Dutasteride/Tamsulosin hydrochloride 0.5 mg /0.4 mg hard capsules

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Dutasteride; Tamsulosin hydrochloride

Disponible des:

McDermott Laboratories Ltd., T/A Gerard Laboratories

Codi ATC:

G04CA; G04CA52

Designació comuna internacional (DCI):

Dutasteride; Tamsulosin hydrochloride

Dosis:

0.5 mg/0.4 milligram(s)

formulario farmacéutico:

Capsule, hard

Área terapéutica:

Alpha-adrenoreceptor antagonists; tamsulosin and dutasteride

Estat d'Autorització:

Marketed

Data d'autorització:

2019-12-06

Informació per a l'usuari

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DUTASTERIDE/TAMSULOSIN HYDROCHLORIDE
0.5MG/0.4 MG HARD CAPSULES
dutasteride/tamsulosin hydrochloride
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/Tamsulosin hydrochloride is and what it is used for
2.
What you need to know before you take Dutasteride/Tamsulosin
hydrochloride
3.
How to take Dutasteride/Tamsulosin hydrochloride
4.
Possible side effects
5.
How to store Dutasteride/Tamsulosin hydrochloride
6.
Contents of the pack and other information
1.
WHAT DUTASTERIDE/TAMSULOSIN HYDROCHLORIDE IS AND WHAT IT IS USED FOR
DUTASTERIDE/TAMSULOSIN HYDROCHLORIDE 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.
Dutasteride/Tamsulosin hydrochloride is a combination of two different
medicines called dutasteride
and tamsulosin. Dutasteride belongs to a group of medicines called
_5-alpha reductase inhibitors_
and
tamsulosin belongs to a group of medicines called
_alpha-blockers_
.
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. Sometimes surgery is necessary
to remove or reduce the size of

Fitxa tècnica

Health Products Regulatory Authority
22 March 2024
CRN00DYWD
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dutasteride/Tamsulosin hydrochloride 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).
Excipients with known effect
Each capsule contains soya lecithin and propylene glycol
This medicine contains 299.46 mg propylene glycol in each hard capsule
which is equivalent to 4.27 mg/kg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule
Dutasteride/Tamsulosin hydrochloride are oblong, hard gelatin
capsules, of 21.4 mm x 7.4 mm approx, with brown body and
orange cap printed with C001 in black ink.
Each hard capsule contains tamsulosin hydrochloride modified release
pellets and one dutasteride soft gelatin capsule.
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 severesymptoms 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 (including elderly) _
The recommended dose of Dutasteride/Tamsulosin hydrochloride is one
capsule (0.5 mg/0.4 mg) daily.
Where appropriate, Dutasteride/Tamsulosin hydrochloride may be used to
substitute concomitant dutasteride and tamsulosin
hydrochloride in existing dual therapy to simplify treatment.
Where clinically appropriate, direct change from dutasteride or
tamsulosin hydrochloride monotherapy to
Dutasteride/Tamsulosin hydrochloride may be considered.
_Renal impairment _
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).
_Hepatic impa