Nimbex Injection 2 mg/ml and Nimbex Forte Injection 5 mg/ml

Read all of this leaflet carefully before you are given 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 doctor.
• If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

Do not use Nimbex:

• if you are allergic to cisatracurium, any other muscle relaxant or any of the other ingredients in Nimbex (listed in section 6)
• you have reacted badly to an anaesthetic before.

Do not have Nimbex if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist before you have Nimbex.

Take special care with Nimbex

Talk to your doctor, nurse or pharmacist before having this medicine:

• if you have muscle weakness, tiredness or difficulty in co-ordinating your movements (myasthenia gravis)
• you have a neuromuscular disease, such as a muscle wasting disease, paralysis, motor neurone disease or cerebral palsy
• if you have a burn which requires medical treatment.
• you have ever had an allergic reaction to any muscle relaxant which was given as part of an operation

If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before you are given Nimbex.

Other medicines and Nimbex

Tell your doctor if you are taking or have recently taken any other medicines. This includes any herbal products or medicines bought without a prescription.

In particular tell your doctor if you are taking any of the following:

• anaesthetics (used to reduce sensation and pain during surgical procedures)
• antibiotics (used to treat infections)
• medicines for uneven heart beats (anti-arrhythmics)
• medicines for high blood pressure
• water tablets (diuretics), such as furosemide
• medicines for inflammation of the joints, such as chloroquine or d-penicillamine
• steroids
• medicines for fits (epilepsy), such as phenytoin or carbamazepine
• medicines for mental illness, such as lithium or chlorpromazine (which can also be used for sickness)
• medicines containing magnesium
• drugs for Alzheimer’s disease (anticholinesterases e.g. donepezil).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

If you are only staying in hospital for the day, your doctor will tell you how long to wait before leaving the hospital or driving a car. It can be dangerous to drive too soon after having an operation.

How your injection is given

You will never be expected to give yourself this medicine. It will always be given to you by a person who is qualified to do so.

Nimbex can be given:

• as a single injection into your vein (intravenous bolus injection)
• as a continuous infusion into your vein. This is where the drug is slowly given to you over a long period of time.

Your doctor will decide the way you are given the drug and the dose you will receive. It will depend on:

• your body weight
• the amount and duration of muscle relaxation required
• your expected response to the medicine.

Children less than 1 month old should not have this medicine.

If you receive more Nimbex than you should

Nimbex will always be given under carefully controlled conditions. However, if you think that you have been given more than you should tell your doctor or nurse immediately.

Reporting of side effects

If you get any side effects, talk to your doctor, nurse or pharmacist. 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.

By reporting side effects you can help provide more information on the safety of this medicine.

What Nimbex contains

• The active substance is 2 mg/ml or 5 mg/ml cisatracurium (as besilate).
• The other ingredients are benzene sulfonic acid (32% w/v) and Water for Injections.

What Nimbex looks like and contents of the pack

Nimbex 2 mg/ml solution for injection/infusion comes:

• 2.5 ml clear glass ampoule in a box of 5 (each 2.5 ml ampoule contains 5 mg of cisatracurium)
• 5 ml clear glass ampoule in a box of 5 (each 5 ml ampoule contains 10 mg of cisatracurium)
• 10 ml clear glass ampoule in a box of 5 (each 10 ml ampoule contains 20 mg of cisatracurium)
• 25 ml clear glass ampoule in a box of 2 (each 25 ml ampoule contains 50 mg of cisatracurium)

Nimbex Forte 5 mg/ml solution for injection/infusion comes in a box containing one 30 ml clear glass vial. Each 30 ml vial contains 150 mg of cisatracurium.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing Authorisation Holder:

Manufacturer: