Label: information for the user

Dutasteride Viatris 0.5 mg soft gelatin capsules EFG

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

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

2. What you need to know before starting to take Dutasteride Viatris

3. How to take Dutasteride Viatris

4. Possible adverse effects

5. Storage of Dutasteride Viatris

6. Contents of the package and additional information

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

Dutasterida Viatris 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.

As the prostate grows in size, 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 blockage of the urine flow (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 Viatris reduces the production of dihydrotestosterone, which helps to reduce the size of the prostate and alleviate symptoms. This reduces the risk of acute urinary retention and the need for surgery.

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

Do not take Dutasterida Viatris

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

- If you have a severe liver disease.

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

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

Warnings and precautions

Consult your doctor before starting to take Dutasterida Viatris.

- In some clinical studies, there were more patients taking dutasteride and another medication 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 is not pumping blood as it should.-Make sure your doctor knows if you have liver problems. You may need additional monitoring during your treatment with Dutasterida Viatris if you have any liver disease..

- Women, children, and adolescents should avoid contact with broken Dutasterida Viatris capsules because the active ingredient can be absorbed through the skin. If there is any skin contact, the affected area should be washed immediately with 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 the PSA (prostate-specific antigen) blood test 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 Dutasterida Viatris.Men taking Dutasterida Viatris should have regular PSA monitoring.

In a clinical study conducted in men at increased risk of developing prostate cancer, men taking dutasteride had a higher frequency of a type of severe prostate cancer than those not taking dutasteride. The effect of dutasteride on these types of severe prostate cancer is unclear.

-Dutasterida Viatris may cause breast enlargement and tenderness.If this causes you discomfort, or if you notice lumps in your breast or nipple discharge, consult your doctor, as these changes may be signs of a serious disease, such as breast cancer.

Consult your doctor or pharmacist if you have any questions related to taking Dutasterida Viatris.

Taking Dutasterida Viatris 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 Dutasterida Viatris, 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 the dose of Dutasterida Viatris.

Taking Dutasterida Viatris with food and drinks

Dutasterida Viatris can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Women who are pregnant (or may be pregnant) should avoid contact with broken capsules. Dutasteride is 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 will affect your ability to drive and operate machinery.

Dutasterida Viatris contains soy lecithin

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

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

What dose should you take

- The recommended dose is one capsule (0.5 mg) once a day. 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.

- Dutasterida Viatris treatment is long-term. Some men may experience rapid improvement in symptoms. However, others may need to take this medication for up to 6 months or more before an effect begins to occur. Continue taking Dutasterida Viatris for the time your doctor has indicated.

If you take more Dutasterida Viatris than you should

Immediately consult your doctor, pharmacist, or call the Toxicological Information Service, phone 915620420, indicating the medication and the amount ingested.

If you forgot to take Dutasterida Viatris

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

If you interrupt treatment with Dutasterida Viatris

Do not stop treatment with Dutasterida Viatris without consulting your doctor first. It may take 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 medications, this medication may produce adverse effects, although not all people may experience them..

Allergic Reaction

The symptoms of an allergic reaction may include:

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

Contact your doctor immediately and stop taking Dutasterida Viatris.

Common Adverse Effects

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

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

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

• breast swelling or tenderness(gynecomastia)
• dizziness, when taken with tamsulosina

Uncommon Adverse Effects

May affect up to 1 in 100 men taking Dutasterida:

• heart failure (the heart becomes less efficient at pumping blood throughout the body. This may cause symptoms such as difficulty breathing, excessive fatigue, and inflammation in the ankles and legs.
• hair loss (usually of the body) or excessive hair growth.

Adverse Effects of Unknown Frequency

The frequency cannot be estimated from the available data:

- depressive mood

- pain and inflammation of the testicles.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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 in the blister pack after CAD or EXP. 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 in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Dutasterida Viatris

The active ingredient is dutasteride. Cada cápsula blanda contiene 0.5 mg de dutasterida.

The other components are:

- Content of the capsule: glycerol monocaprilocaprato (type I), butylhydroxytoluene (E-321).

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

Appearance of the product and content of the container

Soft, opaque, yellow gelatin capsules containing an oily, yellowish liquid, 19 ± 0.8 mm x 6.9 ± 0.4 mm in size. They are available in white, opaque PVC/PVDC-Aluminum blister packs containing 30 and 90 capsules. Some container sizes may only be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible manufacturer:

Galenicum Health S.L.U.

Sant Gabriel, 50

08950 - Esplugues de Llobregat (Barcelona)

Spain

Cyndea Pharma, S.L

Polígono Industrial Emiliano Revilla Sanz,

Avenida de Ágreda, 31

42110-Olvega (Soria)

Spain

Pharmadox Healthcare, Ltd.

KW20A Kordin Industrial Park,

Paola, PLA 3000, Malta

SAG Manufacturing, S.L.U.

Ctra. N-I, Km 36

28750 – San Agustín de Guadalix (Madrid)

Spain

Last review date of this leaflet: September 2020

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/