Pro-Banthine

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Kúpte ho teraz

Stiahnuť Príbalový leták (PIL)
08-04-2013

Aktívna zložka:

Propantheline bromide 15mg;  ; Propantheline bromide 15mg

Dostupné z:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Medzinárodný Name):

Propantheline bromide 15 mg

Dávkovanie:

15 mg

Forma lieku:

Tablet

Zloženie:

Active: Propantheline bromide 15mg   Excipient: Calcium carbonate Carnauba wax Castor oil Cosmetic red oxide No 6205 Cosmetic red ochre No 1624 Lactose monohydrate Light liquid paraffin Magnesium carbonate Magnesium stearate Maize starch Purified talc Saccharin sodium Sucrose Titanium dioxide Yellow beeswax Active: Propantheline bromide 15mg Excipient: Lactose monohydrate Magnesium stearate Maize starch Opadry orange 85G63218 Purified talc

Počet v balení:

Bottle, plastic, 100 tablets

Trieda:

Prescription

Typ predpisu:

Prescription

Výrobca:

RPG Life Sciences Ltd

Terapeutické indikácie:

PRO-BANTHINE is indicated as an adjunctive therapy in the treatment of peptic ulcer (gastric and duodenal) and for the relief of the symptoms of gastritis. PRO-BANTHINE is also indicated for the symptomatic treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis, acute enterocolitis, nervous diarrhoea and functional gastrointestinal disorders). Other indications include renal colic, hyperhidrosis, as adjunctive therapy in ulcerative colitis, diverticulitis, cholecystitis and pancreatitis and for certain gastrointestinal diagnostic procedures.

Prehľad produktov:

Package - Contents - Shelf Life: Bottle, plastic, - 100 tablets - 24 months from date of manufacture stored at or below 25°C

Dátum Autorizácia:

1969-12-31

Príbalový leták

                                PRO-BANTHINE 15 mg  TABLETS 
1
NEW ZEALAND CONSUMER MEDICINE INFORMATION 
PRO-BANTHINE
TM
  
_Propantheline bromide  _
 
 
WHAT IS IN THIS LEAFLET 
 
This leaflet answers some 
common questions about 
PRO-BANTHINE tablets. 
_ _
It does not contain all the 
available information about 
PRO-BANTHINE.  
 
It does not take the place of 
talking to your doctor or 
pharmacist. 
 
All medicines have risks and 
benefits. Your doctor has 
weighed the risks of you 
taking PRO-BANTHINE 
against the benefits he or 
she expects it will have.   
 
IF YOU HAVE ANY CONCERNS 
ABOUT TAKING THIS 
MEDICINE, ASK YOUR DOCTOR 
OR PHARMACIST. 
 
KEEP THIS LEAFLET WITH THE 
MEDICINE. You may need to 
read it again.  
 
WHAT IS PRO-BANTHINE 
 
The name of your medicine 
is PRO-BANTHINE. 
 
The active ingredient is 
called _propantheline _
_bromide._ 
 
_Propantheline bromide_ 
belongs to a group of 
medicines called the 
anticholinergics.   
 
Anticholinergics are used to 
reduce both gastric acid and 
other secretions in the 
stomach, and to reduce 
cramps or spasms in the 
muscles of your stomach, 
intestine and urinary tract.  
 
PRO-BANTHINE is 
available as a 15 mg tablet. 
 
HOW DOES PRO-BANTHINE 
WORK 
 
PRO-BANTHINE works by 
stopping some of the actions 
of a naturally occurring 
substance called 
acetylcholine which then 
reduces: 
•  the amount of acid 
produced by your 
stomach 
•  cramps or spasms in 
the muscles of your 
stomach, intestine and 
urinary tract   
•  the amount of sweat 
produced by your body 
 
WHAT IS PRO-BANTHINE 
USED FOR  
 
PRO-BANTHINE is used to 
treat a number of different 
conditions: 
 
It reduces: 
•  ulcers in the stomach 
(gastric ulcers) and in 
the first part of the 
intestine (duodenal 
ulcers) with the 
assistance of other 
medicines 
•  urinary problems caused 
by nerves or muscles 
that control the bladder  
• excessive 
sweating 
                                
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Súhrn charakteristických

                                NEW ZEALAND DATA SHEET
PRO-BANTHINE New Zealand Data Sheet
Page 1 of 9
1 PRODUCT NAME
PRO-BANTHINE propantheline bromide 15 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
PRO-BANTHINE tablets contain 15 mg of propantheline bromide.
Propantheline bromide powder is a quaternary ammonium compound
(2-diisopropy-laminoethyl
xanthen-9-carboxylate methobromide) with a melting point 157° to
162°C. At relative humidities of
more than 50% it is hygroscopic and it is deliquescent above about
90%.
Propantheline bromide is a white or yellowish-white odourless powder
with a very bitter taste. It is
very soluble in water, alcohol and chloroform, however, is insoluble
in ether.
Propantheline bromide has the molecular formula C
23
H
30
BrNO
3
(CAS-50-34-0) with a molecular weight
of 448.40.
Excipients with known effect: Contains soya bean and sugars as
lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
PRO-BANTHINE tablets: A round, pale orange, film-coated tablet, plain
on both sides
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
PRO-BANTHINE is indicated as an adjunctive therapy in the treatment of
peptic ulcer (gastric and
duodenal) and for the relief of the symptoms of gastritis.
PRO-BANTHINE is also indicated for the
symptomatic treatment of the irritable bowel syndrome (irritable
colon, spastic colon, mucous colitis,
acute enterocolitis, nervous diarrhoea and functional gastrointestinal
disorders). Other indications
include renal colic, hyperhidrosis, as adjunctive therapy in
ulcerative colitis, diverticulitis, cholecystitis
and pancreatitis and for certain gastrointestinal diagnostic
procedure.
4.2
Dose and method of administration
_ADULTS _
In peptic ulcer cases, one tablet three times a day, 30 minutes before
each meal, and two at bedtime
is usual (75 mg daily). There is considerable variation of individual
needs and the dosage may be raised
until dryness of the mouth occurs. A dose slightly lower than this
amount is optimal. The maximum
daily dosage should no
                                
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