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GLYCOPYRRONIUM BROMIDE 200 MICROGRAMS/ML SOLUTION FOR INJECTION

Active substance(s): GLYCOPYRROLATE / GLYCOPYRRONIUM BROMIDE / GLYCOPYRROLATE / GLYCOPYRRONIUM BROMIDE

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Package leaflet: information for the user

Glycopyrronium Bromide 200 micrograms per ml Solution for Injection
Glycopyrronium Bromide
(referred to as Glycopyrronium Injection in this leaflet)

D03286

Read this leaflet carefully before you are given 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,
pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. See section 4.

What is in this leaflet:
1.
2.

3.
4.
5.
6.

What Glycopyrronium Injection is and what it is used for
What you need to know before you are given
Glycopyrronium Injection.
How Glycopyrronium Injection is given.
Possible side effects.
How to store Glycopyrronium Injection.
Contents of the pack and other information

1. What Glycopyrronium Injection is and what
it is used for
Glycopyrronium Bromide belongs to a group of medicines
called anticholinergic drugs.
Glycopyrronium Injection may be used:
• To protect against some of the unwanted effects of drugs
such as Neostigmine or Pyridostigmine, which are used to
reverse the effects of certain types of muscle-relaxing drugs
used during operations (called non-depolarising muscle
relaxants).
• Before an operation, to reduce saliva and other secretions
and to reduce the acidity of the stomach contents.
• Before or during an operation, to reduce or prevent slowing
of the heartbeat during surgery.

2. What you need to know before you are given
Glycopyrronium Injection.
You should not be given Glycopyrronium Injection if:
• you are allergic to Glycopyrronium Bromide, or to any of the
other ingredients in 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.
• Anticholinesterase-antimuscarinic combinations such as
neostigmine plus glycopyrronium should be avoided in
patients with a prolonged QT interval.
Warnings and precautions
Take special care with Glycopyrronium Injection. Tell your
doctor if:
• 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 heartbeat
(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 heartbeats;
• 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 Injection
Tell your doctor or nurse if you are taking, have recently taken
or might take any other medicines.
Medicines which may interact with Glycopyrronium Injection
include:
• 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, 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 for
advice before being given this medicine.
Driving and using machines.
After having Glycopyrronium Injection you should not drive
or operate 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.
Important information about some of the other
ingredients in Glycopyrronium Injection
This injection contains less than 1mmol (23mg) of sodium per
2ml (essentially ‘sodium-free’).

3. How Glycopyrronium Injection is given.
Glycopyrronium Injection is given by injection into a muscle
(intramuscularly) or into a vein (intravenously).
Dosage when used before an operation:
Adults and elderly patients:
You doctor may inject 200 to 400 micrograms (0.2 to 0.4mg)
into a vein or into a muscle before the anaesthetic is given.
Alternatively, they may give you a dose of 4 to 5 micrograms
per kilogram of body weight (0.004 to 0.005mg per kg), up to a
maximum dose of 400 micrograms (0.4mg).

Dosage when used during an operation:
Adults and elderly patients:
Your doctor will give you a single dose of 200 to 400
micrograms (0.2 to 0.4mg) by injection into a vein.
Alternatively, they may give you a single dose of 4 to 5
micrograms per kilogram of body weight (0.004 to 0.005mg
per kg), up to a maximum of 400 micrograms (0.4mg). This
dose may be repeated if necessary.
Children:
Your doctor will give your child a single dose of 200
micrograms (0.2mg) by injection into a vein.
Alternatively they may give them a single dose of 4 to 8
micrograms per kilogram of body weight (0.004 to 0.008mg
per kg) by injection into a vein, up to a maximum of 200
micrograms (0.2mg). This dose may be repeated if necessary.
If you are given too much Glycopyrronium Injection
This medicine will be given to you in hospital so it is unlikely
you will receive too much, however if you are concerned you
may have been given too much you should speak to your
doctor or nurse. If you have any further questions about this
medicine, ask your doctor or nurse.
Dosage when reversing the effects of non-depolarising
muscle relaxants:
Adults and elderly patients:
Your doctor will give you 200 micrograms (0.2mg) per 1,000
micrograms (1mg) of Neostigmine or the equivalent dose of
Pyridostigmine, by injection into a vein. Alternatively, they
may give you a dose of 10 to 15 micrograms per kilogram
of body weight (0.01 to 0.015 mg per kg) into a vein with
50 micrograms per kg (0.05 mg per kg) of Neostigmine or
equivalent dose of Pyridostigmine.
Glycopyrronium Injection may be given at the same time and
from the same syringe as the Neostigmine or Pyridostigmine.

5. How to store Glycopyrronium Injection.
Keep out of the sight and reach of children.
This medicinal product does not require any special storage
conditions. You should not be given this medicine after the
expiry date which is stated on the label and carton after EXP,
or if it shows signs of deterioration. The expiry date refers to
the last day of that month. The doctor or nurse will check this.
If only part of an ampoule is used the remaining solution
should be discarded.
Any unused medicinal product or waste material should be
disposed of in accordance with local requirements.

6. Contents of the pack and other information
What Glycopyrronium Injection contains.
The active substance is Glycopyrronium Bromide.
Each 1ml of solution contains 200 micrograms of
Glycopyrronium Bromide.
The other ingredients are sodium chloride, hydrochloric acid
and water for injections.
What Glycopyrronium Injection looks like and contents of
the pack.
Glycopyrronium Injection is a clear, colourless solution for
injection. Glycopyrronium Injection is available in glass
ampoules containing either 1ml or 3ml of solution. Each
carton supplied contains 10 ampoules.
Marketing Authorisation Holder and Manufacturer
Martindale Pharmaceuticals Ltd, T/A Martindale Pharma,
Bampton Road, Harold Hill, Romford, Essex, RM3 8UG, UK.
Marketing Authorisation Number: PL 00156/0115
The leaflet was last revised in September 2016

Children:
Your doctor may give your child 10 micrograms per kg of
body weight (0.01mg per kg) injected into a vein with 50
micrograms per kg (0.05mg per kg) of Neostigmine or the
equivalent dose of Pyridostigmine. Glycopyrronium Injection
may be given at the same time and from the same syringe as
the Neostigmine or Pyridostigmine.

4. Possible side effects
Like all medicines Glycopyrronium Injection can cause side
effects, although not everybody gets them. Tell your doctor or
nurse if you notice any of the following symptoms:
• changes in heart rate (fast/irregular heartbeats);
• 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.
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: www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the safety of
this medicine.

Children:
Your doctor will give your child 4 to 8 micrograms per
kilogram of body weight (0.004 to 0.008mg per kg) injected
into a vein or into a muscle before the anaesthetic is given, up
to a maximum of 200 micrograms (0.2mg).

Continued overleaf

D03286

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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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