Sugammadex Equity 100 mg Solution

SUGAMMADEX EQUITY belongs to a group of medicines called selective relaxant binding medicines and works with specific muscle relaxants, namely rocuronium bromide and vecuronium bromide. SUGAMMADEX EQUITY is given to speed up your recovery from the muscle relaxant which is part of the anaesthetic regimen to allow the surgeon to perform the operation. SUGAMMADEX EQUITY will be given to you at the end of an operation to allow you to breathe on your own again earlier. In children (above 7 years of age) SUGAMMADEX EQUITY can only be used in the instance where rocuronium bromide is used for a moderate level of relaxation.

SUGAMMADEX EQUITY should not be given to you:

• If you are hypersensitive (allergic) to sugammadex sodium or any of the other ingredients of SUGAMMADEX EQUITY (listed in section 6 of this leaflet).

Warnings and precautions:

Tell your doctor before SUGAMMADEX EQUITY is given to you if you have:

• Kidney disease or have had it in the past.
• Liver disease or have had it in the past.
• Fluid retention (oedema).
• Diseases which are known to give an increased risk of bleeding (disturbances of blood clotting), or if you are using anticoagulation medication.

Children and adolescents:

SUGAMMADEX EQUITY can only be used in certain procedures and should not be used in children under 7 years of age.

Other medicines and SUGAMMADEX EQUITY:

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Some medicines reduce the effect of SUGAMMADEX EQUITY. Tell your doctor if you are using:

• Toremifene (used to treat breast cancer).
• Fusidic acid (an antibiotic).

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself SUGAMMADEX EQUITY. It will be given to you by a person who is qualified to do so. SUGAMMADEX EQUITY is given into a vein (intravenously) or intravenous line as a single injection.

If you are given more SUGAMMADEX EQUITY than you should receive: As your doctor will be monitoring your condition carefully, it is unlikely that you will be given too much SUGAMMADEX EQUITY.

SUGAMMADEX EQUITY can have side effects. Not all side effects reported for SUGAMMADEX EQUITY are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving SUGAMMADEX EQUITY, please consult your doctor, pharmacist or other health care provider for advice. If any side effects occur while you are under anaesthesia, they will be seen and treated by your doctor. Some side effects may also occur shortly afterwards; therefore, you will remain under supervision for a while after the operation.

If any of the following happens, stop receiving SUGAMMADEX EQUITY and tell your doctor immediately:

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to SUGAMMADEX EQUITY. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately if you notice any of the following:

• Severe slowing of the heart and slowing of the heart up to cardiac arrest (abrupt loss of heart function, breathing and consciousness). Symptoms may include chest discomfort, shortness of breath, weakness and fast-beating or fluttering heart.
• Airway complications of anaesthesia, such as violent expiratory contraction of your respiratory muscles against the tube inserted in your airways, coughing during the anaesthetic procedure or during the operation, spontaneous breath (movement of gas in and out of your lungs that is produced in response to your respiratory muscles).
• Complications that may occur during the operation, including your heart beating faster or slower than normal, movement.

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

Side effects that may occur frequently:

• Your muscles may be weakened for longer than expected after the operation.
• A temporary unpleasant taste in your mouth.
• Cough.
• Light anaesthesia – you may start to come out of deep sleep. This might cause you to move or cough at the end of the operation.
• Airway difficulties that may include coughing or moving as if you are waking up.
• Low blood pressure during the operation (which will be monitored and controlled by your doctor during surgery).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (whoumc.org) found on SAHPRA’s website. By reporting side effects, you can help provide more information on the safety of SUGAMMADEX EQUITY.

• Store at or below 25 °C.
• Do not freeze.
• Keep the vial in the outer carton in order to protect from light.
• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.
• Do not use after the expiry date printed on the carton.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).