Package Leaflet: Information for the User

Nimbex 5 mg/ml Injectable/Solution for Infusion

Cisatracurium

Read 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 doctor.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Nimbex contains an active ingredient called cisatracurium, which belongs to a group of medications known as muscle relaxants.

Nimbex is used:

• to relax muscles during surgical procedures, including cardiac surgery, in both adults and children over 1 month of age
• to facilitate the insertion of a tube into the trachea (tracheal intubation), if mechanical assistance for breathing is required
• to relax muscles in adults in Intensive Care.

Do not use Nimbex:

• if you are allergic to cisatracurium, any other muscle relaxant, or any of the other components of Nimbex (listed in section 6)
• if you have had an allergic reaction to an anesthetic in the past

Do not use Nimbex if you are affected by any of the above circumstances. If you are unsure, speak with your doctor, nurse, or pharmacist before using Nimbex.

Be especially careful with Nimbex:

Consult with your doctor, nurse, or pharmacist before using this medication:

• if you have muscle weakness, fatigue, or difficulty coordinating your movements (myasthenia gravis)
• if you have a neuromuscular disease that causes muscle wasting, paralysis, motor neuron disease, or cerebral palsy
• if you have had burns that required medical attention

If you are unsure whether any of the above circumstances affect you, speak with your doctor, nurse, or pharmacist before Nimbex is administered to you.

Use of Nimbex with other medications:

Inform your doctor if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription. This includes herbal products or medications purchased without a doctor's prescription.

Particularly inform your doctor if you are taking any of the following medications:

• anesthetics (used to reduce sensitivity or pain during a surgical procedure)
• antibiotics (used to treat infections)
• medications used to treat irregular heart rhythms (anti-arrhythmics)
• medications used to treat high blood pressure (hypertension)
• diuretics, such as furosemide, to help lose fluids
• medications for joint inflammation, such as chloroquine or D-penicillamine
• steroids
• medications for seizures (epilepsy), such as phenytoin or carbamazepine
• psychiatric medications, such as lithium or chlorpromazine (which may also be used to prevent vomiting)
• medications containing magnesium (such as those used to treat indigestion or heartburn)
• cholinesterase inhibitors used to treat Alzheimer's disease, such as donepezil

Pregnancy and breastfeeding:

The effect of cisatracurium on the infant cannot be ruled out; however, it is not expected to occur if breastfeeding is resumed after the effects of the substance have worn off. Cisatracurium is rapidly eliminated from the body. Women should not breastfeed for 3 hours after treatment is discontinued.

If you are pregnant, breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Driving and operating machinery:

If you will be in the hospital for only one day, your doctor will instruct you on how long to wait before you can drive and operate machinery. It may be hazardous to drive shortly after being operated on.

How the Injection is Administered

Under no circumstances should you attempt to administer this medication yourself. It should always be administered by a qualified person.

Nimbex can be administered:

• as a single intravenous injection (bolus injection)
• as a continuous intravenous infusion. This is when the medication is administered slowly over a long period of time.

Your doctor will decide on the appropriate dose and duration of treatment based on:

• body weight
• the amount and duration of muscle relaxation desired
• the expected response of the patient to the medication.

This medication is not recommended for use in children under 1 month of age.

If You Receive More Nimbex Than You Should

Nimbex will always be administered under controlled conditions. However, if you believe you have been given more medication than you should have, inform your doctor or nurse immediately.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Inform your doctor of any adverse effect. This includes any possible adverse effect not mentioned in this prospectus.

Allergic Reactions (affect less than 1 in 10,000 people treated)

If you have experienced an allergic reaction, inform your doctor or nurse immediately. Symptoms may include:

• sudden wheezing, chest pain, or feeling of pressure in the chest
• inflammation of the eyelids, face, lips, mouth, and tongue
• skin rash or urticarial hives anywhere on the body
• collapse and anaphylactic shock.

Consult your doctor, nurse, or pharmacist if you notice any of the following:

Frequent Adverse Effects(affecting between 1 and 10 in every 100 people treated)

• slowing of heart rate

• low blood pressure (hypotension).

Infrequent Adverse Effects(affecting between 1 and 10 in every 1,000 people treated)

• skin eruption, redness of the skin
• wheezing or cough.

Very Rare Adverse Effects(affecting less than 1 in 10,000 people treated)

• weakness or muscle pain.

Reporting Adverse Effects

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

Keep Nimbex out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Storein refrigerator (between2°Cand8°C). Do not freeze.

Store in the original packaging to protect it from light.

Store the diluted solution for infusion, between 2°C and 8°C, and use within 24 hours. Any remaining solution for infusion not used should be discarded 24 hours after it has been prepared.

Medicines should not be disposed of through drains or in the trash. Your doctor or nurse will dispose of any medication that is no longer needed. This will help protect the environment.

Composition of Nimbex

• The active principle is cisatracurium 5 mg/ml (as besilate).

• The other components are: benzenesulfonic acid (32% v/v) and water for injection preparations.

Appearance of the product and contents of the container

Nimbex 5 mg/ml injectable/perfusion solution is presented in boxes containing a 30 ml transparent glass vial. Each 30 ml vial contains 150 mg of cisatracurium.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Aspen Pharma Trading Limited

3016 Lake Drive,

Citywest Business Campus,

Dublin 24, Ireland

Tel: +34 952 010 137

Responsible for manufacturing:

GlaxoSmithKline Manufacturing S.P.A.

Strada Provinciale Asolana, N. 90

(loc San Polo)43056

Torrile (PR)

Italy

or

Aspen Pharma Ireland Limited

3016 Lake Drive,

Citywest Business Campus,

Dublin 24

Ireland

or

Aspen Bad Oldesloe GmBH

Industriestrasse 32-36

23843 Bad Oldesloe

Germany

Local representative:

ASPEN PHARMACARE ESPAÑA, S.L.

Avenida Diagonal, 512,

Ground Floor 1, Office 4,

Barcelona, 08006, Spain

This medicine is authorized in the Member States of the European Economic Area with the following names:

Nimbex: Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain

Nimbex 5mg <10>: Germany

Cisatracurium: United Kingdom

Date of the last review of this leaflet:July 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

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This information is intended solely for healthcare professionals:

This product is only for single use. Use only clear and almost colorless or slightly yellowish/greenish solutions. The product must be visually inspected before use, and if the visual appearance has changed or the container is damaged, the product must be discarded.

Nimbex diluted remains physically and chemically stable for at least 24 hours at5°Cand25°Cat concentrations between 0.1 and 2 mg/ml in the following perfusion fluids, either inpolyvinyl chlorideor polypropylene containers.

Intravenous perfusion of sodium chloride (0.9% v/v).

Intravenous perfusion of glucose (5% v/v).

Intravenous perfusion of sodium chloride (0.18% v/v) and glucose (4% v/v).

Intravenous perfusion of sodium chloride (0.45% v/v) and glucose (2.5% v/v).

In any case, since the product does not contain antimicrobial preservatives, the dilution must be performed immediately before use or, if this is not possible, it can be stored at 2-8°C for no more than 24 hours.

Nimbex has been shown to be compatible with the following drugs normally used in surgical operations, when mixed under conditions that simulate intravenous administration through a "Y" device:hydrochlorideof alfentanil, droperidol, citrate of fentanil,hydrochlorideof midazolam and citrate of sufentanil. When administering other drugs through the same needle or cannula as Nimbex, it is recommended that each drug be pushed with an appropriate volume of an intravenous fluid, such as:intravenous perfusion of sodium chloride (0.9% v/v).

As with other intravenous drugs, when choosing a small vein as the site of injection, Nimbex must be pushed with an appropriate perfusion fluid, such as:intravenous perfusion of sodium chloride (0.9% v/v).

The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.