TRACRIUM 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Tracrium 10 mg/ml Solution for Injection and Infusion

Atracurium, Besylate

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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Tracrium and what is it used for
2. What you need to know before you use Tracrium
3. How to use Tracrium
4. Possible side effects
5. Storage of Tracrium
6. Contents of the pack and further information

1. What is Tracrium and what is it used for

Tracrium belongs to a group of medicines called muscle relaxants.

It is used to relax muscles during many surgical operations, as well as in Intensive Care Units. It may also be used to help insert a tube into the trachea if mechanical assistance is required to breathe.

2. What you need to know before you use Tracrium

Do not use Tracrium

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

Warnings and Precautions

Tell your doctor if you or a member of your family has had an unusual reaction to an anaesthetic (e.g. an unexpectedly long action), or if you or any member of your family has a warning card indicating that this has happened in the past.

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

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

• Muscle weakness, tiredness or difficulty coordinating your movements (myasthenia gravis).
• Heart disease or low blood pressure.
• Asthma.
• Hay fever or other allergies that cause rash, 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 disturbances (changes in the usual blood levels of certain chemicals in the body).

Tell your doctor:

• If you have ever had an allergic reaction to other muscle relaxants that you have been given during an operation.

Using Tracrium with other medicines

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

Tracrium may interact with other medicines. It is important that you tell your doctor before receiving this medicine if you know you are taking any of the following medicines (consult your doctor if you are in doubt):

• Antibiotics.
• Medicines for treating heart rhythm disturbances.
• Medicines for treating high blood pressure.
• Medicines that help to lose body fluids (diuretics).
• Other muscle relaxants such as pancuronium and suxamethonium.
• Medicines for arthritis or myasthenia gravis.
• Corticosteroids.
• Chlorpromazine (for treating certain mental illnesses).
• Lithium and medicines containing lithium salts (e.g. for treating depression).
• Medicines containing magnesium (such as those used for treating indigestion or heartburn, etc.).
• Inhaled anaesthetics (ketamine).
• Phenytoin (antiepileptic medicine).
• Medicines for Alzheimer's disease (anticholinesterases, e.g. donepezil).

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, 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

It may be dangerous to drive or operate machinery immediately after being operated on. Your doctor will tell you how long you should wait before you can drive and use machinery.

3. How to use Tracrium

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

Your doctor will decide on the dose and duration of treatment with Tracrium that he considers suitable for your operation.

Use in Children

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

The dose of Tracrium is determined based on body weight expressed in kilograms, the amount and duration of muscle relaxation desired, the expected response of the patient to the medicine, and the way the medicine is to be administered. During muscle relaxation, your doctor will monitor neuromuscular function (nerves and muscles) to confirm that the dose being administered is correct.

If you use more Tracrium than you should

The effects of Tracrium are carefully controlled throughout the surgical procedure, and in the unlikely event that too much medicine is administered, corrective actions will be taken immediately.

4. Possible side effects

Like all medicines, Tracrium can cause side effects, although not everybody gets them.

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

Common side effects (may affect between 1 and 10 in every 100 people)

• Decrease in blood pressure (mild, transient) #, flushing of the skin #.

Uncommon side effects (may affect between 1 and 10 in every 1,000 people)

• Difficulty breathing #.

If these 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 in every 10,000 people)

• Urticaria.

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

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

Side effects with frequency not known

• There have been reports of seizures in patients in Intensive Care Units who have been receiving atracurium simultaneously with other medicines. These patients generally had a condition that predisposed them to having seizures, such as head trauma or brain disease.
• There have been reports of muscle weakness and/or inflammatory muscle disease 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 rarely in association with Tracrium, and no causal relationship has been established.

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 or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tracrium

Keep 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 packaging to protect from light.

Any remaining Tracrium in opened ampoules should be discarded.

Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Tracrium

• The active substance is atracurium besylate.
• The other ingredients are benzenesulfonic acid and water for injections. It does not contain antimicrobial preservatives.

Appearance and packaging of the product

Tracrium is a solution for injection, presented in 2.5 ml or 5 ml ampoules.

Each pack contains 5 ampoules.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aspen Pharma Trading Limited

3016 Lake Drive,

Citywest Business Campus,

Dublin 24, Ireland

Tel: +34 952 010 137

Manufacturer

Aspen Bad Oldesloe GmbH,

Industriestrasse 32-36,

23843 Bad Oldesloe,

Germany

Or

GlaxoSmithKline Manufacturing S.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, Oficina 4,

Barcelona, 08006, Spain

This information is intended only for healthcare professionals:

Tracrium is compatible with the following infusion solutions for the times shown below:

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

Date of last revision of this leaflet:September 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/