Produtal

Package leaflet: Information for the patient

PRODUTAL 0.5 mg soft capsules

Dutasteride
Equivalent medicine
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, pharmacist or nurse.
• 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 side effect, including those not listed in this leaflet, talk to 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 taking 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 PRODUTAL is and what it is used for

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

2. What you should 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.

Inform your doctor if you think any of these conditions apply to you.
This medicine is for men only. It must not be used by women, children, or adolescents.
Warnings and precautions
Talk to your doctor or pharmacist before taking PRODUTAL.

• Make sure your doctor knows about any liver problems you have. If you have had any liver disease, you may need additional monitoring while taking PRODUTAL.
• Women, children, and adolescents must not handle crushed or damaged PRODUTAL capsules, as the active ingredient can 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 found in the semen of men taking PRODUTAL. If your partner is or could be pregnant, you must avoid exposing her to your semen, as PRODUTAL could affect the normal development of a male fetus. Dutasteride has been shown to reduce 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 should be aware of this effect and may still use the test to screen for prostate cancer. If you are having a PSA test, inform your doctor that you are taking PRODUTAL. Men taking PRODUTAL should have regular PSA checks.
• In a clinical study conducted in men at increased risk of prostate cancer, men taking dutasteride had 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.
• PRODUTAL may cause breast enlargement and breast pain. If this becomes a problem, or if you notice lumps in the breast or nipple discharge, inform your doctor, as these may be signs of a serious condition, such as breast cancer.

Mood changes and depression
Depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with another medicine of the same therapeutic class (oral 5-alpha reductase inhibitors). If any of these symptoms occur, contact your doctor as soon as possible for further advice.
Contact your doctor or pharmacist if you have any doubts about taking PRODUTAL.
Other medicines and PRODUTAL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may interact with PRODUTAL and increase the risk 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. 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 must not take PRODUTAL.
Women who are (or might be) pregnant must not handle crushed or damaged capsules.
Dutasteride can be absorbed through the skin and may affect the normal development of a male fetus. This is particularly risky during the first 16 weeks of pregnancy. Contact your doctor for advice if a pregnant woman has been exposed to dutasteride.
Use a condom during sexual intercourse.
PRODUTAL has been found in the semen of men taking this medicine. If your partner is or might be pregnant, you must avoid exposing her to your semen.
Dutasteride has been shown to reduce 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 soybean lecithin
This medicine contains soybean lecithin, which may contain soybean oil. If you are allergic to peanuts or soy, do not use this medicine.

3. How to take PRODUTAL

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
If you do not take it regularly, monitoring of PSA levels may be affected.

How much to take:
The recommended dose is one capsule (0.5 mg) taken once daily. The capsules should be swallowed whole with some water. Do not chew or open the capsule. Contact with the contents of the capsule may cause you pain in the 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 starts to have an effect. Continue taking 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 PRODUTAL capsules than prescribed.

If you forget to take PRODUTAL
Do not take a double dose to make up for the forgotten 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 longer to notice an effect.

If you have any questions about how to use this medicine, ask 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 be itchy)
• Hives (urticaria)
• Swelling of the eyelids, face, lips, arms or legs

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

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

• Inability to achieve or maintain an erection (impotence)*, which may continue after stopping PRODUTAL;
• Decreased sexual desire (libido)*, which may continue after stopping PRODUTAL;
• Ejaculation disorders, such as reduced amount of semen released during sexual intercourse, which may continue after stopping PRODUTAL;
• Enlargement of the breasts or breast pain (gynecomastia);
• Dizziness when taken together 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 tiredness, and swelling of the ankles and legs;
• Loss of body hair or excessive hair growth.

Side effects with unknown frequency
Frequency cannot be estimated from the available data

• Depression;
• Pain and swelling of the testicles.

If a side effect worsens, or if you notice any side effect not listed in this leaflet, consult your doctor.

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 PRODUTAL

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 blister after Exp..
The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep in the original packaging to protect the medicine from moisture.
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 PRODUTAL contains

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

Description of the appearance of PRODUTAL and contents of the pack
PRODUTAL soft capsules are size 6, oblong-shaped, opaque, yellow soft gelatin capsules containing a yellowish oily liquid.
Available in packs of 30 capsules.
The soft capsules have the following dimensions: 19 ± 0.8 mm x 6.9 ± 0.4 mm.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Farma Group S.r.l.,
Via Farfisa, 18
60021 Camerano (AN)

Manufacturers responsible for batch release
Galenicum Health S.L.U.
Calle Sant Gabriel, 50, Esplugues de Llobregat, 08950,
Barcelona, Spain
Cyndea Pharma, S.L
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda, 31 Olvega, 42110,
Soria, Spain
SAG Manufacturing S.L.U.
Ctra. N-I, Km 36
28750 San Agustín de Guadalix
Madrid, Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
IT: PRODUTAL