SUGAMMADEX TILLOMED 100 mg/mL Injectable Solution

Introduction

Package Leaflet: Information for the User

Sugammadex Tillomed 100 mg/ml solution for injection EFG

sugammadex

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

Contents of the pack

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

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

What is Sugammadex Tillomed

Sugammadex Tillomed contains the active substance sugammadex. Sugammadex Tillomed is considered a "selective relaxant binding agent" as it only works with specific muscle relaxants, rocuronium bromide or vecuronium bromide.

What is Sugammadex Tillomed used for

If you need to have surgery, your muscles must be completely relaxed, which makes the operation easier for the surgeon. 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.

Sugammadex Tillomed 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 old) when rocuronium bromide is used for moderate muscle relaxation.

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

You should not be given Sugammadex Tillomed

• 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 Tillomed

• if you have kidney disease or have had it in the past. This is important because Sugammadex Tillomed is eliminated from your body through the kidneys.
• if you have liver disease or have had it before.
• if you have fluid retention (edema).
• if you have a disease 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 Tillomed

Tell your anesthesiologist if you are taking, have recently taken, or might take any other medicines. Sugammadex Tillomed may affect other medicines or be affected by them.

Some medicines reduce the effect of Sugammadex Tillomed

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 Tillomed may affect hormonal contraceptives

Sugammadex Tillomed 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 Tillomed is approximately the same as when you forget to take a contraceptive pill.

• If you are taking the pill on the same day that you are given Sugammadex Tillomed, follow the instructions in case of a missed dose in the pill leaflet.
• 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 leaflet.

Effects on blood tests

In general, Sugammadex Tillomed 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 you need to have your progesterone levels tested on the same day that you receive Sugammadex Tillomed.

Pregnancy and breastfeeding

Tell your anesthesiologist if you are pregnant or think you may be pregnant or if you are breastfeeding. You may still be given Sugammadex Tillomed, but it is necessary to discuss it beforehand.

It is not known whether 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 Sugammadex Tillomed for the mother.

Driving and using machines

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

Sugammadex Tillomed contains sodium

This medicine contains 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), i.e., it 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 dietary intake for an adult.

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

3. How Sugammadex Tillomed is administered

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

Dose

Your anesthesiologist will calculate the dose of Sugammadex Tillomed 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 old. A dose of 16 mg/kg may be used in adults if urgent recovery of muscle relaxation is needed.

How Sugammadex Tillomed is administered

Sugammadex Tillomed will be administered to you by your anesthesiologist. It is given as a single injection into a vein.

If you are given more Sugammadex Tillomed than recommended

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

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.

Common side effects(may affect up to 1 in 10 people)

• Cough.
• Respiratory difficulties that may include cough or movements as if you were 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.

Uncommon side effects(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, redness of the skin, 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 can be life-threatening.

Allergic reactions were reported more frequently in healthy conscious volunteers.

• Reappearance of muscle relaxation after surgery

Frequency not known(cannot be estimated from the available data)

• When Sugammadex Tillomed 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 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 Tillomed

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 expiry date which is stated on the carton and on the label after "EXP". The expiry date is the last day of the month shown.

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 between 2 and 8 °C and use within 24 hours.

6. Contents of the pack and further information

Composition of Sugammadex Tillomed

• The active substance is sugammadex.

Each ml of 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, hydrochloric acid (for pH adjustment) and/or sodium hydroxide (for pH adjustment).

Appearance and pack contents

Sugammadex Tillomed is a clear, colorless to slightly yellow/brown solution for injection, practically free of particles.

It comes in two different pack sizes, each containing 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

Marketing authorization holder:

Laboratorios Tillomed Spain, S.L.U.

C/ Cardenal Marcelo Spínola 8

28016 Madrid, España

Manufacturer:

Synthon Hispania S.L.

C/ Castelló, n°1

08830 Sant Boi de Liobregat, Barcelona

Spain

Synthon BV 108612 F

Microweg 22

6545 CM Nijmegen

Netherlands

Tillomed Malta Limited

Malta Life Sciences Park

LS2.01.06 Industrial Estate

San Gwann, SGN 3000, Malta

1. Only the manufacturer will be indicated in each case

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands: Sugammadex Synthon 100 mg/ml, oplossing voor injectie

Germany: Sugammadex Tillomed 100 mg/ml Injektionslösung

France: Sugammadex Tillomed 100 mg/mL solution injectable

Italy: Sugammadex Tillomed 100 mg/mL soluzione iniettabile

Spain: Sugammadex Tillomed 100 mg/mL solución inyectable EFG

Date of last revision of this leaflet: May 2022.

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This information is intended only for healthcare professionals:

For detailed information, consult the Summary of Product Characteristics of Sugammadex Tillomed.