PRODUTAL 0.5 MG Miękka kapsułka

Treść ulotki

1. PRODUTAL 0,5 mg soft capsules
   1. What is PRODUTAL and what is it used for
   2. What you need to know before taking PRODUTAL
   3. How to take PRODUTAL
   4. Possible side effects
   5. How to store PRODUTAL
   6. Contents of the pack and other information

PRODUTAL 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, pharmacist or nurse.
• 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, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is PRODUTAL and what is it used for

The active ingredient is dutasteride, which belongs to a group of medicines called 5-alpha reductase inhibitors.
PRODUTAL is used to treat men with an enlarged prostate (benign prostatic hyperplasia) - a non-cancerous
growth of the prostate gland caused by the excessive production of a hormone called dihydrotestosterone.
An enlarged prostate can cause urinary problems, such as difficulty urinating and the urge to go to the
bathroom frequently. It can also make the urine flow slower and less powerful. If left untreated, there is a
risk that the urine flow may be completely blocked (acute urinary retention). This requires immediate medical
treatment. In some situations, surgery is necessary to remove or reduce the size of the prostate. Dutasteride
lowers the production of dihydrotestosterone and this helps to reduce the size of the prostate and relieve the
symptoms. This will reduce the risk of acute urinary retention and the need for surgery.
PRODUTAL can also be used with another medicine called tamsulosin (used for the treatment of the symptoms
of an enlarged prostate).

2. What you need to know before taking PRODUTAL

Do not take PRODUTAL

• 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;
• if you are a child or adolescent.

Tell your doctor if you think any of these conditions apply to you.

This medicine is only for men.It should not be used by women, children or adolescents.

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

• Make sure your doctor is aware of any liver problems you have.If you have had any liver disease, you may need some additional checks while taking PRODUTAL.
• Women, children and adolescentsshould not handle broken PRODUTAL capsules, as the active ingredient can be absorbed through the skin. If it comes into contact with the skin, wash the affected area immediatelywith soap and water.
• Use a condom during sexual intercourse.Dutasteride has been found in the semen of men taking PRODUTAL. If your partner is or may be pregnant, you should avoid exposing her to your semen as PRODUTAL may affect the normal development of a male child. Dutasteride has been shown to decrease sperm count, semen volume and sperm motility. This may reduce your fertility.
• PRODUTAL affects the blood test for PSA(prostate-specific antigen), which is sometimes used to detect prostate cancer. Your doctor needs to be aware of this effect and may still use the test to detect prostate cancer. If you are having a PSA test, tell your doctor that you are taking PRODUTAL. Men taking PRODUTAL should have regular PSA checks.
• In a clinical study conducted on men at increased risk of prostate cancer, men taking dutasteride had a more frequent occurrence of high-grade prostate cancer compared to men not taking dutasteride. The effect of dutasteride on this high-grade cancer is unclear.
• PRODUTAL may cause breast enlargement and pain.If this becomes a problem or if you notice lumps in your breasts or nipple discharge, you should tell your doctor about these changes as they may be signs of a serious condition, such as breast cancer.

Contact your doctor or pharmacist if you have any doubts about taking PRODUTAL.

Other medicines and PRODUTAL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Some medicines can react with PRODUTAL and may increase the possibility 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).

Tell your doctor if you are taking any of these medicines. The dose of PRODUTAL may need to be
reduced.

PRODUTAL with food and drink
PRODUTAL can be taken with or without food.

Pregnancy, breastfeeding and fertility
Women should not take PRODUTAL.

Women who are (or may be) pregnant should not handle broken capsules.
Dutasteride is absorbed through the skin and can affect the normal development of a male baby. This is
particularly risky during the first 16 weeks of pregnancy. Contact your doctor for advice if a
pregnant woman has come into contact with dutasteride.

Use a condom during sexual intercourse.
PRODUTAL has been found in the semen of men taking this medicine. If your
partner is or may be pregnant, you should avoid exposing her to your semen.
Dutasteride has been shown to decrease sperm count, semen volume and sperm motility.
Therefore, male fertility may be reduced.

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

PRODUTAL contains soy lecithin
This medicine contains soy lecithin, which may contain soy oil. If you are allergic to peanuts or
soy, do not use this medicine.

3. How to take PRODUTAL

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist. If you do not take it regularly, monitoring of PSA levels may be
affected.
How much to take:

The recommended doseis one capsule (0.5 mg) taken once a day. The capsules should be
swallowed whole with a little water. Do not chew or open the capsule. Contact with the capsule contents may
cause pain in your mouth or throat.
PRODUTAL is a long-term treatment. Some men notice an early improvement in their
symptoms. However, others may need to take PRODUTAL for 6 months or longer before it begins
to have an effect. Continue to take PRODUTAL for as long as your doctor has prescribed it.

If you take more PRODUTAL than you should
Contact your doctor or pharmacist if you take more capsules of PRODUTAL than prescribed.

If you forget to take PRODUTAL
Do not take a double dose to make up for a missed dose. Simply take the next
dose at the usual time.

Do not stop taking PRODUTAL
Do not stop taking PRODUTAL without first talking to your doctor. It may
take 6 months or more to notice an effect.
If you have any further questions on 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
Signs of allergic reactions may include:

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

Contact your doctor immediatelyif you experience any of these symptoms and stop taking
PRODUTAL.

Common side effects
May affect up to 1 in 10 people treated with PRODUTAL

• Inability to achieve or maintain an erection (impotence)* this may continue after you stop taking PRODUTAL;
• Decreased sexual drive (libido)* this may continue after you stop taking PRODUTAL;
• Difficulty ejaculating, such as a decrease in the amount of semen released during sexual intercourse, this may continue after you stop taking PRODUTAL;
• Enlargement of the breasts or breast pain (gynecomastia);
• Dizziness when taken with tamsulosin.

Uncommon side effects
May affect up to 1 in 100 men taking PRODUTAL

• Heart failure (the heart becomes less efficient at pumping blood around the body). Symptoms may include shortness of breath, extreme fatigue and swelling of the ankles and legs;
• Hair loss (usually from the body) or hair growth.

Side effects with unknown frequency
The frequency cannot be estimated based on available data

• Depression;
• Pain and swelling of the testicles.

If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at 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 PRODUTAL

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 blister after Exp.. 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 moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What PRODUTAL contains

• The active ingredient is dutasteride. Each capsule contains 0.5 mg of dutasteride.
• The other ingredients are: Capsule content:glycerol monocaprylocaprate (Type I), butylhydroxytoluene (E321) Capsule shell:gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), triglycerides (medium chain), lecithin (may contain soybean oil) (E332) and purified water.

Description of the appearance of PRODUTAL and contents of the pack
PRODUTAL soft capsules are soft gelatin capsules of size 6, oblong in shape, opaque and
yellow, with an oily and yellowish liquid inside.
It is available in packs of 30 capsules.
The soft capsules have these dimensions: 19 ± 0.8 mm x 6.9 ± 0.4 mm.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Farma Group S.r.l.,
Via Farfisa, 18
60021 Camerano (AN)

Manufacturers responsible for batch release
Galenicum Health S.L.
Avda. Cornellá 144, 7º-1ª, Edificio Lekla
Esplugues de Llobregat
08950 Barcelona, Spain
Cyndea Pharma, S.L
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda, 31 Olvega, 42110,
Soria, Spain
Pharmadox Healthcare, Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000, Malta

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
IT: PRODUTAL