Dutasteride/Tamsulosin Rowa 0.5 mg/0.4 mg hard capsules.

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tamsulosin hydrochloride; Dutasteride

Available from:

Rowa Pharmaceuticals Limited

ATC code:

G04CA52

INN (International Name):

Tamsulosin hydrochloride; Dutasteride

Dosage:

0.5/0.4 milligram(s)

Pharmaceutical form:

Capsule, hard

Therapeutic area:

tamsulosin and dutasteride

Authorization status:

Marketed

Authorization date:

2020-09-11

Patient Information leaflet

7mm
126 mm
140 mm
7mm
LAETUS INSERTION 45 MM FROM THE VERTEX
LAETUS INSERTION 45 MM FROM THE VERTEX
LAETUS INSERTION 315 MM FROM THE VERTEX
LAETUS INSERTION 315 MM FROM THE VERTEX
7mm
126 mm
140 mm
7mm
540 mm
7mm
7mm
526 mm
FRONT SIDE / PLEASE, INCLUDE YOUR DESIGN ON THIS KEYLINE
BACK SIDE / PLEASE, INCLUDE YOUR DESIGN ON THIS KEYLINE
570655-01

Summary of Product characteristics

Health Products Regulatory Authority
11 September 2020
CRN009189
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dutasteride/Tamsulosin Rowa 0.5 mg/0.4 mg hard capsules.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 0.5 mg dutasteride and 0.4 mg tamsulosin
hydrochloride (equivalent to 0.367 mg tamsulosin).
Excipient(s) with known effect:
Each capsule contains traces of lecithin (may contain soya oil).
Each capsule contains 299.46 mg propylene glycol, which is equivalent
to 4.27 mg/kg.
Each capsule contains 0.026 mg sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Dutasteride/Tamsulosin Rowa are oblong hard gelatin capsules of
approximately 24.2 mm x 7.7 mm with brown body and
beige cap printed with C001 in black ink.
Each hard capsule contains one dutasteride soft gelatin capsule and
tamsulosin hydrochloride modified release pellets.
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
_Adults(includingelderly):_
The recommended dose of Dutasteride/Tamsulosin Rowa is one capsule
(0.5 mg/ 0.4 mg) daily.
Where appropriate Dutasteride/Tamsulosin Rowa may be used to
substitute dual therapy (dutasteride and tamsulosin
hydrochloride) to simplify treatment regimen.
Under prescriber criteria, change from dutasteride or tamsulosin
hydrochloride monotherapy to Dutasteride/Tamsulosin Rowa
could be considered.
_Renalimpairment_
The effect of renal impairment on dutasteride-tamsulosin
pharmacokinetics has not been studied. No adjustment in dosage is
anticipated for patients with renal impairment (see section 4.4 and
5.2).
_Hepaticimpairment_
The effect of hepatic impairm