Prospect: information for the user

Sugammadex Glenmark 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 another doctor, even if they are not listed in this prospect. See section 4.

1.What isSugammadex Glenmarkand for what it is used

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

3.How to administerSugammadex Glenmark

4.Possible adverse effects

5.Storage ofSugammadex Glenmark

6.Contents of the package and additional information

What is Sugammadex Glenmark

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

What is Sugammadex used for

If you are 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 the muscles of respiration, 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 Glenmark

• 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 sugammadex administration.

• 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 of age.

Other medications and Sugammadex Glenmark

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 Glenmark

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

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

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

Effects on blood tests

In general, sugammadex has no effects 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 may 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 Glenmark contains sodium

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

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

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 2-4 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 Glenmark is Administered

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

If more Sugammadex Glenmark is Injected than Recommended

Since your anesthesiologist will be closely monitoring the situation, it is unlikely that too much sugammadex will be administered. 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 medications, this medication may produce adverse effects, although not all people may 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 may occur.

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 a severe decrease in 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 is administered, it may cause a significant slowing of the heart that 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.Reporting adverse effects can help provide more information about the safety of this medication.

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

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 containers and medications that you no longer need. This will help protect the environment.

Composition ofSugammadex Glenmark

• 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 other components (excipients) are concentrated hydrochloric acid, sodium hydroxide, and water for injectable preparations.

Appearance of the product and contents of the package

Sugammadex Glenmark is a transparent injectable solution,colorless to slightly yellow.

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

Only some package sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Responsible manufacturer:

Pharma Pack Hungary Kft

Vasút u. 13, Budaörs

H-2040 Hungary

Pharma pack Hungary Kft

Building B, Raktárvárosi út 9

Törökbálint, 2045

Hungary

Further information about this medicine can be obtained by contacting the local representative of the marketing authorization holder:

Viso Farmacéutica S.L.U.

c/ Retama 7, 7th floor

28045 Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:March 2023.

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