Sugammadex SUN 100 mg/ml solution for injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your anaesthetist or doctor.
• If you get any side effects, talk to your anaesthetist or doctor. This includes any possible side effects not listed in this leaflet. See section 4.

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

Sugammadex contains the active substance sugammadex. Sugammadex is considered to be a Selective Relaxant Binding Agent since it only works with specific muscle relaxants, rocuronium bromide or vecuronium bromide.

When you have some types of operations, your muscles must be completely relaxed. This makes it easier for the surgeon to do the operation. For this, the general anaesthetic you are given includes medicines to make your muscles relax. These are called muscle relaxants, and examples include rocuronium bromide and vecuronium bromide. Because these medicines also make your breathing muscles relax, you need help to breathe (artificial ventilation) during and after your operation until you can breathe on your own again. Sugammadex is used to speed up the recovery of your muscles after an operation to allow you to breathe on your own again earlier. It does this by combining with the rocuronium bromide or vecuronium bromide in your body. It can be used in adults whenever rocuronium bromide or vecuronium bromide is used and in children and adolescents (aged 2 to 17 years) when rocuronium bromide is used for a moderate level of relaxation.

• if you are allergic to sugammadex or any of the other ingredients of this medicine (listed in section 6).

Tell your anaesthetist if this applies to you.

Talk to your anaesthetist before Sugammadex is given

• if you have kidney disease or had in the past. This is important as Sugammadex is removed from your body by the kidneys.
• if you have liver disease or have had it in the past.
• if you have fluid retention (oedema).
• if you have diseases which are known to give an increased risk of bleeding (disturbances of blood clotting) or anticoagulation medication.

This medicine is not recommended for infants less than 2 years of age.

Tell your anaesthetist if you are taking, have recently taken or might take any other medicines. Sugammadex may affect other medicines or be affected by them.

It is especially important that you tell your anaesthetist if you have recently taken:

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

Sugammadex can make hormonal contraceptives - including the ‘Pill’, vaginal ring, implants or a hormonal IntraUterine System (IUS) - less effective because it reduces how much you get of the progestogen hormone. The amount of progestogen lost by using Sugammadex is about the same as missing one oral contraceptive Pill.

• If you are taking the Pill on the same day as Sugammadex is given to you, follow the instructions for a missed dose in the Pill’s package leaflet.
• If you are using other hormonal contraceptives (for example a vaginal ring, implant or IUS) you should use an additional non-hormonal contraceptive method (such as a condom) for the next 7 days and follow the advice in the package leaflet.

In general, Sugammadex does not have an effect on laboratory tests. However, it may affect the results of a blood test for a hormone called progesterone. Talk to your doctor if your progesterone levels need to be tested on the same day you receive Sugammadex.

Tell your anaesthetist if you are pregnant or might be pregnant or if you are breast-feeding. You may still be given Sugammadex, but you need to discuss it first.

It is not known whether sugammadex can pass into breast milk. Your anaesthetist will help you decide whether to stop breast-feeding, or whether to abstain from sugammadex therapy, considering the benefit of breast-feeding to the baby and the benefit of Sugammadex to the mother.

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

This medicine contains 9.7 mg sodium (main component of cooking/table salt) in each milliliter.

Dose below or equal to 2.4 ml

A dose of 2.4 ml (or below) contains less than 1 mmol sodium (23 mg), that is to say essentially ‘sodium-free’.

Dose above 2.4 ml

A dose of 2.4 ml (or more) contains 1 mmol (or more) sodium (23 mg). This is equivalent to 1.15% (or more) of the recommended maximum daily dietary intake of sodium for an adult.

Tell your anaesthetist if you are on a controlled salt diet.

Your anaesthetist will work out the dose of Sugammadex you need based on:

• your weight
• how much the muscle relaxant medicine is still affecting you.

The usual dose is 2-4 mg per kg body weight for adults and for children and adolescents between 2-17 years old. A dose of 16 mg/kg can be used in adults if urgent recovery from muscle relaxation is needed.

Sugammadex will be given to you by your anaesthetist. It is given as a single injection through an intravenous line.

As your anaesthetist will be monitoring your condition carefully, it is unlikely that you will be given too much Sugammadex. But even if this happens, it is unlikely to cause any problems.

If you get any side effects, talk to your anaesthetist or other doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is sugammadex.
  1 ml solution for injection contains sugammadex sodium equivalent to 100 mg sugammadex.
  Each vial of 2 ml contains sugammadex sodium equivalent to 200 mg sugammadex.
  Each vial of 5 ml contains sugammadex sodium equivalent to 500 mg sugammadex.
• The other ingredients are water for injections, hydrochloric acid (to adjust pH) and/or sodium hydroxide (to adjust pH).

Sugammadex is a clear, colourless to slightly yellow brown solution for injection, practically free from particles.

It comes in two different pack sizes, containing either 10 vials with 2 ml or 10 vials with 5 ml solution for injection.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Manufacturer(s):

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

France Sugammadex SUN 100 mg/ml solution injectable

Germany Sugammadex SUN 100 mg/ml Injektionslösung

Italy Sugammadex SUN

Netherlands Sugammadex SUN 100 mg/ml oplossing voor injectie

Poland Sugammadex Ranbaxy

Romania Sugammadex Terapia 100 mg/ml soluţie injectabilă

Spain Sugammadex SUN 100 mg/ml solución inyectable EFG

United Kingdom (Northern Ireland) Sugammadex SUN 100 mg/ml solution for injection