Viatris 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, stating the medicine and the amount ingested.

If you forget to take Dutasteride Viatris

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

If you stop taking Dutasteride Viatris

Do not stop treatment with Dutasteride Viatris without first consulting your doctor. It may take up to 6 months or longer to notice an effect.

If you have any further questions about 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 everyone gets 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.

Contact your doctor immediately and stop taking Dutasteride Viatris.

Frequent side effects

May affect up to 1 in 10 men taking Dutasteride Viatris:

• inability to achieve or maintain an erection (impotence), *which may continue after stopping dutasteride

• decreased sex drive (libido), *which may continue after stopping Dutasteride Viatris

• difficulty in ejaculation, such as a decrease in the amount of semen released during sexual intercourse*which may continue after stopping Dutasteride Viatris

• swelling or tenderness of the breast (gynecomastia)

• dizziness, when taken with tamsulosin

Uncommon side effects

May affect up to 1 in 100 men taking Dutasteride:

• 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)
• loss of body hair or hair growth.

Side effects of unknown frequency

Frequency cannot be estimated from the available data:

• depressed mood
• pain and inflammation of the testicles.

Reporting of side effects

If you experience any side effect, talk to your doctor, pharmacist or nurse, including any possible side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dutasteride Viatris

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 pack after CAD or 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 unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dutasteride Viatris

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 (E-321).
• Capsule shell: gelatin, glycerol, titanium dioxide (E-171), iron oxide yellow (E-172), medium-chain triglycerides, soy lecithin (may contain soybean oil) (E-322), and purified water.

Appearance of the product and contents of the pack

Soft, opaque yellow gelatin capsules containing a yellowish oily liquid, size 19 ± 0.8 mm x 6.9 ± 0.4 mm. They are available in opaque white 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:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer:

Galenicum Health S.L.U.

Sant Gabriel, 50

08950 - Esplugues de Llobregat (Barcelona)

Spain

Cyndea Pharma, S.L

Emiliano Revilla Sanz Industrial Estate,

Avenida de Ágreda, 31

42110 - Olvega (Soria)

Spain

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: August 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) https://www.aemps.gob.es/