DUTASTERIDE PENSA 0.5 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the User

Dutasteride Pensa 0.5 mg Soft Capsules EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Dutasteride Pensa and what is it used for
2. What you need to know before taking Dutasteride Pensa
3. How to take Dutasteride Pensa
4. Possible side effects
5. Storage of Dutasteride Pensa
6. Package Contents and Additional Information

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

The active substance is dutasteride. It belongs to a group of medications called 5-alpha reductase enzyme inhibitors.

Dutasteride Pensa 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, it can cause urinary problems such as difficulty in urine flow and a need to urinate more frequently. It can also cause the urine stream to be weaker and less forceful. If left untreated, benign prostatic hyperplasia can lead to a risk of the urine flow being 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 remove it. Dutasteride Pensa 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.

Dutasteride Pensa can also be used with another medication called tamsulosin (used to treat symptoms of an enlarged prostate).

2. What you need to know before taking Dutasteride Pensa

Do not take Dutasteride Pensa:

• if you are allergic to dutasteride, other 5-alpha reductase enzyme 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 one of these situations, do not takethis medication until you have consulted your doctor.

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

Warnings and Precautions

Consult your doctor before starting to take Dutasteride Pensa.

• 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 who took only dutasteride or only an alpha-blocker. Heart failure means that your heart does not pump blood as it should.

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

• Women, children, and adolescents should avoid contact with broken dutasteride capsules, as 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 be pregnant, she should avoid exposure to your semen, as dutasteride may affect the normal development of a male fetus. Dutasteride has been shown to decrease sperm count, motility, and semen volume. This may reduce your fertility.

• Dutasteride affects the PSA serum test (prostate-specific antigen) 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 treated with dutasteride should have regular PSA checks.

• In a clinical study in men at increased risk of prostate cancer, men who took dutasteride had a higher frequency of a type of prostate cancer that was more serious than those who did not take dutasteride. The effect of dutasteride on these serious types of prostate cancer is not clear.

• 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.

• Mood changes and depression: depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with another medication in the same therapeutic group (5-alpha-reductase inhibitor) orally. If you experience any of these symptoms, contact your doctor for additional medical advice as soon as possible.

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

Taking Dutasteride Pensa with other medications

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

Do not take Dutasteride Pensa with these medications:

• other alpha-blockers(for an enlarged prostate or high blood pressure).

Certain medications may interact with Dutasteride Pensa, which can increase the risk of you experiencing side effects. Some of these medications are:

• verapamil or diltiazem(for high blood pressure)
• ritonavir or indinavir(for AIDS)
• itraconazole or ketoconazole(for fungal infections)
• nefazodone(an antidepressant)

Tell your doctorif you are taking any of these medications. It may be necessary to reduce the dose of Dutasteride Pensa.

Taking Dutasteride Pensa with food and drinks

Dutasteride Pensa can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnant women (or those who may be pregnant) should avoid contact with broken capsules. Dutasteride is absorbed through the skin and may affect the normal development of a male fetus. 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 be pregnant, she should avoid exposure to your semen.

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

Consult your doctorif a pregnant woman has been in contact with dutasteride.

Driving and using machines

It is unlikely that Dutasteride Pensa will affect your ability to drive or use machines.

Dutasteride Pensa contains soy lecithin

This medication contains soy lecithin, which may contain soybean oil. Do not use this medication if you are allergic to peanuts or soy.

3. How to take Dutasteride Pensa

Follow the instructions for taking Dutasteride Pensa exactly as indicated by your doctor or pharmacist.If you do not take Dutasteride Pensa regularly, your PSA levels may be affected. Consult your doctor or pharmacist if you have any questions.

What dose should you take

• The recommended dose is one capsule (0.5 mg) once a day.The capsules of Dutasteride Pensa 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.

• The treatment with Dutasteride Pensa is long-term. Some men may experience rapid improvement in symptoms. However, others may need to continue treatment for 6 months or more before an effect is seen. Continue taking Dutasteride Pensa for the time indicated by your doctor.

If you take more Dutasteride Pensa than you should

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

If you forget to take Dutasteride Pensa

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

Do not stop treatment with Dutasteride Pensa

Do not stop treatment with Dutasteride Pensa without consulting your doctor first. It may be necessary to take it for 6 months or more to see an effect.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Allergic reaction

The symptoms of an allergic reaction can include:

• skin rash(which can itch)
• hives(like those caused by nettles)
• swelling of the eyelids, face, lips, arms, and legs.

You should contact your doctor immediatelyif you experience any of these symptoms and stop taking Dutasteride Pensa.

Common side effects

These can affect up to 1 in 10 patients taking dutasteride:

• inability to achieve or maintain an erection (impotence), which could continue after stopping dutasteride
• decreased sex drive (libido), which could continue after stopping dutasteride
• difficulty ejaculating, which could continue after stopping dutasteride
• breast tenderness or swelling (gynecomastia)
• dizziness, when taken with tamsulosin.

Uncommon side effects

These can affect up to 1 in 100 patients taking dutasteride:

• heart failure (the heart becomes less efficient at pumping blood through 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 hair growth.

Side effects of unknown frequency

The frequency cannot be estimated from the available data:

• depressive mood
• testicular pain and swelling.

If you think any of the side effects you are experiencing is serious, or if you notice any side effects not mentioned in this package leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Dutasteride Pensa

Do not store above 30°C. Keep in the original packaging to protect from moisture.

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

Do not use this medication after the expiration date shown on the box and blister pack after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Dutasteride Pensa

The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.

The other ingredients are:

• Capsule content: glycerol monocaprylocaprate (type I) and butylhydroxytoluene (E321).

• Capsule shell: gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), medium-chain triglycerides, lecithin (may contain soybean oil) (E322), and purified water.

Appearance of the product and package contents

The soft capsules of Dutasteride Pensa are opaque, oblong, yellow, and contain a yellow oily liquid.

Dutasteride Pensa is available in blister packs of 30 capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

Galenicum Health S.L.U.

San Gabriel, 50

Esplugues de Llobregat

08950 Barcelona - Spain

or

Cyndea Pharma, S.L

Polígono Industrial Emiliano Revilla Sanz,

Avenida de Ágreda, 31 Olvega, 42110,

Soria, Spain

or

Pharmadox Healthcare, Ltd.

KW20A Kordin Industrial Park,

Paola, PLA 3000, Malta

or

SAG Manufacturing, S.L.U.

Ctra. N-I, Km 36

28750 San Agustín de Guadalix

Madrid, Spain

Date of the last revision of this package leaflet: September 2025

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