Prospect: information for the user

Sugammadex Cipla 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 (anesthetist) or doctor.
• If you experience any adverse effects, consult your anesthesiologist or another doctor, even if they are not listed in this prospect. See section 4.

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

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

3. How Sugammadex Cipla is administered

4. Possible adverse effects

5. Storage of Sugammadex Cipla

6. Contents of the package and additional information

What is sugammadex

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 respiratory muscles, you will need assistance with breathing (artificial respiration) during and after your operation until you can breathe on your own again.

This medication 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 Cipla

• 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 with your anesthesiologist before starting the administration of 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 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.

Other medications and Sugammadex Cipla

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

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

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

Sugammadex Cipla may affect hormonal contraceptives

• This medication may make hormonal contraceptives - such as "The Pill", vaginal ring, implants, or an Intrauterine Device (IUD-h) less effective because it reduces the amount of progesterone hormone that reaches you. The amount of progesterone lost as a result of using this medication is approximately the same as when you forget a contraceptive pill.
• If you are taking The Pill on the same day that you are administered this medication, follow the instructions in case of missing a pill from the Pill's prospectus.
• If you are using other hormonal contraceptives (for example, 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 prospectus.

Effects on blood tests

In general, sugammadex has no effect 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 this medication.

Pregnancy and breastfeeding

Inform your anesthesiologist if you are pregnant or may be pregnant or if you are breastfeeding.

It is possible that you may still be administered this medication, but it is necessary to discuss it beforehand.

It is not known if sugammadex can pass 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 this medication for the mother.

Driving and operating machines

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

Sugammadex Cipla contains sodium

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

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

Dose

Your anesthesiologist will calculate the dose of this medication that you need based on:

• Your weight
• The amount of muscle relaxant that is 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 Cipla is administered

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

If you are administered more Sugammadex Cipla than recommended

Since your anesthesiologist will be closely monitoring the situation, it is unlikely that you will be administered too much Sugammadex Cipla. However, even if this happens, it is unlikely to cause any problems. Poison Information Service, phone: 91 562 04 20.

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 will experience them.

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

Frequent (may affect up to 1 in 10 people)

• Cough
• Difficulty with respiratory passages 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 operation
• Complications during the procedure, such as changes in heart rate, coughing, or movement
• Decrease in blood pressure due to 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 pharynx, difficult breathing, changes in blood pressure or heart rate, which sometimes results in a severe decrease in blood pressure. Severe allergic reactions or anaphylaxis can be life-threatening
• Allergic reactions were reported more frequently in healthy, conscious volunteers
• Reappearance of muscle relaxation after the operation

Unknown frequency

• When this medication is administered, a significant slowing of the heart may occur, which 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 the Spanish System for Pharmacovigilance of Medications for Human Use: https://www.notificaram.es//www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

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

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

Sugammadex Cipla Composition

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

Product appearance and packaging contents

Sugammadex Cipla is a transparent, colorless to slightly yellow/brown injectable solution.

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

Only some packaging sizes may be commercially available.

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 subsidiary in Spain,

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

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

Last review date of this leaflet: May 2022

For detailed information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

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This information is intended solely for healthcare professionals:

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

The complete technical dossier 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 technical dossier) are clearly differentiated.