Prospecto: information for the user

Sugammadex SUN 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 or doctor.
• If you experience adverse effects, consult your anesthesiologist or doctor, even if they are not listed in this prospect. See section 4.

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

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

3. How Sugammadex Sun is administered

4. Possible adverse effects

5. Storage of Sugammadex Sun

6. Contents of the package and additional information

What is Sugammadex Sun

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

For what Sugammadex Sun is used

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

This medication is used to accelerate the recovery of your 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 17 years), when bromide of rocuronium is used for a moderate level of relaxation.

Do not receive Sugammadex Sun

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

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 this medication is eliminated from your body by your 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 2 years old.

Other medications and Sugammadex Sun

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 Sun

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

-toremifeno (used to treat breast cancer).

-acid fusidic (an antibiotic).

Sugammadex Sun may affect hormonal contraceptives

This medication may make hormonal contraceptives - such as "The Pill", vaginal ring, implants, or an Intrauterine Device (IUD) less effective because it reduces the amount of progesterone hormone that reaches you. The amount of progesterone lost due to the use of this medication is approximately the same as when you forget a contraceptive pill.

-If you are taking The Pill on the same day that you receive Sugammadex, follow the instructions in case of missing a pill from the contraceptive pill package insert.

-If you are using other hormonal contraceptives (for example vaginal ring, implant, or IUD) you should use a non-hormonal contraceptive method (such as a condom) for the next 7 days and follow the recommendations in the package insert.

Effects on blood tests

In general, this medication does not affect 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 receive this medication, but it needs to be discussed beforehand.

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 machines

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

Sugammadex Sun contains sodium

This medication contains 9.7 mg of sodium (main component of table salt/paracocinar) in each ml.

Doses equal to or less than 2.4 ml

At a dose of 2.4 ml (or less) contains less than 23 mg of sodium (1 mmol); this is essentially "sodium-free".

Doses greater than 2.4 ml

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

Inform your anesthesiologist if you follow a low-sodium diet.

This medication will be administered by your anesthesiologist, or under the supervision of your anesthesiologist.

Dose

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

-Your weight

-The amount of muscle relaxant still in effect.

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 Sun is Administered

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

If you are injected with more Sugammadex Sun than recommended

Since your anesthesiologist will be closely monitoring the situation, it is unlikely that you will be administered 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 cause side effects, although not everyone will experience them.

If these side 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

-Respiratory difficulties 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 pharynx, difficult breathing, changes in blood pressure or heart rate, which sometimes results in a severe decrease in blood pressure. Severe allergic reactions or anaphylactic reactions can be life-threatening

Allergic reactions were reported more frequently in healthy, conscious volunteers

-Reappearance of muscle relaxation after the operation

Unknown frequency (cannot be estimated from available data)

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

Reporting side effects

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

Conservation will be handled by 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 special temperature conservation conditions. Store 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.

Sugammadex Sun Composition

-The active ingredient is sugammadex.

1 ml 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 injectable water, hydrochloric acid (for pH adjustments) and/or sodium hydroxide (for pH adjustments).

Appearance of Sugammadex Sun and packaging contents

This medicine is a transparent, colorless to light brownish yellow 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 marketed.

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Responsible for manufacturing

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Synthon Hispania S.L.

Calle De Castello 1

Sant Boi de Llobregat

08830 Barcelona

Spain

Sinthon B.V.

Microweg 22

6545CM Nijmegen

Gelderland

Netherlands

For further information about this medicine, please contact the local representative of the marketing authorization holder:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 – Barcelona

Spain

Phone: +34 93 342 7890

Last review date of this leaflet:August 2023

For detailed and updated information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

This information is intended solely for healthcare professionals:

For detailed information, please consult the Technical Dossier or the Summary of Characteristics of Sugammadex Sun.