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Package Leaflet: Information for the User

Dutasteride Aurovitas, 0.5 mg, Soft Capsules

Dutasteridum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Dutasteride Aurovitas and what is it used for
• 2. Important information before taking Dutasteride Aurovitas
• 3. How to take Dutasteride Aurovitas
• 4. Possible side effects
• 5. How to store Dutasteride Aurovitas
• 6. Contents of the pack and other information

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

Dutasteride Aurovitasis used to treat men with an enlarged prostate gland (benign prostatic hyperplasia) - a non-cancerous enlargement of the prostate gland, caused by an excessive production of a hormone called dihydrotestosterone. The active substance of the medicine is dutasteride, which belongs to a group of medicines called 5-alpha reductase inhibitors. Enlargement of the prostate gland can lead to problems with urination, such as difficulty urinating and frequent urination. It can also cause a slower and less intense flow of urine. If left untreated, there is a risk that the flow of urine will be completely blocked (acute urinary retention). This situation requires immediate treatment. In some cases, surgical intervention may be necessary to remove or reduce the size of the prostate gland. Dutasteride Aurovitas reduces the production of dihydrotestosterone, which leads to a reduction in the size of the prostate gland and alleviation of symptoms. It therefore reduces the likelihood of acute urinary retention and the need for surgical intervention. Dutasteride Aurovitas may also be used in combination with another medicine called tamsulosin (used to treat symptoms of an enlarged prostate gland).

2. Important information before taking Dutasteride Aurovitas

When not to take Dutasteride Aurovitas

• If you are allergic to dutasteride or other 5-alpha reductase inhibitors or any of the other ingredients of this medicine(listed in section 6). If you have severe liver disease.If any of the above applies to you, do not takethis medicine, until you have consulted a doctor.

as long as the patient consults a doctor. This medicine is for men only.It must not be taken by women, children, or adolescents.

Warnings and precautions

Before taking Dutasteride Aurovitas, consult a doctor or pharmacist.

• Tell your doctor if you have liver disease.If you have ever had liver disease, you may need to have extra tests while taking Dutasteride Aurovitas.
• Women, children, and adolescentsmust not handle damaged Dutasteride Aurovitas capsules, because the active substance can be absorbed through the skin. If contact occurs with the skin, wash the affected area immediately with soap and water.
• Use a condom during sexual intercourse.Dutasteride has been found in the semen of men taking Dutasteride Aurovitas. If your partner is pregnant or could be pregnant, you must avoid exposing her to your semen. Dutasteride Aurovitas may affect the development of a male baby. It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility. This may reduce fertility in men.
• Dutasteride Aurovitas affects the measurement of prostate-specific antigen (PSA),which is sometimes carried out to detect prostate cancer. Despite this, your doctor may still decide to carry out this test to detect prostate cancer. If you are having a PSA test, you should tell your doctor that you are taking Dutasteride Aurovitas. PSA levels should be regularly checked in patients taking Dutasteride Aurovitas.
• In a clinical study of patients at high risk of prostate cancer, patients taking Dutasteride Aurovitas were more likely to be diagnosed with high-grade prostate cancer than patients who did not take Dutasteride Aurovitas. The impact of Dutasteride Aurovitas on the risk of developing high-grade prostate cancer is not clear.
• Dutasteride Aurovitas may cause breast enlargement or tenderness.If these symptoms become troublesome or if you notice any lumps or discharge from the nipple, you should consult a doctor, as these may be signs of a serious condition, such as breast cancer.

You should consult a doctor or pharmacistif you have any questions about taking Dutasteride Aurovitas.

Dutasteride Aurovitas with other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, and about any medicines you plan to take.

• Verapamil or diltiazem(used to treat high blood pressure)
• Ritonavir or indinavir(used to treat HIV infection)
• Itraconazole or ketoconazole(used to treat fungal infections)
• Nefazodone(used to treat depression)
• Alpha-blockers(used to treat enlarged prostate or high blood pressure). Tell your doctorif you are taking these medicines. It may be necessary to reduce the dose of Dutasteride Aurovitas.

It may be necessary to reduce the dose of Dutasteride Aurovitas.

Dutasteride Aurovitas with food and drink

The medicine can be taken with or without food.

Pregnancy, breast-feeding, and fertility

Women must not take Dutasteride Aurovitas. Pregnant women (or women who could be pregnant) must not handle damaged capsules. Dutasteride is absorbed through the skin and may affect the development of a male baby. There is a special risk during the first 16 weeks of pregnancy. Use a condom during sexual intercourse.Dutasteride has been found in the semen of men taking Dutasteride Aurovitas. If your partner is pregnant or could be pregnant, you must avoid exposing her to your semen. It has been shown that Dutasteride Aurovitasreduces sperm count, semen volume, and sperm motility. This may reduce fertility in men. If a pregnant woman has come into contact with dutasteride, she should consult a doctor.

Driving and using machines

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

3. How to take Dutasteride Aurovitas

Dutasteride Aurovitas should always be taken exactly as your doctor or pharmacist has told you.

Irregular use of the medicine may affect the monitoring of PSA levels. If you are in doubt, consult your doctor or pharmacist.

How much to take

• The recommended dose of Dutasteride Aurovitas is one capsule (0.5 mg) taken once a day.The capsule should be swallowed whole with water. The capsule should not be chewed or opened. Contact with the contents of the capsule may cause mouth or throat irritation.
• Treatment with Dutasteride Aurovitas is long-term. Some patients may experience an improvement in symptoms at the start of treatment. However, others may need to take Dutasteride Aurovitas for 6 months or longer to see an improvement. You should take Dutasteride Aurovitas for as long as your doctor recommends.

If you take more Dutasteride Aurovitas than you should

If you have taken more Dutasteride Aurovitas than you should, contact a doctor or pharmacist.

If you forget to take Dutasteride Aurovitas

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

If you stop taking Dutasteride Aurovitas

If you have any further questions on the use of this product, ask your doctor or pharmacist. Do not stop taking Dutasteride Aurovitas without consulting your doctor. To get the most benefit, you may need to continue taking Dutasteride Aurovitas for 6 months or longer.

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 may include:

• skin rash(which may be itchy)
• hives(like nettle rash)
• swelling of the eyelids, face, lips, hands, and feet.

Seek medical attention immediatelyif you experience these symptoms and stop taking Dutasteride Aurovitas.Common side effects(may affect up to 1 in 10 men taking Dutasteride Aurovitas):

• inability to achieve or maintain an erection (impotence), this symptom may persist after stopping Dutasteride Aurovitas
• reduced sex drive (libido), this symptom may persist after stopping Dutasteride Aurovitas
• difficulty with ejaculation, including reduced semen volume, this symptom may persist after stopping Dutasteride Aurovitas
• breast enlargement or tenderness (gynaecomastia)
• dizziness when taken with tamsulosin.

Uncommon side effects(may affect up to 1 in 100 men taking Dutasteride Aurovitas):

• heart failure (the heart becomes less efficient at pumping blood around the body. Symptoms may include shortness of breath, extreme tiredness, and swelling in the ankles and lower limbs)
• hair loss (usually body hair) or increased hair growth.

Side effects with unknown frequency(frequency cannot be estimated from the available data):

• depression
• testicular pain and swelling.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the https://smz.ezdrowie.gov.plwebsite. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dutasteride Aurovitas

Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label, carton, blister, or bottle after EXP. The expiry date refers to the last day of that month. Store in a temperature below 30°C. 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 Dutasteride Aurovitas contains

• 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). Capsule shell: gelatine, glycerol, titanium dioxide (E 171), and yellow iron oxide (E 172), medium-chain triglycerides.

What Dutasteride Aurovitas looks like and contents of the pack

Soft capsule. The capsules are opaque, matt yellow, and of size '6', containing a clear to pale yellowish viscous oil. The size is approximately 18.4 x 6.4 mm. Dutasteride Aurovitas capsules are available in blister packs.

Pack sizes:

Blisters:30, 90, and 120 capsules. Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Aurovitas Pharma Polska Sp. z o.o. ul. Sokratesa 13D lokal 27 01-909 Warszawa

Manufacturer/Importer:

APL Swift Services (Malta) Ltd. HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Portugal:

Dutasterida Generis Phar

Poland:

Dutasteride Aurovitas

Date of last revision of the leaflet: