Detrunorm XL 30 mg Modified-Release Capsules

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Propiverine hydrochloride

Prieinama:

Consilient Health Limited

ATC kodas:

G04BD; G04BD06

INN (Tarptautinis Pavadinimas):

Propiverine hydrochloride

Dozė:

30 milligram(s)

Vaisto forma:

Modified-release capsule, hard

Gydymo sritis:

Drugs for urinary frequency and incontinence; propiverine

Autorizacija statusas:

Marketed

Leidimo data:

2007-09-28

Pakuotės lapelis

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
DETRUNORM
® XL 30 MG MODIFIED RELEASE CAPSULES
(PROPIVERINE 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 your 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).
The name of your medicine is
DETRUNORM XL 30 MG MODIFIED RELEASE CAPSULES
(referred to as
Detrunorm XL 30 mg throughout this leaflet). The active substance is
propiverine hydrochloride and
the other ingredients are listed at the end of the leaflet (section 6,
Contents of the pack and other
information).
WHAT IS IN THIS LEAFLET:
1.
What Detrunorm XL 30 mg is and what it is used for
2.
What you need to know before you take Detrunorm XL 30 mg
3.
How to take Detrunorm XL 30 mg
4.
Possible side effects
5.
How to store Detrunorm XL 30 mg
6.
Contents of the pack and other information
1.
WHAT DETRUNORM XL 30 MG IS AND WHAT IT IS USED FOR
Detrunorm XL 30 mg is used for the treatment of people who have
difficulty in controlling their
bladder due to bladder overactivity. Detrunorm XL 30 mg contains the
active substance propiverine
hydrochloride. This substance prevents the bladder from contracting
and increases the amount that the
bladder can hold. Detrunorm XL 30 mg is used to treat the symptoms of
overactive bladder. It is a
modified-release capsule that needs only to be taken once a day.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DETRUNORM XL 30 MG
DO NOT TAKE DETRUNORM XL 30 MG
Do not take Detrunorm XL 30 mg if you are allergic (hypersensitive) to
propiverine hydrochloride or
to any of the other ingredients of Detrunorm XL 30 mg (these are
listed in s

Prekės savybės

Health Products Regulatory Authority
04 June 2021
CRN00C9QY
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Detrunorm XL 30 mg Modified-Release Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 30 mg propiverine hydrochloride (equivalent to
27.28 mg propiverine).
Excipient with known effect: Lactose monohydrate (5.7 mg)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Modified-release capsule, hard
Orange and white size 3 capsules containing white to off-white
pellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of urinary incontinence and / or increased
urinary frequency and urgency as may occur in patients with
overactive bladder.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Capsules for oral use.
Do not crush or chew the capsules.
The recommended daily doses are as follows:
Adults: As a standard dose one capsule (= 30 mg propiverine
hydrochloride) once a day is recommended.
Elderly: Generally there is no special dose regimen for the elderly
(see section 5.2).
Paediatric population: Due to a lack of data, this product should not
be used in children.
Caution should be exercised and physicians should monitor patients
carefully for side effects in the following dispositions (see
sections 4.4, 4.5, 5.2).
Use in renal impairment
In patients with mild or moderate impairment of renal function, no
dose adjustment is required (see section 5.2).
Use in hepatic impairment
In patients with mildly impaired hepatic function, there is no need
for a dose adjustment,however, treatment should proceed
with caution. No studies have been performed to investigate the use of
propiverine in patients with moderately or severely
impaired hepatic function. Its use is therefore not recommended in
these patients (see section 5.2).
Patients receiving concomitant treatment with drugs that are potent
inhibitors of CYP 3A4 combined with methimazole
In patients receiving drugs that are potent flavin-containing
monooxygenase (FMO) inhibitors su