Label: information for the user

Sugammadex Normon 100 mg/ml injectable solution EFG

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

• Keep this label, as you may need to read it again.
• If you have any questions, 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 label. See section 4.

1. What isSugammadex Normonand what is it used for

2. What you need to know before starting the administration ofSugammadex Normon

3. How to administerSugammadex Normon

4. Possible adverse effects

5. Storage ofSugammadex Normon

6. Contents of the package and additional information

What is Sugammadex Normon

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

What is Sugammadex 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 called muscle blockers, 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 Normon

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 Normon

• If you have any kidney disease or have had it in the past. This is important because Sugammadex 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.

Other medications and Sugammadex Normon

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

Sugammadex Normon may affect other medications or be affected by them.

Some medications reduce the effect of Sugammadex Normon

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

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

Sugammadex Normon 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 progestin hormone that reaches you. The amount of progestin hormone lost due to the use of Sugammadex Normon 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 forgetting a pill from the pill package insert.
• If you are using other hormonal contraceptives (such as 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 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 Sugammadex Normon.

Pregnancy and breastfeeding

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

It is possible that you may still receive Sugammadex, but it is necessary to discuss it beforehand.

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

Driving and operating machinery

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

Sugammadex Normon contains sodium

This medication contains up to 9.3 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.

Sugammadex Normon 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 weightA dose of 16 mg/kg in adults may be used if urgent recovery of muscle relaxation is needed.

The dose of Sugammadex Normon for children is 2.4mg/kg (children and adolescents aged 2-17 years).

How Sugammadex Normon is administered

Sugammadex Normon will be administered by your anesthesiologist. It is given as a single intravenous injection.

If you are given more Sugammadex Normon 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.

They will be responsible for monitoring and treating any adverse effects that occur during the procedure.

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 procedure
• Complications during the procedure, such as changes in heart rate, coughing, or movement
• Decreased blood pressure due to the surgical intervention

Rare (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 medications) – such as rash, skin redness, swelling of your tongue and/or throat, difficulty breathing, changes in blood pressure or heart rate, which sometimes results in severe low blood pressure. Severe allergic reactions can be life-threatening. Allergic reactions were reported more frequently in healthy, conscious volunteers
• Reappearance of muscle relaxation after the procedure

Unknown frequency

• When Sugammadex Normon 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:www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Storage will be handled by healthcare professionals.

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

Store below 30°C. Do not freeze. 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.

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

Composition ofSugammadex Normon

• The active principle is sugammadex. Each ml of injectable solution contains 108.80 mg of sugammadex sodium equivalent to 100 mg of sugammadex.
• The other components are hydrochloric acid, sodium hydroxide, nitrogen, and water for injectable preparations.

Appearance of the product and contents of the packaging

Sugammadex Normon is a transparent injectable solution, incolor to slightly yellow-brown. 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.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos

Madrid (SPAIN)

Last review date of this leaflet:December 2022

Detailed information about this medication is available on 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, consult the Technical Dossier or the Summary of Characteristics of the Product of Sugammadex Normon 100 mg/ml injectable solution EFG.