Novistig

Package Leaflet: Information for the User

Novistig, 0.5 mg/ml + 2.5 mg/ml, Solution for Injection
Glycopyrronium bromide + Neostigmine methylsulfate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Novistig and what is it used for
• 2. Important information 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 is Novistig and what is it used for

Novistig contains two active substances:

• Neostigmine methylsulfate, which belongs to a group of medicines called cholinesterase inhibitors. Its task is to reverse the action of certain muscle relaxant medicines.
• Glycopyrronium bromide belongs to a group of medicines called anticholinergic medicines. Its task is to block some of the unwanted effects that may occur with neostigmine methylsulfate, such as slowing of the heart rate or excessive saliva production. At the end of the procedure, glycopyrronium bromide and neostigmine methylsulfate are administered by injection to reverse the action of certain medicines used during surgery, such as anesthetics and muscle relaxants.

2. Important information before using Novistig

When not to use Novistig

• if you are allergic to glycopyrronium bromide or neostigmine methylsulfate or any of the other ingredients of this medicine (listed in section 6).
• if you have a blockage of the stomach, intestines, or urinary tract, especially the bladder or kidneys
• if you are also receiving suxamethonium, a muscle relaxant usually given during surgery. Make sure your doctor knows your condition.

Warnings and precautions

Before starting to use Novistig, discuss with your doctor or nurse:

• -if you have asthma or wheezing attacks
• if you have glaucoma (increased pressure in the eye)
• if you have recently had intestinal surgery
• if you have a high body temperature (especially children)
• if you have high blood pressure
• if you have an irregular heartbeat or slow heart rate
• if you have heart failure or heart disease
• if you are under the influence of anesthetics, such as cyclopropane or halothane
• if you have myasthenia (leading to muscle weakness and fatigue)
• if you have an enlarged prostate
• if you have a blockage of the stomach or intestines causing vomiting, abdominal pain, and swelling (paralytic ileus)
• if you have hyperthyroidism
• if you have epilepsy or parkinsonism (a brain disorder causing stiffness and tremors of the muscles).

Tell your doctor if any of the above conditions apply to you.

Novistig and other medicines

Tell your doctor about all medicines you are taking or using, or have recently taken or used, and about medicines you plan to take or use.

• medicines used to treat depression (e.g., tricyclic antidepressants, monoamine oxidase inhibitors IMAO)
• medicines used to treat mental disorders (e.g., clozapine)
• medicines used to relieve pain (e.g., nefopam)
• amantadine used to treat Parkinson's disease or viral infections
• suxamethonium, a muscle relaxant usually given during surgery

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.

Driving and using machines

This medicine may cause blurred vision, which may affect your ability to drive or use machines.
Before driving or using machines, consult your doctor.

Novistig contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per 1 ml (ampoule), which means the medicine is considered "sodium-free".

3. How to use Novistig

This medicine can 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) can be administered 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 injection and administer 1 ml per 5 kg of body weight.
Your doctor will decide on the correct dose depending on the circumstances. The dose can be calculated based on body weight. The injection is usually administered over 10-30 seconds and may need to be repeated depending on the patient's response.

Using more than the 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 saliva production, and breathing difficulties. If you suspect that you have been given too much of the medicine, tell your doctor immediately.
If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Important side effects to look out for:

All medicines can cause allergic reactions, although severe allergic reactions are very rare. Any sudden wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash, or itching (especially affecting the whole body) should be reported to a doctor immediately.
You should immediately contact a doctor if you experience any of the following symptoms - you may need urgent medical attention:
Swelling of the face, lips, or throat, which may cause difficulty swallowing or breathing, rash, itching, hives, and dizziness. These may be symptoms of angioedema or a severe allergic reaction (frequency not known, frequency cannot be estimated from the available data).
The following side effects have also been reported, but their frequency is not known:

• dry mouth
• difficulty passing stools (constipation)
• slow heart rate (bradycardia)
• strong, pounding heartbeats (palpitations) or irregular heartbeats
• decreased lung secretions
• difficulty urinating
• increased sensitivity of the skin to light (photosensitivity)
• dry skin
• redness of the skin (flushing)
• disorientation
• nausea, vomiting, dizziness
• eye disorder (glaucoma)
• dilated pupils
• blurred vision
• increased stomach secretions and decreased sweating. If any of the side effects get serious, or if you notice any side effects not listed in this package leaflet, please tell your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Novistig

Keep this medicine out of the 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 month stated.
Do not freeze.
Use immediately after first opening. For single use only.
Do not administer Novistig if the solution is not clear and free from 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. This will help protect the environment.

6. Contents of the pack and other information

What Novistig contains

The active substances are glycopyrronium bromide and neostigmine methylsulfate.
Each ampoule contains 1 ml of solution, which contains the 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 injection.

What Novistig looks like and contents of the pack

This medicine is a solution for injection. The solution for injection is clear, colorless, and practically free from visible particles.
A 2 ml ampoule made of transparent, colorless type I glass, containing 1 ml of solution for injection, in a cardboard box.
The box contains 10 ampoules of 1 ml solution for injection.

Marketing authorization holder and manufacturer:

Sintetica GmbH
Albersloher Weg 11
48155 Münster
Germany

This medicinal product is authorized in the Member States of the European Economic Area 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

Date of last revision of the package leaflet: -------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:
The SmPC is added at the end of the printed Package Leaflet as a tear-off section.