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GLYCOPYRROLATE 200 MICROGRAMS/ML SOLUTION FOR INJECTION

Active substance(s): GLYCOPYRROLATE

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Package leaflet: Information for the user
Glycopyrrolate 200 micrograms/ml Solution for Injection
Glycopyrrolate
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 any further questions, ask your doctor or nurse.
If you get any side effects, talk to your doctor or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
This product will referred to as Glycopyrrolate Injection from here on.
What is in this leaflet
1. What Glycopyrrolate Injection is and what it is used for
2. What you need to know before you use Glycopyrrolate Injection
3. How to use Glycopyrrolate Injection
4. Possible side effects
5. How to store Glycopyrrolate Injection
6. Contents of the pack and other information
1. What Glycopyrrolate Injection is and what it is used for
Glycopyrrolate belongs to a group of medicines called anticholinergic drugs.
Glycopyrrolate 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 musclerelaxing drugs (called non-depolarising muscle relaxants)


before an operation, to reduce saliva and other secretions and to make the stomach
contents less acid



before or during an operation, to reduce or prevent slowness of the heart beat
during surgery.

2. What you need to know before you use Glycopyrrolate Injection
You must not be given Glycopyrrolate Injection if:
 you are allergic to glycopyrrolate or any of the other ingredients of this medicine
(listed in section 6).
Warnings and precautions
Talk to your doctor or nurse before using Glycopyrrolate Injection if
 you are suffering from heart disease, heart failure, irregular heart beats or high
blood pressure.
 you have an overactive thyroid gland.
 you have a high temperature (fever).







you have been administered inhalation anesthesia
you suffer from glaucoma (increased pressure in the eye)
you suffer from myasthenia gravis(leading to muscle weakness and fatiguability)
you have an enlarged prostrate gland
you suffer from obstruction of the stomach (pyloric stenosis) or bowel causing
vomiting, abdominal pain and swelling (paralytic ileus).

Other medicines and Glycopyrrolate Injection
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
A number of drugs can interact with Glycopyrrolate Injection which can significantly
alter their effects.
These drugs include:
 Drugs for depression known as Tricyclic antidepressants and Monoamine Oxidase
Inhibitors (MAOIs)
 Clozapine which is used to treat severe mental disorders
 Strong pain relievers such as Nefopam
 Amantadine which is used to treat Parkinson’s disease or viral infection
Pregnancy and breast-feeding
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 taking this medicine.
Driving and using machines
Glycopyrrolate may cause your eyesight to become blurred and this could interfere with
your ability to drive or operate machinery safely. If you notice any problems with your
vision after you receive your injection, do not drive or operate machinery until these
effects have fully cleared. If you are in any doubt, ask your doctor for advice.
Glycopyrrolate 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 Glycopyrrolate Injection
Always use this medicine exactly as your doctor has told you. Check with your doctor if
you are not sure.
The recommended dose is
Dosage when used before an operation

Adults and elderly
200 to 400 micrograms (0.2 to 0.4mg) may be injected into a vein or into a muscle before
the anaesthetic is given. Alternatively, a dose of 4 to 5 micrograms per kilogram of body

weight (0.004 to 0.005mg per kg) may be used, up to a maximum dose of 400
micrograms (0.4mg).
Use in children and adolescents:
4 to 8 micrograms per kilogram of body weight (0.004 to 0.008mg per kg) up to a
maximum of 200 micrograms (0.2mg) may be injected into a vein or into a muscle before
the anaesthetic is given.
Dosage when used during an operation
Adults and elderly
A single dose of 200 to 400 micrograms (0.2 to 0.4mg) should be given by injection into
a vein. Alternatively, a single dose of 4 to 5 micrograms per kilogram of body weight
(0.004 to 0.005mg per kg) may be used, up to a maximum of 400 micrograms (0.4mg).
This dose may be repeated if necessary.
Use in children and adolescents
A single dose of 200 micrograms (0.2mg) should be given by injection into a vein.
Alternatively, a single dose of 4 to 8 micrograms per kilogram of body weight (0.004 to
0.008mg per kg) may be used, up to a maximum of 200 micrograms (0.2mg). This dose
may be repeated if necessary.
Dosage when reversing the effects of non-depolarising muscle relaxants
Adults and elderly:
200 micrograms (0.2mg) per 1,000 micrograms (lmg) of neostigmine or the equivalent
dose of pyridostigmine, by injection into a vein.
Alternatively, a dose of 10 to 15 micrograms per kilogram of body weight (0.01 to
0.015mg per kg) may be injected into a vein with 50 micrograms per kg (0.05mg per kg)
of neostigmine or equivalent dose of pyridostigmine. Glycopyrrolate Injection may be
administered at the same time and from the same syringe with the neostigmine or
pyridostigmine.
Use in children and adolescents
10 micrograms per kg of body weight (0.0lmg per kg) may be injected into a vein with 50
micrograms per kg (0.05mg per kg) of neostigmine or the equivalent dose of
pyridostigmine. Glycopyrrolate Injection may be administered at the same time and from
the same syringe with the neostigmine or pyridostigmine.
Method of administration
Glycopyrrolate Injection is administered by injection into a muscle or into a vein.
If you are given more Glycopyrrolate Injection than you should.
This is unlikely because the dose will be administered by a health professional.
If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects
Like all medicines, this medicine can sometimes cause side-effects, although not
everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions are very
are. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips,
rash or itching (especially affecting your whole body) should be reported to a doctor
immediately.
The following side effects have also been reported but their frequency is unknown:
 dry mouth
 difficulty in passing stools (constipation)
 absence of sweating
 irregular heart beat, slow heart beats followed by rapid heart beats
 reduced secretions in the lungs
 difficulty in passing urine
 visual disturbances
 increased sensitivity towards light (photophobia)
 confusion
 nausea (feeling sick), vomiting
 eye disorder (glaucoma)
 dryness of the skin
 flushing
 giddiness
Reporting of side effects
If you get any side effects, talk to your doctor 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: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store Glycopyrrolate Injection
Keep 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, carton after
EXP. The expiry date refers to the last day of that month.
The ampoules should be protected from light and stored below 25°C.
If only part of the contents of an ampoule is used, the remaining solution should be
discarded.
Do not throw away any 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 Glycopyrrolate Injection contains
- The active substance is Glycopyrrolate.

Each lml of solution contains the active ingredient glycopyrrolate 200 micrograms
(0.2mg).
- The other ingredients are sodium chloride, dilute hydrochloric acid and water for
injections.
What Glycopyrrolate Injection looks like and contents of the pack
Glycopyrrolate Injection is a clear, colourless, sterile solution for injection.
Glycopyrrolate Injection is available in clear glass ampoules containing lml or 3ml of
solution. Each cardboard carton contains ten l ml ampoules or ten 3 ml ampoules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Mercury Pharma International Ltd., 4045, Kingswood Road, City West Business Park,
Co Dublin, Ireland.
Product Licence Number
PL 2848/0159
This leaflet was last revised in February 2016.

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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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