DUTASTERIDE TARBIS 0.5 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the User

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

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

Dutasteride Tarbis 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 weaker and less forceful. If left untreated, 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 remove it. Dutasteride Tarbis reduces the production of dihydrotestosterone, which helps reduce the size of the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgery.

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

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

Do not take Dutasteride Tarbis

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

If you think you may have any of these conditions, do not takethis medicine until you have consulted your doctor.

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

Warnings and precautions

Consult your doctor before taking Dutasteride Tarbis.

• Make sure your doctor knows if you have liver problems.You may need additional monitoring during your treatment with Dutasteride Tarbis if you have any liver disease.
• Women, children, and adolescentsshould avoid contact with broken Dutasteride Tarbis capsules because the active substance can be absorbed through the skin. If there is any contact with the skin, the affected area should be washed immediatelywith 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 may become pregnant, she should avoid exposure to your semen because dutasteride may 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 Tarbis affects the blood test for PSA(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 Tarbis. Men taking Dutasteride Tarbis should have regular PSA tests.
• In a clinical study in men at increased risk of prostate cancer, men taking Dutasteride Tarbis were more likely to have a type of high-grade prostate cancerthan those not taking Dutasteride Tarbis. The effect of dutasteride on these types of high-grade prostate cancer is not clear.
• Dutasteride Tarbis may cause breast enlargement and breast tenderness. If this causes you discomfort, or if you notice breast lumpsor 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 about taking Dutasteride Tarbis.

Taking Dutasteride Tarbis with other medicines

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

Certain medicines may interact with Dutasteride Tarbis, which may increase the risk of 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)
• other alpha-blockers (for enlarged prostate or high blood pressure).

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

Taking Dutasteride Tarbis with food and drink

Dutasteride Tarbis can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnant women (or women who may become pregnant) should avoid contact with broken capsules.Dutasteride is absorbed through the skin and may affect the normal development of a male fetus. 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 dutasteride. If your partner is pregnant or may become pregnant, she should avoid exposure to your semen.

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

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

Driving and using machines

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

Dutasteride Tarbis contains soybean lecithin and propylene glycol

This medicine contains soybean lecithin and may contain soybean oil.

Do not use this medicine if you are allergic to peanuts or soy.

This medicine contains 299.46 mg of propylene glycol monocaprylate in each capsule.

3. How to take Dutasteride Tarbis

Take this medicine exactly as your doctor has told you.

If you do not take Dutasteride Tarbis regularly, the control of your PSA levels may be affected.

If you are unsure, consult your doctor or pharmacist again.

Recommended dose

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. The capsules can be taken with or without food.

Treatment with Dutasteride Tarbis is long-term. Some men may experience rapid improvement in symptoms. However, others may need to take this medicine for 6 months or more before an effect is seen. Continue taking Dutasteride Tarbis for as long as your doctor has told you.

If you take more Dutasteride Tarbis than you should

Contact your doctor or pharmacist if you take too many Dutasteride Tarbis capsules.

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 Tarbis

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 Tarbis

Do not stop taking Dutasteride Tarbis without consulting your doctor first. It may take 6 months or more to see 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)
• hives (like nettle rash)
• swelling of the eyelids, face, lips, arms, and legs.

If you experience any of these symptoms, contact your doctor immediately and stop taking dutasteride.

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

• inability to achieve or maintain an erection (impotence), which may continue after stopping dutasteride
• decreased sex drive (libido), which may continue after stopping dutasteride
• difficulty with ejaculation, such as a decrease in the amount of semen released during sex, which may continue after stopping dutasteride
• breast tenderness or enlargement (gynaecomastia)
• 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 around the body. This could 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.

Rare side effects(frequency cannot be estimated from the available data):

• depression
• 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 Tarbis

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 is the last day of the month stated.

Do not store above 30°C.

Store in the original package to protect from light.

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

6. Contents of the pack and further information

Composition of Dutasteride Tarbis

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

• capsule content: propylene glycol monocaprylate, butylhydroxytoluene
• capsule shell: gelatin, glycerol, titanium dioxide (E171), medium-chain triglycerides, lecithin (may contain soybean oil) (E322)

Appearance of the product and pack contents

Dutasteride Tarbis soft capsules are yellowish, oblong, soft gelatin capsules (approximately 16.5 x 6.5 mm) containing a clear liquid. They are available in transparent PVC-PE-PVDC/Aluminum blister packs containing 10, 30, 50, 60, and 90 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer:

Laboratorios LEÓN FARMA, SA

Polígono Industrial Navatejera

C/La Vallina, s/n - 24193 Villaquilambre

León

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:May 2021

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