Glycopyrronium Bromide 2mg tablets

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

Glycopyrronium bromide

Available from:

Dawa Limited

ATC code:

A03AB02

INN (International Name):

Glycopyrronium bromide

Dosage:

2mg

Pharmaceutical form:

Tablets

Administration route:

Oral use

Units in package:

packs of 10’s, 20’s, 30’s, 50’s, 60’s, 90’s, 100’s, 14’s, 28’s, 56’s, 84’s & 112’s

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Drugsrus Limited

Therapeutic group:

Anticholinergic,

Therapeutic indications:

For use in adults as add-on therapy in the treatment of peptic ulcer

Authorization status:

Authorised

Authorization date:

2015-03-10

Patient Information leaflet

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DOCUMENT OUTLINE * 132-MOCKUPS * Glycopyrronium bromide 1mg Tablets * 14's * 28's * 56's * 84's * 100's * 112's * 10's * 20's * 30's * 50's * 60's * 90's * Glycopyrronium bromide 2mg Tablets * 14's * 28's * 56's * 84's * 112's * 10's * 20's * 30's * 50's * 60's * 90's * 100's * Glycopyrronium Bromide Leaflet-1mg & 2mg
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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Glycopyrronium Bromide 2mg tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each tablet contains 2mg of Glycopyrronium bromide (or
Glycopyrrolate).  
Contains lactose monohydrate 
For the full list of excipients, see section 6.1 

3 PHARMACEUTICAL 
FORM 
Tablets 
White to off-white, round flat beveled tablet (nominal diameter
7mm) debossed “2” 
on one side and break line on other
side without any visible defects. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
_For use in adults as add-on therapy in the treatment of peptic
ulcer._ 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Posology 
Use in adults: 
One tablet three times daily (in the morning, early afternoon
and at bedtime) 
The dosage of Glycopyrronium Bromide 2mg tablets should
be adjusted to the need 
of the individual patient to assure symptomatic control with
a minimum of adverse 
reactions. The recommended maximum daily dose
of Glycopyrronium bromide is 
8mg. 
Dose adjustment may be required in elderly and in patients
with renal impairment 
Dosage needs to be adjusted as needed as tolerated 
Glycopyrronium Bromide tablets are not recommended for use
in children. 
Method of administration  
Glycopyrronium Bromide 2mg tablets are administered orally 

4.3 CONTRAINDICATIONS 
_Glycopyrronium Bromide tablets _must not be used 
•

In Glaucoma, obstructive uropathy (for example bladder
neck obstruction due to 
prostatic hypertrophy);
obstructive disease of the gastrointestinal tract (as in 
achalasis, pyloroduodenal stenosis, etc.); paralytic ileus;
intestinal atony of the 
elderly or debilitated patient; unstable cardiovascular status in
acute hemorrhage; 
severe ulcerative colitis; toxic megacolon complicating ulcerative
colitis; 
myasthenia gravis. 
•

In those patients with