Propiverine 15mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Propiverine hydrochloride

זמין מ:

A A H Pharmaceuticals Ltd

קוד ATC:

G04BD06

INN (שם בינלאומי):

Propiverine hydrochloride

כמות:

15mg

טופס פרצבטיות:

Oral tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 07040200; GTIN: 5025903085775

עלון מידע

DETRUNORM 15MG COATED TABLETS
(propiverine hydrochloride)
PATIENT INFORMATION LEAFLET
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, pharmacist or
nurse.
*
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, pharmacist or nurse.
This
includes any possible side effects not listed in this leaflet. See
section 4.
The name of your medicine is Detrunorm 15 mg Coated Tablets (referred
to as Detrunorm throughout this leaflet).
WHAT IS IN THIS LEAFLET:
What Detrunorm are and what they are used for
What you need to know before you take Detrunorm
How to take Detrunorm
Possible side effects
How to store Detrunorm
Contents of the pack and other information
WHAT DETRUNORM ARE AND WHAT THEY ARE USED FOR
Detrunorm is used for the treatment of people who have difficulty in
controlling their bladders 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DETRUNORM
DO NOT TAKE DETRUNORM:
*
if you are allergic to propiverine hydrochloride or any of the other
ingredients of this medicine listed in section 6 (allergic reactions
include
mild symptoms such as itching and/or rash. More severe symptoms
include swelling of the face, lips, tongue and/or throat with
difficulty in
swallowing or breathing);
*
if you have obstruction of the bowel;
*
if you have obstruction to the bladder outlet (difficulty in passing
urine);
*
if you have myasthenia gravis (a disease causing muscle weakness);
*
if you have a loss of function of

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Detrunorm 15 mg Coated Tablets
Propiverine Hydrochloride 15mg Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 15 mg propiverine hydrochloride equivalent
to 13.64 mg
propiverine.
Excipients with known effect:
Lactose monohydrate
(63.4 mg/ tablet)
Sucrose
(49.0 mg/ tablet)
Glucose monohydrate
(0.6 mg/ tablet)
Cochineal red A (E124, lake)
(0.2 mg/ tablet)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablets
Rose-coloured, lenticular glazing coated tablets.
4.1
THERAPEUTIC INDICATIONS
Detrunorm 15 mg Coated Tablets are indicated in adults for the
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, e.g. transverse
lesion paraplegia
.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended daily doses are as follows:
Adults
As a standard dose one coated tablet (= 15 mg propiverine
hydrochloride)
twice a day is recommended, this may be increased to three times a
day. Some
patients may already respond to a dose of 15 mg a day.
For neurogenic detrusor overactivity a dose of one coated tablet three
times a
day is recommended. The maximum recommended daily dose is 45 mg.
Paediatric population
The safety and efficacy of propiverine in children has not yet been
established.
Hence this product 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,
5.2) .
Use in renal impairment
In patients with mild to moderate impaired renal function no dose
adjustment
is required. In patients with severe renal impairment (creatinine
clearance < 30
ml/min) the maximum daily dose is 30 mg (see section 5.2).
Use in he