PRO-BANTHINE Propantheline bromide 15mg tablets

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

propantheline bromide, Quantity: 15 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Propantheline bromide

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: maize starch; lactose monohydrate; magnesium stearate; purified talc; titanium dioxide; sunset yellow FCF aluminium lake; iron oxide yellow; polyvinyl alcohol; macrogol 3350; lecithin; indigo carmine aluminium lake

Administration route:

Oral

Units in package:

100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

This product accepted for registration as 'currently supplied' at the time of commencement of the Act. Indications were approved as specified in the letter of 7 April 1993 from Dr L. Hunt are as follows: As an adjunctive therapy in the treatment of peptic ulcer (gastric and duodenal), neurogenic bladder, urinary incontinence in patients with detrusor hyperactivity and hyperhidrosis.

Product summary:

Visual Identification: Pale orange film-coated tablet.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2013-06-17

Patient Information leaflet

PRO-BANTHINE- Product Information
Page 1 of 5
PRO-BANTHINE
TM TABLET
_propantheline bromide _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PRO-BANTHINE
tablets. It does not contain all the
available information about this
medicine. 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
USED FOR
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 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
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
Your doctor may have prescribed
this medicine for another condition.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY PRO-
BANTHINE HAS BEEN PRESCRIBED
FOR YOU.
PRO-BANTHINE tablets are only
available with a doctor’s
prescription.
This medicine is not recommended
for use in children.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PRO-BANTHINE IF

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – PRO-BANTHINE
(PROPANTHELINE BROMIDE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Propantheline bromide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PRO-BANTHINE film-coated tablets contain 15 mg of propantheline
bromide.
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 15 mg, pale orange film-coated tablets.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
PRO-BANTHINE is indicated as an adjunctive therapy in the treatment of
peptic ulcer (gastric and
duodenal). PRO-BANTHINE is also indicated for the neurogenic bladder,
urinary incontinence in
patients with detrusor hyperactivity, and hyperhidrosis.
4.2
D
OSE 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 not exceed 120 mg.
FOR OTHER INDICATIONS: The dose is one or two tablets (15 mg to 30 mg)
four times daily.
4.3
C
ONTRAINDICATIONS
Propantheline bromide is contraindicated in the following conditions:
2
•
Hypersensitivity to propantheline bromide or other anticholinergic
drugs, or any of the
ingredients in PRO-BANTHINE tablets (see section 6.1 LIST OF
EXCIPIENTS).
•
Tachycardia secondary to cardiac insufficiency or thyrotoxicosis.
•
Glaucoma- since mydriasis is to be avoided.
•
Obstructive disease of the gastrointestinal tract (pyloroduodenal
stenosis, achalasia, paralytic
ileus, etc.).
•
Obstructive uropathy (prostatism).
•
Intestinal atony of elderly or debilitated patients.
•
Toxic megacolon complicating ulcerative colitis.
•
Hiatal hernia associated with reflux oesophagitis.
•
Unstable cardiovascular adjustment in acute haemorrhage.
•
Myasthenia gravis.
•
Prostatic en