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Package leaflet: Information for the patient

Glycopyrronium Bromide 1mg Tablets
Glycopyrronium Bromide 2mg Tablets
Glycopyrronium Bromide
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
! 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.
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
6. Contents of the pack and other information
1. What Glycopyrronium Bromide Tablets
are and what they are used for
Glycopyrronium Bromide belongs to a group of
medicines called anticholinergic or
antimuscarinic drugs.
It is used together with other medicines, to make
the stomach contents less acid 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
! if you are allergic to Glycopyrronium Bromide
or any of the other ingredients of this
medicine (listed in section 6).
! if you suffer from:
, glaucoma (increased pressure in the eye)
, an enlarged prostate gland (prostatic
, obstruction of the stomach (pyloric
stenosis) or bowel causing vomiting,
abdominal pain and swelling (paralytic
, myasthenia gravis (leading to muscle
weakness and fatigue)
Warnings and precautions
Talk to your doctor or pharmacist before taking
Glycopyrronium Bromide Tablets if:
! you are over 60 years of age.
! you are a child or this medicine has been
prescribed for a child.
! you have just had a heart attack or are
suffering from heart disease, irregular heart
beats or high blood pressure.
! you have a condition characterised by rapid
heart beat (including an overactive thyroid
gland, heart failure or heart surgery).
! you are receiving inhalation anaesthesia (to
put you to sleep before an operation) as it
may cause a change in your normal heart
! if you have gastric reflux (a condition in which
the liquid stomach contents backs up into the
! if you have diarrhoea.

Glycopyrronium Bromide tablets should be used
during pregnancy only if considered essential by
the doctor.
You should not breast-feed if you are taking this
Driving and using machines
Glycopyrronium Bromide may cause your
eyesight to become blurred and this could
interfere with your ability to drive or operate
machinery safely. Do not drive or operate
machinery until these effects have fully cleared. If
you are in any doubt, ask your doctor for advice.

if you have ulcerative colitis ( a chronic
inflammation of the large intestine (colon)
which can cause abdominal pain, diarrhoea,
and bleeding from the back passage)
you have a high temperature (fever) as the
medicine will inhibit sweating.
you have kidney disease as your dose may
need to be decreased.

Glycopyrronium Bromide Tablets contain

This medicine is not recommended for use in

If you have been told by your doctor that you have
an intolerance to some sugars, contact your
doctor before taking this medicinal product.

Other medicines and Glycopyrronium
Bromide Tablets
Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines,
including medicines obtained without

3. How to take Glycopyrronium Bromide



Taking some medicines together can be harmful.
Remember the doctor at the hospital may not
have been informed if you have recently begun a
course of treatment for another illness.
Use of Glycopyrronium Bromide along with one
or more similar medicines can increase sideeffects such as dry mouth, retention of urine and
constipation. The elderly may become confused.
Please tell the doctor if you are taking, or have
recently taken:
! Drugs for depression such as tricyclic
antidepressants (for example amitriptyline or
imipramine) or monoamine oxidase inhibitor
(MAOIs) antidepressants (for example
phenelzine, tranylcypromine)
! clozapine (used to treat schizophrenia)
! phenothiazines used to treat mental
problems or nausea, vomiting or vertigo (for
example chlorpromazine, fluphenazine,
prochlorperazine, trifluoperazine)
! antihistamines used to treat allergies (for
example promethazine)
! nefopam (used to treat acute and chronic
! pethidine (used to treat moderate to severe
! domperidone or metoclopramide (used to
treat nausea and vomiting)
! ketoconazole (used to treat fungal infections)
! amantadine, levodopa (used to treat
Parkinson's disease)
! memantine (used to treat Alzheimer's
! parasympathomimetics (these are drugs that
affect chemicals in the body which are
involved in transmission of nerve impulses to
a muscle) (for example carbachol,
neostigmine, physostigmine)
! ritodrine (used to prevent complicated
premature labour)
! corticosteroids used to treat various
conditions including: asthma and
inflammatory disease (for example
! slow-dissolving digoxin tablets, disopyramide
(used to treat heart problems)
! glyceryl trinitrate tablets (used to treat
angina) may not dissolve under the tongue as
well as usual owing to the dry mouth which
Glycopyrronium Bromide causes.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.

Always take this medicine exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended dose for adults is:


nausea (feeling sick), vomiting
eye disorder (glaucoma)
flushing and/or dryness of the skin
confusion, especially in the elderly

If any of the side effects get serious, or you notice
any unwanted effects that are not mentioned
here, tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly via the Yellow
Card Scheme at:
By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Glycopyrronium Bromide
Keep this medicine out of the sight and reach of
Do not use this medicine after the expiry date
which is stated on the carton after EXP. The
expiry date refers to the last day of that month.

Glycopyrronium Bromide Tablets 1 mg.
One tablet three times daily (in the morning, early
afternoon, and at bedtime). Some patients may
require two tablets at bedtime to control of
symptoms overnight. When your symptoms are
controlled, a dose of one tablet twice a day may
be sufficient.

Do not throw away any medicines via
wastewater. Ask your pharmacist how to throw
away medicines you no longer use. These
measures will help protect the environment.

Glycopyrronium Bromide Tablets 2 mg.
One tablet two or three times a day at equally
spaced intervals.

What Glycopyrronium Bromide Tablets
The active substance is Glycopyrronium

The score line is not intended for breaking the
This medicine is not recommended for use in
If you take more Glycopyrronium Bromide
Tablets than you should
Consult your doctor or pharmacist immediately or
go to the emergency department of the nearest
hospital. Always take any leftover tablets with
you, as well as the container and label, so that the
medical staff knows what you have taken.
If you forget to take Glycopyrronium Bromide
If you miss a dose, take your dose as soon as you
can, then carry on as before. Do not take a double
dose to make up for the forgotten one.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If you notice any of the following symptoms, and if
these are persistent or troublesome, tell your
! dry mouth
! difficulty in passing stools (constipation)
! irregular heart beat, slow heart beats followed
by rapid heart beats
! reduced secretions in the lungs
! reduced sweating
! difficulty in passing urine
! enlarged pupils accompanied by visual
! increased sensitivity towards light

6. Contents of the pack and other

The other ingredients are Lactose Monohydrate,
Dibasic Calcium Phosphate, Povidone, Sodium
Starch Glycolate and Magnesium stearate
What Glycopyrronium Bromide Tablets look
like and contents of the pack
Glycopyrronium Bromide 1 mg Tablets are white
to off white capsule shaped, flat, beveled edge,
scored tablets engraved with “I 21” on the scored
side and plain on other side.
Glycopyrronium Bromide 2 mg Tablets are white
to off white capsule shaped, flat, beveled edge,
scored tablets engraved with “I 22” on the scored
side and plain on other side.
Tablets are supplied in pack sizes of 10, 14, 28,
30, 56, 60, 90 and 112 tablets. Not all pack sizes
may be marketed.
Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road, Leicester, LE3 0PA, UK
Morningside Pharmaceuticals Ltd
5 Pavilion Way, Loughborough, Leicestershire
LE11 5GW, UK
This leaflet was last revised in January 2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.