SUGAMMADEX SYNTHON 100 mg/mL Injectable Solution

Introduction

Package Leaflet: Information for the Patient

Sugammadex Synthon®100 mg/ml Solution for Injection EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your anesthesiologist (anesthetist) or doctor.
• If you experience side effects, consult 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 Synthon and what is it used for
2. What you need to know before starting treatment with Sugammadex Synthon
3. How to use Sugammadex Synthon
4. Possible side effects
5. Storage of Sugammadex Synthon
6. Package Contents and Additional Information

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

What is sugammadex

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

What is sugammadex used for

If you need to have surgery, your muscles must be completely relaxed, making it easier for the surgeon to perform the operation. For this, you will be given medications during general anesthesia 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.

This medicine is used to speed up muscle recovery after surgery so that you can breathe on your own again sooner. It does this by combining with 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 starting treatment with Sugammadex Synthon

N

• if you are allergic to sugammadex or any of the other components of this medicine (listed in section 6).

Tell your anesthesiologist if this applies to you.

Warnings and Precautions

Consult your anesthesiologist before starting treatment with this medicine

• if you have or have had kidney disease. This is important because this medicine 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 (blood coagulation disorders) or are taking anticoagulant medication.

Children and Adolescents

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

Other Medicines and Sugammadex Synthon

Tell your anesthesiologist if you are taking, have recently taken, or may need to take any other medicine.

This medicine may affect other medicines or be affected by them.

Some Medicines Reduce the Effect of Sugammadex Synthon

It is especially important to inform your anesthesiologist if you have recently taken:

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

This Medicine May Affect Hormonal Contraceptives

This medicine 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 this medicine is approximately the same as when you miss a contraceptive pill.

• If you are taking the Pillon the same day that you are given this medicine, follow the instructions for missing a pill in the pill's package leaflet.
• If you are using otherhormonal 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, this medicine does not affect laboratory tests. However, it may affect the results of a blood test when progesterone levels are measured. Consult your doctor if your progesterone levels need to be analyzed on the same day you receive this medicine.

Pregnancy and Breastfeeding

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

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

It is not known if sugammadex can pass into breast milk. Your anesthesiologist will help you decide whether to interrupt breastfeeding or avoid treatment with sugammadex, considering the benefit of breastfeeding for the baby and the benefit of this medicine for the mother.

Driving and Using Machines

This medicine has no known influence on the ability to drive and use machines.

Sugammadex Synthon Contains Sodium

This medicine contains up to 9.7 mg of sodium (a major component of cooking/table salt) per mL.

Dose less than or equal to 2.4 ml

A dose of 2.4 ml (or less) contains less than 1 mmol of sodium (23 mg), which is essentially "sodium-free".

Dose greater than 2.4 ml

A dose of 2.4 ml (or more) contains 1 mmol (or more) of sodium (23 mg). This is equivalent to 1.15% (or more) of the maximum recommended daily sodium intake for an adult.

Tell your anesthesiologist if you are on a controlled salt diet.

3. How to Use Sugammadex Synthon

This medicine will be given to you by your anesthesiologist or under their supervision.

Dose

Your anesthesiologist will calculate the dose of this medicine 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 for adults and for children and adolescents between 2-17 years. A dose of 16 mg/kg may be used in adults if urgent recovery of muscle relaxation is needed.

How Sugammadex Synthon is Administered

This medicine will be administered by your anesthesiologist. It is injected once into a vein.

If You Are Given Too Much Sugammadex Synthon

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you have any further questions about 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.

F

• Cough
• Respiratory difficulties that may include cough or movements as if waking up or taking a breath
• Light anesthesia – you may start to wake up, so you may need more anesthetic. This can 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

P

• 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, difficult 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

F

• When this medicine is administered, a significant slowing of the heart can occur, which can even lead to cardiac arrest

C

If you experience any side effects, consult your anesthesiologist or another doctor, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sugammadex Synthon

Storage will be the responsibility of healthcare professionals. Keep this medicine out of the sight and reach of children.

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

This medicine does not require any special storage temperature. Keep the vial in the outer packaging to protect it from light.

Once opened and diluted, store at 2-8°C and use within 24 hours.

6. Package Contents and Additional Information

Composition of Sugammadex Synthon

• The active substance is sugammadex.

Each mL of the solution for injection contains sugammadex sodium equivalent to 100 mg of sugammadex.

Each 2 mL vial contains sugammadex sodium equivalent to 200 mg of sugammadex.

Each 5 mL vial contains sugammadex sodium equivalent to 500 mg of sugammadex.

• The other ingredients are water for injections, sodium hydroxide (for pH adjustment), and/or hydrochloric acid (for pH adjustment).

Appearance of the Product and Package Contents

This medicine is a clear, colorless to slightly brown, practically particle-free solution for injection.

It comes in two different package sizes, 10 vials of 2 mL or 10 vials of 5 mL of solution for injection.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Synthon B.V.

Microweg 22

6545 cm, Nijmegen

Netherlands

Manufacturer

Synthon Hispania, S.L.

c/ Castello nº1,

Pol. Las Salinas,

08830 Sant Boi de Llobregat, Barcelona

Spain

or

Synthon B.V.

Microweg 22

6545 cm, Nijmegen

Netherlands

Date of Last Revision of this Leaflet:July 2024

Other Sources of Information

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

----------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

For detailed information, consult the Summary of Product Characteristics of this medicine.