Patient Leaflet Updated 10-Jan-2024 | ADVANZ Pharma
Glycopyrronium Bromide and Neostigmine Metilsulfate 0.5mg/2.5mg per ml Solution for Injection (Robinul-Neostigmine 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
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 nurse. This includes any possible side effects not listed in this leaflet. See section 4.
This product is known by the above name but will be referred to as Glycopyrronium- Neostigmine Injection throughout the rest of this leaflet.
What is in this leaflet
1. What Glycopyrronium-Neostigmine Injection is and what it is used for
2. What you need to know before you are given Glycopyrronium-Neostigmine Injection
3. How Glycopyrronium-Neostigmine Injection is given to you
4. Possible side effects
5. How to store Glycopyrronium-Neostigmine Injection
6. Contents of the pack and other information
1. WHAT GLYCOPYRRONIUM-NEOSTIGMINE INJECTION IS AND WHAT IT IS USED FOR
Glycopyrronium-Neostigmine Injection contains two active ingredients:
Glycopyrronium-Neostigmine Injection is used at the end of an operation to reverse the effects of some of the drugs used during surgery such as anaesthetics and muscle relaxants.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GLYCOPYRRONIUM-NEOSTIGMINE INJECTION
Do not use Glycopyrronium-Neostigmine Injection:
Warnings and precautions
Talk to your doctor or nurse before you are given Glycopyrronium-Neostigmine Injection
Glycopyrronium bromide should be used with caution in children and elderly people.
Other medicines and Glycopyrronium-Neostigmine Injection
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
This is especially important with the following medicines as they may interact with Glycopyrronium-Neostigmine Injection:
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 using 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.
Glycopyrronium-Neostigmine Injection contains sodium
This injection contains less than 1mmol (23mg) of sodium per 2ml (essentially ‘sodium-free’).
3. HOW GLYCOPYRRONIUM-NEOSTIGMINE INJECTION IS GIVEN TO YOU
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
Glycopyrronium-Neostigmine Injection is administered by injection into a vein.
The recommended dose is
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.
Your doctor will decide the correct dose for you depending on your circumstances.
Your dose may be calculated according to your weight.
The injection is usually given over a period of 10-30 seconds, and may need to be repeated depending on your response.
If you have been given more Glycopyrronium-Neostigmine Injection than you should
This is unlikely because the dose will be administered by a health professional. An overdose may cause changes in the speed of heart rate, increased production of saliva and difficulty in breathing.
If you have any further questions on the use of 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.
All medicines can cause allergic reactions although serious allergic reactions are very rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.
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 also been reported but their frequency is not known:
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: Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE GLYCOPYRRONIUM-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 carton and ampoule label after ‘Exp date’. The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the ampoules in the outer carton in order to protect from light.
Once opened, use immediately.
If only part used, discard the remaining solution.
Do not dilute.
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 Glycopyrronium-Neostigmine Injection contains
The active substances are Glycopyrronium bromide and Neostigmine metilsulfate.
Each glass ampoule contains 1 ml of solution, which contains the two active ingredients glycopyrronium bromide 0.5mg and neostigmine metilsulfate 2.5mg.
The other ingredients are disodium phosphate dodecahydrate, citric acid monohydrate, citric acid solution or sodium hydroxide (for pH adjustment) in water for injections.
What Glycopyrronium-Neostigmine Injection looks like and contents of the pack
Glycopyrronium-Neostigmine Injection is a clear, colourless, sterile solution for injection.
Each carton contains ten 1ml ampoules of Glycopyrronium-Neostigmine Injection.
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This leaflet was last revised in December 2023.
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