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GLYCOPYRRONIUM BROMIDE 200 MICROGRAMS/ML INJECTION

Active substance(s): GLYCOPYRRONIUM BROMIDE

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Package leaflet: Information for the user

Glycopyrronium Bromide
200 micrograms/ml injection
(Glycopyrronium Bromide)
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or pharmacist or nurse.
- 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 or nurse. This includes any
possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Glycopyrronium Bromide 200 micrograms/ml Injection is and what it is used for
2. What you need to know before you use Glycopyrronium Bromide 200 micrograms/ml
Injection
3. How to use Glycopyrronium Bromide 200 micrograms/ml Injection
4. Possible side effects
5. How to store Glycopyrronium Bromide 200 micrograms/ml Injection
6. Contents of the pack and other information

1. What Glycopyrronium Bromide 200 micrograms/ml injection is and
what it is used for
Glycopyrronium bromide belongs to a group of medicines called anti-muscarinic drugs.
Glycopyrronium Bromide 200 micrograms/ml Injection may be given:
• To protect against some of the unwanted effects of drugs such as neostigmine or
pyridostigmine, which are given to reverse the effects of certain types of muscle-relaxing
drugs (called non-depolarising muscle relaxants).
• Before an operation to reduce saliva and other secretions and to reduce acidity in the
stomach contents.
• Before or during an operation, to reduce or prevent slowness of the heartbeat during surgery.

2. What you need to know before you use Glycopyrronium
Bromide 200 micrograms/ml Injection
Before you are given Glycopyrronium Bromide 200 micrograms/ml Injection, please read the
following statements:
Do not use Glycopyrronium Bromide 200 micrograms/ml Injection:
• if you are allergic to glycopyrronium bromide or any of the other ingredients of this medicine
(listed in section 6).
• if you have glaucoma
• if you suffer from myasthenia gravis (a disorder that causes extreme muscle weakness and
fatigue)
• if you have an enlarged prostate
• if you have stomach or bowel problems.
Warnings and precautions:
Talk to your doctor or pharmacist or nurse before using Glycopyrronium Bromide 200
micrograms/ml Injection
• if you have Down’s Syndrome
• if you are over 60 years of age
• if you are a child
• if you have just had a heart attack
• if you have a condition characterised by rapid heart beat (including over-active thyroid, heart
failure or heart surgery)
• if you are pregnant or breast-feeding
• if you have a history of high blood pressure, coronary artery disease or irregular heart beats
• if you are receiving inhalation anaesthesia (to put you asleep before an operation) as it may
cause a change in your normal heart rhythm
• if you have gastric reflux (a condition in which the liquid stomach contents backs up
(regurgitates) into the gullet
• if you have diarrhoea
• 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)
• if you have a high temperature (as the drug will inhibit sweating).
Avoid repeated or large doses if you have kidney disease.
Always tell your doctor or nurse about any of these conditions before having your injection.
Other medicines and Glycopyrronium Bromide 200 micrograms/ml Injection:
Tell your doctor or pharmacist if you are taking or have recently taken or might take any
other medicines.
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
side-effects 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:
• tricyclic antidepressants (for example amitriptyline or imipramine) or monoamine oxidase
inhibitor (MAOIs) antidepressants (for example phenelzine, tranylcypramine)
• clozapine (used to treat schizophrenia)
• phenothiazines used to treat severe 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 pain)
• pethidine (used to treat moderate to severe pain)
• 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 disease)
• 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 uncomplicated premature labour)
• corticosteroids used to treat various conditions including asthma and inflammatory disease
(for example prednisolone)
• 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 and breast-feeding:
Always tell your doctor if you are pregnant, think you might be pregnant or are trying to
become pregnant. Glycopyrronium Bromide 200 micrograms/ml Injection should be given
during pregnancy only if considered essential by the doctor.
You should not breast-feed if you are taking this medicine.
Driving and using machines:
Do not drive or use machines because this medicine can cause blurred vision, dizziness and
other effects that may affect your ability to do so. Do not drive or use machinery until these
effects have gone.

Glycopyrronium Bromide 200 micrograms/ml Injection contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially
sodium free.

3. How to use Glycopyrronium Bromide 200 micrograms/ml injection
Glycopyrronium bromide will be given to you as an injection either into a vein (intravenous) or
into a muscle (intramuscular) by a doctor or nurse.
The following doses may be given:
When given before an operation:
Adults and elderly patients:
A single dose of 200-400 micrograms or 4-5 micrograms per kilogram of bodyweight to a
maximum of 400 micrograms given by injection into a vein or muscle.
Children:
4-8 micrograms per kilogram of body weight to a maximum of 200 micrograms, preferably
given by injection into a vein or alternatively into a muscle.
When given during an operation:
Adults and
elderly patients:
A single dose of 200-400 micrograms or 4-5 micrograms per kilogram of body weight to a
maximum of 400 micrograms given by injection into a vein. This dose may be repeated if
necessary.
Children:
A single dose of 4-8 micrograms per kilogram of body weight up to a maximum of 200
micrograms. This dose may be repeated if necessary.
At the end of an operation (for control of side effects of neostigmine in reversing
neuromuscular block):
Adults and elderly patients:
200 micrograms per 1000 micrograms (1 mg) of neostigmine or the equivalent dose of
pyridostigmine given by injection into a vein.
Alternatively, 10–15 micrograms per kilogram of body weight with 50 micrograms per kilogram
of body weight of neostigmine or equivalent dose of pyridostigmine.
Children:
10 micrograms per kilogram of body weight with 50 micrograms per kilogram of body weight
of neostigmine or the equivalent dose of pyridostigmine given by injection into a vein.
Glycopyrronium bromide and neostigmine or pyridostigmine may be administered together
from the same syringe.
If you use more Glycopyrronium Bromide 200 micrograms/ml Injection than you
should:
Tell your doctor or nurse if you think you have been given too much of Glycopyrronium
Bromide 200 micrograms/ml Injection.
The effects of overdose can be treated by repeated (5-10 minutes) injections of neostigmine
metilsulfate 0.25 mg to a maximum of 2.5 mg. Proportionately smaller doses are used in
children.
If you forget to use Glycopyrronium Bromide 200 micrograms/ml Injection:
A doctor, rather than you, will be responsible for administering your injection.

4. Possible side effects
Like all medicines, this medicine can have side effects, although not everyone gets them.
The following side effects can occur:
• changes in heart rate (fast/irregular heart beats)
• confusion may occur in the elderly
• urge to pass water but inability to do so
• nausea
• vomiting
• giddiness
• flushing and dryness of the skin
• enlarged pupils with loss of focus
• intolerance to light
• constipation
• dry mouth
• absence of sweating
• reduced bronchial secretions
• glaucoma
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.

5. How to store Glycopyrronium Bromide 200 micrograms/ml injection
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) which is stated on the label and carton.
The expiry date refers to the last day of that month.
Do not store above 25oC.
Keep the ampoule in the outer carton in order to protect from light.
For single use only.
Use immediately after opening.
Discard any unused solution.
The injection should not be used if particles are present
Do not use this medicine if you notice the ampoule is damaged or if the contents are
discoloured.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the
environment.

6. Contents of the pack and other information
What Glycopyrronium Bromide 200 micrograms/ml Injection contains
The active substance is glycopyrronium bromide.
Each millilitre (ml) of sterile solution contains 200 micrograms of the active substance
glycopyrronium bromide.
The other ingredients are sodium chloride, hydrochloric acid and water for injections.
What Glycopyrronium Bromide 200 micrograms/ml Injection looks like and contents of
the pack
Glycopyrronium Bromide 200 micrograms/ml Injection is a clear, colourless, sterile solution for
injection. Each 1 ml of sterile solution for injection contains 200 micrograms of glycopyrronium
bromide (200 micrograms/ml). Each 3 ml of sterile solution for injection contains 600
micrograms of glycopyrronium bromide (200 micrograms/ml).
Pack sizes: 1 ml glass ampoules in packs of 10 and 3 ml glass ampoules in packs of 3 and 10.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Accord Healthcare Limited,
Sage House, 319 P, inner Road,
North Harrow, Middlesex HA1 4HF,
United Kingdom
This leaflet was last revised in 10/2013.

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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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