Prospect: information for the user

Dutasteride TecniGen 0.5 mg soft capsules EFG

Read this prospect carefully before starting to take the medicine because 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, pharmacist, or nurse.
• This medicine has been prescribed for you only and should not be given 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, pharmacist, or nurse even if they do not appear in this prospect. See section 4.

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

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

3.How to take Dutasteride TecniGen

4.Possible adverse effects

5.Storage of Dutasteride TecniGen

6.Contents of the package and additional information

Dutasterida TecniGenis 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.

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

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

Do not take DutasteridaTecniGen

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

-if you are allergic

• if you have a severe liver disease.

If you think you are in any of these situations, do not take this 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 to take this medication.

• In some clinical studies, there were more 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 additional monitoring during your treatment with dutasteride if you have any liver disease.
• Women, children, and adolescents should avoid contact with broken dutasteride capsulesbecause the active ingredient can be absorbed through the skin. If there is any skin contact, the affected area should be washed immediately with 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 the PSA blood test (prostate-specific antigen)used sometimes 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 dutasteride should have regular PSA checks.
• In a clinical study in men at increased risk of developing prostate cancer, men taking dutasteride had a higher frequency of a type of severe prostate cancer than 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 notice lumps in your 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 about taking this medication.

Use of Dutasterida TecniGenTecniGenwith other medications

Inform your doctor or pharmacist if you are using or have recently used other medications.

Do not take dutasteride with these medications:

• Other alpha blockers (for enlarged prostate or high blood pressure).

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)

Inform your doctor if you are taking any of these medications. You may need to reduce the dose of Dutasterida TecniGen

Taking Dutasterida TecniGenTecniGenwith food, drinks, and alcohol

Dutasterida TecniGencan be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnant women (or those who may be pregnant) should avoid contact with broken dutasteride capsules. Dutasteride can be 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 this medication. 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 dutasteride will affect your ability to drive and operate machinery.

Important information about some of the components of Dutasterida TecniGenTecniGenThis 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 or pharmacist. If in doubt, consult your doctor or pharmacist again.

Always take this medication regularly. If you do not take this medication regularly, the control of your PSA levels may be affected (see section 2 “Warnings and precautions”).

What dose should you take

The usual dose is one capsule (0.5 mg) once a day.Dutasterida 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 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 more before an effect begins to occur. Continue taking this medication for the time your doctor has indicated.

If you take more Dutasterida TecniGen 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 TecniGen

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

If you interrupt treatment with Dutasterida TecniGen

Do not interrupt treatment with Dutasterida TecniGen without 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 medications, this medication may produce adverse effects, although not all people will 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.

You should immediately contact your doctor if you experience any of these symptoms and stop taking dutasteride.

Frequent Adverse Effects (may affect up to 1 in 10 men)

• 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 tamsulosina.

Rare Adverse Effects (may affect up to 1 in 100 men)

• 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 the available data:

• depressive mood
• testicular pain and inflammation.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 Medicines for Human Use. Website: 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 use this medication after the expiration date that appears on the packaging or in the bottleafter CAD. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C). Store in the original packaging to protect from moisture.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Dutasteride TecniGen

The active ingredient is dutasteride. Each soft capsule contains 0.5 mg of dutasteride. The other components are:

Content of the capsule: Glycerol monocaprylate (type I) and butylhydroxytoluene (E-321)

Capsule coating: Gelatin, glycerol, titanium dioxide (E-171), iron oxide yellow (E-172), medium-chain triglycerides, lecithin (may contain soybean oil) and purified water.

Appearance of Dutasteride TecniGen and content of the container

Dutasteride TecniGen are soft gelatin capsules, oblong, opaque, yellow in color, and unprinted, containing a yellowish oily liquid. It is available in containers of 30 capsules.

Only some sizes of containers may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) Spain

Responsible for manufacturing

Cyndea Pharma S.L.

Polígono Industrial Emiliano Revilla Sanz

Avenida de Ágreda, 31

Olvega, 42110 Soria

Spain

or

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

SAG Manufacturing S.L.U.

Ctra. N-I, Km 36

28750 San Agustín de Guadalix

Madrid, Spain

Last review date of this leaflet: August 2016

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