Prospect: Information for the User

Dutasteride Kern Pharma 0.5 mg Soft Capsules EFG

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

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

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

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

3.How to take Dutasteride Kern Pharma

4.Possible adverse effects

5Storage of Dutasteride Kern Pharma

6.Contents of the package and additional information

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

Dutasterida Kern Pharma 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 can produce urinary problems such as difficulty in urinating and a need to urinate more frequently. It can also cause a smaller and weaker urine stream.

If benign prostatic hyperplasia is not treated, there is a risk of complete blockage of 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 Kern Pharma reduces dihydrotestosterone production, which helps to reduce prostate size and alleviate symptoms. This reduces the risk of acute urinary retention and the need for surgery.

Dutasterida Kern Pharma can also be used with another medication, tamsulosin (used to treat symptoms of an enlarged prostate).

Do not take Dutasterida Kern Pharma

• 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 takethis 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 or pharmacist before starting dutasteride if:

• In some clinical studies, a higher number of patients taking dutasteride and another medication 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 is not pumping 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 adolescentsshould avoid contact with broken dutasteride capsules because the active ingredient can be absorbed through the skin. If there is any skin contact,the affected area must be washed immediatelywith 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 PSA serum analysis(prostatic specific antigen)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 dutasteride.Men taking this medication should have regular PSA checks.
• In a clinical study conducted in men at increased risk of developing prostate cancer, men taking dutasteride hada higher frequency of a type of severe prostate cancerthan those not taking dutasteride. The effect of dutasteride on these types of severe prostate cancer is unclear.
• Dutasteride may cause breast enlargement and tenderness. If this causes you discomfort, or if you noticelumps in the breast or nipple dischargeconsult your doctor, as these changes may be signs of a serious disease, such as breast cancer.

Consult your doctor or pharmacistif you have any questions about taking this medication.

Taking Dutasterida Kern Pharma 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 dutasteride, which may cause you to experience 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)
• alpha blockers(for enlarged prostate or high blood pressure).

Inform your doctorif you are taking any of these medications. You may need to reduce your dutasteride dose.

Taking Dutasterida Kern Pharma with food and drinks

This medication 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 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.

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

Driving and operating machinery

It is unlikely that Dutasterida Kern Pharma will affect your ability to drive and operate machinery.

Dutasterida Kern Pharma contains soy lecithin

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. If you do not take Dutasterida Kern Pharma regularly, the control of your PSA levels may be affected. Consult your doctor or pharmacist if you have doubts.

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.
• The treatment with Dutasterida Kern Pharma is of long duration. Some men may experience a rapid improvement in symptoms. However, others may need to take Dutasterida Kern Pharma for up to 6 months or more before an effect begins to occur. Continue taking Dutasterida Kern Pharma for the time your doctor has indicated.

If you take more Dutasterida Kern Pharma than you should

In case of overdose or accidental ingestion, 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 Kern Pharma

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

If you interrupt the treatment with Dutasterida Kern Pharma

Do not interrupt the treatment with Dutasterida Kern Pharma 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.

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

Frequent Adverse 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 libido, which may continue after stopping dutasteride
• difficulty with ejaculation, which may continue after stopping dutasteride
• breast swelling or tenderness (gynecomastia)
• dizziness, when taken with tamsulosin.

Less Frequent Adverse Effects(may affect up to 1 in 100 patients taking dutasteride):

• 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 body hair) or excessive hair growth.

Adverse Effects of Unknown Frequency

The frequency cannot be estimated from available data:

• depressive mood
• testicular pain and inflammation.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: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 store above 86°F (30°C).

Store in the original packaging to protect it from moisture.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging 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 packaging and medications you no longer need.By doing so, you will help protect the environment.

Composition of Dutasterida Kern Pharma

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

The other components are:

• capsule content: glycerol monocaprilocaprato (type I), butylhydroxytoluene (E321).
• capsule coating: gelatin, glycerol (E422), titanium dioxide (E171), iron oxide yellow (E172), triglycerides (medium-chain), lecithin (may contain soy oil) (E322) and purified water.

Appearance of the product and contents of the packaging

Dutasterida Kern Pharma soft capsules are oblong, opaque, yellow, soft gelatin capsules containing 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 packaging of 30 and 90 capsules.

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

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

Last review date of this leaflet: December 2016.

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