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GLYCOPYRRONIUM BROMIDE 1 MG/5 ML ORAL SOLUTION

Active substance(s): GLYCOPYRRONIUM BROMIDE

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Glycopyrronium Bromide 1mg/5ml Oral Solution
Package leaflet: Information for the Patient

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Glycopyrronium Bromide 1mg/5ml
Oral Solution
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 oral solution is
and what it is used for
2. What you need to know before you take
Glycopyrronium Bromide oral solution
3. How to take Glycopyrronium Bromide
oral solution
4. Possible side effects
5. How to store Glycopyrronium Bromide
oral solution
6. Contents of the pack and other information


1. What Glycopyrronium Bromide oral
solution is and what it is used for
This medicine is called Glycopyrronium Bromide
and belongs to a group of medicines called
anticholinergic or antimuscarinic drugs. It
contains the active substance glycopyrronium
bromide. Each 5ml dose of oral solution
contains 1mg of glycopyrronium bromide.
± Glycopyrronium Bromide is used, in
combination with other medicines, to treat
peptic (stomach) ulcers in adults


2. What you need to know before
you take Glycopyrronium Bromide
oral solution
Do not take Glycopyrronium Bromide oral
solution if:
± you are allergic (hypersensitive) to
glycopyrronium bromide or any of the other
ingredients of this medicine (listed in
section 6)
± you have glaucoma (increased pressure in
the eye)
± you have a condition called myasthenia
gravis which leads to muscle weakness
and fatigue
± you have obstruction of the stomach
(pyloric stenosis) or bowel causing vomiting,
abdominal pain and swelling (paralytic ileus)
± you have an enlarged prostate gland
(prostatic hypertrophy)
Warnings and precautions
Talk to your doctor or pharmacist before taking
Glycopyrronium Bromide if:
± you are over 60 years of age
± you have gastric reflux (a condition in which
the liquid stomach contents back up into
the gullet)
± 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 just had a heart attack or are
suffering from heart disease, irregular heart
beats or high blood pressure, because this
medicine can cause a change to your normal
heart rate
± you have a condition characterised by a faster
heart beat than normal (this can be caused
by conditions such as an overactive thyroid
gland, heart failure or heart surgery)
± you are due to have surgery (including at the
dentist) during which you will be ‘put to sleep’
using inhalation anaesthesia. This is because
this medicine may cause a change in your
normal heart rhythm
± you have diarrhoea, especially if have had an
ileostomy or colostomy
± you have a high temperature (fever) or the
environmental temperature is high, as this
medicine will reduce the amount you sweat,
making it harder for your body to cool down
± you have kidney disease, because this
medicine’s dose may need to be decreased
± you have been told by your doctor that you
have an intolerance to some sugars, because
this medicine contains sorbitol

Colonis Pharma Limited

Children
This medicine is not recommended for children.
Talk to your doctor or pharmacist before taking
this medicine if you are a child or this medicine
has been prescribed for a child.
Other medicines and Glycopyrronium
Bromide oral solution
Tell your doctor or pharmacist if you are taking,
have recently taken, or might take any other
medicines. This includes medicines you have
bought without a prescription.
± If your doctor tells you to take both this
medicine and one or more similar medicines
such as oxybutynin, then you may need to
take less than the usual dose of this
medicine. This is because elderly people may
become confused and there is an increased
risk of other side effects such as dry mouth,
retention of urine and constipation when
Glycopyrronium Bromide and similar
medicines are taken together
Please tell the doctor if you are taking or have
recently taken:
± Antidepressants such as amitriptyline,
clomipramine, lofepramine or imipramine
(known as tricyclic antidepressants) or
monoamine oxidase inhibitors (MAOIs) such
as phenelzine, moclobemide, rasagiline,
selegiline or tranylcypromine
± Phenothiazines such as chlorpromazine,
fluphenazine, prochlorperazine or
trifluoperazine, used to treat mental
problems or nausea, vomiting or vertigo
± Antihistamines such as promethazine, used
to treat allergies
± Parasympathomimetics such as carbachol,
neostigmine or physostigmine which affect
the transmission of nerve impulses to muscles
± Corticosteroids such as prednisolone, used to
treat various conditions including asthma and
inflammation
± Inhaled anaesthetics, given to you before you
have surgery (including at the dentist)
± Clozapine or haloperidol, used to treat
schizophrenia
± Nefopam, used to treat acute and
chronic pain
± Domperidone or metoclopramide, used to
treat nausea and vomiting
± Amantadine or levodopa, used to treat
Parkinson’s disease
± Memantine, used to treat Alzheimer’s
disease
± Slow-dissolving digoxin tablets such as
disopyramide or atenolol, used to treat
heart problems
± Metformin, used to treat type 2 diabetes
± Glyceryl trinitrate tablets, used to treat
angina. These may not dissolve under the
tongue as well as usual because this
medicine can cause a dry mouth
± Topiramate or zonisamide, used to treat
epilepsy and to prevent migraines
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
± As a precautionary measure, the use of
Glycopyrronium Bromide oral solution during
pregnancy should be avoided
± Breastfeeding should be discontinued during
treatment with this medicine
Driving and using machines
Glycopyrronium Bromide may make you feel
drowsy or 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.

Glycopyrronium Bromide oral solution
contains E420 (sorbitol), E217 and E219
± This medicine contains sorbitol (E420). If you
have been told by your doctor that you have
an intolerance to some sugars, contact your
doctor before taking this medicinal product
± This medicine contains sodium propyl
parahydroxybenzoate (E217) and sodium
methyl parahydroxybenzoate (E219). These
may cause allergic reactions (possibly
delayed) and exceptionally, bronchospasms
(a narrowing of the airways)
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Glycopyrronium Bromide 1mg/5ml Oral Solution


3. How to take Glycopyrronium
Bromide oral solution
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:
± 5ml (1mg), three times a day (in the morning,
early afternoon and at bedtime). You may
require 10ml (2mg) at bedtime to control
symptoms overnight. When your symptoms
are controlled, a dose of 5ml (1mg) two times
a day may be sufficient
± Do not take more than 20ml (4mg) per day

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Malta: ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3
Rue D’Argens
Gżira GŻR-1368
Malta
www.medicinesauthority.gov.mt
e-mail:
postlicensing.medicinesauthority@gov.mt

5
 . How to store Glycopyrronium
Bromide oral solution

this medicine out of the sight and reach
of children
± Do not use this medicine after the expiry
date, which is stated on the label after EXP.
The expiry date refers to the last day of
that month
± This medicine should be stored below 25°C
in its original bottle
± Do not freeze
± Keep the bottle in the original carton in order
to protect from light
± Once the bottle has been opened, this
medicine should be used within 28 days
Children
± Do not throw away any medicines via
wastewater. Ask your pharmacist how to
This medicine is not recommended for children.
throw away medicines you no longer use.
Talk to your doctor or pharmacist before taking
These measures will help protect the
this medicine if you are a child or this medicine
environment
has been prescribed for a child.
Directions for use
± This medicine should be taken at least one
hour before or two hours after a meal
± This medicine is for oral use only
± Carefully pour the solution into the dosage
cup provided. Use the markings on the side of
the cup to measure the correct amount to take
± Pour the measured amount from the dosage
cup into your mouth and swallow it
± After use, wash the dosage cup with clean
water (do not put it in a dishwasher)

If you take more Glycopyrronium Bromide
oral solution than you should
If you take more of this medicine than you have
been prescribed you are more likely to
experience side effects. Consult your doctor or
get medical advice immediately. If possible,
give any leftover solution, the bottle and this
leaflet to the medical staff so they know what
you have taken.

± Keep


6. Contents of the pack and
other information

What Glycopyrronium Bromide
oral solution contains
± The active substance is glycopyrronium
bromide. Each 5ml of oral solution contains
1mg of glycopyrronium bromide.
If you forget to take Glycopyrronium Bromide The other ingredients are:
oral solution
± Glycerol
± Sorbitol (E420) (see section 2)
± If you forget to take a dose, take it as soon as
± Sodium methyl parahydroxybenzoate (E219)
possible. Then take the next dose at the
(see section 2)
correct time, in accordance with the
± Sodium propyl parahydroxybenzoate (E217)
instructions given to you by your doctor.
(see section 2)
However, if your next dose is due, do not take
± Citric acid monohydrate
the dose you have missed; just take the next
± Trisodium citrate dihydrate
dose as normal
± Do not take a double dose to make up for the ± Strawberry flavour:
± Flavouring substance
forgotten one
± Maltodextrin (maize)
± If you have any further questions on the use
of this medicine, ask your doctor or pharmacist ± Acacia (E414)
± Triacetin (E1518)

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 side effects
tell your doctor:
± Dry mouth
± Reduced movement of the stomach and
intestines leading to constipation
± Difficulty passing urine
± Increased body temperature
± Reduced sweating
± Difficulty swallowing
± Difficulty talking
± Thirst
± Slow heart beats followed by rapid, pounding/
fluttering and irregular heartbeats
± Reduced secretions in the airways
± Urgency to pass urine
± Enlarged pupils accompanied by visual
disturbances
± Increased sensitivity towards light
(photophobia)
± Flushing
± Dry skin
± Confusion, especially in the elderly
± Feeling sick (nausea)
± Being sick (vomiting)
± Drowsiness
± Dizziness
± Eye disorder (glaucoma)

What Glycopyrronium Bromide oral solution
looks like and contents of the pack
Glycopyrronium Bromide oral solution is a clear,
colourless, strawberry flavoured liquid supplied
in a 150ml amber glass bottle with a child
resistant cap. Each pack contains one 150ml
bottle and one dosage cup.
Marketing Authorisation Holder
Colonis Pharma Limited
Hanover Place
8 Church Road
Royal Tunbridge Wells
Kent
TN1 1JP
United Kingdom
Manufacturer
Dales Pharmaceuticals Limited
Snaygill Industrial Estate
Keighley Road
Skipton
North Yorkshire
BD23 2RW
United Kingdom
Marketing and Distribution
Quantum Pharmaceutical Limited
Hobson Industrial Estate
Burnopfield
County Durham
NE16 6EA
United Kingdom

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible This leaflet was last revised in June 2015
side effects not listed in this leaflet.
You can also report side effects directly to the
relevant authority (see details below). By
reporting side effects you can help provide more
information on the safety of this medicine.
United Kingdom: The Yellow Card Scheme
Medicines and Healthcare Products
Regulatory Agency
151 Buckingham Palace Road
Victoria, London, SW1W 9SZ
United Kingdom
www.yellowcard.mhra.gov.uk
Colonis Pharma Limited
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Glycopyrronium Bromide 1mg/5ml Oral Solution

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Colonis Pharma Limited
Product name:
Glycopyrronium Bromide oral solution
PL/PA no:
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Type: Leaflet
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Date of first artwork: 21 July 2014
Reason for request: Text addition
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Date of revision:
18 June 2015
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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.

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