Prospecto:Information for the User

Sugammadex Sandoz 100 mg/ml Injectable Solution EFG

Read this prospect carefully before starting to use this medication,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult youranesthesiologist (anesthetist) or your doctor.
• If you experience any adverse effects,consult your anesthesiologist or another doctor, evenif the adverse effects do not appear in this prospect. See section 4.

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

2.What you need to knowbeforestarting the administration ofSugammadex Sandoz

3.How to administer Sugammadex Sandoz

4.Possible adverse effects

5.Storage of Sugammadex Sandoz

6.Contents of the package and additional information

What is Sugammadex Sandoz

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

What is Sugammadex Sandoz used for

If you need to undergo surgery, your muscles must be completely relaxed, which facilitates the surgeon's operation. To achieve this, during general anesthesia, they will administer medications to relax your muscles. These are calledmuscle relaxants, and examples include bromide of rocuronium and bromide of vecuronium. As these medications also block respiratory muscles, you will need assistance with breathing (artificial respiration) during and after your operation until you can breathe on your own again.

Sugammadex is used to accelerate muscle recovery after surgery 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 moderate relaxation.

Do not receive Sugammadex Sandoz

• 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 the administration of sugammadex

• 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 2 years.

Other medications and Sugammadex Sandoz

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

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

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

Sugammadex 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 progesterone hormone that reaches you. The amount of progesterone lost due to the use of sugammadex is approximately the same as when you forget a contraceptive pill.

→ If you are taking The Pill on the same day that sugammadex is administered, follow the instructions in case of missing a pill from the Pill package insert.

→ If you are using other hormonal contraceptives (for example, 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 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 sugammadex.

Pregnancy and breastfeeding

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

It is possible that sugammadex will still be administered, but it is necessary to discuss it 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 sugammadex treatment, considering the benefits of breastfeeding for the baby and the benefits of sugammadex for the mother.

Driving and operating machinery

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

Sugammadex Sandoz contains sodium

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

The 2 ml vial contains less than 23 mg of sodium, which is essentially "sodium-free".

The 5 ml vial contains up to 48.5 mg of sodium (main component of table salt/for cooking) in each ml. This is equivalent to 2.5% of the maximum daily sodium intake recommended for an adult.

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

Dose

Your anesthesiologist will calculate the dose of sugammadex 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 Sandoz is administered

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

If you are given more Sugammadex Sandoz than recommended

Since your anesthesiologist will be closely monitoring the situation, it is unlikely that you will be given too much sugammadex. However, 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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 respiratory pathways 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 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 directly through theSpanish System for Pharmacovigilance of 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.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe boxafter CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature. Do not freeze.Store the vial in the outer packaging to protect it from light.

After the first opening

After the first opening, physical and chemical stability in use has been demonstrated for 96 hours at2 °C-8 °C protected from light and at 20 °C-25 °Cwithout light protection (solution removed with a syringe or injection spike).

In addition, the injection solution, removed as described above, is chemically and physically stable in polypropylene syringes for 96 hours at 2 °C-8 °C with light protection and at 20 °C-25 °Cwithout light protection.

From a microbiological point of view, the diluted product should be used immediately. If not used immediately, storage times in use and conditions before use are the responsibility of the user and in general should not exceed 24 hours between

2 °C and 8 °C, unless the dilution was performed in controlled and validated aseptic conditions

After dilution

After dilution, chemical and physical stability in use has been demonstrated for 48 hours between 2°C and 25°C. From a microbiological point of view, the diluted product should be used immediately. If not used immediately, storage times in use and conditions before use are the responsibility of the user and in general should not exceed 24 hours between 2°C and 8°C, unless the dilution was performed in controlled and validated aseptic conditions

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This way, you will help protect the environment.

Composition of Sugammadex Sandoz

• The active ingredient is sugammadex

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

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

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

• The othercomponentsare water for injection, concentrated hydrochloric acid and/or sodium hydroxide.

Appearance of the product and contents of the package

Sugammadex is an injectable solution. It is a transparent, colorless to slightly yellow-brown solution, practically free of visible particles, in a colorless type I glass vial with astopperof gray rubber.

It is presented in three different package sizes, 10 vials of 2 ml or 1 or 10 vials of 5 ml of injectable solution.

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals, d.d.

Verovškova 57,

SLO-1526 Ljubljana

Slovenia

This medicinal product is authorized in the member states of the European Economic Area and the United Kingdom (Northern Ireland) with the following names:

Last review date of thisleaflet:December 2022

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

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This information is intended solely for healthcare professionals.

For detailed information, consult the Technical Dossier or the Summary of Characteristics of the Product Sugammadex Sandoz 100 mg/ml injectable solution EFG.