Patient Information Leaflet: Information for the User

PRODUXEN 0.5 mg Soft Capsules

Dutasteride
"Generic medicinal product"
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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What PRODUXEN is and what it is used for

PRODUXEN is used to treat men who suffer from an enlarged prostate
(benign prostatic hyperplasia) – a non-cancerous increase in the size of the prostate gland caused by the production of excessive amounts of a hormone called dihydrotestosterone.
The active substance of this medicine is dutasteride. It belongs to a group of medicines called 5-alpha-reductase inhibitors.
An enlarged prostate can over time cause urinary problems, such as difficulty in passing urine and the need to urinate frequently. It may also make the urine stream slower and weaker. If the enlargement is not treated, there is a risk of complete blockage of urine flow (acute urinary retention), which requires immediate medical treatment. In some cases, surgery may be needed to remove the prostate gland or reduce its size. PRODUXEN reduces the production of dihydrotestosterone, helping to decrease the size of the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgical intervention.
PRODUXEN may also be used together with another medicine called tamsulosin (used to treat symptoms of an enlarged prostate).

2. What you need to know before taking PRODUXEN

Do not take PRODUXEN

if you are allergic to dutasteride, to 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. If you think any of these situations apply to you, do not take this medicine until you have consulted your doctor.
This medicine is intended for men only. It must not be used by women, children, or adolescents.

Warnings and precautions
Talk to your doctor before taking PRODUXEN

Make sure your doctor is aware of any liver problems you may have. If you have previously suffered from liver disease, you may require additional monitoring during treatment with PRODUXEN.
Women, children, and adolescents must avoid contact with damaged PRODUXEN capsules, as the active ingredient can be absorbed through the skin. If skin contact occurs, the affected area should be washed 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 or could be pregnant, you must avoid exposing her to your semen, as dutasteride may impair the normal development of a male fetus. Dutasteride has been shown to reduce sperm count, volume, and motility. This may reduce fertility.
PRODUXEN affects a blood test measuring PSA (prostate-specific antigen), which is sometimes used to detect prostate cancer. Your doctor should be informed of this effect and may still use this test to screen for prostate cancer. If you undergo a blood test to measure PSA, inform your doctor that you are taking PRODUXEN. Men taking PRODUXEN should have periodic PSA checks.
In a clinical study conducted in men at increased risk of prostate cancer, men treated with dutasteride developed a more aggressive form of prostate cancer more frequently than men not treated with dutasteride. The effect of dutasteride on this aggressive form of prostate cancer is not fully understood.
PRODUXEN may cause breast enlargement and tenderness. If this effect causes discomfort, or if you notice breast lumps or nipple discharge, inform your doctor about these changes, as they may be signs of a serious condition, such as breast cancer. Consult your doctor or pharmacist if you have any doubts about the use of PRODUXEN.

Other medicines and PRODUXEN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may interact with PRODUXEN and increase the risk of side effects. These 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 PRODUXEN.

PRODUXEN with food and drink
PRODUXEN can be taken with or without food.
Pregnancy, breastfeeding, and fertility
Pregnant women (or those who might be pregnant) must avoid any contact with damaged capsules. Dutasteride can be absorbed through the skin and may impair the normal development of a male fetus. This risk is particularly present during the first 16 weeks of pregnancy.
Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking PRODUXEN. If your partner is or suspects she might be pregnant, you must avoid exposing her to your semen.
Dutasteride has been shown to reduce sperm count, volume, and motility. Therefore, it may reduce male fertility.
Contact your doctor immediately if a pregnant woman has been exposed to dutasteride.
Driving and using machines
It is unlikely that PRODUXEN will affect your ability to drive or operate machinery.
PRODUXEN contains soy lecithin and 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 propylene glycol monocaprylate in each capsule.

3. How to take PRODUXEN

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 your PSA levels may be affected.
Recommended dose
The recommended dose is one capsule (0.5 mg) once daily. Swallow the capsule whole with water. Do not chew or open the capsule. Contact with the capsule contents may cause pain in the mouth or throat. The capsule may be taken with or without food.
PRODUXEN is a long-term treatment. Some men notice a rapid improvement in symptoms, while others may need to take PRODUXEN for 6 months or longer before experiencing an effect. Continue taking PRODUXEN for as long as directed by your doctor.
If you take more PRODUXEN than you should
Contact your doctor or pharmacist for advice if you take too many PRODUXEN capsules.
If you forget to take PRODUXEN
Do not take a double dose to make up for the forgotten dose. Take the next dose at the usual time.
If you stop taking PRODUXEN
Do not stop taking PRODUXEN without first talking to your doctor. It may take up to 6 months or longer to achieve 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 experiences them.
Allergic reaction
Signs of allergic reactions may include:

skin rash (which may cause itching);
hives (such as redness and itching);
swelling of the eyelids, face, lips, arms or legs. Stop taking PRODUXEN and contact your doctor immediately if you notice any of these symptoms.

Common side effects (may affect up to 1 in 10 men):

inability to achieve or maintain an erection (impotence), which may continue after stopping PRODUXEN;
decreased sex drive (libido), which may continue after stopping PRODUXEN;
ejaculation difficulties, such as a reduced amount of semen released during sexual intercourse, which may continue after stopping PRODUXEN;
enlargement or tenderness of the breasts (gynecomastia);
dizziness if taken together with tamsulosin.

Uncommon side effects (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 loss of body hair) or excessive hair growth.

Side effects of unknown frequency (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, pharmacist or nurse. You can also report side effects directly via the national reporting system at the website 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 PRODUXEN

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 on the blister pack.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine 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 PRODUXEN contains

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

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

Marketing Authorization Holder
S&R Farmaceutici S.p.a.
Via dei Pioppi n.2
06083 Bastia Umbra (PG)
Italy

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

This medicinal product is authorized in the European Economic Area countries under the following names:
DK: Dutasteride Medical Valley
NO: Dutasteride Medical Valley, 0.5 mg myke capsules
SE: Dutasteride Medical Valley
IT: PRODUXEN