Novistig

Patient Information Leaflet

Novistig, 0.5 mg/ml + 2.5 mg/ml, solution for injection
Glycopyrronium bromide + Neostigmine methylsulfate
Please read this leaflet carefully before using this medicine, as it contains
important information for the patient

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Novistig is and what it is used for
2. What you need to know before using Novistig
3. How to use Novistig
4. Possible side effects
5. How to store Novistig
6. Contents of the pack and other information

1. What Novistig is and what it is used for

Novistig contains two active substances:

• Neostigmine methylsulfate, which belongs to a group of medicines called cholinesterase inhibitors. Its function is to reverse the effects of certain muscle-relaxing drugs.
• Glycopyrronium bromide, which belongs to a group of medicines called anticholinergic agents. It blocks certain unwanted effects that may occur with neostigmine methylsulfate, such as slowing of the heart rate or excessive salivation. At the end of a surgical procedure, glycopyrronium bromide and neostigmine methylsulfate are administered by injection to reverse the effects of certain drugs used during surgery, such as anaesthetics and muscle relaxants.

2. Important information before using Novistig

When not to use Novistig

• if the patient is allergic to glycopyrronium bromide or neostigmine methylsulfate or any of the other ingredients of this medicine (listed in section 6).
• if the patient has gastric or intestinal obstruction, or urinary tract obstruction, especially of the bladder or kidneys
• if the patient is also receiving suxamethonium, a muscle relaxant usually administered during surgery. Ensure that the doctor is aware of the patient's condition.

Warnings and precautions
Before starting treatment with Novistig, discuss with the doctor or nurse:

• if the patient has asthma or wheezing
• if the patient has glaucoma (increased pressure in the eye)
• if the patient has recently undergone intestinal surgery
• if the patient has elevated body temperature (especially in children)
• if the patient has high blood pressure
• if the patient has heart arrhythmia (irregular heartbeat) or bradycardia (slow heart rate)
• if the patient has heart failure or heart disease
• if the patient is under the influence of anaesthetic agents such as cyclopropane or halothane
• if the patient has myasthenia gravis (a condition causing muscle weakness and fatigue)
• if the patient has an enlarged prostate
• if the patient has gastric (pyloric) or intestinal obstruction causing vomiting, abdominal pain and distension (paralytic ileus)
• if the patient has hyperthyroidism
• if the patient has epilepsy or parkinsonism (a brain disorder causing muscle stiffness and tremors).

Inform the doctor if any of the above conditions apply to the patient.
Novistig and other medicines
Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

• medicines used to treat depression (e.g. tricyclic antidepressants, monoamine oxidase inhibitors MAOIs)
• medicines used to treat psychiatric disorders (e.g. clozapine)
• medicines used to relieve pain (e.g. nefopam)
• amantadine used in the treatment of Parkinson's disease or viral infection
• suxamethonium, a muscle relaxant usually administered during surgery

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Driving and operating machinery
This medicine may cause blurred vision, which could impair the ability to drive or operate machinery safely.
Consult the doctor before driving or operating machinery.
Novistig contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 1 ml (ampoule), meaning the medicine is considered "sodium-free".

3. How to use Novistig

This medicine may only be administered by a doctor or nurse.
The recommended dose is:
Adults and elderly patients: 1-2 ml intravenously over 10 to 30 seconds. Alternatively, a dose based on body weight (i.e. 0.02 ml/kg) may be given over 10-30 seconds.
Children and adolescents: a dose based on body weight (i.e. 0.02 ml/kg) should be administered over 10-30 seconds. Alternatively, dilute to 10 ml with water for injections and administer 1 ml per 5 kg body weight.
The doctor will decide the appropriate dose depending on the circumstances. The dose may be calculated based on body weight. The injection is usually given over 10-30 seconds and may need to be repeated depending on the patient's response.
Use of a higher than recommended dose of Novistig
This is unlikely, as the medicine will be administered by qualified medical personnel.
Overdose may cause changes in heart rate, increased salivation, and breathing difficulties. If the patient suspects that an excessive dose has been administered, they should inform the doctor immediately.
If you have any further questions about the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Important adverse reactions to be aware of:
All medicines may cause allergic reactions, although severe allergic reactions occur very rarely. Any sudden wheezing, breathing difficulties, swelling of the eyelids, face or lips, rash or itching (especially affecting the whole body) should be reported to a doctor immediately.
Contact a doctor immediately if the patient experiences any of the following symptoms – urgent medical assistance may be required:
Swelling of the face, lips or throat causing difficulty in swallowing or breathing, rash, itching, hives and dizziness. These may be symptoms of angioedema or a severe allergic reaction (frequency unknown, frequency cannot be estimated from available data).
The following adverse reactions have also been reported, but their frequency is unknown:

• dry mouth
• difficulty passing stools (constipation)
• slow heartbeat (bradycardia)
• occurrence of strong, pounding heartbeats (palpitations) or irregular heartbeats
• reduced secretions in the lungs
• difficulty in passing urine
• increased skin sensitivity to light (photosensitivity)
• dry skin
• skin redness (erythema)
• disorientation
• nausea, vomiting, dizziness
• eye disorder (glaucoma)
• dilated pupils
• blurred vision
• increased gastric secretions and inhibited or reduced sweating. If any of the adverse reactions worsen or if any adverse symptoms not listed in this leaflet occur, inform the doctor.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform the doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Novistig

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the ampoule and carton.
The expiry date refers to the last day of the stated month.
Do not freeze.
Use immediately after first opening. For single use only.
Do not administer Novistig if the solution is found to be cloudy or contains particles.
Since this medicine is intended for hospital use only, disposal is carried out directly in the hospital.
Medicines should not be disposed of via wastewater. Such action helps protect the environment.

6. Contents of the pack and other information

What Novistig contains
The active substances in this medicinal product are glycopyrronium bromide and neostigmine methylsulfate.
Each ampoule contains 1 ml of solution which includes two active substances: 0.5 mg of glycopyrronium bromide and 2.5 mg of neostigmine methylsulfate.
The other excipients are: disodium phosphate dodecahydrate (E 339), anhydrous citric acid (E 330), sodium hydroxide (for pH adjustment) (E 524), citric acid (for pH adjustment), water for injections.

What Novistig looks like and contents of the pack
This medicinal product is available as a solution for injection. The solution for injection is clear, colourless, and practically free from visible particles.
A 2 ml ampoule made of colourless, transparent type I glass, containing 1 ml of solution for injection, packed in a cardboard box.
The box contains 10 ampoules with 1 ml of solution for injection each.

Marketing Authorisation Holder and Manufacturer:
Sintetica GmbH
Albersloher Weg 11
48155 Münster
Germany

This medicinal product is authorised in the European Economic Area member states under the following names:
AUSTRIA Combistig 0.5 mg/ml + 2.5 mg/ml Injektionslösung
GERMANY Novistig 0.5 mg/ml + 2.5 mg/ml Injektionslösung
GREECE Novistig
CROATIA Novistig
HUNGARY Novistig 0.5 mg/ml + 2.5 mg/ml oldatos injekció
IRELAND Novistig 0.5 mg/ml + 2.5 mg/ml solution for injection
NETHERLANDS Novistig
POLAND Novistig
SLOVENIA Novistig 0.5 mg/2.5 mg v 1 ml raztopina za injiciranje

Information intended exclusively for healthcare professionals:

ChPL is added at the end of the printed Patient Leaflet as a detachable section.