Dutasteride STADA 0.5 mg soft capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dutasteride STADA 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 you should not give it to other people, even if they have the same symptoms as you. It may 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.

What is in this leaflet

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

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

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

Dutasteride STADA is used in men to treat enlarged prostate (benign prostatic hyperplasia), a non-cancerous growth of the prostate caused by overproduction of a hormone called dihydrotestosterone.

As the prostate enlarges, it can cause urinary problems such as difficulty in urine flow and a need to urinate more frequently. It may also result in a weaker and less forceful urine stream. 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. In some cases, surgery may be necessary to reduce the size of the prostate or to remove it. Dutasteride STADA 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 STADA 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 STADA

Do not take Dutasteride STADA:

• if you are allergic to dutasteride, to other 5-alpha reductase enzyme 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 are a child or adolescent.

Inform your doctor if you think you are in any of these situations.

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 STADA.

• In some clinical studies, a higher number of patients taking dutasteride together with 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 STADA if you have a condition affecting your liver.

-Women, children, and adolescents must avoid contact with broken Dutasteride STADA capsules because the active substance can be absorbed through the skin. If any contact with the skin occurs, the affected area must be washed immediately with water and soap.

-Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Dutasteride STADA. If your partner is pregnant or suspects she might 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 STADA affects the serum PSA test (prostate-specific antigen), 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 STADA. Men taking Dutasteride STADA should have regular PSA monitoring. In a clinical study conducted in men at increased risk of prostate cancer, men who took Dutasteride STADA developed a higher frequency of high-grade prostate cancer than those who did not take Dutasteride STADA. The effect of Dutasteride STADA on these high-grade types of prostate cancer is not clear.

-Dutasteride STADA may cause breast enlargement and breast tenderness. If this causes you 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 as soon as possible for further medical advice.

Consult your doctor or pharmacist if you have any questions about taking Dutasteride STADA.

Taking Dutasteride STADA with other medicines

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

Certain medicines may interact with Dutasteride STADA, increasing the likelihood that you experience 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. It may be necessary to reduce the dose of Dutasteride STADA.

Taking Dutasteride STADA with food and drinks

Dutasteride STADA can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Women must not take dutasteride.

Pregnant women (or women who might be pregnant) must avoid contact with broken capsules. Dutasteride can be 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. Consult your doctor if a pregnant woman has been exposed to dutasteride.

Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Dutasteride STADA. If your partner is pregnant or suspects she might be pregnant, you must avoid exposing her to your semen.

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

Driving and using machines

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

Dutasteride STADA contains soy lecithin

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

3. How to take Dutasterida STADA

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. If you do not take Dutasterida STADA regularly, your PSA levels may be affected.

What dose should you take

• The recommended dose is one capsule (0.5 mg) once daily. The capsules should 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 STADA 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 STADA for as long as your doctor has instructed.

If you take more Dutasterida STADA than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Dutasterida STADA

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 STADA

Do not stop treatment with Dutasterida STADA 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 experiences them.

Allergic reaction

Symptoms of an allergic reaction may include:

• skin rash (which may be itchy)
• bumps on the skin (such as hives)
• 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 Dutasterida STADA.

Frequent adverse effects

May affect up to 1 in 10 men taking Dutasterida STADA:

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

Uncommon adverse 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 may cause symptoms such as difficulty breathing, excessive tiredness, and swelling in the ankles and legs).
• hair loss (usually of the body) or hair growth.

Adverse effects of unknown frequency

Frequency cannot be estimated from the available data:

• depressive mood
• pain and inflammation of the testicles.

If any of the adverse effects you experience is severe, or if you experience any adverse effect not listed in this leaflet, consult your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not mentioned in this leaflet. You may also report them directly through 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 Dutasterida STADA

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

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

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This way, you will help protect the environment.

6. Contents of the container and other information

Composition of Dutasterida STADA

• The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.
• The other components are:
• capsule contents: glycerol monocaprylocaprate (type I), 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 medicine and contents of the container

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

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

Only certain pack sizes may be marketed.

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

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

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 medicinal product is authorised in the European Economic Area member states under the following names:

Austria: Dutasterid STADA 0.5 mg Weichkapseln

Spain: Dutasterida STADA 0.5 mg cápsulas blandas EFG

France: Dutasteride EG 0.5 mg, capsule molle

Croatia: Dutasterid STADA 0.5 mg meke kapsule

Italy: DUTASTERIDE EG

Portugal: Dutasterida Ciclum

Romania: Maxtrid 0.5 mg capsule moi

Date of latest revision of this leaflet: October 2025

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