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GLYCOPYRROLATE-NEOSTIGMINE INJECTION

Active substance(s): GLYCOPYRROLATE / NEOSTIGMINE METILSULFATE

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Patient Information Leaflet
Glycopyrrolate-Neostigmine Injection
This leaflet will provide you with important information about your medicine. Please read it
carefully before your medicine is administered.
WHAT'S IN YOUR MEDICINE
Each glass ampoule contains 1ml of clear, colourless, sterile solution.
Each 1ml of solution contains the two active ingredients Glycopyrrolate 500 micrograms (0.5mg)
and Neostigmine Metilsulfate 2,500 micrograms (2.5mg).
Inactive ingredients: Disodium Hydrogen Phosphate Dodecahydrate, Citric Acid Monohydrate,
Sodium Hydroxide and Water for Injections.
Pack sizes: Each pack contains 10 x 1ml ampoules.
Holder of Product Licence: Mercury Pharma International Ltd., 4045, Kingswood Road, City
West Business Park, Co Dublin, Ireland
PL 02848/0200.
Manufacturer: Mercury Pharmaceuticals (Ireland) Ltd., 4045, Kingswood Road, City West
Business Park, Co Dublin, Ireland
ABOUT YOUR MEDICINE
Neostigmine belongs to a group of medicines called cholinesterase inhibitors.
It can be used to reverse the effects of a group of muscle-relaxing drugs called nondepolarising
muscle relaxants.
Glycopyrrolate belongs to a group of medicines called anticholinergic drugs.
It is used to counteract some unwanted effects that may occur with neostigmine.
USES
Glycopyrrolate-Neostigmine Injection is used to reverse the muscle relaxation produced by nondepolarising muscle relaxants.
BEFORE RECEIVING THIS MEDICINE
You must not be given Glycopyrrolate-Neostigmine Injection if:
 you suffer from an enlargement of the prostate gland
 you suffer from myasthenia gravis(muscle weakness)
 you are allergic to glycopyrrolate or neostigmine
 you think you may have a blockage in the intestine/stomach(pyloric stenosis, paralytic ileus)
or urinary passages
Before you are given Glycopyrrolate-Neostigmine Injection, you should tell your doctor if:














you are suffering from coronary artery disease, a heart attack, heart failure,
, irregular heart beats or high blood pressure.
you have an overactive thyroid gland.
you have a high temperature (fever).
you have Down’s syndrome which is mental retardation that interferes with the normal
intellectual and physical development of a child.
you have problems with your stomach or bowels causing acid indigestion or loose stool.
you are suffering from epilepsy or Parkinsonism
you suffer from a condition in which the acid from the stomach moves upwards in the
food pipe resulting in severe heartburn (gastro-oesophageal reflux disease).
you suffer from diarrhoea (loose watery stools).
you suffer from ulceration of the intestine.
you have recently undergone a heart surgery.
you are administered inhalation anaesthesia (which causes temporary loss of bodily
sensations).

Glycopyrronium bromide should be used with caution in children and elderly people.
Tell your doctor if any of these apply to you.
Taking other medicines:
Please tell your doctor if you are taking or have recently taken any other medicines,
including medicines obtained without prescription.
A large number of drugs can interact with Glycopyrrolate-Neostigmine Injection which can
significantly alter their effects. These drugs include:
• Anticholinergics like ipratropium bromide, tiotropium used to treat nerve disease like
Parkinson’s disease, spasm of the gut or a weak bladder, or some inhalers to relieve wheeziness in
asthma or chronic bronchitis.
• Medicines like chlorpromazine and promethazine which may be used to treat various
conditions, including mental illness, feeling sick, being sick or a specific type of dizziness causes
a feeling of fall.
• Medicines for depression known as Tricyclic antidepressants and Monoamine Oxidase
Inhibitors (MAOIs) like Amitriptyline, Benoxin and minaprine
• Clozapine which is used to treat severe mental disorders.
• Disopyramide, Procainamide and Quinidine (used to treat irregular heart beats).
• Antihistamines (for allergic conditions).
• Strong pain relievers such as Meperidine and Nefopam (used to relieve pain).
• Corticosteroids (e.g. to reduce inflammation or to relieve asthma).
• Digoxin tablets (for heart condition).
• Metoclopramide and Domperidone which stimulate the bowels and are used to help vomiting.
• Amantadine which is used to treat Parkinson’s disease or viral infection.
• Ketoconazole which is used to treat fungal infections.
• Memantine which is used for memory loss (Dementia, Alzheimer's disease.).
. Haloperidol used for the treatment of abnormal condition of mind or mental state.
. Levodopa used to treat brain disorders like Parkinson’s disease.
. Antibiotics e.g. Clindamycin, Polymyxins.
. Propyfenone used for the treatment of various kinds of heart problems.

. Propranolol used for the treatment of high blood pressure.
. Nitrates like glyceryl trinitrate (GTN), isosorbide dinitrate and isosorbide mononitrate
which are used to treat the angina (chest pain).
. Chloroquine and Hydroxychloroquine, used for treatment of malaria.
· Drug or poisons that act by stimulating the nervous system like acetylcholine, neostigmine and
cisapride.
Pregnancy and breast feeding:
Ask your doctor for advice before taking this medicine or any other medicine, if you are pregnant,
planning to become pregnant, think you may be pregnant or are breast-feeding.
Driving and operating machinery:
This medicine may cause your eyesight to become weak and this could interfere with your ability
to drive or operate machinery safely.
Ask your doctor for advice before you drive or operate machinery.

HOW THIS MEDICINE IS ADMINISTERED
Glycopyrrolate-Neostigmine Injection is administered by injection into a vein.
Recommended Dosage
Adults and older patients : 1-2 ml injected into a vein over a period of 10 to 30 seconds.
Alternatively, a dose of 0.02 ml per kg body weight may be injected into a vein over a period of
10 to 30 seconds.
Children: 0.02ml per kg body weight may be injected into a vein over a period of 10 to 30
seconds.
Alternatively, the medicine may be diluted to 10ml with Water for Injections BP or Sodium
Chloride Injection BP 0.9% w/v and 1ml per 5kg body weight may then be injected into a vein.
WHILST RECEIVING THIS MEDICINE
Along with its needed effects, a medicine may cause unwanted effects. If you notice any of the
following symptoms, tell your doctor:
• a dry mouth, dryness of skin, redness of the face and often other areas of the skin, difficulty in
passing water, uncontrollable urge to pass urine, , nausea(feeling sick,) difficulty in passing
stools, reduced secretion from the lungs, blurred vision, enlargement of pupil, glaucoma
(increased pressure in the eye), or absence of sweating (these could be related to glycopyrrolate)
• a very slow heart beat, too much saliva, wheeziness, tummy cramps, vomiting (being sick) or
diarrhoea. (these could be related to neostigmine)
• palpitations or irregular heart beats (could be related to either glycopyrrolate or neostigmine)
If you notice any unwanted effects that are not mentioned here, tell your doctor.
WHAT TO DO IN CASE OF OVERDOSE
In case of overdose or suspected overdose, the doctor should be informed, immediately.

STORING THIS MEDICINE
Store below 25°C.
Protect from light.
Use as directed by physican.
Keep out of reach of children.
If only part of an ampoule is used, discard the remaining solution.
Do not use this product after the expiry date printed on carton and label.

Marketing authorization holder
Mercury Pharma International Ltd., 4045, Kingswood Road, City West Business Park,
Co Dublin, Ireland.
Date of revision: March 2012

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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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