Dutasteride Mylan 0.5mg Soft Capsules

Country: Malta

Bahasa: Inggeris

Sumber: Medicines Authority

Beli sekarang

Download Risalah maklumat (PIL)
01-04-2024
Download Ciri produk (SPC)
01-04-2024

Bahan aktif:

DUTASTERIDE

Boleh didapati daripada:

Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, 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:

Authorised

Tarikh kebenaran:

2019-02-12

Risalah maklumat

                                Page 1 of 5
PACKAGE LEAFLET
Page 2 of 5
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DUTASTERIDE MYLAN 0.5 MG SOFT CAPSULES
Dutasteride
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 further questions, ask your doctor, pharmacist or
nurse.
−
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Dutasteride Mylan is and what it is used for
2.
What you need to know before you take Dutasteride Mylan
3.
How to take Dutasteride Mylan
4.
Possible side effects
5.
How to store Dutasteride Mylan
6.
Contents of the pack and other information
1.
WHAT DUTASTERIDE MYLAN IS AND WHAT IT IS USED FOR
DUTASTERIDE MYLAN 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 Mylan 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 Mylan may also be
                                
                                Baca dokumen lengkap
                                
                            

Ciri produk

                                Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 16
1.
NAME OF THE MEDICINAL PRODUCT
Dutasteride Mylan 0.5 mg soft capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 0.5 mg dutasteride.
Excipient with known effect
Each soft capsule contains soya lecithin
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, soft.
The soft capsules are opaque, yellow, oblong soft gelatin capsules
filled with an oily and
yellowish liquid, without printing.
Soft capsules dimensions are: 19 ± 0.8 mm x 6.9 ± 0.4 mm
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 Mylan 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 Mylan is one capsule (0.5 mg)
taken orally once a
day. 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).
_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
Page 3 of 16
and section 5.2). In patients with severe hepatic impairment, the use
of dutasteride is
contraindicated (see section 4.3).
Method of administration
The capsules should be swallowed whole and not chewed or 
                                
                                Baca dokumen lengkap
                                
                            

Cari amaran yang berkaitan dengan produk ini