Label: Information for the User

Tracrium 10 mg/ml Injectable Solution and for Infusion

Atracurium besilate

Read the entire label carefully before starting to use the medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribedonlyfor you,and you should not give it to others even if they have the same symptomsas you, as it may harm them.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this label. See section 4.

Tracrium belongs to a group of medications known as muscle relaxants.

It is used to relax muscles in numerous surgical operations, as well as in Intensive Care Units. It may also be used to facilitate the insertion of a tube into the trachea, if mechanical assistance with breathing is required.

No use Tracrium

• If you are allergic (hypersensitive) to atracurium, cisatracurium, or benzenesulfonic acid or to any of the other components of Tracrium or to any other muscle relaxant such as suxamethonium(listed in section 6).

Warnings and precautions

Consult your doctor if you or a family member has had any adverse reaction to an anesthetic (e.g. an unexpectedly long action), or if you or a family member has a warning card indicating that this has occurred in the past.

During the administration of Tracrium, there is a possibility of histamine release (a substance involved in allergies) in susceptible patients. Caution should be exercised when administering Tracrium to patients with a history suggesting increased sensitivity to histamine effects.

Before starting treatment with Tracrium, inform your doctor if you have or have had:

• Muscle weakness, fatigue, or difficulty coordinating movements (myasthenia gravis).
• Heart disease or low blood pressure.
• Asthma.
• Hay fever or other allergies that cause rashes, itching, or shortness of breath.
• A severe burn that required medical attention in the last 2 or 3 months.
• A disease that causes muscle wasting, paralysis, motor neuron disease, or cerebral palsy.
• Electrolyte imbalances (changes in the usual blood levels of certain chemical substances in the body).

Inform your doctor:

• If you have ever had an allergic reaction to other muscle relaxants that were administered during surgery.

Use of Tracrium with other medications

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

Tracrium may interact with other medications. It is essential to inform your doctor before receiving this medication if you know you are taking any of the following medications (consult your doctor if you have doubts):

• Antibiotics.
• Medications to treat arrhythmias.
• Medications to treat high blood pressure.
• Diuretics (medications that help lose body fluids).
• Other muscle relaxants such as pancuronium and suxamethonium.
• Medications for arthritis or myasthenia gravis.
• Corticosteroids.
• Clorpromazine (for certain mental illnesses).
• Lithium and medications containing lithium salts (e.g. for treating depression).
• Medications containing magnesium (e.g. for treating indigestion or heartburn, etc.).
• Inhaled anesthetics (ketamine).
• Phenytoin (antiepileptic medication).
• Medications for Alzheimer's disease (cholinesterase inhibitors, e.g. donepezil).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

It may be hazardous to drive or operate machinery immediately after surgery. Your doctor will tell you how long you should wait before driving and using machinery

Tracrium should only be administered in carefully controlled conditions under the supervision of an experienced and familiarized doctor with the use and action of muscle relaxants.

Your doctor will decide on the dose and duration of Tracrium treatment that they consider suitable for your operation.

Use in children

The use of Tracrium in children under 1 month of age is not recommended.

The dose of Tracrium is established based on body weight expressed in kilograms, the amount and duration of muscle relaxation desired, the expected response of the patient to the medication, and the method of administration of the drug. During muscle relaxation, your doctor will monitor neuromuscular function (nerves and muscles) to confirm that the dose you are receiving is correct.

If you use more Tracrium than you should

The effects of Tracrium are carefully controlled throughout the entire surgical intervention, and in the unlikely event that you are administered too much medication, the necessary corrective actions should be taken immediately.

Like all medications,Tracriummay cause side effects, although not everyone will experience them.

The side effects that may appear during or after the operation are as follows (those marked with the symbol # are attributed to histamine release):

Frequent side effects(may affect between 1 and 10 of every 100 people)

• Decreased blood pressure (mild, transient)#, skin redness #.

Infrequent side effects(may affect between 1 and 10 of every 1,000 people)

• Difficulty breathing #.

If these side effects appear, they will not last long and will be controlled by your doctor during the procedure.

Rare side effects(may affect between 1 and 10 of every 10,000 people)

• Urticaria.

Very rare side effects(may affect up to 1 of every 10,000 people)

• Anaphylactoid and anaphylactic reactions (severe allergic reactions) including anaphylactic shock, in patients receiving Tracrium along with one or more anesthetic agents.

Side effects of unknown frequency

• Cases of seizures have been reported in intensive care unit patients who have been receiving atracurium simultaneously with other medications. These patients generally suffered from a condition that predisposed them to seizures, for example, head trauma or brain disease.
• Some cases of muscle weakness and/or inflammatory muscle disease have been reported after prolonged use of muscle relaxants in critically ill patients in intensive care units. Most patients were receiving corticosteroids at the same time. These effects have been reported infrequently in association with Tracrium, without establishing a causal relationship.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect not listed in this leaflet.You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

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

Store in original packaging to protect from light.

Any remaining Tracrium in opened vials must be discarded.

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of packaging and unused medications. This will help protect the environment.

Composition of Tracrium

• The active principle is besylate of atracurium.
• The other components are benzenesulfonic acid and water for injectable preparations.No conservants are present.

Aspect of the product and content of the packaging

Tracrium is an injectable solution that is presented in ampoules of 2.5 ml or 5 ml.

Each package contains 5 ampoules.

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

Aspen Bad Oldesloe GmbH,

Industriestrasse 32-36,

23843 Bad Oldesloe,

Germany

Or

GlaxoSmithKline ManufacturingS.p.A.

Strada Provinciale Asolana, 90

43056 San Polo di Torrile (Parma)

Italy

Or

Aspen Pharma Ireland Limited

3016 Lake Drive, Citywest Business Campus

Dublin 24, Ireland

Local representative:

ASPEN PHARMACARE ESPAÑA, S.L.

Avenida Diagonal, 512,

Planta Interior 1, Office 4,

Barcelona, 08006, Spain

This information is intended solely for doctors or healthcare professionals:

Tracrium is compatible with the following infusion solutions for the periods below:

When diluted in these infusion solutions to achieve concentrations of besylate of atracurium of 0.5 mg/ml and above, the resulting solutions will be stable at temperatures up to 25°C, under daylight, and for the established periods.

Last review date of this leaflet:September 2023

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