Dutasteride Kern Pharma 0.5 mg soft capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Dutasteride Kern Pharma 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 as 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 you should not give it to others, even if they have the same symptoms as you, because 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.

Contents of the leaflet

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

1. What Dutasteride Kern Pharma is and what it is used for

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

Dutasteride Kern Pharma is used in men to treat benign prostatic hyperplasia (BPH), a non-cancerous enlargement 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 not treated, there is a risk that urine flow may become 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 Kern Pharma reduces the production of dihydrotestosterone, which helps shrink the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgery.

Dutasteride Kern Pharma 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 Kern Pharma

Do not take Dutasteride Kern Pharma

• 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. It must not be taken by women, children, or adolescents.

Warnings and precautions

Talk to your doctor or pharmacist before taking dutasteride if:

• In some clinical studies, a higher number of patients taking dutasteride and 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 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 condition affecting your liver.
• Women, children, and adolescents should avoid contact with crushed or damaged dutasteride capsules because the active ingredient can be absorbed through the skin. If skin contact occurs, the affected area must 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 PSA (prostate-specific antigen) blood test used sometimes 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. Men taking this medicine should have regular PSA monitoring.
• In a clinical study in men at increased risk of developing prostate cancer, men taking dutasteride were found to have a higher frequency of high-grade prostate cancer than those not taking dutasteride. The effect of dutasteride on these high-grade types of prostate cancer is not clear.
• 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 (5-alpha-reductase inhibitor) taken orally. 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 this medicine.

Taking Dutasteride Kern Pharma 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, 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)
• alpha blockers (for enlarged prostate or high blood pressure).

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

Taking Dutasteride Kern Pharma with food and drinks

This medicine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnant women (or women who may be pregnant) must avoid contact with crushed capsules. Dutasteride can be 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 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 Kern Pharma will affect your ability to drive or operate machinery.

Dutasteride Kern Pharma 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 Dutasterida Kern Pharma

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again. If you do not take Dutasterida Kern Pharma regularly, monitoring of 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. The 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 Kern Pharma is long-term. Some men may experience a rapid improvement in symptoms. However, others may need to take Dutasterida Kern Pharma for up to 6 months or longer before an effect begins. Continue taking Dutasterida Kern Pharma for the length of time prescribed by your doctor.

If you take more Dutasterida Kern Pharma 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 medicine and the amount ingested.

If you forget to take Dutasterida Kern Pharma

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

If you stop taking Dutasterida Kern Pharma

Do not stop treatment with Dutasterida Kern Pharma without first consulting your doctor. It may take up to 6 months or longer before an effect is noticed.

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)
• lumps on the skin
• swelling of the eyelids, face, lips, arms and legs.

If you experience any of these symptoms, contact your doctor immediately and stop taking dutasteride.

Frequent adverse effects (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 sex drive (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 (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

Frequency cannot be estimated from the available data:

• depressive mood
• pain and inflammation of the testicles.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dutasteride Kern Pharma

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

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Do not use this medicine after the expiry date stated on the container 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 containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dutasteride Kern Pharma

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 (E321).
• capsule shell: gelatin, glycerol (E422), 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

Dutasteride Kern Pharma soft capsules are oblong, opaque, yellow-colored, soft gelatin capsules containing a yellowish oily liquid.

Dimensions of the soft capsule: 19 ± 0.8 mm x 6.9 ± 0.4 mm.

Available in packs of 30 and 90 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Galenicum Health S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950, Barcelona

Spain

or

Pharmadox Healthcare, Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000, Malta

or

Cyndea Pharma, S.L.

Pol. Ind. Emiliano Revilla Sanz

Avenida de Ágreda, 31, 42110 Olvega (Soria) - Spain

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: August 2025.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/