SUGAMMADEX NORMON 100 mg/mL Injectable Solution

Introduction

Package Leaflet: Information for the User

Sugammadex Normon 100 mg/ml Solution for Injection EFG

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 anesthesiologist (anesthetist) or doctor.
• If you experience any side effects, talk to your anesthesiologist or another doctor, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Sugammadex Normon and what is it used for
2. What you need to know before you start using Sugammadex Normon
3. How Sugammadex Normon is administered
4. Possible side effects
5. Storage of Sugammadex Normon
6. Contents of the pack and further information

1. What is Sugammadex Normon and what is it used for

What is Sugammadex Normon

This medicine contains the active substance sugammadex. Sugammadex is considered a Selective Relaxant Binding Agent as it only works with specific muscle relaxants, rocuronium bromide or vecuronium bromide.

What Sugammadex Normon is used for

If you have to undergo surgery, your muscles must be completely relaxed, making it easier for the surgeon to perform the operation. For this, during general anesthesia, you will be given medications to relax your muscles. These are called muscle relaxants, such as rocuronium bromide and vecuronium bromide. Since these medications also block the respiratory muscles, you will need help breathing (artificial respiration) during and after surgery until you can breathe on your own again.

Sugammadex Normon is used to speed up the recovery of your muscles after surgery so that you can breathe on your own again sooner. It does this by binding to rocuronium bromide or vecuronium bromide in your body. It can be used in adults when rocuronium bromide or vecuronium bromide is used, and in children and adolescents (between 2 and 17 years) when rocuronium bromide is used for moderate muscle relaxation.

2. What you need to know before you start using Sugammadex Normon

You should not be given Sugammadex Normon

If you are allergic to sugammadex or any of the other ingredients of this medicine (listed in section 6).

Tell your anesthesiologist if this applies to you.

Warnings and precautions

Talk to your anesthesiologist before you start using Sugammadex Normon

• if you have or have had kidney disease. This is important because Sugammadex Normon is eliminated from your body by the kidneys.
• if you have or have had liver disease.
• if you have fluid retention (edema).
• if you have a disease that increases the risk of bleeding (coagulation disorders) or if you are taking anticoagulant medication.

Children and adolescents

This medicine is not recommended for children under 2 years of age.

Other medicines and Sugammadex Normon

Tell your anesthesiologist if you are taking, have recently taken, or might take any other medicines.

Sugammadex Normon may affect other medicines or be affected by them.

Some medicines reduce the effect of Sugammadex Normon

It is especially important that you tell your anesthesiologist if you have recently taken:

• toremifene (used to treat breast cancer).
• fusidic acid (an antibiotic).

Sugammadex Normon may affect hormonal contraceptives

Sugammadex may make hormonal contraceptives such as the "Pill", vaginal ring, implants, or an Intrauterine Hormonal Device (IUD-h) less effective because it reduces the amount of progestogen that reaches you. The amount of progestogen lost due to the use of Sugammadex Normon is approximately the same as when you miss a birth control pill.

• If you are taking the Pill on the same day that you are given Sugammadex Normon, follow the instructions in case of a missed pill in the package leaflet of the Pill.
• If you are using other hormonal contraceptives (e.g., vaginal ring, implant, or IUD-h), you should use a non-hormonal contraceptive method (such as a condom) for the next 7 days and follow the recommendations in the package leaflet.

Effects on blood tests

In general, Sugammadex Normon does not affect laboratory tests. However, it may affect the results of a blood test when progesterone levels are measured. Talk to your doctor if your progesterone levels need to be analyzed on the same day that you receive Sugammadex Normon.

Pregnancy and breastfeeding

Tell your anesthesiologist if you are pregnant or think you may be pregnant or if you are breastfeeding.

Sugammadex Normon may still be given to you, but this needs to be discussed beforehand.

It is not known whether sugammadex passes into breast milk. Your anesthesiologist will help you decide whether to stop breastfeeding or avoid treatment with sugammadex, considering the benefit of breastfeeding to the baby and the benefit of Sugammadex Normon to the mother.

Driving and using machines

Sugammadex Normon has no known influence on the ability to drive and use machines.

Sugammadex Normon contains sodium

This medicine contains up to 9.3 mg of sodium (a major component of cooking/table salt) per ml. This is equivalent to 0.5% of the maximum recommended daily intake of sodium for an adult.

3. How Sugammadex Normon is administered

Sugammadex Normon will be administered to you by your anesthesiologist or under their supervision.

Dose

Your anesthesiologist will calculate the dose of Sugammadex Normon that you need based on:

• your weight
• the amount of muscle relaxant that is still affecting you.

The usual dose is 2-4 mg per kg of body weight. A dose of 16 mg/kg may be used in adults if urgent recovery from muscle relaxation is needed.

The dose of Sugammadex Normon for children is 2.4 mg/kg (children and adolescents between 2 and 17 years).

How Sugammadex Normon is administered

Sugammadex Normon will be administered to you by your anesthesiologist. It is injected once into a vein.

If you are given more Sugammadex Normon than recommended

Since your anesthesiologist will be carefully monitoring the situation, it is unlikely that you will be given too much Sugammadex Normon. But even if this happens, it is unlikely to cause any problems.

If you have any further questions on the use of this medicine, ask your anesthesiologist or another doctor.

4. Possible side effects

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

If these side effects occur while you are under anesthesia, your anesthesiologist will detect and treat them.

Common (may affect up to 1 in 10 people)

• Cough
• Respiratory difficulties that may include cough or movements as if you were awake or taking a breath
• Light anesthesia – you may start to wake up, so you may need more anesthetic. This may cause you to move or cough at the end of the operation
• Complications during the procedure, such as changes in heart rate, cough, or movement
• Decrease in blood pressure due to the surgical procedure

Uncommon (may affect up to 1 in 100 people)

• Difficulty breathing due to muscle spasms in the airways (bronchospasm) that occur in patients with a history of lung problems

• Allergic reactions (hypersensitivity to medicines) - such as rash, skin redness, swelling of your tongue and/or pharynx, difficulty breathing, changes in blood pressure or heart rate, which sometimes result in a severe drop in blood pressure. Allergic reactions or severe allergic reactions can be life-threatening. Allergic reactions were reported more frequently in healthy conscious volunteers
• Reappearance of muscle relaxation after surgery

Frequency not known

• When Sugammadex Normon is administered, a significant slowing of the heart can occur, which can even lead to cardiac arrest.

Reporting of side effects

If you experience any side effects, talk to your anesthesiologist or another doctor, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sugammadex Normon

Keep this medicine out of the sight and reach of children.

Storage will be the responsibility of healthcare professionals.

Do not use this medicine after the expiry date which is stated on the label and carton after "EXP". The expiry date is the last day of the month stated.

Store below 30°C. Do not freeze. Keep the vial in the outer packaging to protect it from light.

After opening and dilution, store at 2-8°C and use within 24 hours.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Sugammadex Normon

• The active substance is sugammadex. Each ml of solution for injection contains 108.80 mg of sugammadex sodium equivalent to 100 mg of sugammadex.
• The other ingredients are hydrochloric acid, sodium hydroxide, nitrogen, and water for injections.

Appearance and pack size

Sugammadex Normon is a clear, colorless to slightly yellow-brown solution for injection. It comes in two different pack sizes, 10 vials of 2 ml or 10 vials of 5 ml of solution for injection.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos

Madrid (SPAIN)

Date of last revision of this leaflet:December 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/)

This information is intended only for healthcare professionals:

For detailed information, consult the Summary of Product Characteristics or the Package Leaflet of Sugammadex Normon 100 mg/ml solution for injection EFG.