Propinorm XL 30 mg Modified-Release Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Propiverine hydrochloride

Available from:

Amdipharm Limited

ATC code:

G04BD; G04BD06

INN (International Name):

Propiverine hydrochloride

Dosage:

30 milligram(s)

Pharmaceutical form:

Capsules Modified Release

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Drugs for urinary frequency and incontinence; propiverine

Authorization status:

Not marketed

Authorization date:

2007-09-28

Patient Information 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).
Do not take Propinorm XL if you suffer from any of the following
conditions:
-
obstruction

Summary of Product characteristics

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
combination with potent CYP 3A4/5 inhibitors treatment should start
wit