Sugammadex Cipla 100 mg/ml solution for injection EFG

Package leaflet: Information for the user

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, as you may need to read it again.
• If you have any questions, ask your anaesthesiologist (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.

Contents of the leaflet

1. What Sugammadex Cipla is and what it is used for
2. What you need to know before administration of Sugammadex Cipla
3. How Sugammadex Cipla is administered
4. Possible side effects
5. How to store Sugammadex Cipla
6. Contents of the pack and other 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 Binding Agent because it works only with specific muscle relaxants, rocuronium bromide or vecuronium bromide.

What sugammadex is used for

If you are having surgery, your muscles need to be completely relaxed, which makes it easier for the surgeon to 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 help with breathing (mechanical ventilation) during and after your operation until you can breathe on your own again.

This medicine is used to speed up muscle recovery 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.

It can be used in newborns, infants, children, and adolescents (from birth up to 17 years of age) when rocuronium bromide is used.

2. What you need to know before receiving Sugammadex Cipla

Do not receive Sugammadex Cipla

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

Inform your anaesthetist if this applies to you.

Warnings and precautions

Talk to your anaesthetist before receiving Sugammadex Cipla

• if you have 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 (oedema).
• if you have any condition that increases the risk of bleeding (blood coagulation disorders) or if you are taking anticoagulant medication.

Other medicines and Sugammadex Cipla

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

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 Cipla may affect hormonal contraceptives

• This medicine 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 this medicine is approximately the same as when you miss one of your contraceptive pills.
• If you are taking the Pill on the same day this medicine is administered, follow the missed-dose instructions provided in the contraceptive 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 does not have any effects on laboratory tests. However, it may affect the results of a blood test measuring levels of the hormone progesterone. Consult your doctor if your progesterone levels need to be tested on the same day you receive this medicine.

Pregnancy and breastfeeding

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

You may still be given this medicine, but this needs to be discussed beforehand.

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

Driving and using machines

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

Sugammadex Cipla contains sodium

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

3. How Sugammadex Cipla is administered

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

Dosage

Your anaesthetist will calculate the dose of this medicine 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 patients of any age. A dose of 16 mg/kg may be used in adults when urgent reversal of muscle relaxation is required.

How Sugammadex Cipla is administered

This medicine will be administered to you by your anaesthetist. It is given as a single intravenous injection.

If you are given more Sugammadex Cipla than recommended

As your anaesthetist will be carefully monitoring your condition, it is unlikely that you will be given too much Sugammadex Cipla. However, even if this happens, it is unlikely to cause any problems. Toxicology Information Service, telephone: 91 562 04 20.

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 may cause adverse effects, although not everyone experiences them.

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

Frequent (may affect up to 1 in 10 people)

• Cough
• Respiratory difficulties which may include coughing or movements as if awake or gasping for breath
• Superficial anesthesia – you may begin to wake up, thus requiring more anesthetic. This may cause you to move or cough at the end of the surgery
• Complications during the procedure, such as changes in heart rate, coughing, or movement
• Decreased blood pressure due to the surgical intervention

Uncommon (may affect up to 1 in 100 people)

• Breathing difficulty 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, skin redness, 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-like reactions or severe allergic reactions may be life-threatening
• Allergic reactions have been reported more frequently in healthy conscious volunteers
• Recurrence of muscle relaxation after surgery

Frequency not known

• When this medicine 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 anesthesiologist or another doctor, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sugammadex Cipla

Storage shall be managed by 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 carton and label after "CAD". The expiry date refers to the last day of the month indicated.

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

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

6. Contents of the pack and other information

Composition of Sugammadex Cipla

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

Appearance of the product and contents of the pack

Sugammadex Cipla is a clear, colourless to slightly yellow/brown injectable solution.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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, Spain

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

Date of the last revision of this leaflet: February 2026

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

This information is intended for healthcare professionals only:

For detailed information, please consult the Summary of Product Characteristics or the Technical Data Sheet of Sugammadex Cipla.