Sugammadex Glenmark 100 mg/ml solution for injection EFG

Package leaflet: Information for the user

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

Leaflet contents

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

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

What Sugammadex Glenmark is

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

What Sugammadex is used for

During surgery, your muscles need to be completely relaxed, which helps the surgeon perform the operation. For this reason, during general anaesthesia, you will be given medicines to relax your muscles. These are called muscle relaxants, and examples include rocuronium bromide and vecuronium bromide. Since these medicines also block the muscles used for breathing, you will need assistance with breathing (artificial ventilation) during and after surgery until you can breathe on your own again.

Sugammadex is used to speed up the recovery of muscle function after surgery, so that you can breathe on your own again sooner. It works by binding to 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 (aged 2 to 17 years) when rocuronium bromide is used for moderate muscle relaxation.

2. What you need to know before starting administration of Sugammadex Glenmark

Do not receive Sugammadex Glenmark

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

Inform your anaesthetist if this applies to you.

Warnings and precautions

Talk to your anaesthetist before starting 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 through the kidneys.
• if you have liver disease or have had it previously.
• if you have fluid retention (edema).
• if you have any condition that increases the risk of bleeding (blood coagulation disorders) or if you are taking anticoagulant medication.

Children and adolescents

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

Other medicines and Sugammadex Glenmark

Inform your anaesthetist if you are taking, have recently taken, or might need to take any other medicines.

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

Some medicines reduce the effect of Sugammadex Glenmark

It is especially important that you inform your anaesthetist if you have recently taken:

• toremifene (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 progestogen hormone available. The amount of progestogen lost due to sugammadex use is approximately the same as when a contraceptive pill is missed.

• If you are taking the Pill on the same day that sugammadex is administered, follow the missed-dose instructions provided in the pill's package leaflet.
• If you are using other hormonal contraceptives (e.g., 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 product leaflet.

Effects on blood tests

Generally, sugammadex has no effects on laboratory tests. However, it may affect the results of a blood test measuring progesterone hormone levels. Consult your doctor if progesterone levels need to be tested on the same day you receive sugammadex.

Pregnancy and breastfeeding

Inform your anaesthetist if you are pregnant or may be pregnant, or if you are breastfeeding.

You may still be given sugammadex, but this should be discussed beforehand.

It is not known whether sugammadex passes into breast milk. Your anaesthetist will help you decide whether to stop breastfeeding or avoid treatment with sugammadex, considering the benefits of breastfeeding for the baby and the benefits of sugammadex for the mother.

Driving and use of machines

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

Sugammadex Glenmark contains sodium

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

3. How Sugammadex Glenmark is administered

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

Dosage

Your anaesthetist will calculate the dose of sugammadex you need based on:

• your body weight
• the amount of residual muscle relaxant effect still present.

The usual dose is 2–4 mg per kg of body weight for adults and for children and adolescents aged 2–17 years. A dose of 16 mg/kg may be used in adults if rapid reversal of muscle relaxation is required.

How Sugammadex Glenmark is administered

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

If you are given more Sugammadex Glenmark than you should

As your anaesthetist will be carefully monitoring your condition, it is unlikely that you will receive too much sugammadex. However, even if this were to happen, it is unlikely to cause any problems.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If these adverse effects occur while you are under anesthesia, your anaesthetist will detect and treat them.

Frequent (may affect up to 1 in 10 people)

• Cough
• Respiratory tract difficulties which may include coughing or movements as if awake or gasping for breath
• Superficial anaesthesia – you may begin to wake up, so you will require more anaesthetic. 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
• Decrease in blood pressure due to the surgical intervention

Uncommon (may affect up to 1 in 100 people)

• Difficulty breathing due to muscle cramps in the airways (bronchospasm), occurring in patients with a history of lung problems

• Allergic reactions (hypersensitivity to medicines) – such as rash, redness of the skin, swelling of the tongue and/or pharynx, difficulty breathing, changes in blood pressure or heart rhythm, which sometimes result in a severe drop in blood pressure. Allergy-type or severe allergic reactions may be life-threatening. Allergic reactions were reported more frequently in healthy conscious volunteers

• Recurrence of muscle relaxation after surgery

Frequency not known

• When sugammadex is administered, a significant slowing of the heart may occur, which could even lead to cardiac arrest.

Reporting of adverse effects

If you experience any type of adverse effect, consult your anaesthetist or another doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish System of Pharmacovigilance for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation 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 stated on the label and the carton after "EXP". The expiry date is the last day of the month indicated.

Store the vial in the outer packaging to protect it from light. After opening and dilution, 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 and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Sugammadex Glenmark

• The active substance is sugammadex.

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

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

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

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

Appearance of the product and contents of the pack

Sugammadex Glenmark is a clear, colourless to slightly yellow, injectable solution.

It is available in two different pack sizes containing either 10 vials of 2 ml or 10 vials of 5 ml of injectable solution.

Only certain 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the last revision of this leaflet: March 2023.

Detailed 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/)