Dutasteride PensA

Package leaflet: Information for the user

Dutasteride Pensa 0.5 mg soft capsules

Dutasteride
Generic medicine
Please read all of this leaflet carefully before you start 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 pass it on to other people, even if they have the same symptoms as you, because it may be harmful to them.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Dutasteride Pensa is and what it is used for

2. What you need to know before taking Dutasteride Pensa

3. How to take Dutasteride Pensa

4. Possible side effects

5. How to store Dutasteride Pensa

6. Contents of the pack and other information

7. What Dutasteride Pensa is and what it is used for
   The active substance is dutasteride. It belongs to a class of medicines called 5-alpha reductase inhibitors. Dutasteride Pensa 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 in urinating and a frequent need to go to the bathroom. It may also make the urine flow slower and weaker. If left untreated, there is a risk that the urinary flow becomes completely blocked (acute urinary retention). This requires immediate medical treatment. In some cases, surgery may be needed to remove or reduce the size of the prostate. Dutasteride Pensa reduces the production of dihydrotestosterone and helps shrink the size of the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgery. Dutasteride Pensa 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 Pensa

Do not take Dutasteride Pensa

• 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 an adolescent

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Inform your doctor if you think any of the above conditions apply to you.
This medicine is intended for use in men only. It must not be taken by women, children, or adolescents.

Warnings and precautions
Talk to your doctor before taking Dutasteride Pensa.

• In some clinical studies, a higher number of patients treated with dutasteride and another medicine called an alpha-blocker, such as tamsulosin, developed heart failure compared to patients treated with dutasteride alone or with an alpha-blocker alone. Heart failure is a condition in which the heart cannot pump blood properly.
• Ensure your doctor is aware of any liver problems you have. If you have had any liver disease, you may need additional monitoring during treatment with Dutasteride Pensa.
• Women, children, and adolescents must not handle broken (damaged) capsules of Dutasteride Pensa, as the active substance can be absorbed through the skin. Wash the affected area immediately with soap and water if any skin contact occurs.
• 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 Pensa affects the blood test used to measure 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 PSA blood test to screen for prostate cancer. If you are due for a PSA test, inform your doctor that you are taking Dutasteride Pensa. Men taking Dutasteride Pensa 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 severe form of prostate cancer more frequently than patients not taking dutasteride. The effect of dutasteride on this severe form of prostate cancer is not fully understood.
Dutasteride Pensa 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 about 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 in 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.

Talk to your doctor or pharmacist if you have any doubts about using Dutasteride Pensa.

Other medicines and Dutasteride Pensa
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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Some medicines may interact with Dutasteride Pensa and increase the likelihood 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. It may be necessary to reduce the dose of Dutasteride Pensa.

Dutasteride Pensa with food and drink
Dutasteride Pensa can be taken with or without food.

Pregnancy, breastfeeding and fertility
Women must not take Dutasteride Pensa.
Women who are (or may be) pregnant must not handle broken (damaged) 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. Consult your doctor if a pregnant woman has been exposed to dutasteride.
Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking dutasteride. If your partner is pregnant or may 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.

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

Dutasteride Pensa 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.

How to take Dutasteride Pensa
Take this medicine exactly as your doctor has instructed. If you have any doubts, contact your doctor or pharmacist. Failure to take the medicine regularly may affect the monitoring of your PSA levels.

How much medicine to take

• The recommended 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 pain in the mouth or throat.

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• Dutasteride Pensa is a long-term treatment. Some men notice early improvement in symptoms. However, others may need to take Dutasteride Pensa for 6 months or longer before it starts to work. Continue taking Dutasteride Pensa for the duration prescribed by your doctor.

If you take more Dutasteride Pensa than you should
Ask your doctor or pharmacist for advice if you take too many capsules of Dutasteride Pensa.

If you forget to take Dutasteride Pensa
Do not take a double dose to make up for the missed dose.
Take the next dose at your usual time.

If you stop taking Dutasteride Pensa
Do not stop taking Dutasteride Pensa without first discussing it with your doctor.
It may take 6 months or longer before you notice an effect.

If you have any doubts about how to use 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 reactions
Signs of an allergic reaction may include:

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

Stop taking Dutasteride Pensa and contact your doctor immediately if you notice any of
these symptoms.
Common side effects
May affect up to 1 in 10 men taking Dutasteride Pensa

• inability to achieve or maintain an erection (impotence)*; this may continue even after stopping Dutasteride Pensa
• decreased sex drive (libido)*; this may continue even after stopping Dutasteride Pensa
• problems with ejaculation*; this may continue even after stopping Dutasteride Pensa
• breast enlargement or breast tenderness (gynecomastia)
• dizziness when also taking tamsulosin

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

• 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 hair growth

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

• depressed mood
• pain and swelling of the testicles

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If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your
doctor or pharmacist.
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 Pensa

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 Dutasteride Pensa above 30°C.
Store 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 Pensa 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), butylated hydroxytoluene (E321).

• Capsule shell: gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), medium-chain triglycerides, lecithin (may contain soybean oil) (E322), purified water.

Description of the Appearance of Dutasteride Pensa and Package Contents
Dutasteride Pensa soft capsules are oblong, opaque, yellow soft gelatin capsules containing a yellowish oily liquid. Dutasteride Pensa soft capsules are available in packs of 10, 30, 50, 60, and 90 capsules.
Not all pack sizes may be marketed.
The dimensions of the soft capsules are 19 ± 0.8 mm x 6.9 ± 0.4 mm.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan
Italy

Manufacturers:
Galenicum Health S.L.U.
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

Pharmadox Healthcare, Ltd.
KW20A Kordin Industrial Park,
Paola, PLA 3000, Malta

SAG Manufacturing S.L.U.
Ctra. N-I, Km 36
28750 San Agustín de Guadalix
Madrid, Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: Dutasteride Pensa 0.5 mg soft capsules
Malta: Dutasteride Galenicum 0.5 mg soft capsules
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