DECUSTER 0.5 MG Soft capsules

Зміст інструкції

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

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

1. What is Decuster and what is it used for

Decuster is used to treat male subjects with enlarged prostate ( hyperplasia

prostatic benigna) - a non-cancerous increase in the volume of the prostate gland,
due to excessive production of a hormone called dihydrotestosterone.
The active ingredient is dutasteride. It belongs to a class of drugs called 5-
alpha reductase inhibitors.
If the prostate increases in volume, it can lead to urinary problems such as difficulty passing
urine and the need to urinate frequently. This can also result in a slower and weaker urine flow.
If left untreated, there is a risk that the urine flow may become completely
blocked ( acute urinary retention). This requires immediate medical treatment. In some cases, surgery is
necessary to remove or reduce the volume of the prostate. Decuster reduces the
production of dihydrotestosterone and this promotes a decrease in prostatic volume and relieves the
symptoms. This reduces the risk of acute urinary retention and the need for surgery.
Decuster can be used with another medicine called tamsulosin (used in the treatment
of symptoms of prostate enlargement).

2. What you need to know before taking Decuster

Do not take Decuster

• if you are allergic to dutasteride, other 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 .
• This medicine is intended for use by men only. It should not be taken by women, children or adolescents.

► Inform your doctor if you think any of the above applies to you.

Take special care with Decuster
In some clinical studies, more patients taking dutasteride and another medicine called
alpha blocker such as tamsulosin, experienced heart failure compared to
patients treated with dutasteride alone or an alpha blocker alone. Heart failure means
that the heart does not pump blood as well as it should.
Make sure your doctor is aware of any liver problems you have. If you have had any
liver disease, further checks may be needed while you are taking Decuster.
Women, children and adolescents should avoid contact with broken Decuster capsules, because
the active ingredient is absorbed through the skin. If contact occurs with the skin, wash
the affected area immediately with water and soap.
Use a condom during sexual intercourse .Dutasteride has been found in the semen of
men treated with Decuster. If your partner is or may become pregnant, she must avoid exposure to your
semen as dutasteride may impair the normal development of a
male child. Dutasteride has been shown to reduce sperm count, semen volume
and sperm motility. This may decrease your fertility.
Decuster affects the PSA ( prostate-specific antigen) test, which is used in
some cases to detect the presence of prostate cancer. Your doctor should be aware of
this effect and may still prescribe the test to find out if you have prostate cancer.
If you need to have a PSA test, tell your doctor that you are taking Decuster. Men
who take Decuster should have the PSA test regularly.
In a clinical study conducted on men at increased risk of prostate cancer, men
who took Decuster were more likely to have a severe form of prostate cancer than men
who did not take it. The effect of Decuster on this severe form of
prostate cancer is unclear.
Decuster may cause breast enlargement and tenderness. If this becomes concerning, or if
you notice the presence of breast lumps or nipple discharge, you should talk to your doctor
about these changes as they can be signs of a serious condition, such as breast
cancer.
► Talk to your doctor or pharmacistif you have any doubts about using Decuster.

Children and adolescents
This medicine is only for men. Broken capsules should not be handled by women,
children and adolescents.

Other medicines and Decuster
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Some medicines can interact with Decuster and can 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 Decuster.

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

Pregnancy, breastfeeding and fertility
If you are pregnant, or suspect you are pregnant or are planning a pregnancy, you should not handle broken
capsules .Dutasteride is absorbed through the skin and can interfere with the normal development
of a male child. 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 who were taking dutasteride. If your partner is pregnant or suspects she is, she should avoid
contact with your semen.
Decuster has been shown to reduce sperm count, semen volume and sperm motility.
Therefore, male fertility may decrease.
►Ask your doctor for advice if a pregnant woman has come into contact with dutasteride.

Driving and using machines
It is unlikely that Decuster will affect your ability to drive or use machines.

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

3. How to take Decuster

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
If you do not take it regularly, the control of PSA levels may be affected.

Recommended dose
The usual dose is one capsule (0.5 mg) to be taken once a day. Swallow the capsules whole with
water. Do not chew or open the capsules. Contact with the contents of the capsules may irritate the mouth
or throat. The capsules can be taken with or without food
Treatment with Decuster is long-term. Some individuals notice an early improvement in
symptoms. However, others may need to take Decuster for 6 months or more before it begins to
take effect. Continue to take Decuster for as long as your doctor tells you.

Hepatic impairment
If you have liver problems (mild or moderate), ask your doctor or pharmacist. The use of Decuster is not
recommended in patients with severe liver disease (see section “Do not take Decuster”)

If you take more Decuster than you should
If you take more Decuster capsules than prescribed, contact your doctor or pharmacist for advice.

If you forget to take Decuster
Do not take a double dose to make up for a missed dose. Take the next dose as usual.

If you stop taking Decuster
Do not stop taking Decuster without first consulting your doctor. It may take 6 months or
more before you notice an improvement.

►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 immediately if you experience any of these symptoms and stop taking Decuster. Common(may affect up to 1 in 10 people) inability to achieve or maintain an erection (impotence), this may continue after you stop taking Decuster decreased sex drive (libido), this may continue after you stop taking Decuster difficulty ejaculating, this may continue after you stop taking Decuster enlargement or tenderness of the breasts (gynaecomastia) dizziness if taken together with tamsulosin.

Uncommon(may affect up to 1 in 100 people):
heart failure (the heart becomes less efficient at pumping blood around the body. It can
have symptoms such as shortness of breath, extreme tiredness and swelling of the ankles and legs)
hair loss (generally from the body) or hair growth.

Not known(frequency cannot be estimated from available data)
depressed mood
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 or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Decuster

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 aluminium foil
of the blisters. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Keep the blister in its cardboard box in order to protect it from light.
Medicines should not be disposed of via 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 Decuster contains
The active ingredient is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.
The other ingredients are:

• capsule shell: propylene glycol monocaprylate and butylhydroxytoluene
• capsule coating: gelatin, glycerol, titanium dioxide (E171), triglycerides (medium chain), lecithin (may contain soybean oil) (E322).

Description of the appearance of Decuster and contents of the pack
Decuster soft capsules are oblong soft gelatin capsules (approximately 16.5 x 6.5 mm), light yellow in colour,
filled with a transparent liquid. They are available in packs of 10, 30, 50, 60 and 90
capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Ecupharma S.r.l.
Via Mazzini 20
20123 Milan (Italy)

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

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