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)

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.

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

• 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.
• if you think you may have a blockage in your intestine or urinary passage.
• Anticholinesterase-antimuscarinic combinations such as neostigmine plus glycopyrronium should be avoided in patients with a prolonged QT interval (irregular heart rhythm).

Talk to your doctor or nurse before you are given Glycopyrronium-Neostigmine Injection

• if you suffer from asthma attacks, wheezing or difficulty in breathing
• 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 stomach ulcers
• if you have a high temperature (fever)
• if you have low or high blood pressure
• if you suffer from cardiac arrhythmia (irregular heart beats) or slow heart rate (less than 60 beats per minute) or you are suffering from coronary artery disease
• if you suffer from coronary artery disease, a heart attack, 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 (a disease resulting in severe 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)
• if you suffer from kidney problems
• if you have disorder resulting from overstimulation of the vagus nerve, causing a slowing of the heart rate, fainting, constipation and sweating
• if you are pregnant or breast feeding

Glycopyrronium bromide should be used with caution in children and elderly people.

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:

• medicines to treat depression (e.g. Tricyclic Antidepressant for example amitriptyline or imipramine, MAOI's for example phenelzine, tranylcypramine)
• 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
• medicines used to treat bacterial infections known as aminoglycoside antibiotics, such as gentamicin and streptomycin
• medicines used to treat bacterial infections known as polymyxins, 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

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.

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.

This injection contains less than 1mmol (23mg) of sodium per 2ml (essentially ‘sodium-free’).

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.

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)
• a very slow heart rate (Bradycardia)
• an awareness of strong, thumping heart beats (Palpitation) or irregular heart beats (could be related to either glycopyrrolate or neostigmine)
• reduced secretion in lungs
• difficulty in passing urine
• inability to completely empty the bladder (urinary retention)
• uncontrollable urge to pass urine
• visual disturbances
• increased sensitivity of the skin to light (Photophobia)
• enlargement of pupil
• glaucoma (increased pressure in the eye)
• absence of sweating
• dryness of the skin
• reddening of the skin and other areas of the skin (Flushing)
• confusion
• nausea (feeling sick)
• vomiting (being sick), dizziness
• increased secretions of stomach
• increase in mucus secretion
• too much saliva
• tummy cramps
• diarrhea

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.

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.

Glycopyrronium-Neostigmine Injection is a clear, colourless, sterile solution for injection.

Each carton contains ten 1ml ampoules of Glycopyrronium-Neostigmine Injection.

This leaflet was last revised in December 2023.