Glycopyrronium Bromide And Neostigmine Metilsulfate 0.5mg/2.5mg Per Ml Solution For Injection
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Glycopyrrolate 0.5mg and Neostigmine metilsulfate 2.5mg
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
In this leaflet:
1. What Robinul-Neostigmine Injection is and what it is used for
2. Before you are given Robinul-Neostigmine Injection
3. How Robinul-Neostigmine Injection is given to you
4. Possible side effects
5. How to store Robinul-Neostigmine Injection
6. Further information
1. WHAT ROBINUL-NEOSTIGMINE INJECTION IS AND WHAT IT IS USED FOR
Robinul-Neostigmine Injection contains two active ingredients:
• Neostigmine which belongs to a group of medicines called cholinesterase inhibitors. It has the effect of reversing the action of certain muscle-relaxing drugs
• Glycopyrrolate which belongs to a group of medicines called anticholinergic drugs. Its purpose is to block some of the unwanted effects that may occur with Neostigmine such as slowing the heart rate or excess production of saliva.
Robinul-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. BEFORE YOU ARE GIVEN ROBINUL-NEOSTIGMINE INJECTION You should not be given Robinul-Neostigmine Injection if:
• you know you are allergic to Glycopyrrolate or Neostigmine or any other ingredient present in this injection
• you are also receiving Suxamethonium, a muscle relaxant usually given during operations. Make sure your doctor knows if you suffer from any of the above.
Before you are given Robinul-Neostigmine Injection, you should tell your doctor if:
• you suffer from asthma or attacks of wheezing
• you suffer from glaucoma (Increased pressure in the eye)
• you have had a recent operation on the intestines (Gut)
• you suffer from increased body temperature
• you have high blood pressure
• you suffer from cardiac arrhythmia (irregular heart beats) or slow heart rate
• you suffer from heart failure or heart disease
• you are under influence of anaesthetics like Cyclopropane or Halothane
• you have an overactive thyroid gland
• you are suffering from epilepsy or Parkinsonism (A disorder in the brain causing muscle stiffness and shaking)
• you suffer from myasthenia gravis (leading to muscle weakness and fatigue)
• you have an enlarged prostrate gland
• you suffer from obstruction of the stomach (pyloric stenosis) or bowel causing vomiting, abdominal pain and swelling (paralytic ileus).
Tell your doctor if any of these apply to you.
Taking other medicines
Please talk to your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
• medicines to treat depression (e.g. Tricyclic Antidepressant, MAOI's)
• medicine used to treat mental illness (e.g. Clozapine)
• medicine used to relieve the pain (e.g. Nefopam)
• Amantadine which is used to treat Parkinson’s disease or viral infection
• Suxamethonium, a muscle relaxant usually given during operations.
Pregnancy and breast feeding
Tell your doctor if you are pregnant, think you may be pregnant or are breastfeeding.
Important information about some of the ingredients in Robinul-Neostigmine Injection
This injection contains less than 1mmol (23mg) of sodium per 2ml (essentially ‘sodium-free’).
3. HOW ROBINUL-NEOSTIGMINE INJECTION IS GIVEN TO YOU
Robinul-Neostigmine Injection is administered 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.
The injection is usually given over a period of 10-30 seconds, and may need to be repeated depending on your response.
What to do if you have been given more Robinul-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 product ask your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines Robinul-Neostigmine Injection can sometimes 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.
The following side effects have also been reported but their frequency is not known:
• dry mouth
• difficulty in passing stools (Constipation)
• slow heart rate (Bradycardia)
• an awareness of strong, thumping (Palpitation) or irregular heart beats
• reduced secretion in lung
• difficulty in passing urine
• increased sensitivity of the skin to light (Photophobia)
• dryness of the skin
• reddening of the skin (Flushing)
• confusion
• nausea (Feeling sick), vomiting (Being sick), dizziness
• eye disorder (Glaucoma)
• Increased secretions of stomach and increased sweating
If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor.
5. HOW TO STORE GLYCOPYRRONIUM-NEOSTIGMINE INJECTION
Keep out of the reach and sight 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 container 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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
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 Robinul-Neostigmine Injection looks like and contents of pack
Robinul-Neostigmine Injection is a clear, colourless, sterile solution for injection.
Each carton contains ten 1ml ampoules of Robinul-Neostigmine Injection.
Marketing authorization holder
MercuryPharm Ltd
4045, Kingswood Road, City West Business Park, Co Dublin, Ireland.
Manufacturer
B. Braun Melsungen AG, Mistelweg 2, 12357 Berlin, Germany.
This leaflet was last revised in March 2012