Dutasteride Rowa 0.5 mg soft capsules

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Dutasteride

Boleh didapati daripada:

Rowa Pharmaceuticals Limited

Kod ATC:

G04CB02

INN (Nama Antarabangsa):

Dutasteride

Dos:

0.5 milligram(s)

Borang farmaseutikal:

Capsule, soft

Kawasan terapeutik:

dutasteride

Status kebenaran:

Marketed

Tarikh kebenaran:

2019-07-15

Risalah maklumat

1
WHAT DUTASTERIDE ROWA IS AND WHAT IT IS USED
FOR
Dutasteride Rowa 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 Rowa 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 Rowa may also be used with another medicine called
tamsulosin (used to treat the symptoms of an enlarged prostate).
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DUTASTERIDE ROWA
DO NOT TAKE DUTASTERIDE ROWA
− if you are allergic to dutasteride, other 5-alpha reductase
inhibitors,
or to any of the other ingredients of this medicine (listed in section
6). This medicinal product may contain lecithin from soya oil. If you
are allergic to peanut or soya do not use this medicine.
− if you have a severe liver disease
− this medicine is for men only. It must not be taken by women,
children or adolescents.
è Tell your doctor if you think any of these apply to you.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING DUTASTERIDE
ROWA
− In some clinical studies, more patients taking dutasteride and
another medicine called an alpha-blocker, like tamsulosin,
experienced heart failure than patients taking only dustasteride or
only an alpha blocker. Heart failure mea

Ciri produk

Health Products Regulatory Authority
23 February 2024
CRN00DX8C
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dutasteride Rowa 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 traces of lecithin (may contain soya oil)
(E322).
Each capsule contains 299.46 mg propylene glycol
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Soft capsule
Dutasteride Rowa soft capsules are oblong soft gelatine 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 Rowa 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 Rowa 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