Glycopyrronium bromide 2mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Glycopyrronium bromide

Available from:

Special Order

ATC code:

A03AB02

INN (International Name):

Glycopyrronium bromide

Dosage:

2mg

Pharmaceutical form:

Oral tablet

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01020000

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
•
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 you only. Do not pass
it on to others. It may harm them, even if their signs of illness
are the same as yours.
•
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 take Glycopyrronium
Bromide Tablets
3. How to take 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
Glycopyrronium bromide (the active substance in Glycopyrronium
Bromide
Tablets)
belongs
to
a
group
of
medicines
called
anticholinergics or antimuscaranics.
It is used together with other medicines to make the stomach
contents less acidic and to help treat peptic (stomach) ulcers in
adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
GLYCOPYRRONIUM BROMIDE TABLETS
DO NOT TAKE GLYCOPYRRONIUM BROMIDE TABLETS AND TALK
TO YOUR DOCTOR IF:
•
you are allergic to glycopyrronium bromide or any of the
ingredients of this medicine (listed in section 6 at the end of
the leaflet)
•
you suffer from:
o
glaucoma (increased pressure in the eye)
o
an enlarged prostate gland (prostatic hypertrophy)
o
obstruction of the stomach (pyloric stenosis) or bowel
causing vomiting, abdominal pain and swelling (paralytic
ileus)
o
myasthenia
gravis
(leading
to
muscle
weakness
and
fatigue).
Tell your doctor if you are not sure about any of the above.
WARNINGS AND PRECAUTIONS
TALK
TO
YOUR
DOCTOR
OR
PHARMACIST
before
taking
Glycopyrronium Bromide Tablets if you:
•
are over 60 years of age
•
are a child or thi

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 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