Dutasteride 0.5mg Soft Capsules

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Dutasteride

Mevcut itibaren:

Actavis Group PTC ehf

ATC kodu:

G04CB; G04CB02

INN (International Adı):

Dutasteride

Doz:

0.5 milligram(s)

Farmasötik formu:

Capsule, soft

Uygulama yolu:

Oral use

Paketteki üniteler:

10, 30, 50, 60 and 90 capsules

Reçete türü:

Product subject to prescription which may not be renewed (A)

Tarafından üretildi:

Balkanpharma – Dupnitsa AD

Terapötik grubu:

Drugs used in benign prostatic hypertrophy - testosterone-5-alpha-reductase inhibitors

Terapötik alanı:

Testosterone-5-alpha reductase inhibitors; dutasteride

Terapötik endikasyonlar:

Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH). Reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of BPH.

Yetkilendirme durumu:

Not marketed

Yetkilendirme tarihi:

2015-06-26

Bilgilendirme broşürü

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DUTASTERIDE 0.5 MG CAPSULES PIL - IRELAND
Black
BBBA0891
S.Anson
12.06.17
19.09.17
S.Anson
160 x 240
7pts
Procaps
12.06.17
28.07.17
6
DUTASTERIDE 0.5 MG SOFT CAPSULES
Dutasteride
PACKAGE LEAFLET: INFORMATION FOR THE USER
_Continued over page_
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1
WHAT DUTASTERIDE IS AND WHAT IT IS USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DUTASTERIDE
3
HOW TO TAKE DUTASTERIDE
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE DUTASTERIDE
6
CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT DUTASTERIDE IS AND WHAT IT IS USED FOR
DUTASTERIDE IS USED TO TREAT MEN WITH AN ENLARGED PROSTATE
_(benign prostatic hyperplasia)_ - a non-cancerous growth of the
prostate gland, caused by producing too much of a hormone called
dihydrotestosterone.
The active ingredient is dutasteride. It belongs to a group of
medicines
called 5-alpha reductase inhibitors.
As the prostate grows, it can lead to urinary problems, such as
difficulty in passing urine and a need to go to the toilet frequently.
It
can also cause the flow of the urin

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dutasteride 0.5mg Soft Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0.5 mg dutasteride.
Excipient with known effect:
Each capsule may contain trace amounts of soya lecithin
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Soft capsules
Yellow, opaque, oblong capsule 16.65 mm x 6.68 mm, filled with clear
transparent oily solution, imprinted with
“2632” in black ink.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of moderate to severe symptoms of benign prostatic
hyperplasia (BPH).
Reduction in the risk of acute urinary retention (AUR) and surgery in
patients with moderate to severe symptoms of
BPH.
For information on effects of treatment and patient populations
studied in clinical trials please see section 5.1.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dutasteride can be administered alone or in combination with the
alpha-blocker tamsulosin (0.4mg) (see sections 4.4,
4.8 and 5.1).
_Adults (including elderly):_
The recommended dose of Dutasteride is one capsule (0.5 mg) taken
orally once a day. The capsules should be
swallowed whole and not chewed or opened as contact with the capsule
contents may result in irritation of the
oropharyngeal mucosa. The capsules may be taken with or without food.
Although an improvement may be observed at
an early stage, it can take up to 6 months before a response to the
treatment can be achieved. No dose adjustment is
necessary in the elderly.
_Renal impairment_
The effect of renal impairment on dutasteride pharmacokinetics has not
been studied.
No adjustment in dosage is
anticipated for patients with renal impairment (see section 5.2).
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