DUTASTERIDE TECNIGEN 0.5 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the User

Dutasteride TecniGen 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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

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

Dutasteride TecniGen is used in men to treat the enlargement of the prostate (benign prostatic hyperplasia), a non-cancerous growth of the prostate caused by an excess of a hormone called dihydrotestosterone.

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

As the prostate grows, it can cause urinary problems such as difficulty in the flow of urine and a need to urinate more frequently. It can also cause the stream of urine to be less and less strong. If benign prostatic hyperplasia is not treated, there is a risk that the flow of urine will be completely blocked (acute urinary retention). This requires immediate medical treatment. In some cases, surgery may be necessary to reduce the size of the prostate or to remove it. Dutasteride 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.

Dutasteride can also be used with another medicine called tamsulosin (used to treat symptoms of an enlarged prostate).

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

Do not take Dutasteride TecniGen

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

• if you have a severe liver disease.

If you think you are in any of these situations, do not take this medicine until you have consulted your doctor.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

• In some clinical studies, there were more patients taking dutasteride and another medicine called 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 some additional checks during your treatment with dutasteride if you have any liver disease.
• Women, children, and adolescents should avoid contact with broken capsulesof dutasteride because the active substance can be absorbed through the skin. If there is any contact with the skin, the affected area should be washed immediately with water and soap.
• Use a condom during sexual intercourse.Dutasteride has been found in the semen of men taking dutasteride. If your partner is pregnant or thinks she may be pregnant, she should avoid exposure to your semen because dutasteride may affect the normal development of a male baby. Dutasteride has been shown to decrease sperm count, motility, and semen volume. This may reduce fertility.
• Dutasteride affects the PSA test in serum(prostate-specific antigen) 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 treated with dutasteride should have regular PSA checks.
• In a clinical study in men at high risk of prostate cancer, men who took dutasteride had a higher frequency of a type of prostate cancer that is more serious than those who did not take dutasteride. The effect of dutasteride on these serious types of prostate cancer is not clear.
• Dutasteride may cause breast enlargement and breast tenderness.If this causes you discomfort, or if you notice breast lumps or nipple discharge, consult your doctor, as these changes can be signs of a serious disease, such as breast cancer.

Consult your doctor or pharmacist if you have any questions related to taking this medicine.

Using Dutasteride TecniGen with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines.

Do not take dutasteride with these medicines:

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

Certain medicines may interact with dutasteride, which may increase the risk of you experiencing side 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)

Tell your doctor if you are taking any of these medicines. It may be necessary to reduce the dose of Dutasteride TecniGen.

Taking Dutasteride TecniGen with food, drinks, and alcohol

Dutasteride TecniGen can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnant women (or women who may be pregnant) should avoid contact with broken capsules.Dutasteride is absorbed through the skin and may affect the normal development of a male baby. This risk is especially important during the first 16 weeks of pregnancy.

Use a condom during sexual intercourse.Dutasteride has been found in the semen of men taking this medicine. If your partner is pregnant or thinks she may be pregnant, she should avoid exposure to your semen.

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

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

Driving and using machines

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

Important information about some of the ingredients of Dutasteride TecniGenThis medicine contains soy lecithin and may contain soybean oil. Do not use this medicine if you are allergic to peanuts or soy.

3. How to take Dutasteride TecniGen

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Take this medicine regularly.If you do not take this medicine 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.The capsules of dutasteride 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 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 this medicine for as long as your doctor has told you.

If you take more Dutasteride TecniGen than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 915620420, indicating the medicine and the amount taken.

If you forget to take Dutasteride TecniGen

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

If you stop taking Dutasteride TecniGen

Do not stop taking Dutasteride TecniGen without consulting your doctor first. It may take up to 6 months or more for you to notice an effect.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reaction

Symptoms of an allergic reaction can include:

• skin rash (which may itch)
• skin lumps
• 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.

Common side effects (may affect up to 1 in 10 men)

• inability to get or maintain an erection (impotence), which may continue after stopping dutasteride
• decreased sex drive (libido), which may continue after stopping dutasteride
• difficulty with ejaculation, which may continue after stopping dutasteride
• breast tenderness or enlargement (gynecomastia)
• dizziness, when taken with tamsulosin.

Uncommon side effects (may affect up to 1 in 100 men)

• heart failure (the heart becomes less efficient at pumping blood through the body. This may cause symptoms such as difficulty breathing, excessive tiredness, and swelling in the ankles and legs)
• hair loss (usually from the body) or increased hair growth.

Side effects of unknown frequency

Frequency cannot be estimated from the available data:

• depressive mood
• testicular pain and swelling.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) at www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dutasteride TecniGen

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

Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C. Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Dutasteride TecniGen

The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride. The other ingredients are:

Capsule content: glycerol monocaprylate (type I) and butylhydroxytoluene (E-321)

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

Appearance of Dutasteride TecniGen and contents of the pack

Dutasteride TecniGen are yellow, oblong, opaque soft gelatin capsules, without engraving, containing a yellowish oily liquid. It is available in packs of 30 capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Tecnimede España Industria Farmacéutica, S.A.

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

28108 Alcobendas (Madrid) Spain

Manufacturer

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

Date of last revision of this leaflet: August 2016

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