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GLYCOPYRROLATE-NEOSTIGMINE INJECTION

Active substance(s): GLYCOPYRROLATE / NEOSTIGMINE METILSULFATE

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Patient leaflet: Information for the user
Glycopyrrolate and Neostigmine Metilsulfate 0.5mg / 2.5mg per ml Solution for Injection
Read all of 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 or nurse.
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. See section 4.
This product will referred to as Glycopyrrolate-Neostigmine Injection from here on.
What is in this leaflet
1. What is Glycopyrrolate-Neostigmine Injection and what it is used for
2. What you need to know before you are given Glycopyrrolate-Neostigmine Injection
3. How Glycopyrrolate-Neostigmine Injection is given to you
4. Possible side effects
5. How to store Glycopyrrolate-Neostigmine Injection
6. Contents of the pack and other information
1. What is Glycopyrrolate-Neostigmine Injection and what it is used for
Glycopyrrolate-Neostigmine Injection contains two active ingredients:
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.
Glycopyrrolate-Neostigmine Injection is used to reverse the muscle relaxation produced by
nondepolarising muscle relaxants.
2. What you need to know before you are given Glycopyrrolate-Neostigmine Injection
You must not be given Glycopyrrolate-Neostigmine Injection
. if you are allergic to Glycopyrronium Bromide or Neostigmine Metilsulfate or any of the other
ingredients of this medicine (listed in section 6).
 If you suffer from an enlargement of the prostate gland
 If you suffer from myasthenia gravis(muscle weakness)
 If you think you may have a blockage in the intestine/stomach(pyloric stenosis, paralytic
ileus) or urinary passages
Warnings and precautions

Talk to your doctor or pharmacist or nurse before you are given GlycopyrrolateNeostigmine Injection
 If you are suffering from coronary artery disease, a heart attack, heart failure,
 If you have irregular heart beats or high blood pressure.
 If you have an overactive thyroid gland.
 If you have a high temperature (fever).
 If you have Down’s syndrome which is mental retardation that interferes with the normal
intellectual and physical development of a child.
 If you have problems with your stomach or bowels causing acid indigestion or loose stool.
 If you are suffering from epilepsy or Parkinsonism
 If 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).
 If you suffer from diarrhoea (loose watery stools).
 If you suffer from ulceration of the intestine.
 If you have recently undergone a heart surgery.
 If you are administered inhalation anaesthesia (which causes temporary loss of bodily
sensations).
Glycopyrronium bromide should be used with caution in children and elderly people.
Other medicines and Glycopyrrolate-Neostigmine Injection
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines
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, 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 or pharmacist for advice before taking this medicine.
Driving and using machines
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.
Glycopyrrolate-Neostigmine Injection contains Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially
‘sodium- free’.
3. How Glycopyrrolate-Neostigmine Injection is given to you
Glycopyrrolate-Neostigmine Injection is administered by injection into a vein.
Recommended dose
Adults and elderly: 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.
Use in 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.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
If you are given more Glycopyrrolate-Neostigmine Injection than you should:
In case of overdose or suspected overdose, the doctor should be informed, immediately.
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 symptoms, tell your doctor:
Contact a doctor right away if you notice any of the following symptoms - you may need
urgent medical treatment:
Swelling of the face, lips or throat which makes it difficult to swallow or breathe, rash,
itching, hives and dizziness. This could be a sign of an angioedema or a severe allergic
reaction (frequency not known, cannot be estimated from the available data).
The following side effects have been reported but their frequency is unknown:
• 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.
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 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-Neostigmine 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 and carton after EXP.
The expiry date refers to the last day of that month.
Store below 25°C.
Keep the ampoules in the outer carton in order to protect from light.
Use as directed by physican.
If only part of an ampoule is used, discard the remaining solution.
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-Neostigmine Injection contains
- The active substances are Glycopyrrolate and Neostigmine metilsulfate. Each 1 ml contains
Glycopyrrolate 500 micrograms (0.5mg) and Neostigmine metilsulfate 2,500 micrograms
(2.5mg).
- The other ingredients are disodium hydrogen phosphate dodecahydrate, citric acid
monohydrate, sodium hydroxide and water for injections.

What Glycopyrrolate-Neostigmine Injection looks like and contents of the pack
Glycopyrrolate-Neostigmine Injection is a clear, colourless sterile solution for injection.
It is available in 1 ml glass ampoule.
Pack sizes: Each pack contains 10 x 1ml ampoules or 5 x 1ml ampoules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
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
This leaflet was last revised in July 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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