Detrunorm XL 45 mg Modified-Release Capsules

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Propiverine hydrochloride

Dostupno od:

Amdipharm Limited

ATC koda:

G04BD; G04BD06

INN (International ime):

Propiverine hydrochloride

Doziranje:

45 milligram(s)

Farmaceutski oblik:

Modified-release capsule, hard

Tip recepta:

Product subject to prescription which may be renewed (B)

Područje terapije:

Drugs for urinary frequency and incontinence; propiverine

Status autorizacije:

Marketed

Datum autorizacije:

2011-09-30

Uputa o lijeku

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DETRUNORM
® XL 45 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 45 MG MODIFIED-RELEASE CAPSULES
(referred to as
Detrunorm XL 45 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 45 mg is and what it is used for
2.
What you need to know
before you take Detrunorm XL 45 mg
3.
How to take Detrunorm XL 45 mg
4.
Possible side effects
5.
How to store Detrunorm XL 45 mg
6.
Contents of the pack and other
information
1.
WHAT DETRUNORM XL 45 MG IS AND WHAT IT IS USED FOR
Detrunorm XL 45 mg is used for the treatment of people who have
difficulty in controlling their
bladder due to bladder overactivity or who have problems with the
spinal cord. Detrunorm XL 45 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 45 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 45 MG
DO NOT TAKE DETRUNORM XL 45 MG
Do not take Detrunorm XL 45 mg if you are allergic (hypersensitive) to
propiverine hydrochloride or
to any of the other ingredients of Detrunorm XL 4

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Detrunorm XL 45 mg Modified-Release Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 45 mg propiverine hydrochloride (equivalent to
40.92 mg propiverine).
Excipients with known effect: Lactose monohydrate (8.5 mg),
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Modified-release capsule, hard
Orange size 2 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 in patients with
overactive bladder syndrome or neurogenic detrusor overactivity
(detrusor hyperreflexia) from spinal cord injuries.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The recommended daily doses are as follows:
Adults: One capsule (= 45 mg propiverine hydrochloride) once daily.
As a standard treatment, one Detrunorm XL 30 mg modified-release
capsule (= 30 mg propiverine hydrochloride) once
a day or one tablet of Detrunorm (= 15 mg of propiverine
hydrochloride) twice a day is recommended, this may be
increased to one 15 mg tablet three times a day. Some patients may
already respond to a dosage of 15 mg propiverine
hydrochloride a day.
In patients whom Detrunorm (= 15 mg of propiverine hydrochloride)
tablet three times daily is indicated, the 15 mg
tablet three times daily regimen could be replaced by Detrunorm XL 45
mg modified-release capsules once a day.
The maximum daily dose is one Detrunorm XL 45 mg modified-release
capsule daily.
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 the treatment of this group of patients caution has to be
exercised. In patients with severe renal impairment
(crea