DAVOSTER 0.5 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Davoster, 0.5 mg, Soft Capsules
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Davoster and what is it used for
4. Important information before taking Davoster
   1. When not to take Davoster:
   2. Warnings and precautions
   3. Davoster and other medicines
   4. Taking Davoster with food and drink
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Davoster contains soy lecithin and propylene glycol
5. How to take Davoster
   1. Recommended dose
   2. Taking more than the recommended dose of Davoster
   3. Missing a dose of Davoster
   4. Stopping treatment with Davoster
6. Possible side effects
   1. Allergic reactions
   2. Reporting side effects
7. How to store Davoster
8. Contents of the pack and other information
   1. What Davoster contains
   2. What Davoster looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet: 29.08.2024

Package Leaflet: Information for the User

Davoster, 0.5 mg, Soft Capsules

Dutasteride

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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Davoster and what is it used for

Davoster is used in men with an enlarged prostate gland (benign prostatic hyperplasia) - a non-cancerous enlargement of the prostate gland caused by an excess 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.
An enlarged prostate gland can cause problems with urination, such as difficulty urinating and frequent urination. There may also be a decrease in urine flow and a weak urine stream. If left untreated, it can lead to complete blockage of urine flow (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. Davoster reduces the production of dihydrotestosterone, which reduces the size of the prostate gland and alleviates symptoms. It therefore reduces the likelihood of acute urinary retention and the need for surgical intervention.
Davoster 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 Davoster

When not to take Davoster:

If any of the above statements apply to you, do not takethe medicine before consulting your doctor.
The medicine is intended only for men. Do not use it in women, children, and adolescents.

Warnings and precautions

Before starting to take Davoster, discuss it with your doctor.

• Tell your doctor if you have liver disease. If you have had liver disease, you may need to have additional tests while taking Davoster.
• Women, children, and adolescents must not handle damaged Davoster capsules, as the active substance may be absorbed through the skin. If skin contact occurs, wash the affected area with soap and water immediately.
• 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, avoid exposing her to contact with semen, as dutasteride may interfere with the development of a male child. It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility. This may lead to reduced fertility.
• Davoster affects the measurement of prostate-specific antigen (PSA) levels, which is sometimes performed to detect prostate cancer. However, your doctor may still order this test to detect prostate cancer. If you are having a PSA test, tell your doctor that you are taking Davoster. Men taking Davoster should have their PSA levels checked regularly.
• In a clinical study involving patients at high risk of prostate cancer, patients taking dutasteride were diagnosed with high-grade prostate cancer more often than patients who did not take dutasteride. The effect of dutasteride on high-grade prostate cancer is not clear.
• Davoster may cause breast enlargement and tenderness. If this becomes troublesome or you notice lumps in your breasts or discharge from your nipples, discuss these changes with your doctor, as they may be signs of a serious condition, such as breast cancer.

If you have any questions about taking Davoster, contact your doctor or pharmacist.

Davoster and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Some medicines may interact with Davoster and increase the risk of side effects. These include:

• 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 doctor if you are taking any of these medicines. It may be necessary to reduce the dose of Davoster.

Taking Davoster with food and drink

Davoster can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnant women (or women who may become pregnant) must not handle damaged capsules. Dutasteride is absorbed through the skin and may interfere with the development of a male child. 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 Davoster. If your partner is pregnant or may become pregnant, avoid exposing her to contact with semen.
It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility. This may lead to reduced fertility in men.
If a pregnant woman has come into contact with dutasteride, she should contact her doctor immediately.

Driving and using machines

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

Davoster contains soy lecithin and propylene glycol

Davoster contains soy lecithin (may contain soybean oil). The medicine should not be taken by people allergic to peanuts or soy.
Davoster contains 299.46 mg of propylene glycol monocaprylate in each capsule.

3. How to take Davoster

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Irregular intake of the medicine may affect monitored PSA levels.

Recommended dose

The usual dose is one capsule (0.5 mg) taken once a day. The capsule should be swallowed whole, with water. Do not chew or open the capsules. Contact with the contents of the capsules can cause mouth pain or throat pain.
Davoster is intended for long-term use. Some men may experience relief from symptoms at the beginning of treatment. However, others may need to take Davoster for 6 months or longer to see an improvement. Take Davoster for as long as your doctor recommends.

Taking more than the recommended dose of Davoster

If you have taken more than the recommended dose of Davoster, contact your doctor or pharmacist.

Missing a dose of Davoster

Do not take a double dose to make up for a forgotten dose.
Take the next dose at the usual time and continue with the previous dosing schedule.

Stopping treatment with Davoster

Do not stop taking Davoster without talking to your doctor. To see an improvement, you may need to continue treatment for 6 months or longer.
If you have any further questions about taking 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 reactions

Symptoms of an allergic reaction may include:

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

If you experience any of these symptoms, stop taking Davoster and contact your doctor immediately.
Common side effects(may affect up to 1 in 10 men):

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

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

• heart failure (less efficient heart function, which may cause symptoms such as shortness of breath, extreme tiredness, and swelling in the ankles and legs);
• hair loss (usually body hair loss) or excessive hair growth.

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

• depression;
• testicular pain and swelling.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych,
Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +48 22 49 21 301, faks: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Davoster

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister pack. The expiry date refers to the last day of the month.
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 other information

What Davoster contains

• The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.
• Other ingredients are:
• inside the capsule: butylhydroxytoluene (E 321) and propylene glycol monocaprylate, Type II;
• capsule shell: gelatin, glycerol, titanium dioxide (E 171), saturated fatty acid triglycerides, soy lecithin.

What Davoster looks like and contents of the pack

Davoster soft capsules are oblong, soft gelatin capsules (approx. 16.5 x 5.6 mm) of light yellow color, filled with a clear liquid. The medicine is available in packs (transparent triple-layer PVC/PE/PVDC-Aluminum blister pack in a cardboard box) of 10, 30, 50, 60, or 90 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Synthaverse S.A.
ul. Uniwersytecka 10
20-029 Lublin
Poland
Tel.: +48 81 533 82 21
Fax: +48 81 533 80 60
e-mail [email protected]

Manufacturer

Laboratorios LEÓN FARMA, S.A.
Polígono Industrial Navatejera
C/La Vallina s/n,
24193 Villaquilambre -León
Spain

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

Denmark
Dutasteride Universal Farma
Poland
Davoster
Slovenia
Amdut 0.5 mg soft capsules
Italy
VIVISTER

Date of last revision of the leaflet: 29.08.2024