Glycopyrronium Bromide 0.5mg/Ml And Neostigmine Metilsulfate 2.5mg/Ml Solution For Injection
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Glycopyrronium Bromide 0.5mg/ml and Neostigmine Metilsulfate 2.5 mg/ml
Solution for Injection
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Read this leaflet carefully before you are given
this medicine.
• 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.
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
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 Bromide belongs to a group of medicines called anticholinergic drugs. It is used to counteract some unwanted effects that may occur with Neostigmine.
Glycopyrronium and Neostigmine Injection is used to reverse the muscle relaxation produced by nondepolarising 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 of this leaflet.
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 Parkinsons.
■ you have a fever.
Other medicines and Glycopyrronium and Neostigmine Injection
Tell your doctor or nurse if you are taking, have 'ecently 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 polymixins, 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
Pregnancy and breast-feeding.
f you are pregnant or breast-feeding, think you may ae 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 and Neostigmine njection you should not drive or operate machinery until you have been advised that it is safe to do so.
Important information about some of the ingredients of Glycopyrronium and Neostigmine Injection.
This medicinal product contains less than 1mmol Sodium (23mg) per dose, i.e. essentially 'Sodium-free'.
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3. How Glycopyrronium and Neostigmine Injection is given.
Glycopyrronium and Neostigmine Injection is given by injection into a vein.
Adults and elderly patients:
Your doctor will inject 1-2ml into a vein over a period of 10 to 30 seconds. Alternatively, your doctor may nject 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.
Children:
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 or being sick, or diarrhoea
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.
Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www. mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.
5. How to store Glycopyrronium and Neostigmine Injection.
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.
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, diluted citric acid solution, diluted 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, Bampton Road, Harold Hill, Romford, Essex, RM3 8UG, UK.
Date of revision: November 2012
Marketing Authorisation Number: PL 00156/0116
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Text: 9.5pt
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