DUTASTERIDE AUROVITAS 0.5 mg SOFT CAPSULES

Introduction

Patient Information: Summary of Product Characteristics

Dutasteride Aurovitas 0.5 mg Soft Capsules EFG

Read 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 pack

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

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

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

The active substance is dutasteride. It 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 urine stream to be weaker and less forceful.

If left untreated, benign prostatic hyperplasia can lead to a risk of the urine flow being 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 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 the symptoms of an enlarged prostate).

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

Do not take Dutasteride:

• if you are allergic to dutasteride, to other 5-alpha reductase inhibitors,or to 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 take this medicine until you have spoken to your doctor.

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

Warnings and precautions

Talk to your doctor before you start taking this medicine.

• In some clinical studies, there was a higher number of patients taking dutasteride and another medicine 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 to have additional checks during your treatment with dutasteride if you have any liver disease.
• Women, children, and adolescentsshould avoid contact with the contents of the capsules, as the active substance can be absorbed through the skin. If contact occurs, the affected area must be washed immediatelywith soap and water.
• Use a condom during sexual intercourse.Dutasteride has been found in the semen of men taking this medicine. If your partner is pregnant or could be pregnant, she should avoid exposure to your semen, as dutasteride may affect the normal development of a male baby. Dutasteride has been shown to decrease sperm count, sperm motility, and semen volume. This may reduce fertility.
• Dutasteride 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 must be aware of this effect. If you have a blood test for PSA, tell your doctor that you are taking this medicine. Men taking dutasteride should have regular PSA tests.
• In a clinical study in men at increased risk of prostate cancer, men taking dutasteride were more likely to have a higher-grade prostate cancer than those not taking it. The effect of dutasteride on these high-grade prostate cancers 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.

Ask your doctor or pharmacistif you have any questions about taking this medicine.

Taking Dutasteride with other medicines

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

Certain medicines can 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 HIV)
• 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 medicines. It may be necessary to reduce the dose of this medicine.

Taking Dutasteride with food and drink

This medicine can be taken with or without food.

Pregnancy, breast-feeding, and fertility

Pregnant women (or women who could be pregnant) should avoid contact with the contents of the 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 could be pregnant, she should avoid exposure to your semen.

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

Ask your doctorif 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.

3. How to take Dutasteride Aurovitas

Take this medicine exactly as your doctor or pharmacist has told you.If you do not take dutasteride regularly, the control of your PSA levels may be affected. If you are unsure, consult your doctor or pharmacist again.

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.

• The 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 than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service (telephone 915620420), indicating the medicine and the amount taken. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Dutasteride

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

Do not stop taking Dutasteride

Do not stop taking this medicine 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 product, 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
• swelling of the eyelids, face, lips, arms, and legs.

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

Common side effects

These may affect up to 1 in 10 patients taking dutasteride:

• inability to get or maintain an erection (impotence), which may continue after stopping this medicine
• reduced 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 this medicine
• breast tenderness or enlargement (gynaecomastia)
• dizziness, when taken with tamsulosin.

Uncommon side effects

These may affect up to 1 in 100 patients taking dutasteride:

• heart failure (the heart becomes less efficient at pumping blood around the body. This could lead to 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

The 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 they are not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Dutasteride Aurovitas

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

Do not store above 30°C.

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

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 other information

What is in Dutasteride Aurovitas

The active substance is dutasteride.Each capsule contains 0.5 mg of dutasteride.

The other ingredients are:

• capsule content: glycerol monocaprylocaprate (type I) and butylhydroxytoluene (E321)
• capsule shell: gelatine, glycerol, titanium dioxide (E171), and yellow iron oxide (E172)

Appearance and packaging

Dutasteride Aurovitas capsules are oblong, opaque, yellow, and contain a yellowish oily liquid.

They are available in blister packs, in packs of 30 and 90 capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D,

28036 Madrid,

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmaceutica, S.A.

Rua João de Deus, n.o 19, Venda Nova, 2700-487

Amadora, Portugal

Date of last revision of this leaflet: October 2019

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