DUTASTERIDE STADA 0.5 mg SOFT CAPSULES

2. What you need to know before taking Dutasteride STADA

Do not take Dutasteride STADA:

• if you are allergic to dutasteride, other 5-alpha reductase enzyme inhibitors, soy, peanuts, or any of the other components of this medication (listed in section 6).
• if you have severe liver disease.
• if you are a child or adolescent.

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

This medication is only for men. Women, children, and adolescents should not take it.

Warnings and precautions

Consult your doctor before starting to take Dutasteride 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 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 additional checks during your treatment with Dutasteride STADA if you have any liver disease.
• Women, children, and adolescents should avoid contact with broken Dutasteride STADA capsules, as the active ingredient can be absorbed through the skin. If there is any skin contact, the affected area should be washed immediately with soap and water.
• Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Dutasteride STADA. If your partner is pregnant or may be pregnant, she should avoid exposure to your semen, as dutasteride can affect the normal development of a male fetus. Dutasteride has been shown to decrease sperm count, motility, and semen volume. This may reduce fertility.
• Dutasteride STADA affects the PSA test in serum (prostate-specific antigen) used to detect prostate cancer. Your doctor can still use this test to detect prostate cancer, but should be aware of this effect. If you have a blood test for PSA, tell your doctor that you are taking Dutasteride STADA. Men being treated with Dutasteride STADA should have regular PSA checks. In a clinical study of men at high risk of prostate cancer, men who took Dutasteride STADA were more likely to develop a serious type of prostate cancer than those who did not take Dutasteride STADA. The effect of Dutasteride STADA on these serious types of prostate cancer is not clear.
• Dutasteride STADA may cause breast enlargement and pain on palpation. If this causes discomfort, or if you notice lumps in the breast or nipple discharge, consult your doctor, as these changes can be signs of a serious disease, such as breast cancer.

Consult your doctor or pharmacistif you have any doubts related to taking Dutasteride STADA.

Taking Dutasteride STADA with other medications

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

Certain medications may interact with Dutasteride STADA, which can increase the risk of side effects. Some of these medications 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 medications. 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 should not take dutasteride.

Pregnant women (or those who may be pregnant) should avoid contact with broken capsules. Dutasteride is absorbed through the skin and can affect the normal development of a male fetus. This risk is especially important during the first 16 weeks of pregnancy. Consult your doctorif a pregnant woman has been in contact with 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 may be pregnant, she should avoid exposure to your semen.

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

Driving and using machines

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

Dutasteride STADA contains soy lecithin

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

3. How to take Dutasteride STADA

Follow your doctor's instructions for taking this medication exactly.If you are unsure, consult your doctor or pharmacist again. If you do not take Dutasteride STADA regularly, your PSA levels may be affected.

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 STADA is long-term. Some men may experience rapid improvement in symptoms. However, others may need to continue treatment for 6 months or more before an effect is seen. Continue taking Dutasteride STADA for the duration specified by your doctor.

If you take more Dutasteride STADA than you should

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

If you forget to take Dutasteride STADA

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

Do not stop taking Dutasteride STADA

Do not stop taking Dutasteride STADA without consulting your doctor first. It may take up to 6 months or more to see an effect.

If you have any other questions about taking this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Allergic reaction

Symptoms of an allergic reaction can include:

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

You should immediatelycontact your doctor if you experience any of these symptoms and stop taking Dutasteride STADA.

Common side effects

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

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

Uncommon side effects

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

• heart failure (the heart becomes less efficient at pumping blood through the body, which can cause symptoms such as shortness of breath, excessive tiredness, and swelling in the ankles and legs).
• hair loss (usually from the body) or excessive hair growth.

Side effects of unknown frequency

Frequency cannot be estimated from available data:

• depressive mood
• testicular pain and swelling.

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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's online system: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Dutasteride STADA

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

Do not use this medication after the expiration date stated on the packaging or blister 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 from moisture.

Medications should not be disposed of through wastewater or household waste. Return the packaging and any unused medication to the pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of the packaging and medication you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Dutasteride STADA

• The active ingredient is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.
• The other ingredients are:
• capsule interior: 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 product and package contents

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

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

Not all pack sizes may be marketed.

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

Marketing authorization holder and manufacturer

Marketing authorization 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

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 medication is authorized in the member states of the European Economic Area under the following names:

Austria:Dutasterid STADA 0.5 mg soft capsules

Spain:Dutasterida STADA 0.5 mg soft capsules EFG

France:Dutasteride EG 0.5 mg, soft capsule

Croatia:Dutasterid STADA 0.5 mg soft capsules

Italy:DUTASTERIDE EG

Portugal:Dutasterida Ciclum

Romania:Maxtrid 0.5 mg soft capsules

Date of last revision of this leaflet: November 2015

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

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