Dutasteride Accord 0.5mg soft capsules

Country: Malta

Bahasa: Inggeris

Sumber: Medicines Authority

Bahan aktif:

DUTASTERIDE

Boleh didapati daripada:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

Kod ATC:

G04CB02

INN (Nama Antarabangsa):

DUTASTERIDE 0.5 mg

Borang farmaseutikal:

SOFT CAPSULE

Komposisi:

DUTASTERIDE 0.5 mg

Jenis preskripsi:

POM

Kawasan terapeutik:

UROLOGICALS

Status kebenaran:

Withdrawn

Tarikh kebenaran:

2015-07-27

Risalah maklumat

Page 1 of 6
PACKAGE LEAFLET
Page 2 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
DUTASTERIDE ACCORD 0.5 MG SOFT CAPSULES
Dutasteride
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 Accord is and what it is used for
2.
What you need to know before you take Dutasteride Accord
3.
How to take Dutasteride Accord
4.
Possible side effects
5.
How to store Dutasteride Accord
6.
Contents of the pack and other information
1.
WHAT DUTASTERIDE ACCORD IS AND WHAT IT IS USED FOR
DUTASTERIDE ACCORD 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
urine to be slower and less forceful. If
left untreated, there is a risk that your urine flow will be
completely blocked
_(acute urinary _
_retention)_
. This requires immediate medical treatment. In some situations
surgery is necessary to
remove or reduce the size of the prostate gland. Dutasteride Accord
lowers the production of
dihydrotestosterone, which helps to shrink the prostate and relieve
the symptoms. This will reduce
the risk of acute urinary retention and the need for surgery.
Dutasteride Accord may also be used with anoth

Ciri produk

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Dutasteride Accord 0.5 mg 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 Accord 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 Accord 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).
3
_Hepatic impairment _
The effect of hepatic impairment on dutasteride pharmacokinetics has
not been studied so caution should be
used in patients with mild to moderate hepatic impairment (see section
4.4 and section 5.2). In patients with
severe hepatic impairment, t