SUGAMMADEX CIPLA 100 mg/mL Injectable Solution

Introduction

Package Leaflet: Information for the User

Sugammadex Cipla 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 (anesthetist) or doctor.
• If you experience any side effects, talk to your anesthesiologist or another doctor, even if you think the side effects are not listed in this leaflet. See section 4.

Contents of the pack

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

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

What is sugammadex

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 is used for

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

This medicine is used to speed up the recovery of your muscles 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 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 Cipla

Do not receive Sugammadex Cipla

• 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 Cipla

• 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 before.
• if you have fluid retention (edema).
• if you have a disease 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 Cipla

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

Sugammadex may affect other medicines or be affected by them.

Some medicines reduce the effect of sugammadex

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 Cipla may affect hormonal contraceptives

• This medicine may make hormonal contraceptives - such as the "Pill", vaginal ring, implants, or an Intrauterine Hormonal Device (IUD-h) - less effective because it reduces the amount of progestogen you receive. The amount of progestogen lost due to the use of this medicine is approximately the same as when you miss a birth control pill.
• If you are taking the Pillon the same day you are given this medicine, follow the instructions for missing a pill in the pill leaflet.
• If you are using otherhormonal 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 leaflet.

Effects on blood tests

In general, sugammadex does not affect 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 you receive this medicine.

Pregnancy and breastfeeding

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

This medicine may still be given to you, but it needs to be discussed first.

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 to the baby and the benefit of this medicine to the mother.

Driving and using machines

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

Sugammadex Cipla contains sodium

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

3. How Sugammadex Cipla is given

This medicine will be given to you by your anesthesiologist or under their supervision.

Dose

Your anesthesiologist will calculate the dose of this medicine 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 may be used in adults if urgent recovery of muscle relaxation is needed.

How Sugammadex Cipla is given

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

If you are given more Sugammadex Cipla than recommended

Since your anesthesiologist will be carefully monitoring the situation, it is unlikely that you will be given too much Sugammadex Cipla. But even if this happens, it is unlikely to cause any problems. Toxicology Service, phone: 91 562 04 20.

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, your anesthesiologist will detect and treat them.

Common (may affect up to 1 in 10 people)

• Cough
• Respiratory difficulties that may include cough or movements as if you were awake 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 surgery

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 or severe allergic reactions can be life-threatening
• Allergic reactions were reported more frequently in healthy conscious volunteers
• Reappearance of muscle relaxation after surgery

Frequency not known

• When this medicine 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 you think the side effects are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Sugammadex Cipla

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 carton and label after "EXP". The expiry date is the last day of the month shown.

Do not freeze. Store the vial in the outer packaging to protect it from light.

After first opening and dilution, chemical and physical stability has been demonstrated for 48 hours between 2 °C and 25 °C. From a microbiological point of view, the diluted product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and normally should not exceed 24 hours between 2 °C and 8 °C, unless the dilution has been made in controlled and validated aseptic conditions.

6. Contents of the pack and further information

Composition of Sugammadex Cipla

• 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 are water for injections, hydrochloric acid 3.7% (for pH adjustment) and/or sodium hydroxide 0.4% w/v (for pH adjustment).

Appearance and packaging

Sugammadex Cipla is a clear, colorless to slightly yellow/brown solution for injection.

It comes in two different pack sizes, 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

Cipla Europe NV

De Keyserlei 58-60,

Box 19, 2018 Antwerp, Belgium

Manufacturer

Medichem S.A.

Narcís Monturiol 41A

08970 Sant Joan Despí

Barcelona, Spain

or

Combino Pharm Malta, Ltd

HF60 Hal Far Industrial Estate

Hal Far BBG3000

Malta

or

Pharmidea

4 Rupnicu Street

Olaine, Olaine district, LV-2114

Latvia

Local representative

Cipla Europe NV, Spanish branch,

C/ Guzmán el Bueno, 133 Edif Britannia-28003- Madrid

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

Date of last revision of this leaflet: May 2022

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/).

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This information is intended only for healthcare professionals:

For detailed information, consult the Summary of Product Characteristics or the Package Leaflet of Sugammadex Cipla.

The full Summary of Product Characteristics will be added as a detachable section at the end of the printed leaflet, so that the information for the patient (i.e., the leaflet) and the information for the healthcare professional (i.e., the Summary of Product Characteristics) are clearly differentiated.