Decuster

Package leaflet: Information for the patient

Decuster 0.5 mg soft capsules

Dutasteride
Generic 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 or pharmacist.
• 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, talk to 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 taking 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 Decuster is and what it is used for

Decuster is used to treat men with an enlarged prostate ( benign prostatic hyperplasia ) – a non-cancerous increase 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.
When the prostate enlarges, it can cause urinary problems such as difficulty in passing urine and the need to urinate frequently. This may also result in a weaker and slower urine flow. If left untreated, there is a risk that urine flow may become completely blocked ( acute urinary retention ). This requires immediate medical treatment. In some cases, surgery may be necessary to remove or reduce the size of the prostate. Decuster reduces the production of dihydrotestosterone, thereby helping to reduce the size of the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgical intervention.
Decuster may be used together with another medicine called tamsulosin (used to treat symptoms of an enlarged prostate).

2. What you should know before taking Decuster

Do not take Decuster

• 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. DK-H-2497-001-DC

➔ If you think any of the above apply to you, do not take this medicine without first consulting your doctor.
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 or pharmacist before taking Decuster:
In some clinical studies, more patients taking dutasteride and another medicine called an alpha blocker such as tamsulosin developed heart failure compared to patients treated only with dutasteride or only with an alpha blocker. Heart failure means that the heart does not pump blood as well as it should.
Ensure your doctor is aware of any liver problems you have. If you have had any liver disease, you may require additional monitoring while taking Decuster.
Women, children, and adolescents must avoid contact with damaged Decuster capsules, because the active ingredient can be absorbed through the skin. If contact with the skin occurs, 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 dutasteride. If your partner is or could be pregnant, you must avoid exposing her to your semen, as dutasteride may impair 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.
Decuster affects the PSA (prostate-specific antigen) test, which is sometimes used to detect prostate cancer. Your doctor should be aware of this effect and may still recommend that you have the test to check for prostate cancer.
If you are due to have a PSA test, inform your doctor that you are taking Decuster. Men taking Decuster should have regular PSA tests.
In a clinical study conducted in men at increased risk of prostate cancer, men taking dutasteride developed 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 fully understood.
Decuster may cause breast enlargement and tenderness. If this becomes bothersome, or if you notice breast lumps or nipple discharge, speak to your doctor about these changes, as they may be signs of a serious condition such as breast cancer.
➔ Talk to your doctor or pharmacist if you have any doubts about using Decuster.

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

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

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, do not handle damaged capsules. Dutasteride can be absorbed through the skin and may interfere with 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. If your partner is pregnant or suspects she may be pregnant, you must avoid exposing her to your semen.
Decuster has been shown to reduce 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 operating machinery
It is unlikely that Decuster will affect your ability to drive or operate machinery.

Decuster contains soy lecithin and propylene glycol
This medicine contains soy lecithin, which may contain soybean oil. If you are allergic to peanuts or soy, do not use this medicine.
This medicine contains 299.46 mg of monocaprylate in each capsule.

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.

3. How to take Decuster

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

Recommended dose
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 irritate the mouth or throat. The capsules may be taken with or without food.

Treatment with Decuster is long-term. Some individuals may notice an early improvement in symptoms. However, others may need to take Decuster for 6 months or longer before it starts to work. Continue taking Decuster for as long as your doctor tells you to.

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 the 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 longer before you notice an improvement.

➔ 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 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 side effects (may affect up to 1 in 10 people):
inability to achieve or maintain an erection (impotence), which may continue after stopping Decuster
decreased sexual desire (libido), which may continue after stopping Decuster
ejaculation difficulties, such as reduced amount of semen released during sexual intercourse, which may continue after stopping Decuster
breast enlargement or tenderness (gynecomastia)
dizziness if taken together with tamsulosin.

Uncommon side effects (may affect up to 1 in 100 people):
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 of unknown frequency (frequency cannot be estimated from the available data):
depression
pain and swelling in 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 Decuster

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 on the aluminium foil of the blister packs.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep the blister pack in the outer cardboard box to protect it from light.
Medicines must 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. Package contents and other information

What Decuster contains
The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.
The other components are:

• capsule core: propylene glycol monocaprylate and butylated hydroxytoluene;
• capsule shell: gelatin, glycerol, titanium dioxide (E171), medium-chain triglycerides, lecithin (may contain soybean oil) (E322).

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

Marketing Authorization Holder
Ecupharma S.r.l.
Via Mazzini 20
20123 Milano (Italy)

Manufacturer:
Laboratorios LEÓN FARMA, S.A.
Polígono Industrial Navatejera
C/La Vallina, s/n - 24193 Villaquilambre - León
SPAIN

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
Denmark: Dutasterid Liconsa 0.5 mg, soft capsules
Italy: Decuster
Germany: Dutasterid AXiromed 0.5 mg Weichkapseln
Netherlands: Dutasteride Xiromed 0.5 mg zachte capsules

This leaflet was last updated on