Propinorm XL 30 mg Modified-Release Capsules

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Propiverine hydrochloride

Beszerezhető a:

Apogepha Arzneimittel GmbH

ATC-kód:

G04BD; G04BD06

INN (nemzetközi neve):

Propiverine hydrochloride

Adagolás:

30 milligram(s)

Gyógyszerészeti forma:

Modified-release capsule, hard

Terápiás terület:

Drugs for urinary frequency and incontinence; propiverine

Engedélyezési státusz:

Not marketed

Engedély dátuma:

2007-09-28

Betegtájékoztató

Version 4.0, 02/2016
Propinorm XL 30 mg modified-release capsules
v008ie
1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROPINORM
® 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 theirsigns 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
PROPINORM XL 30 MG MODIFIED-RELEASE CAPSULES
(referred to as
Propinorm XL 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 packs and other information).
IN THIS LEAFLET:
1.
What Propinorm XL is and what it is used for
2.
What you need to know before you take Propinorm XL
3.
How to take Propinorm XL
4.
Possible side effects
5.
How to store Propinorm XL
6.
Contents of the pack and other information
1.
WHAT PROPINORM XL IS AND WHAT IT IS USED FOR
Propinorm XL is used for the treatment of people who have difficulty
in controlling their bladder due
to bladder overactivity. Propinorm XL contains the active substance
propiverine hydrochloride. This
substance prevents the bladder from contracting and increases the
amount that the bladder can hold.
Propinorm XL 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 PROPINORM XL
DO NOT TAKE PROPINORM XL
Do not take Propinorm XL if you are allergic (hypersensitive) to
propiverine hydrochloride or to any
of the other ingredients of Propinorm XL (these are listed in section
6).

Termékjellemzők

Health Products Regulatory Authority
04 June 2021
CRN00CD5M
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Propinorm XL 30 mg Modified-Release Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 30 mg propiverine hydrochloride (equivalent to
27.28 mg propiverine).
Excipients 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
Posology
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 sections 4.4 and 5.2).
_Use in hepatic impairment_
In patients with mildly impaired hepatic function, there is no need
for 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 sections 4.3, 4.4 and 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 such as methimazole in