DETRUNORM 15 Milligram Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PROPIVERINE HYDROCHLORIDE

Available from:

Amdipharm Limited

ATC code:

G04BD06

INN (International Name):

PROPIVERINE HYDROCHLORIDE

Dosage:

15 Milligram

Pharmaceutical form:

Coated Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Drugs for urinary frequency and incontinence

Authorization status:

Authorised

Authorization date:

2008-12-12

Patient Information leaflet

page 2of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
DETRUNORM
® 15 MG FILM-COATED TABLETS
(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 gets, 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 15 MG FILM-COATED TABLETS
(referred to as Detrunorm
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 is and what it is used for
2.
What you need to know before you take Detrunorm
3.
How to take Detrunorm
4.
Possible side effects
5.
How to store Detrunorm
6.
Contents of the pack and other information
1.
WHAT DETRUNORM IS AND WHAT IT IS USED FOR
Detrunorm is used for the treatment of people who have difficulty in
controlling their bladder due to
bladder overactivity or, in some cases, problems with the spinal cord.
Detrunorm contains the active
substance propiverine hydrochloride. This substance prevents the
bladder from contracting and
increases the amount that the bladder can hold. Detrunorm is used to
treat the symptoms of overactive
bladder.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DETRUNORM
DO NOT TAKE DETRUNORM
Do not take Detrunorm if you are allergic (hypersensitive) to
propiverine hydrochloride or to any of
the other ingredients of Detrunorm (these are listed in section 6).
Do not take Detrunorm if you suffer from any of the following
conditions:
-
obstruction of the bowel
-
obstruction to the bladder outlet (difficulty

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Detrunorm 15 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 15 mg propiverine hydrochloride
(equivalent to 13.64 mg propiverine).
Excipients with known effect: Lactose monohydrate (100.7 mg).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablets
White, biconvex, round film-coated tablets.
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 syndrome or neurogenic detrusor
overactivity (detrusor hyperreflexia) from spinal cord
injuries, e.g. transverse lesion paraplegia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Film-coated tablets for oral use.
The recommended daily doses are as follows:
Adults: As a standard dose one film-coated tablet (= 15 mg propiverine
hydrochloride) twice daily is recommended,
this may be increased to three times daily. Some patients may already
respond to a dosage of 15 mg daily.
For neurogenic detrusor overactivity a dose of one film-coated tablet
three times daily is recommended. The maximum
recommended daily dose is 45 mg.
Elderly: Generally there is no special dosage regimen for the elderly
(see section 5.2).
Paediatric population: Due to a lack of data Detrunorm 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; however, they should
be treated with caution.
In patients with severely impaired renal function (creatinine
clearance < 30 ml/min), the
maximum daily dose is 30 mg.
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