Dutasteride Doc Generici

Package leaflet: Information for the patient

DUTASTERIDE DOC Generici 0.5 mg soft capsules

Generic medicine
Please read all of this leaflet carefully before you start 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What is DUTASTERIDE DOC Generici and what is it used for?

DUTASTERIDE DOC Generici is used for the treatment of men with enlarged prostate
( benign prostatic hyperplasia ) – a non-cancerous growth in the size of the prostate gland caused by excessive
production of a hormone called dihydrotestosterone.
The active substance is dutasteride. It belongs to a class of medicines known as 5-alpha reductase inhibitors.
An enlarged prostate can cause urinary problems such as difficulty urinating and the need to urinate frequently.
It may also result in a weaker and less forceful urine 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. DUTASTERIDE DOC Generici reduces the production of dihydrotestosterone, helping to shrink the size of the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgical intervention.
DUTASTERIDE DOC Generici 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 DOC Generici

Do not take DUTASTERIDE DOC Generici

• 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 think any of the above apply to you, do not take this medicine without first consulting your doctor.
This medicine is intended only for men. It must not be taken by women, children, or adolescents.

Warnings and precautions

Talk to your doctor before taking DUTASTERIDE DOC Generici.

• Make sure your doctor is aware of any liver problems you may have. If you have previously suffered from any liver disease, you may require additional monitoring during treatment with DUTASTERIDE DOC Generici.
• Women, children, and adolescents must not handle broken (crushed) capsules of DUTASTERIDE DOC Generici, as the active ingredient may be absorbed through the skin. Wash immediately with soap and water the affected area in case of any skin contact.
• 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 affect 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 DOC Generici affects blood tests measuring PSA (prostate-specific antigen), which are sometimes used to detect prostate cancer. Your doctor should be aware of this effect and may still use the PSA blood test to detect prostate cancer. If you are due to have a PSA test, inform your doctor that you are taking DUTASTERIDE DOC Generici. Men taking DUTASTERIDE DOC Generici should have regular PSA checks.
• In a clinical study conducted in men at higher risk of prostate cancer, patients treated with dutasteride developed a more frequent occurrence of aggressive forms of prostate cancer compared to patients not taking dutasteride. The effect of dutasteride on this aggressive form of prostate cancer is not fully understood.
• DUTASTERIDE DOC Generici may cause breast enlargement and breast tenderness. If this becomes bothersome, or if you notice lumps in the breast or nipple discharge, inform your doctor of these changes, as they may be signs of a serious condition, such as breast cancer.

Mood changes and depression
In patients treated with another medicine of the same therapeutic class (oral 5-alpha-reductase inhibitors), depressive mood, depression, and less frequently suicidal thoughts have been reported. 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 the use of DUTASTERIDE DOC Generici.

Other medicines and DUTASTERIDE DOC Generici
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Some medicines may interact with DUTASTERIDE DOC Generici and increase the likelihood of experiencing 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 DUTASTERIDE DOC Generici.

DUTASTERIDE DOC Generici with food and drink
DUTASTERIDE DOC Generici can be taken with or without food.

Pregnancy, breastfeeding and fertility
Women who are (or may be) pregnant must not handle broken (crushed) capsules. Dutasteride can be absorbed through the skin and may impair 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 DOC Generici. If your partner is pregnant or could be pregnant, you must avoid exposing her to your semen.
It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility. Therefore, male fertility may be reduced.
Ask your doctor for advice if a pregnant woman has been exposed to dutasteride.

Driving and using machines
It is unlikely that DUTASTERIDE DOC Generici affects the ability to drive or use machinery.
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DUTASTERIDE DOC Generici contains soy lecithin
This medicine contains soy lecithin, which may contain soybean oil. If you are allergic to peanuts or soy, do not use this medicine.

3. How to take DUTASTERIDE DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist. If you do not take the medicine regularly, monitoring of your PSA levels may be affected. If you have any doubts, contact your doctor or pharmacist.
How much medicine to take

• 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 capsule contents may cause mouth or throat irritation.
• DUTASTERIDE DOC Generici is a long-term treatment. Some men notice an early improvement in symptoms. However, others may need to take DUTASTERIDE DOC Generici for 6 months or longer before an effect is noticed. Continue taking DUTASTERIDE DOC Generici for the duration prescribed by your doctor.

If you take more DUTASTERIDE DOC Generici than you should
Consult your doctor or pharmacist if you have taken too many DUTASTERIDE DOC Generici capsules.
If you forget to take DUTASTERIDE DOC Generici
Do not take a double dose to make up for the forgotten dose.
Take the next dose at your usual time.
Do not stop treatment with DUTASTERIDE DOC Generici without medical advice
Do not stop taking DUTASTERIDE DOC Generici without first talking to your doctor.
It may take 6 months or longer before you 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 everybody gets them.
Allergic reaction
Signs of an allergic reaction may include:

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

Contact your doctor immediately if you notice any of these symptoms and stop taking DUTASTERIDE DOC Generici.
Common side effects
These may affect up to 1 in 10 men taking DUTASTERIDE DOC Generici:

• inability to achieve or maintain an erection (impotence); this may continue even after stopping DUTASTERIDE DOC Generici
• decreased sexual desire (libido); this may continue even after stopping DUTASTERIDE DOC Generici
• problems with ejaculation, such as a decrease in the amount of semen released during sexual intercourse; this may continue even after stopping DUTASTERIDE DOC Generici
• breast enlargement or breast tenderness (gynaecomastia)
• dizziness when also taking tamsulosin.

Uncommon side effects
These may affect up to 1 in 100 men taking DUTASTERIDE DOC Generici:

• heart failure (the heart becomes less efficient at pumping blood around the body. Symptoms may include breathlessness, extreme tiredness, and swelling of the ankles and legs)
• hair loss (generally from the body) or hair growth

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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 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 DOC Generici

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 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 DUTASTERIDE DOC Generici contains
The active substance is dutasteride.
Each soft capsule contains 0.5 mg of dutasteride.
The other components are:

• Capsule contents: monoglycerides of caprylic/capric acid (type I), butylhydroxytoluene (E321).
• Capsule shell: gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), triglycerides (medium chain), lecithin (may contain soybean oil) (E322), purified water.

Description of the appearance of DUTASTERIDE DOC Generici and package contents
DUTASTERIDE DOC Generici soft capsules are oblong, soft gelatin capsules, opaque and yellow in colour, containing a yellowish oily liquid. The capsule dimensions are 19 ± 0.8 mm x 6.9 ± 0.4 mm.
DUTASTERIDE DOC Generici soft capsules are available in pack sizes of 30 and 60 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici srl
Via Turati 40,
20121 Milan, Italy

Manufacturers
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 A-I, km.36
28750 San Agustín del Guadalix (Madrid) - Spain
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This medicinal product is authorised in the European Economic Area countries under the following names:
Malta: Dutasteride Doc Generici 0.5 mg soft capsules
Italy: DUTASTERIDE DOC Generici
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