Active ingredient
- glycopyrronium bromide
- neostigmine metilsulfate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00156/0116 .
Glycopyrronium Bromide and Neostigmine Metilsulfate 0.5mg/2.5mg per ml Solution for Injection
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)
Read this leaflet carefully before you are given this medicine because it contains important information for you.
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 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:
Warnings and precautions
Take special care with Glycopyrronium and Neostigmine Injection. Tell your doctor if:
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:
Important information about some of the other ingredients in Glycopyrronium-Neostigmine Injection
This injection contains less than 1mmol (23mg) of sodium per 1ml (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.
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.
Recommended dose:
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 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.
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:
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.
Consult a doctor straight away if you notice any of the following symptoms - you may need urgent medical treatment:
Swelling mainly of the face, lips or throat which makes it difficult to swallow or breathe, itching and rashes. This could be a sign of a severe allergic reaction or angioedema (frequency not known, cannot be estimated from the available data).
Tell your doctor or nurse if you notice any of the following symptoms:
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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
or search for MHRA Yellow Card in the Google Play or Apple App Store.
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, 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
Marketing Authorisation Number: PL 00156/0116
The leaflet was last revised in: October 2018
D04517 00000
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