SUGAMMADEX GLENMARK 100 mg/mL Injectable Solution

Introduction

Package Leaflet: Information for the User

Sugammadex Glenmark 100 mg/ml Solution for Injection EFG

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your anesthesiologist or doctor.
• If you experience any side effects, talk to your anesthesiologist or another doctor, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What is Sugammadex Glenmark and what is it used for
2. What you need to know before you are given Sugammadex Glenmark
3. How Sugammadex Glenmark is given
4. Possible side effects
5. Storage of Sugammadex Glenmark
6. Contents of the pack and other information

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

What is Sugammadex Glenmark

This medicine contains the active substance sugammadex. Sugammadex is considered a Selective Relaxant Binding Agentas it only works with specific muscle relaxants, rocuronium bromide or vecuronium bromide.

What Sugammadex Glenmark is used for

If you need to have surgery, your muscles must be completely relaxed, which makes it easier for the surgeon to perform the operation. For this, you will be given medicines during general anesthesia to relax your muscles. These are called muscle relaxants, such as rocuronium bromide and vecuronium bromide. Since these medicines also block the breathing muscles, you will need help breathing (artificial respiration) during and after the operation until you can breathe on your own again.

Sugammadex Glenmark is used to speed up the recovery of your muscles after an operation 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 when rocuronium bromide or vecuronium bromide is used, and in children and adolescents (between 2 and 17 years) when rocuronium bromide is used for moderate muscle relaxation.

2. What you need to know before you are given Sugammadex Glenmark

Do not receive Sugammadex Glenmark

• If you are allergic to sugammadex or any of the other ingredients of this medicine (listed in section 6).

Tell your anesthesiologist if this applies to you.

Warnings and precautions

Talk to your anesthesiologist before you are given sugammadex

Children and adolescents

This medicine is not recommended for children under 2 years of age.

Other medicines and Sugammadex Glenmark

Tell your anesthesiologist if you are taking, have recently taken, or might take any other medicines.

Sugammadex Glenmark may affect other medicines or be affected by them.

Some medicines reduce the effect of Sugammadex Glenmark

It is especially important that you tell your anesthesiologist if you have recently taken:

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

Sugammadex Glenmark may affect hormonal contraceptives

Sugammadex Glenmark may make hormonal contraceptives such as the "Pill", vaginal ring, implants, or an Intrauterine Hormonal Device (IUD) less effective because it reduces the amount of progestogen that reaches you. The amount of progestogen lost due to the use of sugammadex is approximately the same as when you forget one of the contraceptive pills.

• If you are taking the Pillon the same day that you are given sugammadex, follow the instructions in case of a missed pill in the pill leaflet.
• If you are using otherhormonal contraceptives (e.g., 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 leaflet.

Effects on blood tests

In general, sugammadex has no effect on laboratory tests. However, it may affect the results of a blood test when progesterone levels are measured. Talk to your doctor if your progesterone levels need to be analyzed on the same day that you receive sugammadex.

Pregnancy and breastfeeding

Tell your anesthesiologist if you are pregnant or think you may be pregnant or if you are breastfeeding.

You may still be given sugammadex, but it needs to be discussed beforehand.

It is not known if sugammadex passes 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 using machines

Sugammadex Glenmark has no known influence on the ability to drive and use machines.

Sugammadex Glenmark contains sodium

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

3. How Sugammadex Glenmark is given

Sugammadex Glenmark will be given to you 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 affecting you.

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

How Sugammadex Glenmark is given

Sugammadex Glenmark will be given to you by your anesthesiologist. It is injected once into a vein.

If you are given more Sugammadex Glenmark than recommended

Since your anesthesiologist will be carefully monitoring the situation, it is unlikely that you will be given too much sugammadex. But even if this happens, it is unlikely to cause any problems.

If you have any further questions on the use of this medicine, ask your anesthesiologist or another doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If these side effects occur while you are under anesthesia, it will be your anesthesiologist who detects and treats them.

Common (may affect up to 1 in 10 people)

• Cough
• Respiratory difficulties that may include cough or movements as if you were waking up or taking a breath
• Light anesthesia – you may start to wake up, so you may need more anesthetic. This can cause you to move or cough at the end of the operation
• Complications during the procedure, such as changes in heart rate, cough, or movement
• Decrease in blood pressure due to the surgical procedure

Uncommon (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 medicines) - such as rash, skin redness, swelling of your tongue and/or pharynx, difficult breathing, changes in blood pressure or heart rate, which sometimes result in a severe drop in blood pressure. Allergic reactions can be life-threatening. Allergic reactions were reported more frequently in healthy conscious volunteers
• Reappearance of muscle relaxation after the operation

Frequency not known

• When sugammadex is given, a significant slowing of the heart can occur, which can even lead to cardiac arrest.

Reporting of side effects

If you experience any side effects, talk to your anesthesiologist or another doctor, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sugammadex Glenmark

Storage will be the responsibility of healthcare professionals.

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

Do not use this medicine after the expiry date which is stated on the label and carton after "EXP". The expiry date is the last day of the month shown.

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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sugammadex Glenmark

• The active substance is sugammadex.

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

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

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

• The other ingredients (excipients) are hydrochloric acid, sodium hydroxide, and water for injections.

Appearance and packaging

Sugammadex Glenmark is a clear, colorless to slightly yellow solution for injection.

It is available in two different pack sizes, each containing 10 vials of 2 ml or 10 vials of 5 ml of solution for injection.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Pharma Pack Hungary Kft

Building B, Raktárvárosi út 9

Törökbálint, 2045

Hungary

Pharma Pack Hungary Kft

Vasút u. 13, Budaörs

H-2040 Hungary

You can request more information about this medicine from the local representative of the marketing authorization holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7ª planta

28045 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:March 2023.

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