Mictonorm 15mg film coated tablets

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Propiverine HCL

Boleh didapati daripada:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

Propiverine HCL

Unit dalam pakej:

28 Tablets; 56 Tablets

Dikeluarkan oleh:

ROTTENDORF PHARMA GMBH

Risalah maklumat

MICTONORM
® FILM COATED TABLETS
Propiverine HCl (15mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Mictonorm
®
Film Coated
Tablets is used for
2.
How Mictonorm
®
Film Coated
Tablets works
3.
Before you use Mictonorm
®
Film
Coated Tablets
4.
How to use Mictonorm
®
Film
Coated Tablets
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Mictonorm
®
Film Coated Tablets
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT MICTONORM
®
FILM COATED
TABLETS
IS USED FOR
Mictonorm
®
Film Coated Tablets 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.
Mictonorm
®
Film Coated Tablets is used
to treat the symptoms of overactive
bladder.
HOW MICTONORM
® FILM COATED TABLETS
WORKS
Mictonorm
®
Film Coated Tablets
contains the active substance propiverine
hydrochloride. This substance prevents
the bladder from contracting and
increases the amount that the bladder can
hold.
BEFORE YOU USE MICTONORM
®
FILM
COATED TABLETS
-
_When you must not use it _
Do not take Mictonorm
®
if you are
allergic (hypersensitive) to propiverine
hydrochloride or to any of the other
ingredients of Mictonorm
®
Film
Coated Tablets (these are listed in
Product Description).
_ _
_ _
Do not take Mictonorm
®
Film Coated
Tablets 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 disease causing
muscle weakness)
-
a loss of function of the muscles
controlling your bowel movements
(intestinal atony)
-
severe inflammation of the bowel
(ulcerative colitis) that may lead to
diarrhoea containing blood and
mucus and stomach pains
-
toxic megacolon (a condition
involving enlargement of the bowel)
-
increased pressure in the eye
(uncontrolled angle closure
glaucoma)
-
moderate or severe liver disease
-
fast and irregular heartbea

Ciri produk

pl-mictonorm15-mar23-v002my-mockup3-1
Creation date: 19.01.23, 14:15
MICTONORM® 15 MG
film-coated tablets
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.
Name and strength of active ingredient(s)
Pharmacodynamic properties
Pharmacotherapeutic group: Urologicals, drugs for urinary
frequency and incontinence.
Inhibition of calcium influx and modulation of intracellular calcium
in
urinary bladder smooth muscle cells causing musculotropic
spasmolysis. Inhibition of the efferent connection of the nervus
pelvicus due to anticholinergic action.
In animal models propiverine hydrochloride causes a dose-dependent
decrease of the intravesical pressure and an increase in bladder
capacity. The effect is based on the sum of the pharmacological
properties of propiverine and three active urinary metabolites as
shown
in isolated detrusor strips of human and animal origin.
Pharmacokinetic properties
Propiverine is nearly completely absorbed from the gastrointestinal
tract. It undergoes extensive first pass metabolism. Effects on
urinary bladder smooth muscle cells are due to the parent
compound and three active metabolites as well, which are rapidly
excreted into the urine.
Bioequivalence of Mictonorm® 15 mg film-coated tablets with the
reference medicinal product Mictonorm® has been demonstrated by
an appropriate bioavailability study.
After oral administration of Mictonorm®, propiverine is rapidly
absorbed from the gastrointestinal tract with maximal plasma
concentrations reached after 2.3 hours. The mean absolute
bioavailability of Mictonorm® is 40.5 % (arithmetic mean value for
AUC
0
-
∞
(p.o.) / AUC
0
-
∞
(i.v.)).
Food intake increases the bioavailability of propiverine (mean
increase
1.3fold), but does not significantly affect the maximum plasma
concentrations of propiverine or of its main metabolite,
propiverine-N-
oxide. This difference in bioavailability is unlikely to