Dutasteride Pensa 0.5 mg soft capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dutasteride Pensa 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.
• If you have any questions, ask your doctor or pharmacist.
• 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. It could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

Dutasteride Pensa is used in men to treat enlarged prostate (benign prostatic hyperplasia), a non-cancerous growth of the prostate caused by excessive production 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. Surgery may sometimes be necessary to reduce the size of the prostate or to remove it. Dutasteride Pensa reduces the production of dihydrotestosterone, helping to shrink the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgery.

Dutasteride Pensa may also be used in combination with another medicine 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, to other 5-alpha reductase enzyme inhibitors, to soya, 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 are in any of these situations, 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 Pensa.

• In some clinical studies, there was a higher number of patients taking dutasteride and another medicine 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 does not pump blood as well as it should.

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

• Women, children, and adolescents must avoid contact with broken dutasteride capsules because the active substance 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 may be pregnant, you must avoid exposing her to your semen because dutasteride may affect the normal development of a male baby. 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 detect 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. Men taking dutasteride should have regular PSA monitoring.

• In a clinical study in men at increased risk of prostate cancer, men taking dutasteride had a higher frequency of high-grade prostate cancer compared to those not taking dutasteride. The effect of dutasteride on these high-grade types of prostate cancer is unclear.

• Dutasteride may cause breast enlargement and 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.

• 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 group (oral 5-alpha-reductase inhibitors). If you experience any of these symptoms, contact your doctor for medical advice as soon as possible.

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

Taking Dutasteride Pensa with other medicines

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

Do not take Dutasteride Pensa with these medicines:

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

Certain medicines may interact with Dutasteride Pensa, increasing the likelihood 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)

Inform your doctor if you are taking any of these medicines. A dose reduction of Dutasteride Pensa may be necessary.

Taking Dutasteride Pensa with food and drink

Dutasteride Pensa can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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 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 may 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.

Consult your doctor if a pregnant woman has been exposed to dutasteride.

Driving and using machines

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

Dutasteride Pensa contains soya lecithin

This medicine contains soya lecithin and may therefore contain soya oil. Do not use this medicine if you are allergic to peanuts or soya.

3. How to take Dutasterida Pensa

Follow exactly the administration instructions for Dutasterida Pensa provided by your doctor or pharmacist. If you do not take Dutasterida Pensa regularly, your PSA levels may be affected. Consult your doctor or pharmacist if you have any doubts.

What dose should you take

• The recommended dose is one capsule (0.5 mg) once daily. Dutasterida Pensa capsules must 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 Dutasterida Pensa is long-term. Some men may experience a rapid improvement in symptoms. However, others may need to continue treatment for up to 6 months or longer before an effect begins. Continue taking Dutasterida Pensa for as long as your doctor has instructed.

If you take more Dutasterida Pensa 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, indicating the medication and the amount ingested.

If you forget to take Dutasterida Pensa

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

Do not stop treatment with Dutasterida Pensa

Do not stop treatment with Dutasterida Pensa without consulting your doctor first. It may take up to 6 months or longer before you notice an effect.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Allergic reaction

Symptoms of an allergic reaction may include:

• skin rash (which may be itchy)
• hives (a nettle-like rash)
• swelling of the eyelids, face, lips, arms and legs.

You must immediately contact your doctor if you experience any of these symptoms and stop taking Dutasteride Pensa.

Frequent adverse effects

These may affect up to 1 in every 10 patients taking dutasteride:

• inability to achieve or maintain an erection (impotence), which may continue after stopping dutasteride
• decreased sexual desire (libido), which may continue after stopping dutasteride
• difficulty with ejaculation, which may continue after stopping dutasteride
• swelling or tenderness of the breast (gynecomastia)
• dizziness, when taken with tamsulosin.

Uncommon adverse effects

These may affect up to 1 in every 100 patients 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.

Adverse effects with unknown frequency

The frequency cannot be estimated from the available data:

• depressive mood
• pain and inflammation of the testicles.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dutasteride Pensa

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

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dutasterida Pensa

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

The other components are:

• Capsule contents: 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 contents of the pack

Dutasterida Pensa soft capsules are opaque, oblong, yellow soft gelatin capsules containing a yellow oily liquid.

Dutasterida Pensa is available in blisters 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

Emiliano Revilla Sanz Industrial Estate,

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 most recent revision of this leaflet: September 2025

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