The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.Source: electronic medicines compendium (emc), DatapharmActive substance: glycopyrronium bromide, neostigmine metilsulfateOfficial document: view the original leaflet on emc →Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

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Glycopyrronium Bromide and Neostigmine Metilsulfate 0.5mg/2.5mg per ml Solution for Injection

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Glycopyrronium bromide, Neostigmine metilsulfate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Glycopyrronium bromide, Neostigmine metilsulfate

Source: electronic medicines compendium (emc)

Official leaflet: Read the PIL on emc

What it is and what it is used for

for 2. What you need to know before you are given Glycopyrronium and Neostigmine Injection.

What you need to know before you take it

Glycopyrronium and Neostigmine Injection. You should not be given Glycopyrronium and Neostigmine Injection if:

you are allergic to Glycopyrronium Bromide or Neostigmine Metilsulfate, or to any of the other ingredients in this medicine, (listed in section 6).
you think you may have a blockage in your intestine or urinary passage.
you have been given suxamethonium, a drug used to relax your muscles during surgery. Warnings and precautions Take special care with Glycopyrronium and Neostigmine Injection. Tell your doctor if:
you are pregnant or breast feeding;
you suffer from glaucoma (increased pressure in the eye);
you have had a recent operation on your intestines;
you suffer from stomach ulcers;
you suffer from asthma attacks, wheezing or difficulty breathing;
you have a very slow heart beat (less than 60 beats per minute) or you are suffering from coronary artery disease; heart failure, irregular heartbeats or high or low blood pressure;

you have recently suffered a heart attack;
you have an overactive thyroid gland;
you suffer from kidney problems;
you suffer from myasthenia gravis (a disease resulting in severe muscle weakness and fatigue);
you are suffering from epilepsy or Parkinson's;
you have a fever;
you suffer from enlarged prostate gland;
you suffer from obstruction of the stomach (pyloric stenosis) or bowel causing vomiting, abdominal pain and swelling (paralytic ileus);
you are under the influence of anaesthetics like Cyclopropane or Halothane. 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:
suxamethonium, a drug used to relax your muscles during surgery;
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
medicines to treat depressions (e.g. Tricyclic Antidepressant, MAOIs)
Amantadine which is used to treat Parkinson's disease or viral infections
medicines used to treat mental illness (e.g. Nefopam) 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:

How to take it

. 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 Bromide belongs to a group of medicines called anticholinergic drugs. It is used to counteract some unwanted effects that may occur with Neostigmine.
Neostigmine belongs to a group of medicines called cholinesterase inhibitors. It can be used to reverse the effects of a type of muscle-relaxing drug used during operations called non-depolarising muscle relaxants. Glycopyrronium and Neostigmine Injection is used to reverse the muscle relaxation produced by non-depolarising muscle relaxants.

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).

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.

How to store it

Glycopyrronium and Neostigmine Injection.

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.

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.

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:

difficulty breathing
you have too much saliva or increased sweating
watering eyes or pinpoint pupils
losing control of your bowels or bladder
an unusually fast or slow or irregular heartbeat, or low blood pressure (you may feel faint)
feeling agitated or an increase in the amount you dream
weakness, muscle twitching or paralysis If you have any further questions about this medicine, ask your doctor or nurse.

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 Martindale Pharmaceuticals Ltd, T/A Martindale Pharma, Bampton Road, Harold Hill, Romford, Essex, RM3 8UG, UK. Marketing Authorisation Number: PL 00156/0116 The leaflet was last revised in: October 2018

Tell your doctor or nurse if you notice any of the following symptoms:

a dry mouth;
difficulty in passing urine;
blurred vision;
absence of sweating;
a very slow heartbeat, palpitations or irregular heartbeats;
too much saliva;
wheeziness;
stomach cramps, feeling sick (nausea), or being sick (vomiting);
diarrhoea;
hypotension;
intolerance to light;
weakness;
increased lung secretions;
increased secretions of stomach;
increased sweating;
confusion;
increased pressure in eye (glaucoma); 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. Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Continued overleaf

4517-B

D04517

100mm Measurement Verification Bar

Frequently asked questions about Glycopyrronium Bromide and Neostigmine Metilsulfate 0.5mg/2.5mg per ml Solution for Injection

How do I take Glycopyrronium Bromide and Neostigmine Metilsulfate 0.5mg/2.5mg per ml Solution for Injection?

Glycopyrronium Bromide and Neostigmine Metilsulfate 0.5mg/2.5mg per ml Solution for Injection comes as injection containing 0.5mg / 2.5mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Glycopyrronium Bromide and Neostigmine Metilsulfate 0.5mg/2.5mg per ml Solution for Injection?

The active substance in Glycopyrronium Bromide and Neostigmine Metilsulfate 0.5mg/2.5mg per ml Solution for Injection is glycopyrronium bromide, neostigmine metilsulfate.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Glycopyrronium Bromide and Neostigmine Metilsulfate 0.5mg/2.5mg per ml Solution for Injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Glycopyrronium Bromide and Neostigmine Metilsulfate 0.5mg/2.5mg per ml Solution for Injection without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Source: electronic medicines compendium (emc), Datapharm
Active substance: glycopyrronium bromide, neostigmine metilsulfate
Official document: view the original leaflet on emc →

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Glycopyrronium bromide (30 medicines), Glycopyrronium bromide, neostigmine metilsulfate (2 medicines)

See every medicine containing this substance, or browse the full A–Z of active substances.

⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+

Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Reversal of residual non-depolarising (competitive) Neuromuscular block

4.2. Posology and method of administration

Posology:

Adults and elderly

1-2ml intravenously over a period of 10 to 30 seconds (equivalent to Glycopyrronium Bromide 0.5mg with Neostigmine Metilsulfate 2.5mg to Glycopyrronium Bromide 1mg with Neostigmine Metilsulfate 5mg). Alternatively 0.02ml/kg intravenously over a period of 10 to 30 seconds may be used, (equivalent to Glycopyrronium Bromide 0.01mg/kg with Neostigmine Metilsulfate 0.05mg/kg), dose may be repeated (total maximum 2ml)

Paediatric population:

0.02ml/kg intravenously over a period of 10 to 30 seconds (equivalent to Glycopyrronium Bromide 0.01mg/kg with Neostigmine Metilsulfate 0.05mg/kg ).

These doses may be repeated if adequate reversal of neuromuscular blockade is not achieved. Total doses in excess of 2ml are not recommended as this dose of Neostigmine may produce depolarising neuromuscular block.

Method of administration

For intravenous injection

4.3. Contraindications

Hypersensitivity to the Glycopyrronium Bromide or Neostigmine Metilsulfate or to any of the excipients listed in section 6.1.

Glycopyrronium Bromide and Neostigmine Metilsulfate Injection should not be given to patients with known hypersensitivity to either of the two active ingredients or given to patients with mechanical obstruction of the gastrointestinal or urinary tracts. In addition, this product should not be given in conjunction with suxamethonium, as Neostigmine potentiates the depolarising myoneural blocking effects of this agent.

Anticholinesterase-antimuscarinic combinations such as neostigmine plus glycopyrronium should be avoided in patients with a prolonged QT interval.

4.4. Special warnings and precautions for use

Administer with caution to patients with bronchospasm (extreme caution), bradycardia, arrhythmias, recent myocardial infarction, epilepsy, hypotension, parkinsonism, vagotonia, peptic ulceration, hyperthyroidism, renal impairment or glaucoma.

Administration of anticholinesterase agents to patients with intestinal anastomoses may produce rupture of the anastomosis or leakage of intestinal contents.

Although Glycopyrronium Bromide and Neostigmine Metilsulfate Injection has been shown to have less impact on the cardiovascular system than Atropine with Neostigmine Metilsulfate, use with caution in patients with coronary artery disease, congestive heart failure, cardiac dysrhythmias, hypertension or thyrotoxicosis.

Quaternary ammonium compounds in large dose have been shown to block the nicotinic muscle end plate receptors. This must be evaluated prior to its administration in patients with myasthenia gravis.

Use with caution in patients with epilepsy or Parkinson's disease.

This product should be used cautiously in pyrexial patients due to inhibition of sweating.

This medicinal product contains less than 1 mmol sodium (23mg) per dose, i.e. essentially 'sodium free'.

4.5. Interaction with other medicinal products and other forms of interaction

Anticholinesterase drugs enhance neuromuscular transmission in voluntary and involuntary muscle in myasthenia gravis.

Non-depolarizing neuromuscular block induced by the muscle relaxants used in anesthesia; neuromuscular block induced by aminoglycoside antibiotics and antiarrhythmic agents.

Aminoglycosides -Effects of Neostigmine antagonised by aminoglycosides

Chloroquine and Hydroxychloroquine - effects of Neostigmine may be diminished because of potential for Chloroquine and Hydroxychloroquine to increase symptoms of myasthenia gravis

Many drugs have antimuscarinic effects; concomitant use of two or more such drugs can increase side-effects such as dry mouth, urine retention, and constipation; concomitant use can also lead to confusion in the elderly.

Clindamycin - Effects of Neostigmine antagonised by Clindamycin

Lithium - Effects of Neostigmine antagonised by lithium

Muscle Relaxants, non-depolarising - Neostigmine antagonises effects of non- depolarising muscle relaxants

Polymyxins - Effects of Neostigmine antagonised by polymyxins

Procainamide - Effects of Neostigmine antagonised by Procainamide

Propafenone -Effects of Neostigmine possibly antagonised by Propafenone

Propranolol -Effects of Neostigmine antagonised by Propranolol

Quinidine -Effects of Neostigmine antagonised by Quinidine

Suxamethonium -Neostigmine enhances effects of Suxamethonium

Antimuscarinics - Effects of parasympathomimetics antagonised by antimuscarinics

4.6. Fertility, pregnancy and lactation

Pregnancy

For use as indicated, animal studies (see section 5.3) are of very limited relevance. Use in human pregnancy has not been systematically evaluated.

The use of Neostigmine in pregnant patients with myasthenia gravis has revealed no untoward effect of the drug on the course of pregnancy.

Breast-feeding:

May reach breast milk but in amounts probably too small to be harmful.

4.7. Effects on ability to drive and use machines

Not applicable.

4.8. Undesirable effects

The Glycopyrronium Bromide component of Glycopyrrolate - Neostigmine Metilsulfate Injection can give rise to a dry mouth, difficulty in micturition, cardiac dysrhythmias, and disturbances of visual accommodation and inhibition of sweating.

The Neostigmine component of Glycopyrronium Bromide and Neostigmine Metilsulfate Injection can give rise to nausea, vomiting, increased salivation, diarrhoea, abdominal cramps (more marked with higher doses); signs of overdosage include bronchoconstriction, increased bronchial secretions, lacrimation, excessive sweating, involuntary defecation and micturition, miosis, nystagmus, bradycardia, photophobia, heart block, arrhythmias, hypotension, agitation, excessive dreaming, and weakness eventually leading to fasciculation and paralysis.

Glycopyrronium-Neostigmine component of injection can give rise to hypersensitivity, angioedema and anaphylactic reaction. Their frequency is not known

Hypersensitivity

If severe Neostigmine induced muscarinic side effects occur (bradycardia, hypotension, increased or pharyngeal secretions, decreased cardiac conduction rate, bronchospasm or increased gastrointestinal activity etc), these may be treated by the intravenous administration of Glycopyrronium Bromide Injection 200 – 600 micrograms (0.2 – 0.6mg) or atropine 400 – 1200 micrograms (0.4 – 1.2mg).

Reporting of suspected adverse reactions

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

The treatment of overdosage depends on whether signs of anticholinesterase or anticholinergic overdose is the predominant presenting feature.

Signs of Neostigmine overdosage include those of muscarinic effects (nausea, vomiting, increased salivation, diarrhoea, abdominal cramps (more marked with higher doses); signs of overdosage include bronchoconstriction, increased bronchial secretions, lacrimation, excessive sweating, involuntary defecation and micturition, miosis, nystagmus, bradycardia, heart block, arrhythmias, hypotension, agitation, excessive dreaming, and weakness eventually leading to fasciculation and paralysis.) may be treated by administration of Glycopyrronium Bromide Injection 0.2 – 0.6mg or atropine 0.4 – 1.2mg. In severe cases, respiratory depression may occur, artificial ventilation may be necessary in such patients.

Signs of Glycopyrronium Bromide overdose (tachycardia, ventricular irritability etc.) may be treated by intravenous administration of Neostigmine Metilsulfate 1.0mg for each 1.0mg of Glycopyrronium Bromide known to have been administered. As Glycopyrronium Bromide is a quaternary ammonium agent, symptoms of overdosage are peripheral rather than central in nature. Centrally acting anticholinesterase drugs such as physostigmine are therefore unnecessary to treat Glycopyrronium Bromide overdosage.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

⚠ Not the same combination. This medicine contains Glycopyrronium bromide, Neostigmine metilsulfate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.

⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.

NEOSTIGMINA LPH 15 mg prescription partial — not the same combinationNEOSTIGMINI BROMIDUM · taken by mouth

Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako