DETRUNORM« PAED Coated tablet

Страна: ПАР

мова: англійська

Джерело: South African Health Products Regulatory Authority (SAHPRA)

Доступна з:

LITHA PHARMA (PTY) LTD

Дозування:

Not Indicated

Фармацевтична форма:

Coated tablet

Склад:

Each tablet contains PROPIVERINE HYDROCHLORIDE EQUIVALENT TO PROPIVERINE 5,0 mg

Статус Авторизація:

Registered

Дата Авторизація:

2023-07-07

інформаційний буклет

RESPONSE TO CLINICAL COMMITTEE RECOMMENDATION DATED 21 SEPTEMBER 2017
APPLICANT:
PHARMAFRICA (PTY) LIMITED
PROPRIETARY NAME:
DETRUNORM®
REGISTRATION NUMBER:
36/5.4/0019
STRENGTH AND DOSAGE FORM
EACH TABLET CONTAINS 15 MG PROPIVERINE HYDROCHLORIDE
PROPOSED PATIENT INFORMATION LEAFLET
_Submitted to MCC: _
_30 July 2018 _
_Module 1.3.2 Proposed Patient Information Leaflet _
_ZA CTD July 12_v5 _
_Version: Clean Copy _
_Page 1 of 8 _
_ _
PROPOSED PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S3
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM:
DETRUNORM® (Tablets). Each tablet contains 15 mg propiverine
hydrochloride.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING DETRUNORM
®.

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor, professional
healthcare provider, or your pharmacist.

DETRUNORM has been prescribed for you personally and you should
not share your medicine with other people. It may harm them, even
if their symptoms are the same as yours.
WHAT DETRUNORM CONTAINS
The active substance is propiverine hydrochloride.
The other ingredients are:
Lactose monohydrate, powdered cellulose, magnesium stearate, sucrose,
talc, heavy kaolin, calcium carbonate, titanium dioxide (E 171),
acacia
gum, colloidal anhydrous silica, Macrogol 6000, glucose monohydrate,
montan wax.
Contains sugar – lactose monohydrate; glucose and sucrose.
RESPONSE TO CLINICAL COMMITTEE RECOMMENDATION DATED 21 SEPTEMBER 2017
APPLICANT:
PHARMAFRICA (PTY) LIMITED
PROPRIETARY NAME:
DETRUNORM®
REGISTRATION NUMBER:
36/5.4/0019
STRENGTH AND DOSAGE FORM
EACH TABLET CONTAINS 15 MG PROPIVERINE HYDROCHLORIDE
PROPOSED PATIENT INFORMATION LEAFLET
_Submitted to MCC: _
_30 July 2018 _
_Module 1.3.2 Proposed Patient Information Leaflet _
_ZA CTD July 12_v5 _
_Version: Clean Copy _
_Page 2 of 8 _
_ _
WHAT DETRUNORM IS USED FOR
Detrunorm is used to treat people who have difficulty controlling
their
bladder (incontinence)
_ _
due to bladder overactivity or, in some cases, problems w

Характеристики продукта

PACKAGE INSERT FOR DETRUNORM
®
SCHEDULING STATUS:
S3
PROPRIETARY NAME (AND DOSAGE FORM):
DETRUNORM
®
Tablets
COMPOSITION:
Each tablet contains 15 mg propiverine hydrochloride.
INACTIVE INGREDIENTS: Lactose monohydrate, powdered cellulose,
magnesium stearate,
sucrose, talc, heavy kaolin, calcium carbonate, titanium dioxide (E
171), acacia gum, colloidal
anhydrous silica, Macrogol 6000, glucose monohydrate, Cochineal red A
(E124, lake), moutan
wax.
Contains sugar – lactose monohydrate; glucose and sucrose.
PHARMACOLOGICAL CLASSIFICATION:
A.5.4 Medicines affecting autonomic functions Cholinolytics
(Anticholinergics)
PHARMACOLOGICAL ACTION:
DETRUNORM
®
Tablets are spasmolytic and anticholinergic:
Inhibition of calcium influx causing musculotropic spasmolysis.
PHARMACODYNAMIC PROPERTIES
In animal models propiverine hydrochloride causes a dosage 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 its three
active metabolites which are directly musculotropic and
anticholinergic.
PHARMACOKINETIC PROPERTIES
_ABSORPTION _
After oral administration of DETRUNORM
® propiverine hydrochloride is rapidly absorbed from
the gastrointestinal tract. Maximal plasma concentrations are reached
after 2.3 hours as an
average after a single dose of one coated tablet. The average absolute
bioavailability of
DETRUNORM
®
is 40.5 % (arithm. Mean value for AUC
o-

(p.o.)
/AUC
0-

(i.v.)
).
_DISTRIBUTION _
Propiverine is already intensively metabolized pre-systemically.
After repeated application (15 mg two to three times a day) steady
state is reached after four to
five days at a higher concentration level than after single dose
application (C
average
= 61 ng/ml).
The calculated volume of distribution (after 10 mg, 20 mg
respectively) of approximately 253 l
(125 – 473 l) indicates, that a large amount of available
propiverine is distributed to peripheral
compartments. The protein binding is around 90% for the pare