Dutasteride 0.5mg Soft Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dutasteride

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

G04CB; G04CB02

INN (International Name):

Dutasteride

Dosage:

0.5 milligram(s)

Pharmaceutical form:

Capsule, soft

Prescription type:

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

Therapeutic area:

Testosterone-5-alpha reductase inhibitors; dutasteride

Authorization status:

Not marketed

Authorization date:

2015-06-26

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DUTASTERIDE 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 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 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 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 may also be used with another medicine called tamsulosin
(used to treat the symptoms of an
enlarged prostate).
2.
WHAT YOU NEED TO KN

Summary of Product characteristics

Health Products Regulatory Authority
01 November 2019
CRN009FLR
Page 1 of 12
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).
_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 patient