PRODUXEN 0.5 MG Софт капсула

Содержание инструкции

1. PRODUXEN 0.5 mg soft capsules
   1. What is PRODUXEN and what is it used for
   2. What you need to know before taking PRODUXEN
   3. How to take PRODUXEN
   4. Possible side effects
   5. How to store PRODUXEN
   6. Contents of the pack and other information

PRODUXEN 0.5 mg soft capsules

Dutasteride
“Generic medicine”

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is PRODUXEN and what is it used for

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

2. What you need to know before taking PRODUXEN

Do not take PRODUXEN

• if you are allergic to dutasteride, 5-alpha reductase inhibitors, soybeans, peanuts or any of the other ingredients of this medicine (listed in section 6).
• if you have a severe liver disease. If you think any of these apply to you,do nottake this medicine until you have checked with your doctor.
• This medicine is intended for use by men only. It should 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 have. If you have suffered from a liver disease, you may need additional checks during treatment with PRODUXEN.
• Women, children and adolescents should avoid contact with broken PRODUXEN capsules because the active ingredient can be absorbed through the skin. The affected area should be washed immediately with water and soap if contact with the skin occurs.
• Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking dutasteride. If your partner is or may be pregnant, you should 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 alters a blood test for measuring PSA (prostate-specific antigen) which is sometimes used to detect prostate cancer. Your doctor must be informed of this effect and may still use this test to detect prostate cancer. If you are undergoing a blood test to measure PSA, tell your doctor that you are taking PRODUXEN. Men taking PRODUXEN should undergo periodic PSA checks.
• In a clinical study conducted on men at increased risk of prostate cancer, men treated with dutasteride developed a severe form of prostate cancer more often than men not treated with dutasteride. The effect of dutasteride on this severe form of prostate cancer is unclear.
• PRODUXEN can cause enlargement and tenderness of the breasts. If this effect causes you discomfort or if you notice lumps in the breasts or nipple discharge, you should inform your doctor of these changes as they may be signs of a serious illness, such as breast cancer. Talk to your doctor or pharmacist if you have any doubts about using 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 can interact with PRODUXEN and may increase the possibility of having
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). Tell 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 may become pregnant) should avoid any contact with broken
capsules. Dutasteride is absorbed through the skin and can impair the normal development of
a male fetus. This risk is especially 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 is pregnant, you should 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 come into contact with
dutasteride.

Driving and using machines
It is unlikely that PRODUXEN will affect your ability to drive or operate machinery.

PRODUXEN contains soybean lecithin and propylene glycol
This medicine contains soybean lecithin which may contain soybean oil. If you are allergic to peanuts
or soybeans, 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 following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.
If you do not take it regularly, the monitoring of your PSA levels may be affected.

Recommended dose
The recommended dose is one capsule (0.5 mg) once a day. 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 can be taken with or without food.
PRODUXEN is a long-term treatment. Some men notice a rapid improvement
of symptoms, while others may need to take PRODUXEN for 6 months or more before
obtaining an effect. Continue to take PRODUXEN for as long as indicated by your doctor.

If you take more PRODUXEN than you should
Contact your doctor or pharmacist for advice if you take too many capsules of PRODUXEN.

If you forget to take PRODUXEN
Do not take a double dose to make up for a missed 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 more to obtain an effect.
If you have any doubts about the use of 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 reaction
The signs of allergic reactions can include:

• skin rash (which may be itchy);
• hives (like redness and itching);
• swelling of 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 people):

• inability to get or keep an erection (impotence), this may continue after stopping taking PRODUXEN;
• decreased sexual drive (libido), this may continue after stopping taking PRODUXEN;
• difficulty ejaculating, such as a decrease in the amount of semen released during sexual intercourse, this may continue after stopping taking PRODUXEN;
• enlargement or tenderness of the breasts (gynecomastia);
• dizziness when taken with tamsulosin.

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

• 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 ankles and legs);
• hair loss (generally loss of body hair) or excessive hair growth.

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

• depression
• pain and swelling of the testicles

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through 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 PRODUXEN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package or on the blister.
The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Store in the original package to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What PRODUXEN contains

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

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

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

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

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
DK: Dutasteride Medical Valley
NO: Dutasteride Medical Valley, 0.5 mg soft capsules
SE: Dutasteride Medical Valley
IT: PRODUXEN