Prospecto: information for the user

Sugammadex Aspen 100mg/ml injectable solution EFG

sugammadex

Read this prospect carefully before this medication 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 another doctor, even if they do not appear in this prospect. See section4.

1.What isSugammadex Aspenand for what it is used

2.What you need to know before Sugammadex Aspen is administered to you

3.How Sugammadex Aspen is administered

4.Possible adverse effects

5.Storage of Sugammadex Aspen

6.Contents of the package and additional information

What isSugammadex Aspen

Sugammadex Aspen contains the active ingredient sugammadex. Sugammadex is aselective neuromuscular blocking agent, as it only works with specific muscle relaxants: rocuronium bromide or vecuronium bromide.

What is Sugammadex Aspen used for

If you need to undergo surgery, your muscles must be completely relaxed, which facilitates the operation for the surgeon. To achieve this, during general anesthesia, they will administer medications to relax your muscles. These are calledmuscle relaxants, and some examples are rocuronium bromide and vecuronium bromide. As these medications also block the muscles of respiration, you will need assistance with breathing (mechanical ventilation) 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 rocuronium bromide or vecuronium bromide in your body. It can be used in adults whenever rocuronium bromide or vecuronium bromide is used, and in children and adolescents (between 2 and 17years) when rocuronium bromide is used for moderate relaxation.

Do not receiveSugammadex Aspen

• 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 beforestarting 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 the body through 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 recommendedin children under 2years.

Other medications and Sugammadex Aspen

→ 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 Aspen

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

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

Sugammadex Aspen may affect hormonal contraceptives

?Sugammadex may make hormonal contraceptives such as, for example, the pill, vaginal ring, implants, or a hormonal intrauterine device (IUD) less effective because it reduces the amount of progesterone that reaches you. The amount of progesterone lost as a result of using sugammadex is approximately the same as when you forget to take a contraceptive pill.

→ If you take thepillon the same day as you receive sugammadex, follow the instructions for missed doses in the pill package insert.

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

Effects on blood tests

In general, sugammadex has no effect on analytical tests. However, it may affect the results of a blood test when measuring progesterone 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 may still be administered to you, but it is necessary to discuss it first.

The passage of sugammadex to breast milk is unknown. Your anesthesiologist will help you decide whether to stop breastfeeding or avoid sugammadex treatment, 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 Aspen contains sodium

This medication contains up to 9.5mg of sodium (main component of table salt) in each ml. This is equivalent to 0.5% of the recommended daily maximum sodium intake for an adult.

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

Dose

Your anesthesiologist will calculate the dose of sugammadex needed based on:

?your weight;

?the amount of muscle relaxant still in effect.

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

How Sugammadex Aspen is Administered

An anesthesiologist will administersugammadex. It is administered as a single intravenous injection.

If You Are Given More Sugammadex Aspen Than Recommended

As your anesthesiologist will be closely monitoring the situation, it is unlikely that you will be given an excessive amount of sugammadex. However, 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 medicines, this medicine 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 side effects (which may affect up to 1 in 10 people)

• Coughing
• Respiratory difficulties that may include coughing or movements as if you were 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, for example, changes in heart rate, coughing, or movement
• Decrease in blood pressure due to surgical intervention

Rare side effects (which 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, for example, rash, skin redness, swelling of the tongue or pharynx, difficult breathing, changes in blood pressure or heart rate, which sometimes cause a severe decrease in blood pressure. Allergic reactions or severe allergic reactions can be potentially fatal

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 of side effects

If you experience any type of side effect, consult your doctor or anesthesiologist, 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 Medicines for Human Use:www.notificaRAM.esBy reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 vial label after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C. Do not freeze. Store the vial in the outer packaging to protect it from light.

After the first opening and dilution, chemical and physical stability has been demonstrated for use within 48 hours between 2 °C and 25 °C. From a microbiological standpoint, 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 generally should not exceed 24 hours between 2 °C and 8 °C, unless the dilution was performed in controlled and validated aseptic conditions.

Do not use this medication if you notice visible signs of deterioration.

Sugammadex Aspen Composition

• The active ingredient is sugammadex.

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

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

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

• The other components are injectable water, hydrochloric acid, and sodium hydroxide.

Product appearance and packaging contents

Sugammadex Aspenis a transparent and colorless to light yellow/brown injectable solution without visible particles.

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

Only some packaging sizes may be commercially available.

Marketing authorization holder

Aspen Pharma Trading Limited

3016 Lake Drive

Citywest Business Campus

Dublín 24, Ireland

Local representative

Aspen Pharmacare España S.L.

Avenida Diagonal, 512

First floor, Office 4

08006 Barcelona

Spain

Responsible manufacturer

PHARMIDEA

4 Rupnicu Street

Olaine, Olaine district, LV-2114

Latvia

COMBINO PHARM MALTA LTD

HF-60, Hal Far Industrial Estate

Hal Far BBG 3000

Malta

MEDICHEM S.A.

Narcís Monturiol 41A

08970 Sant Joan Despí - Barcelona.

Spain

Last review date of this leaflet: December 2022

For detailed information on this medication, please visit 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:

For detailed information, please consult the technical data sheet ofSugammadex Aspen.