Dutasteride Krka 0.5 mg capsules, soft

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Dutasteride

Boleh didapati daripada:

KRKA, d.d., Novo mesto

Kod ATC:

G04CB; G04CB02

INN (Nama Antarabangsa):

Dutasteride

Dos:

0.5 milligram(s)

Borang farmaseutikal:

Capsule, soft

Jenis preskripsi:

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

Kawasan terapeutik:

Testosterone-5-alpha reductase inhibitors; dutasteride

Status kebenaran:

Marketed

Tarikh kebenaran:

2017-03-01

Risalah maklumat

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DUTASTERIDE KRKA 0.5 MG CAPSULES, SOFT
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 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 Krka is and what it is used for
2.
What you need to know before you take Dutasteride Krka
3.
How to take Dutasteride Krka
4.
Possible side effects
5.
How to store Dutasteride Krka
6.
Contents of the pack and other information
1.
WHAT DUTASTERIDE KRKA IS AND WHAT IT IS USED FOR
Dutasteride Krka 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 of this medicine 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 Krka 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 Krka may also be used with another medicine called
tamsulosin

Ciri produk

Health Products Regulatory Authority
26 August 2021
CRN00C64X
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dutasteride Krka 0.5 mg capsules, soft
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 0.5 mg dutasteride.
Excipient with known effect:
Each soft capsule contains 299.46 mg of propylene glycol.
For the full list of excipients, see section 6.
3 PHARMACEUTICAL FORM
Capsule, soft (capsule)
Dutasteride Krka soft capsules are oblong soft gelatin capsules
(approximately 16.5 x 6.5 mm) of light yellow colour, filled with
transparent liquid.
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
Dutasteride Krka can be administered alone or in combination with the
alpha-blocker tamsulosin (0.4 mg) (see sections 4.4, 4.8
and 5.1).
Posology
_Adults (including elderly):_
The recommended dose of Dutasteride Krka 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).
_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