Package Insert: Information for the User

Sugammadex Teva 100 mg/ml Injectable Solution EFG

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your anesthesiologist or doctor.
• If you experience any adverse effects, consult your anesthesiologist or doctor, even if they are not listed in this package insert. See section 4.

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

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

3. How to administer Sugammadex Teva

4. Possible adverse effects

5. Storage of Sugammadex Teva

6. Contents of the package and additional information

What is Sugammadex Teva

This medication contains the active ingredient sugammadex. Sugammadex is considered aSelective Blocker Bindersince it only works with specific muscle relaxants, bromide of rocuronium or bromide of vecuronium.

For what Sugammadex Teva is used

When you have some types of operations, your muscles must be completely relaxed. This facilitates the surgeon's operation. For this, during general anesthesia, they will give you medications so that your muscles relax. They are calledmuscle relaxants, and as an example, bromide of rocuronium and bromide of vecuronium are included. Since those medications also block the muscles of breathing, you will need help to breathe (artificial respiration) during and after your operation until you can breathe again on your own.

This medication is used to accelerate the recovery of muscles after an operation 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 17years), when bromide of rocuronium is used for a moderate level of relaxation.

You should not receive Sugammadex Teva

• if you are allergic to sugammadex or any of the other components of this medication (listed in section6).

→ Inform your anesthesiologist if this is the case.

Warnings and precautions

Consult your anesthesiologist before startingthe administration of this medication

• if you have any kidney disease or have had it in the past. This is important because sugammadex is eliminated from your body by your 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 under2years.

Other medications and Sugammadex Teva

→ 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 Teva

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

• toremifeno (used to treat breast cancer).
• acid fusidic (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 progestin hormone that reaches you. The amount of progestin hormone lost due to the use of sugammadex is approximately the same as when you forget a contraceptive pill.

→ If you are takingThe Pillon the same day that sugammadex is administered, follow the instructions in case of missing a pill from the pill package.

→ If you are usingotherhormonal contraceptives (for example vaginal ring, implant, or IUD‑h) you should use a non-hormonal contraceptive method (such as a condom) for the next 7days and follow the recommendations in the package insert.

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 sugammadex.

Pregnancy and breastfeeding

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

It is possible that you will still receive this medication, but it is necessary to discuss it first.

No information is available on whether sugammadex can pass into breast milk. Your anesthesiologist will help you decide whether to stop breastfeeding or avoid treatment with sugammadex, considering the benefits of breastfeeding for the baby and the benefits of sugammadex for the mother.

Driving and operating machinery

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

Sugammadex Teva contains sodium

This medication contains up to9.7mgof sodium (main component of table salt/for cooking) per 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 sugammadex that you need based on:

• Your weight
• The amount of muscle relaxant 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 Teva is Administered

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

If you are given more Sugammadex Teva than recommended

Since your anesthesiologist will be closely monitoring the situation, it is unlikely that you will be given too much Sugammadex Teva. Even if this happens, it is unlikely to cause any problems.

If you have any other questions about the use of this medication, ask your anesthesiologist or another doctor.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If these side 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)

• Coughing
• Respiratory difficulties that may include coughing or movements as if waking up 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
• Decreased blood pressure due to surgical intervention

Rare (may affect up to 1 in 100 people)

• Difficulty breathing due to muscle cramps 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 throat, difficult breathing, changes in blood pressure or heart rate, which sometimes results in severe blood pressure drop. Severe allergic reactions or anaphylactic reactions can be life-threatening
  Allergic reactions were reported more frequently in healthy, conscious volunteers
• Reappearance of muscle relaxation after the operation

Unknown frequency

• When sugammadex is administered, a significant slowing of the heart may occur, which can even lead to cardiac arrest

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

The conservation will be in charge 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. Storethe vial in the outer packaging to protect it from light.

Once opened and diluted, store at 2‑8°C protected from light and use within 24hours.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This way, you will help protect the environment.

Composition of Sugammadex Teva

• The active ingredient is sugammadex.

Each milliliter of injectable solution contains sugammadex sodium equivalent to 100 mg of sugammadex.

Each vial of 2 ml contains sugammadex sodium equivalent to 200 mg of sugammadex.

Each vial of 5 ml contains sugammadex sodium equivalent to 500 mg of sugammadex.

• The other components are water for injectable preparations, hydrochloric acid and/or sodium hydroxide.

Appearance of the product and contents of the packaging

Sugammadex Teva 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 of injectable solution.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem,

Netherlands

Responsible for Manufacturing

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, 1st floor

28108, Alcobendas, Madrid (Spain)

Last review date of this leaflet: July 2022

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