Sugammadex Normon 100 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sugammadex Normon 100 mg/ml solution for injection EFG

Read the entire leaflet carefully before you are given this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your anaesthetist (anesthesiologist) or your doctor.
• If you experience any adverse reactions, consult your anaesthetist or another doctor, even if these adverse reactions are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

What Sugammadex Normon is

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

What Sugammadex is used for

If you require surgery, your muscles must be completely relaxed, which helps the surgeon perform the procedure. For this reason, during general anaesthesia, you will be given medicines to relax your muscles. These are called muscle relaxants, such as rocuronium bromide and vecuronium bromide. Since these medicines also block the muscles used for breathing, you will need assistance with breathing (artificial ventilation) during and after your surgery until you can breathe on your own again.

Sugammadex is used to accelerate the recovery of muscle function after surgery so that you can breathe independently again sooner. It works by binding to rocuronium bromide or vecuronium bromide in your body. It can be used in adults whenever rocuronium bromide or vecuronium bromide is used, and in children and adolescents (aged 2 to 17 years) when rocuronium bromide is used for moderate levels of relaxation.

2. What you need to know before receiving Sugammadex Normon

Do not receive Sugammadex Normon

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

Inform your anesthesiologist if this applies to you.

Warnings and precautions

Talk to your anesthesiologist before receiving Sugammadex Normon

• if you have any kidney disease or have had it in the past. This is important because Sugammadex is eliminated from your body through the kidneys.
• if you have liver disease or have had it previously.
• if you have fluid retention (edema).
• if you have any condition that increases the risk of bleeding (blood 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

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

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

Some medicines reduce the effect of Sugammadex Normon

It is especially important that you inform 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 a hormonal intrauterine device (IUD-h) less effective, because it reduces the amount of progestogen hormone available. The amount of progestogen lost due to the use of Sugammadex Normon is approximately the same as when a contraceptive pill is missed.

• If you are taking the Pill on the same day Sugammadex is administered, follow the missed pill instructions provided in the contraceptive pill’s package leaflet.
• If you are using other hormonal contraceptives (e.g. vaginal ring, implant, or IUD-h), you should use an additional non-hormonal contraceptive method (such as a condom) for the following 7 days and follow the recommendations in the product leaflet.

Effects on blood tests

In general, Sugammadex has no effects on laboratory tests. However, it may affect the results of a blood test when measuring levels of the hormone progesterone. Consult your doctor if your progesterone levels need to be tested on the same day you receive Sugammadex Normon.

Pregnancy and breastfeeding

Inform your anesthesiologist if you are pregnant, may be pregnant, or are breastfeeding.

You may still be given Sugammadex, but this should be discussed beforehand.

It is not known whether sugammadex passes into breast milk. Your anesthesiologist will help you decide whether to interrupt breastfeeding or to avoid treatment with sugammadex, taking into account the benefits of breastfeeding for the baby and the benefits of Sugammadex for the mother.

Driving and using machines

Sugammadex has no known influence on the ability to drive or operate machinery.

Sugammadex Normon contains sodium

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

3. How Sugammadex Normon is administered

Sugammadex will be administered by your anaesthetist, or under the supervision of your anaesthetist.

Dosage

Your anaesthetist will calculate the dose of Sugammadex you need based on:

• your body weight
• the amount of residual muscle relaxant effect still present.

The usual dose is 2–4 mg per kg of body weight. A dose of 16 mg/kg may be used in adults when urgent reversal of muscle relaxation is required.

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

How Sugammadex Normon is administered

Sugammadex will be administered by your anaesthetist. It is given as a single intravenous injection.

If you are given more Sugammadex Normon than you should

As your anaesthetist will be carefully monitoring your condition, it is unlikely that you will receive too much Sugammadex. However, even if this occurs, it is unlikely to cause any problems.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Frequent (may affect up to 1 in 10 people)

• Cough
• Respiratory tract difficulties which may include coughing or movements as if awake or gasping for breath
• Light anaesthesia – you may begin to wake up, so you will need more anaesthetic. This may cause you to move or cough at the end of surgery
• Complications during the procedure, such as changes in heart rate, coughing or movement
• Decrease in blood pressure due to the surgical intervention

Uncommon (may affect up to 1 in 100 people)

• Breathing difficulty due to muscle cramps in the airways (bronchospasm) occurring in patients with a history of lung problems

• Allergic reactions (hypersensitivity to medicines) – such as rash, skin redness, swelling of the tongue and/or pharynx, difficult breathing, changes in blood pressure or heart rhythm, sometimes resulting in a severe drop in blood pressure. Allergy-type or severe allergic reactions may be life-threatening. Allergic reactions have been reported more frequently in healthy conscious volunteers

• Recurrence of muscle relaxation after surgery

Frequency not known

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your anaesthetist or another doctor, even if these are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es

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

5. Storage of Sugammadex Normon

Keep this medicine out of sight and reach of children.

Storage should be handled by healthcare professionals.

Do not use this medicine after the expiry date stated on the label and carton following "EXP". The expiry date refers to the last day of the month indicated.

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

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sugammadex Normon

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

Appearance of the medicinal product and contents of the container

Sugammadex Normon is a clear, colourless to slightly yellowish-brown, injectable solution. It is available in two different pack sizes: 10 vials of 2 ml or 10 vials of 5 ml of injectable solution.

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos
Madrid (SPAIN)

Date of the most recent revision of this leaflet: December 2022

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

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You may also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/88606/P_88606.html

This information is intended for healthcare professionals only:

For detailed information, please consult the Summary of Product Characteristics or the Technical Data Sheet of Sugammadex Normon 100 mg/ml solution for injection EFG.