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ROBINUL NEOSTIGMINE INJECTION

Active substance(s): GLYCOPYRROLATE / NEOSTIGMINE METILSULFATE / GLYCOPYRROLATE / NEOSTIGMINE METILSULFATE / GLYCOPYRROLATE / NEOSTIGMINE METILSULFATE

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Package leaflet: Information for the user
Robinul-Neostigmine 0.5mg/2.5mg per ml Solution for Injection
Glycopyrronium bromide 0.5mg and Neostigmine metilsulfate 2.5mg
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 Robinul-Neostigmine
Injection throughout the rest of this leaflet.
What is in this leaflet
1. What Robinul-Neostigmine Injection is and what it is used for
2. What you need to know 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. Contents of the pack and other 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.



Glycopyrronium bromide 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. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ROBINULNEOSTIGMINE INJECTION
You should not be given Robinul-Neostigmine Injection:
•If you are allergic to Glycopyrronium bromide or Neostigmine or any of the other ingredients of
this medicine (listed in section 6).
• If 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.
Warnings and precautions

Talk to your doctor or nurse before you are given Robinul-Neostigmine Injection
• If you suffer from asthma or attacks of wheezing
• If you suffer from glaucoma (Increased pressure in the eye)
• If you have had a recent operation on the intestines (Gut)
• If you suffer from increased body temperature
• If you have high blood pressure
• If you suffer from cardiac arrhythmia (irregular heart beats) or slow heart rate
• If you suffer from heart failure or heart disease
• If you are under influence of anaesthetics like Cyclopropane or Halothane
• If you have an overactive thyroid gland
• If you are suffering from epilepsy or Parkinsonism (A disorder in the brain causing muscle
stiffness and shaking)
• If you suffer from myasthenia gravis (leading to muscle weakness and fatigue)
• If you have an enlarged prostrate gland
• If 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.
Other medicines and Robinul-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 RobinulNeostigmine Injection:
• 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, 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.
Robinul-Neostigmine Injection contains sodium
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.
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 medicine ask your doctor or nurse.
4. POSSIBLE SIDE EFFECTS4. PO
SSIBLE 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:
• dry mouth
• difficulty in passing stools (Constipation)
• slow heart rate (Bradycardia)
• an awareness of strong, thumping heartbeats (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.
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: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE ROBINUL-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 Robinul-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 Robinul-Neostigmine Injection looks like and contents of the 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 October 2016.

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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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