SUGAMMADEX TEVA 100 mg/mL Injectable Solution

Introduction

Package Leaflet: Information for the User

Sugammadex Teva 100 mg/ml Solution for Injection EFG

Read all of this leaflet carefully before you start using 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 doctor, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Sugammadex Teva and what is it used for
2. What you need to know before you start using Sugammadex Teva
3. How Sugammadex Teva is administered
4. Possible side effects
5. Storage of Sugammadex Teva
6. Contents of the pack and further information

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

What is Sugammadex Teva

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

What Sugammadex Teva is used for

When you have certain types of surgery, your muscles must be completely relaxed. This makes the operation easier for the surgeon. To achieve this, you will be given medicines during general anesthesia 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 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 start using Sugammadex Teva

Do not use Sugammadex Teva

• 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 start using this medicine

• if you have kidney disease or have had it in the past. This is important because sugammadex is removed 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 Teva

→ 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 Teva

→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 Teva may affect hormonal contraceptives

• Sugammadex 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 sugammadex is approximately the same as when you miss a birth control pill.

→ If you are taking the Pillon the same day that you are given sugammadex, follow the instructions for missing a pill in the package leaflet of your pill.

→ 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 package 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 sugammadex.

Pregnancy and breastfeeding

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

It may still be given to you, but this needs to be discussed beforehand.

It is not known whether 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 to the baby and the benefit of sugammadex to the mother.

Driving and using machines

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

Sugammadex Teva contains sodium

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

3. How Sugammadex Teva is administered

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

Dose

Your anesthesiologist will calculate the dose of sugammadex 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 from muscle relaxation is needed.

How Sugammadex Teva is administered

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

If you are given more Sugammadex Teva than recommended

Since your anesthesiologist will be carefully monitoring the situation, it is unlikely that you will be given too much Sugammadex Teva. 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, your anesthesiologist will detect and treat them.

Common (may affect up to 1 in 10 people)

• Cough
• Respiratory difficulties that may include coughing or movements as if waking up or gasping for air
• 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, coughing, 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 throat, difficulty breathing, changes in blood pressure or heart rate, which can sometimes result in a severe drop in blood pressure. Allergic reactions were reported more frequently in healthy, conscious volunteers
• Return of muscle relaxation after surgery

Frequency not known

• When sugammadex is administered, 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 doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sugammadex Teva

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 opening and dilution, store at 2-8°C, protected from light, 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 further information

Composition of Sugammadex Teva

• 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, and/or sodium hydroxide.

Appearance and packaging

Sugammadex Teva 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

Teva B.V.

Swensweg 5,

2031GA Haarlem,

Netherlands

Manufacturer

PLIVA CROATIA LIMITED (PLIVA KRVATSKA D.O.O.)

Prilaz baruna Filipovicá 25,

Zagreb, 10000

Croatia

For further information about this medicine, please contact the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta

28108, Alcobendas, Madrid (Spain)

Date of last revision of this leaflet: July 2022

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