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GLYCOPYRRONIUM BROMIDE 0.5MG/ML AND NEOSTIGMINE METILSULFATE 2.5MG/ML SOLUTION FOR INJECTION

Active substance(s): GLYCOPYRRONIUM BROMIDE / NEOSTIGMINE METILSULFATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Glycopyrronium Bromide and Neostigmine Metilsulfate
0.5mg/2.5mg per ml Solution for Injection
Glycopyrronium Bromide
Neostigmine Metilsulfate
(referred to as Glycopyrronium and Neostigmine Injection in this leaflet)
D03283

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

1. What Glycopyrronium and Neostigmine
Injection is and what it is used for
Glycopyrronium-Neostigmine Injection contains two active
ingredients:
• Glycopyrronium Bromide belongs to a group of medicines
called anticholinergic drugs. It is used to counteract some
unwanted effects that may occur with Neostigmine.
• Neostigmine belongs to a group of medicines called
cholinesterase inhibitors. It can be used to reverse the
effects of a type of muscle-relaxing drug used during
operations called non-depolarising muscle relaxants.
Glycopyrronium and Neostigmine Injection is used to reverse
the muscle relaxation produced by non-depolarising muscle
relaxants.


2. What you need to know before you are given
Glycopyrronium and Neostigmine Injection.
You should not be given Glycopyrronium and Neostigmine
Injection if:
• you are allergic to Glycopyrronium Bromide or Neostigmine
Metilsulfate, or to any of the other ingredients in this
medicine, (listed in section 6).
• you think you may have a blockage in your intestine or
urinary passage.
• you have been given suxamethonium, a drug used to relax
your muscles during surgery.
Warnings and precautions
Take special care with Glycopyrronium and Neostigmine
Injection. Tell your doctor if:
• you are pregnant or breast feeding;
• you suffer from glaucoma (increased pressure in the eye);
• you have had a recent operation on your intestines;
• you suffer from stomach ulcers;
• you suffer from asthma attacks, wheezing or difficulty
breathing;
• you have a very slow heart beat (less than 60 beats per
minute) or you are suffering from coronary artery disease;
heart failure, irregular heartbeats or high or low blood
pressure;

• you have recently suffered a heart attack;
• you have an overactive thyroid gland;
• you suffer from kidney problems;
• you suffer from myasthenia gravis (a disease resulting in
severe muscle weakness and fatigue);
• you are suffering from epilepsy or Parkinson’s;
• you have a fever;
• you suffer from enlarged prostate gland;
• you suffer from obstruction of the stomach (pyloric stenosis)
or bowel causing vomiting, abdominal pain and swelling
(paralytic ileus);
• you are under the influence of anaesthetics like
Cyclopropane or Halothane.
Other medicines and Glycopyrronium and Neostigmine
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 and
Neostigmine Injection include:
• suxamethonium, a drug used to relax your muscles during
surgery;
• medicines used to treat bacterial infections known as
aminoglycoside antibiotics, such as gentamicin and
streptomycin;
• medicines used to treat bacterial infections known as
polymyxins, such as colistimethate sodium;
• clindamycin, a medicine used to treat bacterial infections;
• medicines used to treat an irregular heartbeat, such as
procainamide, propafenone and quinidine;
• chloroquine, a medicine used to treat and prevent malaria;
• lithium, a medicine used to treat bipolar disorder;
• medicines used to relax your muscles during surgery known
as non-depolarising muscle relaxants
• propranolol, a medicine used to treat a number of
conditions including migraines, heart problems and anxiety
• a type of medicine used to dry body secretions during
surgery, known as antimuscarinics
• medicines to treat depressions (e.g. Tricyclic Antidepressant,
MAOIs)
• Amantadine which is used to treat Parkinson’s disease or
viral infections
• medicines used to treat mental illness (e.g. Nefopam)
Important information about some of the other
ingredients in Glycopyrronium-Neostigmine Injection
This injection contains less than 1mmol (23mg) of sodium per
2ml (essentially ‘sodium-free’).
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.

Recommended dose:
Adults and elderly patients:

5. How to store Glycopyrronium and
Neostigmine Injection.

Your doctor will inject 1-2ml into a vein over a period of 10
to 30 seconds. Alternatively, your doctor may inject a dose of
0.02ml per kg body weight into a vein over a period of 10 to 30
seconds, up to a maximum of 2ml.

Keep out of the sight and reach of children.
Do not store above 25°C. Keep the container in the outer
carton to protect from light.

Paediatric patients:
Your doctor will inject 0.02ml per kg body weight into a vein
over a period of 10 to 30 seconds, up to a maximum of 2ml.
If you are given too much Glycopyrronium and
Neostigmine Injection
This medicine will be given to you in hospital so it is unlikely
you will receive too much, however if you experience any of
the following symptoms you should tell your doctor or nurse
immediately:
• difficulty breathing
• you have too much saliva or increased sweating
• watering eyes or pinpoint pupils
• losing control of your bowels or bladder
• an unusually fast or slow or irregular heartbeat, or low blood
pressure (you may feel faint)
• feeling agitated or an increase in the amount you dream
• weakness, muscle twitching or paralysis
If you have any further questions about this medicine, ask your
doctor or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them. Tell your
doctor or nurse if you notice any of the following symptoms:
• a dry mouth;
• difficulty in passing urine;
• blurred vision;
• absence of sweating;
• a very slow heartbeat, palpitations or irregular heartbeats;
• too much saliva;
• wheeziness;
• stomach cramps, feeling sick (nausea), or being sick
(vomiting);
• diarrhoea;
• hypotension;
• intolerance to light;
• weakness;
• increased lung secretions;
• increased secretions of stomach;
• increased sweating;
• confusion;
• increased pressure in eye (glaucoma);

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.

6. Contents of the pack and other information
What Glycopyrronium and Neostigmine Injection contains.
The active substances are Glycopyrronium Bromide and
Neostigmine Metilsulfate. Each 1ml of Glycopyrronium and
Neostigmine Injection contains 0.5mg of Glycopyrronium
Bromide and 2.5mg of Neostigmine Metilsulfate.
The other ingredients are sodium phosphate, citric acid
monohydrate, citric acid solution, sodium hydroxide and water
for injections.
What Glycopyrronium and Neostigmine Injection looks
like and contents of the pack.
Glycopyrronium and Neostigmine Injection is a clear,
colourless, sterile solution for injection.
Glycopyrronium and Neostigmine Injection is available in
glass ampoules each containing 1ml of solution. Each carton
supplied contains ten 1ml 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 00156/0116
The leaflet was last revised in: February 2016

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.

Driving and using machines.
After having Glycopyrronium and Neostigmine Injection you
should not drive or operate machinery until you have been
advised that it is safe to do so because it can cause blurred
vision and other effects that may affect your ability to do so.
Do not drive or use machinery until these effects have gone

3. How Glycopyrronium and Neostigmine
Injection is given.
Glycopyrronium and Neostigmine Injection is given by
injection into a vein.
Your doctor will decide the correct dose for you depending on
your circumstances. Your dose may be calculated according to
your weight.

Continued overleaf

3283-A

D03283

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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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