DUTASTERIDE KERN PHARMA 0.5 mg SOFT CAPSULES

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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Dutasteride Kern Pharma and what is it used for
2. What you need to know before you take Dutasteride Kern Pharma
3. How to take Dutasteride Kern Pharma
4. Possible side effects

5 Conservation of Dutasteride Kern Pharma

1. Contents of the pack and further information

1. What is Dutasteride Kern Pharma and what is it 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 the enlargement of the 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 the flow of urine and a need to urinate more frequently. It can also cause the stream of urine to be weaker and less forceful.

If benign prostatic hyperplasia is not treated, there is a risk that the flow of urine will be 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 to reduce the size of the prostate and relieve the symptoms. This reduces the risk of acute urinary retention and the need for surgery.

Dutasteride Kern Pharma can also be used with another medicine called tamsulosin (used to treat the symptoms of an enlarged prostate).

2. What you need to know before you take Dutasteride Kern Pharma

Do not take Dutasteride Kern Pharma

• if you are allergic to dutasteride, to other 5-alpha reductase inhibitors, to soy, 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 may be in one of these situations, do not takethis medicine until you have consulted your doctor.

This medicine is only for men. It must not be taken by women, children, or adolescents.

Warnings and precautions

Consult your doctor or pharmacist before starting to take dutasteride if:

• In some clinical studies, there were more patients taking dutasteride and another medicine 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 to have additional checks during your treatment with dutasteride if you have any liver disease.
• Women, children, and adolescentsshould avoid contact with broken dutasteride capsules because the active ingredient can be absorbed through the skin. If there is any contact with the skin, the affected area should be washed immediatelywith 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 because dutasteride may affect the normal development of a male baby.

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

• Dutasteride affects the blood test for PSA(prostate-specific antigen) which 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, tell your doctor that you are taking dutasteride. Men taking this medicine should have regular PSA tests.
• In a clinical study in men at increased risk of prostate cancer, men who took dutasteride were more likely to have a more serious form of prostate cancerthan those who did not take dutasteride. The effect of dutasteride on these serious forms of prostate cancer is not clear.
• Dutasteride may cause breast enlargement and breast tenderness. If this causes you any problems, or if you notice breast lumps 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 medicine in the same therapeutic group (5-alpha reductase inhibitor) by mouth. If you experience any of these symptoms, contact your doctor for further medical advice as soon as possible.

Consult your doctor or pharmacistif you have any questions related to taking this medicine.

Taking Dutasteride Kern Pharma with other medicines

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

Certain medicines may interact with dutasteride, which may increase the risk of you experiencing side 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 an enlarged prostate or high blood pressure).

Tell your doctorif you are taking any of these medicines. It may be necessary to reduce the dose of dutasteride.

Taking Dutasteride Kern Pharma with food and drink

This medicine can be taken with or without food.

Pregnancy, breast-feeding, and fertility

Pregnant women (or women 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 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 may be pregnant, she should avoid exposure to your semen.

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

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

Driving and using machines

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

Dutasteride Kern Pharma contains soy lecithin

This medicine contains soy lecithin, which may contain soybean oil. It must not be used in case of peanut or soy allergy.

3. How to take Dutasteride Kern Pharma

Follow exactly the instructions for administration of this medicine given by your doctor. If you are in doubt, consult your doctor or pharmacist again. If you do not take Dutasteride Kern Pharma regularly, the control 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 a day. The capsules 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.
• Treatment with Dutasteride Kern Pharma is long-term. Some men may experience rapid improvement in symptoms. However, others may need to take Dutasteride Kern Pharma for 6 months or more before an effect is seen. Continue to take Dutasteride Kern Pharma for as long as your doctor has told you.

If you take more Dutasteride Kern Pharma than you should

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

If you forget to take Dutasteride Kern Pharma

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

If you stop taking Dutasteride Kern Pharma

Do not stop taking Dutasteride Kern Pharma without consulting your doctor first. It may take up to 6 months or more for you to notice an effect.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reaction

Symptoms of an allergic reaction can include:

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

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

Common side effects(may affect up to 1 in 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
• breast tenderness or enlargement (gynaecomastia)
• dizziness, when taken with tamsulosin.

Uncommon side effects(may affect up to 1 in 100 patients taking dutasteride):

• heart failure (the heart becomes less efficient at pumping blood around the body. This could lead to symptoms such as difficulty breathing, excessive tiredness, and swelling in the ankles and legs)
• hair loss (usually from the body) or increased hair growth.

Side effects with unknown frequency

Frequency cannot be estimated from the available data:

• depressed mood
• testicular pain and swelling.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Dutasteride Kern Pharma

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

Do not store above 30°C.

Store in the original package to protect from moisture.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and further information

Composition of Dutasteride Kern Pharma

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

The other ingredients are:

• capsule content: glycerol monocaprylocaprate (type I), butylhydroxytoluene (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

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

The dimensions of the soft capsule are: 19 ± 0.8 mm x 6.9 ± 0.4 mm.

They are available in packs of 30 and 90 capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 last revision of this leaflet: August 2025.

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