Prospecto: information for the user

Sugammadex Accord 100 mg/ml injectable solution EFG

Read this prospect carefully before this medicine is administered to you,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your anesthesiologist (anesthetist) or doctor.
• If you experience any adverse effects, consult your anesthesiologist or another doctor, even if they are not listed in this prospect.See section4.

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

2.What you need to know before starting the administration of Sugammadex Accord

3.How to administer Sugammadex Accord

4.Possible adverse effects

5.Storage of Sugammadex Accord

6.Contents of the package and additional information

What isSugammadex Accord

This medication contains the active ingredient sugammadex. Sugammadex is considered aSelective Agent for Binding Blockersas it only works with specific muscle relaxants, bromide of rocuronium or bromide of vecuronium.

What is it used forSugammadex Accord

If you have to undergo surgery, your muscles must be completely relaxed, which facilitates the surgeon's operation. For this, during general anesthesia, they will give you medications to relax your muscles. They are calledmuscle blockers, and for example, bromide of rocuronium and bromide of vecuronium are. As those medications also block the muscles of breathing, you will need help breathing (artificial respiration) during and after your operation until you can breathe again on your own.

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

Do not receiveSugammadex Accord

• If you are allergic to sugammadex or any of the other components of this medication (listed in section6).

Inform your anesthesiologist if this is the case.

Warnings and precautions

Consult your anesthesiologist before starting administration of this medication:

• If you have any kidney disease or have had it in the past. This is important because sugammadex is eliminated from your body by the kidneys.
• If you have liver disease or have had it previously.
• If you have fluid retention (edema).
• If you have a disease that increases the risk of bleeding (blood clotting disorders) or are taking anticoagulant medication.

Children and adolescents

This medication is not recommended for children under 2years.

Other medications and Sugammadex Accord

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

Sugammadex may affect other medications or be affected by them.

Some medications reduce the effect of Sugammadex Accord

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

• Toremifeno (used to treat breast cancer).
• Fusidic acid (an antibiotic).

Sugammadex Accord may affect hormonal contraceptives

This medication 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 progesterone hormone that reaches you. The amount of progesterone lost as a result of using this medication is approximately the same as when you forget a contraceptive pill.

• If you are takingThe Pillon the same day that you are administered this medication, follow the instructions in case of missing a pill from the pill package insert.
• If you are usingotherhormonal contraceptives (for example, vaginal ring, implant, or IUD‑h), you should use a non-hormonal contraceptive method (such as a condom) for the next 7days and follow the recommendations in the package insert.

Effects on blood tests

In general, sugammadex has no effect on laboratory tests. However, it may affect the results of a blood test when measuring progesterone hormone levels. Consult your doctor if your progesterone levels need to be analyzed on the same day you receive this medication.

Pregnancy and breastfeeding

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

It is possible that you will still be administeredthis medication, but it needs to be discussed first.

No information is available on whether sugammadex can pass into breast milk. Your anesthesiologist will help you decide whether to stop breastfeeding or avoid treatment with sugammadex, considering the benefits of breastfeeding for the baby and the benefits of this medication for the mother.

Driving and operating machinery

This medication has no known influence on the ability to drive and operate machinery.

Sugammadex Accord contains sodium

This medication contains up to 9.7mg of sodium (main component of table salt/for cooking) in each ml. This is equivalent to 0.5% of the maximum recommended daily sodium intake for an adult.

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

Dose

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

• Your weight
• The amount of muscle relaxant that is still in effect.

The usual dose is 2-4 mg per kg of body weight for adults and for children and adolescents aged 2 to 17 years. A dose of 16 mg/kg may be used in adults if urgent recovery of muscle relaxation is needed.

How Sugammadex Accord is administered

This medication will be administered by your anesthesiologist. It is injected once via intravenous route.

If you are given more Sugammadex Accord than recommended

Since your anesthesiologist will be closely monitoring the situation, it is unlikely that you will be given too much sugammadex. Even if this happens, it is unlikely to cause any problems.

If you have any other questions about the use of this medication, ask your anesthesiologist or another doctor.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

If these adverse effects occur while you are under the effects of anesthesia, it will be your anesthesiologist who will detect and treat them.

Frequent (may affect up to 1 in 10 people)

• Coughing
• Difficulty with breathing that may include coughing or movements as if you are awake or taking a breath
• Superficial anesthesia‑You may start to wake up, so you will 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, coughing, or movement
• Decreased blood pressure due to surgical intervention

Rare (may affect up to 1 in 100 people)

• Difficulty breathing due to muscle cramps in the airways (bronchospasm) that occur in patients with a history of lung problems
• Allergic reactions (hypersensitivity to medications)‑such as rash, skin redness, swelling of your tongue and/or throat, difficult breathing, changes in blood pressure or heart rate, which sometimes results in a severe decrease in blood pressure. Severe allergic reactions or anaphylaxis can be life-threatening
  Allergic reactions were reported more frequently in healthy, conscious volunteers
• Reappearance of muscle relaxation after the operation

Unknown frequency

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your anesthesiologist or another doctor, even if it is a possible adverse effect not listed in this prospectus. You can also report them directlythrough the Spanish System of Pharmacovigilance for Medications for Human Use: https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Conservation will be the responsibility of healthcare professionals.

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

Do not use this medication after the expiration date that appears on the box and on the label after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require any special conservation temperature.Storethe vial in the outer packaging to protect it from light.

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

Composition of Sugammadex Accord

• The active ingredient is sugammadex.

Each milliliter of injectable solution contains sugammadex sodium equivalent to 100 mg of sugammadex.

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

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

• The other components are water for injectable preparations, hydrochloric acid (to adjust the pH) and/or sodium hydroxide (to adjust the pH).

Appearance of Sugammadex Accord and packaging contents

Sugammadex Accord is a transparent, colorless to slightly yellowish injectable solution, practically free of particles.

It is presented in two different packaging sizes, 10 vials of 2 ml or 10 vials of 5 ml of injectable solution.

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Accord Healthcare, S.L.U

World Trade center

Moll de Barcelona, s/n

Edifici Est 6th floor

08039 Barcelona

Spain

Manufacturer responsible

Synthon Hispania S.L.

Calle De Castello 1

Sant Boi de Llobregat

08830, Barcelona,

Spain

or

Synthon B.V

Microweg 22

Nijmegen

6545 CM, Gelderland

Netherlands

Member states Medicinal product name

Netherlands Sugammadex Genthon 100 mg/mL, oplossing voor injectie

Spain Sugammadex Accord 100 mg/ml solución inyectable EFG

Italy Sugammadex Accord

Portugal Sugamadex Accord

Last review date of this leaflet: July 2023.

The detailed information of this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

To obtain detailed information, consult the Technical Dossier or the Summary of Characteristics of the Product of Sugammadex Accord.