Package leaflet: Information for the user

Dutasteride Zentiva 0.5 mg soft capsules

Generic medicine
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Dutasteride Zentiva is used to treat men with an enlarged prostate
( benign prostatic hyperplasia ) – a non-cancerous enlargement of the prostate gland caused by excessive production of a hormone called dihydrotestosterone.
The active substance of this medicine is dutasteride. It belongs to a class of medicines known as 5-alpha reductase inhibitors.
An enlarged prostate can lead to urinary problems such as difficulty passing urine and the need to urinate frequently. This may also result in a weaker and slower urinary stream. If left untreated, there is a risk that urine flow may become completely blocked ( acute urinary retention ), which requires immediate medical treatment.
In some cases, surgery may be needed to remove or reduce the size of the prostate gland. Dutasteride Zentiva reduces the production of dihydrotestosterone, thereby decreasing prostate volume and relieving symptoms. This reduces the risk of acute urinary retention and the need for surgical intervention.
Dutasteride Zentiva may also be used in combination with another medicine called tamsulosin (used to treat symptoms of an enlarged prostate).

2. What you need to know before taking Dutasteride Zentiva

Do not take Dutasteride Zentiva

if you are allergic to dutasteride, to other 5-alpha reductase inhibitors, to soy, to peanuts, or to any of the other ingredients of this medicine (listed in section 6);
if you have severe liver disease. Inform your doctor if you think any of the conditions listed above apply to you. This medicine is intended for men only. It must not be taken by women, children or adolescents.

Warnings and precautions
Talk to your doctor or pharmacist before taking Dutasteride Zentiva.

Make sure your doctor is aware of any liver problems you may have. If you have had any liver disease, additional monitoring may be required while you are taking Dutasteride Zentiva.
Women, children and adolescents must not handle damaged or leaking capsules of Dutasteride Zentiva, because the active substance can be absorbed through the skin. In case of skin contact, wash the affected area immediately with water and soap.
Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking dutasteride. If your partner is or may be pregnant, you must avoid exposing her to your semen, as dutasteride may interfere with the normal development of a male fetus. It has been shown that dutasteride reduces sperm count, semen volume and sperm motility. This may reduce your fertility.
Dutasteride Zentiva affects the blood test used to measure PSA (prostate-specific antigen), which is sometimes used to detect prostate cancer. Your doctor should be aware of this effect and may still recommend the test to check for prostate cancer. If you are due to have a blood test to measure PSA, inform your doctor that you are taking Dutasteride Zentiva. Men taking Dutasteride Zentiva should have regular PSA checks.
In a clinical study conducted in men at increased risk of prostate cancer, men taking dutasteride developed a higher incidence of high-grade prostate cancer compared to men not taking dutasteride. The effect of dutasteride on this high-grade form of prostate cancer is not clear.
Dutasteride Zentiva may cause breast enlargement and tenderness. If this becomes bothersome, or if you notice breast lumps or nipple discharge, speak to your doctor about these changes, as they may be signs of a serious condition, such as breast cancer.

Talk to your doctor or pharmacist if you have any doubts about taking Dutasteride Zentiva.
Other medicines and Dutasteride Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may interact with Dutasteride Zentiva and increase the likelihood of side effects. These medicines include:

Verapamil or diltiazem (for high blood pressure).
Ritonavir or indinavir (for HIV).
Itraconazole or ketoconazole (for fungal infections).
Nefazodone (an antidepressant).
Alpha-blockers (for enlarged prostate or high blood pressure).

Inform your doctor if you are taking any of these medicines. It may be necessary to reduce the dose of Dutasteride Zentiva.
Dutasteride Zentiva with food and drink
Dutasteride Zentiva can be taken with or without food.
Pregnancy, breastfeeding and fertility
Women who are pregnant (or who may be pregnant) must not handle damaged or leaking capsules. Dutasteride is absorbed through the skin and may interfere with the normal development of a male fetus. This is particularly risky during the first 16 weeks of pregnancy.
Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Dutasteride Zentiva. If your partner is pregnant or suspects she may be pregnant, you must avoid exposing her to your semen.
Dutasteride reduces sperm count, semen volume and sperm motility. Therefore, male fertility may be reduced.
Consult your doctor if a pregnant woman has been exposed to dutasteride.
Driving and using machines
It is unlikely that Dutasteride Zentiva will affect your ability to drive or operate machinery.
Dutasteride Zentiva contains soy lecithin and monocaprylate propylene glycol
This medicine contains soy lecithin, which may contain soybean oil. If you are allergic to peanuts or soy, do not use this medicine.
This medicine contains 299.46 mg of monocaprylate propylene glycol in each capsule.

3. How to take Dutasteride Zentiva

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
If you do not take it regularly, monitoring of PSA levels may be affected.
Recommended dose
The usual dose is one capsule (0.5 mg) taken once daily. Swallow the capsules whole with water. Do not chew or open the capsules. Contact with the contents of the capsules may irritate the mouth or throat. The capsules may be taken with or without food.
Treatment with Dutasteride Zentiva is long-term. Some men may notice an early improvement in their symptoms. However, others may need to take Dutasteride Zentiva for 6 months or longer before it starts to work. Continue taking Dutasteride Zentiva for as long as your doctor recommends.
If you take more Dutasteride Zentiva than you should
Contact your doctor or pharmacist for advice if you take too many capsules of Dutasteride Zentiva.
If you forget to take Dutasteride Zentiva
Do not take a double dose to make up for the missed dose. Simply take the next dose at the usual time.
If you stop taking Dutasteride Zentiva
Do not stop taking Dutasteride Zentiva without first consulting your doctor. It may take 6 months or longer to notice an effect.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Allergic reaction
Signs of allergic reactions may include:

skin rash (which may cause itching)
hives (similar to redness with itching)
swelling of the eyelids, face, lips, arms or legs.

Contact your doctor immediately if you experience any of these symptoms, and stop taking Dutasteride Zentiva.
Common (may affect up to 1 in 10 men):

inability to achieve or maintain an erection (impotence), which may continue after stopping Dutasteride Zentiva
decreased sexual desire (libido), which may continue after stopping Dutasteride Zentiva
problems with ejaculation, such as reduced amount of semen released during sexual activity, which may continue after stopping Dutasteride Zentiva
breast enlargement or tenderness (gynecomastia)
dizziness when taking tamsulosin.

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

heart failure (the heart pumps blood around the body less efficiently). You may develop symptoms such as shortness of breath, extreme tiredness, and swelling of the ankles and legs
hair loss (generally from the body) or hair growth.

Frequency not known (frequency cannot be estimated from the available data):

depression
pain and swelling of the testicles.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dutasteride Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep the blister in the outer packaging to protect the medicine from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Dutasteride Zentiva contains

The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.
The other components are:
capsule contents: propylene glycol monocaprylate and butylhydroxytoluene.
capsule shell: gelatin, glycerol, titanium dioxide (E171), medium-chain triglycerides, lecithin (may contain soybean oil) (E322).

Description of the appearance of Dutasteride Zentiva and contents of the pack
Dutasteride Zentiva soft capsules are light yellow, elongated (approximately 16.5 x 6.5 mm) gelatin capsules filled with a clear liquid. They are available in packs (Triplex (PVC-PE-PVDC)/transparent aluminum blisters) containing 10, 30, 50, 60 and 90 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Zentiva Italia S.r.l. – Viale L. Bodio n. 37/B, 20158 Milan, Italy

Manufacturer
Laboratorios LEÓN FARMA, S.A.
Polígono Industrial Navatejera
C/La Vallina, s/n - 24008 Navatejera - León
Spain

This medicinal product is authorised in other EEA Member States under the following names:
Denmark, Poland: Dutasterid Zentiva
France: Dutasteride Zentiva
United Kingdom: Dutasteride
Italy: Dutasteride Zentiva
Romania: Dutasteridă Zentiva
Portugal: Dutasteridă Zentiva