PATIENT INFORMATION LEAFLET

Cisatracurium NORMON 5 mg/ml Injectable Solution and Infusion EFG

Cisatracurium

Read this leaflet carefully before you start using the medicine, as 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, nurse, or pharmacist.
• If you experience any side effects, consult your doctor, nurse, or pharmacist, even if they are not listed in this leaflet.

Cisatracurio NORMON is a medication that contains cisatracurio. It belongs to a group of medications known as muscle relaxants.

Cisatracurio NORMON is used:

• To relax muscles during surgical operations, 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.

You should not be administered Cisatracurio NORMON if

• You are allergic (hypersensitive) to cisatracurium besylate or to any of the other components of Cisatracurio NORMON (see section 6).
• You have previously had an allergic reaction to an anesthetic.

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

You should take special care with Cisatracurio NORMON

Consult with your doctor, nurse or pharmacist before starting to use Cisatracurio NORMON if: - you have muscle weakness, fatigue or difficulty coordinating your movements (myasthenia gravis)

• You have a neuromuscular disease that causes muscle wasting, paralysis, motor neuron disease or cerebral palsy
• You have had burns that required medical attention
• You have ever had an allergic reaction to any muscle relaxant that was administered to you during an operation.

If you are unsure if you apply the above, speak with your doctor, nurse or pharmacist before Cisatracurio NORMON is administered to you.

NChildren

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

Use of other medications

Inform your doctor, nurse or pharmacist if you are using or have used recently other medications, even those acquired without a prescription.

This is because some medications may affect the proper functioning of Cisatracurio NORMON or cause adverse effects.

Particularly inform your doctor, nurse or pharmacist if you are taking any of the following medications:

• Anesthetics (used to reduce sensitivity or pain during a surgical intervention)
• Antibiotics (used to treat infections)
• Medications used to treat arrhythmias (anti-arrhythmics)
• Medications used to treat high blood pressure (hypertension)
• Medications that help lose liquids (diuretics), such as furosemide
• Medications for joint inflammation, such as chloroquine or penicillamine
• Steroids
• Medications for seizures (epilepsy), such as phenytoin or carbamazepine
• Medications used in psychiatry, such as lithium, monoamine oxidase inhibitors (MAOIs), or chlorpromazine (which may also be used to prevent vomiting)
• Medications that contain magnesium (such as those used to treat indigestion or heartburn)
• Medications to treat Alzheimer's disease (cholinesterase inhibitors such as donepezil).

Pregnancy and breastfeeding

A potential adverse effect of cisatracurium on the infant cannot be excluded; however, it is not expected to occur if breastfeeding is resumed after the effects of the substance have disappeared. Cisatracurium is rapidly eliminated from the body. Women should not breastfeed for 3 hours after treatment is discontinued.

Pregnancy: Cisatracurio NORMON should not be used during pregnancy.

Breastfeeding: Breastfeeding should be interrupted during treatment with Cisatracurio NORMON.

If you are pregnant or breastfeeding, or think you might be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

This medication may affect your ability to drive or operate machinery. If you are only in the hospital for a day, your doctor will tell you how long you should wait before you can drive or operate machinery. It may be dangerous to drive shortly after surgery.

How the injection is administered

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

Cisatracurio NORMON can be administered:

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

Your doctor will decide on the dose and duration of treatment that they consider suitable for your procedure. This will depend on:

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

If you receive more Cisatracurio NORMON than you should

Cisatracurio NORMON will always be administered under adequately controlled conditions. However, if you consider that 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 or pharmacist.

Like all medications, Cisatracurio NORMON may produce adverse effects, although not all people may experience them. The adverse effects that may occasionally appear with this medication are:

Allergic Reactions(may affect up to 1 in 10,000 patients)

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

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

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

Frequent Adverse Effects(may affect up to 1 in 10 patients)

• slowing of heart rate
• drop in blood pressure (hypotension)

Less Frequent Adverse Effects(may affect up to 1 in 100 patients)

• eruption, redness of the skin
• wheezing or cough

Very Rare Adverse Effects(may affect up to 1 in 10,000 patients)

• weakness or muscle pain

If you consider that any of these adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor, nurse, or pharmacist.

Keep this medication out of the reach and sight of children.

Store in refrigerator (between 2°C and 8°C). Do not freeze.

Store in original packaging to protect it from light.

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.

If diluted, store the infusion solution between 2°C and 8°C and use within 24 hours. Any remaining infusion solution not used should be discarded 24 hours after preparation.

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

Cisatracurium NORMON Composition

The active principle is cisatracurium (as besilate). Each ml of solution contains 5 mg of cisatracurium.

The other components are: benzenesulfonic acid solution and water for injectable preparations.

Product Appearance and Packaging Contents

Cisatracurium NORMON 5 mg/ml is an injectable and perfusion solution that is presented in 30 ml ampoules. Each package contains 1 ampoule.

Marketing Authorization Holder and Responsible Manufacturer

Laboratorios NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

This leaflet was approved in June 2021

This information is intended solely for medical professionals or 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 if the container is damaged, the product must be discarded.

Cisatracurium NORMON diluted remains physically and chemically stable for at least 24 hours at 5°C and 25°C at concentrations between 0.1 and 2 mg/ml in the following perfusion fluids, either in polyvinyl chloride or polypropylene containers:

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

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

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

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

Cisatracurium NORMON 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: hydrochloride of alfentanil, droperidol, citrate of fentanil, hydrochloride of midazolam, and citrate of sufentanil. When administering other drugs through the same needle or cannula as Cisatracurium NORMON, it is recommended that each drug be pushed with an adequate volume of an appropriate intravenous fluid, such as: intravenous perfusion of sodium chloride (0.9% w/v).

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

OTHER PRESENTATIONS

Cisatracurium NORMON 2 mg/ml injectable and perfusion solution EFG.

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