CISATRACURIO NORMON 5 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cisatracurium NORMON 5 mg/ml solution for injection and infusion EFG

Cisatracurium

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

Contents of the pack:

1. What Cisatracurium NORMON is and what it is used for
2. Before you use Cisatracurium NORMON
3. How to use Cisatracurium NORMON
4. Possible side effects
5. Storage of Cisatracurium NORMON
6. Further information

1. What Cisatracurium NORMON is and what it is used for

Cisatracurium NORMON is a medicine that contains cisatracurium. It belongs to a group of medicines called muscle relaxants.

Cisatracurium 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 to breathe is required.
• To relax muscles in adults in Intensive Care.

2. Before you use Cisatracurium NORMON

Cisatracurium NORMON will not be administered to you if

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

Do not use Cisatracurium NORMON if any of the above applies to you. If you are not sure, talk to your doctor, nurse or pharmacist before using Cisatracurium NORMON.

Be especially careful with Cisatracurium NORMON

Talk to your doctor, nurse or pharmacist before starting to use Cisatracurium NORMON if:

• You have muscle weakness, tiredness 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 you have been given during an operation.

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

Children

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

Using other medicines

Tell your doctor, nurse or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

This is because some medicines may affect the way Cisatracurium NORMON works or cause side effects.

In particular, tell your doctor, nurse or pharmacist if you are taking any of the following medicines:

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

Pregnancy and breastfeeding

An adverse effect of cisatracurium on the breastfed 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 the end of treatment.

Pregnancy: Cisatracurium NORMON should not be used during pregnancy.

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

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

This medicine may affect your ability to drive or use machines. If you are in the hospital for only one day, your doctor will tell you how long you should wait before you can drive or use machines. It may be dangerous to drive soon after surgery.

3. How to use Cisatracurium NORMON

How the injection is given

Never try to give yourself this medicine. It should always be given by a person qualified to do so.

Cisatracurium NORMON can be given:

• As a single injection into a vein (intravenous bolus injection)
• As a continuous infusion into a vein. This is when the medicine is given slowly over a long period of time.

Your doctor will decide on the dose and duration of treatment that they think is right for you. This will depend on:

• your body weight
• the amount and duration of muscle relaxation that is needed
• the patient's expected response to the medicine.

If you are given too much Cisatracurium NORMON

Cisatracurium NORMON will always be given under properly controlled conditions. However, if you think you have been given too much medicine, tell your doctor or nurse immediately.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cisatracurium NORMON can cause side effects, although not everybody gets them. The side effects that may occasionally occur with this medicine are:

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

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

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

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

Common side effects(may affect up to 1 in 10 patients)

• slowing of the heart rate
• fall in blood pressure (hypotension)

Uncommon side effects(may affect up to 1 in 100 patients)

• skin rash, redness of the skin
• wheezing or coughing

Rare side effects(may affect up to 1 in 10,000 patients)

• muscle weakness or pain

If you think any of the side effects you are experiencing are serious or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

5. Storage of Cisatracurium NORMON

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

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

Store in the original package to protect from light.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date is the last day of the month shown.

If you dilute the medicine, store the infusion solution between 2°C and 8°C and use within 24 hours. Any unused infusion solution should be discarded after 24 hours.

Medicines should not be disposed of via wastewater or household waste. Ask your doctor or nurse to dispose of any medicine that you no longer need. This will help protect the environment.

6. Further information

What Cisatracurium NORMON contains

The active substance is cisatracurium (as besylate). Each ml of solution contains 5 mg of cisatracurium.

The other ingredients are: benzene sulfonic acid solution and water for injections.

Appearance and packaging

Cisatracurium NORMON 5 mg/ml is a solution for injection and infusion that comes in 30 ml vials. Each pack contains 1 vial.

Marketing authorisation holder and 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 only for healthcare professionals:

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

Diluted Cisatracurium NORMON 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 infusion fluids, either in polyvinyl chloride or polypropylene containers:

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

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

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

Intravenous infusion 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 should be made 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 commonly used in surgical operations, when mixed under conditions simulating intravenous infusion through a "Y" device: alfentanil hydrochloride, droperidol, fentanyl citrate, midazolam hydrochloride and sufentanil citrate. When other drugs are administered through the same needle or cannula as Cisatracurium NORMON, it is recommended that each drug be flushed with a suitable volume of an appropriate intravenous fluid such as sodium chloride infusion (0.9% w/v).

As with other intravenous drugs, when a small vein is chosen as the injection site, Cisatracurium NORMON should be flushed with a suitable infusion fluid such as sodium chloride infusion (0.9% w/v).

OTHER PRESENTATIONS

Cisatracurium NORMON 2 mg/ml solution for injection and infusion EFG.

Detailed and up-to-date information on this product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/