Detrunorm 15mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Propiverine hydrochloride

Available from:

Waymade Healthcare Plc

ATC code:

G04BD06

INN (International Name):

Propiverine hydrochloride

Dosage:

15mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07040200

Patient Information leaflet

PROPIVERINE HYDROCHLORIDE
DETRUNORM
®
15 mg
FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
103822/LF/014/02
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 15 MG FILM-COATED TABLETS,
referred to as Detrunorm throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Detrunorm 15 mg film-coated tablets are and what they are used
for
2. What you need to know before you take Detrunorm 15 mg film-coated
tablets
3. How to take Detrunorm 15 mg film-coated tablets
4. Possible side effects
5. How to store Detrunorm 15 mg film-coated tablets
6. Contents of the pack and other information
1. WHAT DETRUNORM 15 MG FILM-COATED TABLETS ARE AND WHAT
THEY ARE 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 15 MG
FILM-COATED TABLETS
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).
-
if you suffer from any of the following conditions:
• obstruction of the bowel
• obstruction to the bladder outlet (difficulty in passing urine)
• myasthenia gravis (a

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: Each film-coated tablet contains 100.7
mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
White, round, biconvex film-coated tablets.
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 from spinal cord injuries
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 dose 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.
Paediatric population:
Due to a lack of data Detrunorm 15 mg film-coated tablets should not
be used in
children.
Elderly:
Generally there is no special dose regimen for the elderly (see
section 5.2).
Caution should be exercised and physicians should monitor patients
carefully for side
effects in the following dispositions (see sections 4.4, 4.5):
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
have been
performed to inves