Package leaflet: Information for the user

Davoster, 0.5 mg, soft capsules
Dutasteridum
Please read all of this leaflet carefully before 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 or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Davoster is and what it is used for
What you need to know before taking Davoster
How to take Davoster
Possible side effects
How to store Davoster
Contents of the pack and other information

1. What Davoster is and what it is used for

Davoster is used in men with an enlarged prostate gland (benign prostatic hyperplasia) – a non-cancerous enlargement of the prostate caused by excessive production of a hormone called dihydrotestosterone.
The active substance in this medicine is dutasteride, which belongs to a group of medicines known as 5-alpha reductase inhibitors.
An enlarged prostate may lead to problems with urination, such as difficulty in passing urine and increased frequency of urination. There may also be a reduced flow of urine and a weak urine stream. If left untreated, this may result in a complete blockage of urine flow (acute urinary retention). This condition requires immediate treatment. In some cases, surgery may be needed to remove or reduce the size of the prostate. Davoster reduces the production of dihydrotestosterone, leading to a reduction in the size of the prostate and relief of symptoms. Therefore, it 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).

2. Important information before using Davoster

When not to use Davoster:

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

If any of the above apply to the patient, do not take Davoster without first
consulting a doctor.
Davoster is intended for use in men only. Do not use in women, children or adolescents.
Warnings and precautions
Before starting Davoster, discuss this with your doctor.

Inform your doctor if you have liver disease. If you have liver disease, additional tests may be required during treatment with Davoster.
Women, children and adolescents must not handle damaged capsules of Davoster, as the active substance may be absorbed through the skin. In case of skin contact, wash the affected area immediately with soap and water.
Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking dutasteride. If your partner is pregnant or may be pregnant, avoid exposing her to contact with semen, because dutasteride may impair the development of a male fetus. 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. Despite this, your doctor may deliberately order this test to detect prostate cancer. If you are having PSA testing, inform your doctor that you are taking Davoster. Men taking Davoster should have their PSA levels monitored regularly.
In a clinical study involving patients with an increased risk of prostate cancer, a more severe form of prostate cancer was diagnosed more frequently in patients taking dutasteride than in those not taking dutasteride. The effect of dutasteride on high-grade prostate cancer is not clear.
Davoster may cause breast enlargement and tenderness. If this becomes bothersome, or if you feel lumps in your breasts or notice nipple discharge, 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 using Davoster, contact your doctor or
pharmacist.
Davoster and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking,
have recently taken, or plan to take.
Some medicines may interact with Davoster and increase the likelihood of
adverse 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-blocking drugs (used to treat benign prostatic hyperplasia or high blood pressure).

Inform your doctor if you are taking any of these medicines. A dose reduction of Davoster may be necessary.
Taking Davoster with food and drink
Davoster can be taken with or without food.
Pregnancy, breastfeeding and effects on fertility
Women who are pregnant (or who may become pregnant) must not handle damaged capsules. Dutasteride is
absorbed through the skin and may impair the development of a male fetus. The risk is particularly high during
the first 16 weeks of pregnancy.
Use a condom during sexual intercourse. Dutasteride has been detected in the semen of
men taking Davoster. If your partner is pregnant or may be 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 been exposed to dutasteride, seek immediate medical advice from a doctor.
Driving and operating machinery
It is unlikely that Davoster will affect the ability to drive or operate machinery.
Davoster contains soya lecithin and propylene glycol
Davoster contains soya lecithin (may contain soya oil). This medicine should not be used by
persons allergic to peanuts or soya.
Davoster contains 299.46 mg of propylene glycol monocaprylate in each capsule.
Mood changes and depression
In patients taking orally another medicine from the same therapeutic group (5-alpha reductase inhibitor), depressive mood, depression and, less frequently, suicidal thoughts have been reported. If any of these symptoms occur, seek immediate medical advice from your doctor.

3. How to use Davoster

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Irregular use of this medicine may affect monitored PSA levels.
Recommended dose
The usual dose is one capsule (0.5 mg) taken once daily. The capsule should be swallowed whole
with water. Do not chew or open the capsule. Contact with the capsule contents may cause
oral discomfort or sore throat.
Davoster is intended for long-term use. Some men may experience symptom relief early in treatment.
However, others may require treatment with Davoster for 6 months or longer to achieve improvement.
Continue taking Davoster for as long as your doctor recommends.
Taking more Davoster than recommended
If you take more Davoster capsules than recommended, consult your doctor or pharmacist immediately.
If you miss a dose of Davoster
Do not take a double dose to make up for a missed dose.
Take the next dose at the usual time and continue as directed.
Stopping Davoster treatment
Do not stop taking Davoster unless your doctor advises you to do so. Treatment for 6 months or longer may be necessary to achieve improvement.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Allergic reactions
Symptoms of an allergic reaction may include:

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

If any of these symptoms occur, stop taking Davoster and contact a doctor immediately.
Common adverse effects (may occur in up to 1 in 10 men):

inability to achieve or maintain an erection (impotence), which may persist after stopping Davoster;
decreased sexual desire (libido), which may persist after stopping Davoster;
difficulties with ejaculation, including reduced semen volume during ejaculation, which may persist after stopping Davoster;
enlargement or tenderness of the breasts (gynecomastia);
dizziness when used with tamsulosin.

Uncommon adverse effects (may occur in up to 1 in 100 men):

heart failure (reduced heart function; possible symptoms include shortness of breath, extreme fatigue, and swelling in the ankles and lower limbs);
hair loss (usually loss of body hair) or excessive hair growth.

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

depression;
pain and swelling of the testicles.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Davoster

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or foil blister pack. The expiry date refers to the last day of the specified month.
Do not store above 30°C.
Store in the outer packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Davoster contains

The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.
Other components are:
- Inside the capsule: butylhydroxytoluene (E 321) and propylene glycol monocaprylate, Type II;
- Capsule shell: gelatin, glycerol, titanium dioxide (E 171), medium-chain saturated fatty acid triglycerides, soybean lecithin.

What Davoster looks like and contents of the pack
Davoster soft capsules are elongated, 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 three-layer PVC/PE/PVDC-Aluminium blister sealed in a cardboard box) containing 10, 30, 50, 60 or 90 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following names:
Denmark: Dutasteride Universal Farma
Poland: Davoster
Slovenia: Amdut 0.5 mg mehke capsule
Italy: VIVISTER