Leaflet: information for the patient

Dutasteride STADA 0.5 mg soft capsules EFG

Read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to take Dutasteride STADA

3. How to take Dutasteride STADA

4. Possible side effects

5. Storage of Dutasteride STADA

6. Contents of the pack and additional information

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

Dutasterida STADA 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 may produce urinary problems such as difficulty in urinating and a need to urinate more frequently. It may also cause a smaller and weaker urine stream. If benign prostatic hyperplasia is not treated, there is a risk of complete blockage of the 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 STADA 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.

Dutasterida STADA may also be used with another medication, tamsulosin (used to treat symptoms of an enlarged prostate).

Do not take Dutasterida STADA:

-if you are allergic to dutasteride, other 5-alpha reductase inhibitors, soy, peanuts, or any of the other ingredients of this medication (listed in section 6)..

-if you have a severe liver disease..

-if you are a child or adolescent.

Inform your doctorif you think you are in any of these situations.

This medication is only for men. Do not take it women, children, or adolescents.

Warnings and precautions

Consult your doctor before starting to take Dutasterida STADA.

-In some clinical studies, there was a higher number of patients taking dutasteride and another medication 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 is not pumping blood as it should.

-Make sure your doctor knows if you have liver problems.. You may need some additional checks during your treatment with Dutasterida STADA if you have any liver disease.

-Women, children, and adolescentsshould avoid contact with broken Dutasterida STADA capsules because the active ingredient can be absorbed through the skin. If there is any contact with the skin,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 Dutasterida STADA. 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.

-Dutasterida STADA affects PSA blood tests(prostate-specific antigen) that are sometimes used to detect prostate cancer. Your doctor may still use this test to detect prostate cancer, but he or she should know about this effect. If you have a blood test for PSA, inform your doctor that you are taking Dutasterida STADA.Men taking Dutasterida STADA should have regular PSA checks.In a clinical study in men at increased risk of prostate cancer, men taking Dutasterida STADA had a higher frequency of a type of aggressive prostate cancer than those not taking Dutasterida STADA. The effect of Dutasterida STADA on these aggressive types of prostate cancer is not clear.

-Dutasterida STADA may cause breast enlargement and tenderness.If this causes you discomfort, or if you noticelumps in the breast or nipple discharge, consult 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 related to taking Dutasterida STADA.

Taking Dutasterida STADA with other medications

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

Certain medications may interact with Dutasterida STADA, 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 the dose of Dutasterida STADA.

Taking Dutasterida STADA with food and drinks

Dutasterida STADA can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Women should not take dutasteride.

Women who are pregnant (or may be pregnant) should avoid contact with brokenDutasterida STADA 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.Consult your doctorif a pregnant woman has come into contact with dutasteride.

Use a condom during sex.Dutasteride has been found in the semen of men taking Dutasterida STADA. If your partner is pregnant or thinks she may be pregnant, you should avoid exposing her to your semen.

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

Driving and operating machinery

It is unlikely that Dutasterida STADA will affect your ability to drive and use machinery.

Dutasterida STADA contains soy lecithin

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

Follow exactly the administration instructions for this medication as indicated by your doctor.If in doubt, consult your doctor or pharmacist again.If you do not takeDutasterida STADAregularly, the control of your PSA levels may be affected.

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 STADA is long-term. Some men may experience rapid improvement in symptoms. However, others may need to continue treatment for up to 6 months or more before an effect begins to occur. Continue taking Dutasterida STADA for the time your doctor has indicated.

If you take more Dutasterida STADA than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Dutasterida STADA

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

Do not interrupt treatment with Dutasterida STADA

Do not interrupt treatment withDutasterida STADAwithout consulting your doctor first. You may need 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 medicines, this medicine can cause side effects, although not everyone will experience them.

Allergic reaction

The symptoms of an allergic reaction may include:

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

You should contact your doctor immediatelyif you experience any of these symptoms andstop taking Dutasterida STADA.

Common side effects

May affect up to 1 in 10 men takingDutasterida STADA:

• inability to achieve or maintain an erection(impotence), which could continue after stoppingDutasterida STADA
• decreased libido(sex drive), which could continue after stoppingDutasterida STADA
• difficulty with ejaculation, which could continue after stoppingDutasterida STADA
• breast tenderness or swelling(gynecomastia)
• dizziness, when taken with tamsulosina

Uncommon side effects

May affect up to 1 in 100 men taking Dutasterida STADA:

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

Side effects of unknown frequency

The frequency cannot be estimated from the available data:

• depressive mood
• testicular pain and inflammation.

If any of the side effects you experience are severe, or if you experience any side effect not mentioned in this leaflet, consult your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging or in the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Dispose of 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 unused packaging and medications. By doing so, you will help protect the environment.

Composition of Dutasteride STADA

• The active ingredient is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.
• The other components are:
• Interior of the capsule: glycerol monocaprilocaprato (type I), butylhydroxytoluene (E321)
• Capsule coating: gelatin, glycerol, 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 package

Dutasteride STADA are soft gelatin capsules, oblong, opaque, yellow in color, containing an oily and yellowish liquid.

They are available in white opaque PVC/PVDC-Aluminum blisters containing 10, 30, 50, 60, 90 or 100 capsules or single-dose opaque white PVC/PVDC-Aluminum blisters containing 10x1, 30x1, 50x1, 60x1, 90x1 or 100x1 capsules.

Only some package sizes may be marketed.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Galenicum Health S.L.U.

Sant Gabriel, 50

08950 Esplugues de Llobregat (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

STADA Arzneimittel AG

Stadastrasse 2-18

6118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Austria

or

SAG MANUFACTURING, S.L.U.

Ctra. N-I, km 36

28750 San Agustín de Guadalix

Madrid - Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria: Dutasterid STADA 0.5 mg Weichkapseln

Spain: Dutasterida STADA 0.5 mg soft capsules EFG

France: Dutasteride EG 0.5 mg, soft capsule

Croatia: Dutasterid STADA 0.5 mg meke kapsule

Italy: DUTASTERIDE EG

Portugal: Dutasterida Ciclum

Romania: Maxtrid 0.5 mg soft capsule

Date of the last review of this leaflet: November 2015

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

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