Sugammadex Teva 100 mg/ml solution for injection EFG

Package leaflet: Information for the user

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, as you may need to read it again.
• If you have any questions, consult your anaesthetist or doctor.
• If you experience any side effects, talk to your anaesthetist or doctor, including any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

What Sugammadex Teva is

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

What Sugammadex Teva is used for

During certain types of surgery, your muscles need to be completely relaxed. This 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 involved in breathing, you will need assistance with breathing (mechanical ventilation) during and after your surgery until you can breathe on your own again.

This medicine is used to speed up the recovery of muscle function after surgery, so that you can breathe independently 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 also 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 Teva

Do not receive Sugammadex Teva

• 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 this medicine

• 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 (edema).
• if you have a condition that increases your risk of bleeding (blood coagulation disorders) or if you are taking anticoagulant medication.

Other medicines and Sugammadex Teva

→ 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 Teva

→ 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 Teva 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 to you. The amount of progestogen lost due to sugammadex use is approximately equivalent to missing one contraceptive pill.

→ If you take the Pill on the same day that sugammadex 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 an additional 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

In general, sugammadex has no effects on laboratory tests. However, it may affect the results of a blood test measuring levels of the hormone progesterone. 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, may be pregnant, or are breastfeeding.

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

It is unknown whether sugammadex passes into breast milk. Your anaesthetist will help you decide whether to discontinue breastfeeding or to avoid treatment with sugammadex, taking into account 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 Teva contains sodium

This medicine contains up to 9.7 mg of sodium (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 Teva is administered

This medicine will be given 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 muscle relaxant still affecting you.

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 if urgent reversal of muscle relaxation is required.

How Sugammadex Teva is administered

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

If you are given more Sugammadex Teva than you should have

As your anaesthetist will be carefully monitoring your condition, it is unlikely that you will be given too much sugammadex. However, even if this happens, 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 the effects of anesthesia, your anesthetist 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 waking up or gasping for air
• Light anesthesia – you may begin 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
• 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 throat, 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 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 doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sugammadex Teva

Storage is 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 carton and label following "EXP". 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 opening and dilution, store protected from light 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 packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sugammadex Teva

• 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 injections, hydrochloric acid and/or sodium hydroxide.

Appearance of the product and contents of the container

Sugammadex Teva is a clear, injectable solution ranging from colourless to slightly yellow-brown.

It is available in two 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

Teva B.V.

Swensweg 5,

2031GA Haarlem,

The Netherlands

Manufacturer

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

Prilaz baruna Filipovića 25,

Zagreb, 10000

Croatia

Further information on this medicine can be obtained from the local representative of the marketing authorisation holder:

Teva Pharma, S.L.U.

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

28108, Alcobendas, Madrid (Spain)

Date of the most recent revision of this leaflet: October 2025.

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/).