Glycopyrronium bromide 2mg tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Glycopyrronium bromide

Beschikbaar vanaf:

DE Pharmaceuticals

ATC-code:

A03AB02

INN (Algemene Internationale Benaming):

Glycopyrronium bromide

Dosering:

2mg

farmaceutische vorm:

Oral tablet

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 01020000

Bijsluiter

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS TAKING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR
THEM.
!
Keep this leaflet. You may need to read it again.
!
If you have any further questions, ask your doctor or
pharmacist.
!
This medicine has been prescribed for your child only. Do not
pass it on to others. It may harm them, even if their signs of
illness are the same as your child's.
!
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1.
What Glycopyrronium Bromide Tablets are and what they are
used for
2.
What you need to know before you give Glycopyrronium
Bromide Tablets
3.
How to use Glycopyrronium Bromide Tablets
4.
Possible side effects
5.
How to store Glycopyrronium Bromide Tablets
6.
Contents of the pack and other information
1.
WHAT GLYCOPYRRONIUM BROMIDE TABLETS ARE AND WHAT THEY
ARE USED FOR
This medicine is called Glycopyrronium Bromide and belongs to a
group of medicines known as quaternary ammonium
anticholinergics, which are agents that block or reduce the
transmission between nerve cells. This reduced transmission can
de-activate the cells that produce saliva.
Glycopyrronium Bromide is used to treat excessive production of
saliva (sialorrhoea) in children and adolescents aged 3 years and
older. Sialorrhoea (drooling or excessive salivation) is a common
symptom of many diseases of the muscles or nerves. It is mainly
caused by poor control of muscles in the face. Glycopyrronium
Bromide Tablets act on the salivary glands to reduce production of
saliva.
2.
WHAT YOU NEED TO KNOW BEFORE YOU GIVE GLYCOPYRRONIUM
BROMIDE TABLETS
DO NOT GIVE GLYCOPYRRONIUM BROMIDE TABLETS IF THE CHILD OR
ADOLESCENT:
!
is ALLERGIC (hypersensitive) to Glycopyrronium Bromide or any
of the other ingredients of this medicine (listed in section 6),
!
has GLAUCOMA (increased pressure in the eye),
!
has a condition called MYASTHENIA GRAVIS which leads to
muscle weakness and fatigue,

Productkenmerken

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 a hypersensitivity to Glycopyrronium bromide
or, any other
excipient(s) listed in section 6.1.
•
In patients taking solid oral dosage forms of potassium chloride.
Slower
gastrointestinal time produced by Glycopyrronium bromide may increase
th