What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 04515/0099.


Atracurium Besilate 10 mg/ml Solution for Injection - Ampoule

PACKAGE LEAFLET: INFORMATION FOR THE USER

Atracurium Besilate 10 mg/ml Solution for Injection

The active substance is atracurium besilate

Read all of this leaflet carefully before you start using this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Atracurium Besilate Solution for Injection is and what it is used for
2. What you need to know before you use Atracurium Besilate Solution for Injection
3. How to use Atracurium Besilate Solution for Injection
4. Possible side effects
5. How to store Atracurium Besilate Solution for Injection
6. Contents of the pack and other information

1. WHAT ATRACURIUM BESILATE SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR

Atracurium Besilate Solution for Injection is a medicine which acts as a muscle relaxant.

Atracurium Besilate Solution for Injection is used during surgery to relax muscles and to assist with inserting a breathing tube and with artificial breathing. It is also used to help with artificial breathing in patients in intensive care.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE ATRACURIUM BESILATE SOLUTION FOR INJECTION

Do not use Atracurium Besilate Solution for Injection

  • if you are allergic (hypersensitive) to atracurium besilate or any of the other ingredients of this drug (see section 6)

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Atracurium Besilate Solution for Injection if you

  • are pregnant or breast-feeding (see Pregnancy and breast-feeding)
  • have heart or circulation problems
  • have problems with your lungs
  • have a history of allergy or asthma
  • suffer from myasthenia gravis, Eaton-Lambert syndrome or other neuromuscular diseases (these may result in muscle weakness)
  • have severe electrolyte disorders (unusual levels of ions such as sodium, potassium or chloride in your blood)
  • are suffering from burns
  • have had allergic reactions to other muscle relaxants (e.g. curares)

Using other medicines

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

Some medicines are known to interact with atracurium besilate, tell your doctor if you are taking any of the following:

  • antibiotics (e.g. aminoglycosides, polymyxins, spectinomycin, tetracyclines, lincomycin, clindamycin and vancomycin)
  • antiarrhythmic medicines (used to control the rhythm of the heart) (e.g. lidocaine, procainamide, quinidine)
  • diuretics (water tablets) (e.g. frusemide, thiazides, acetazolamide, mannitol)
  • medicines used to control blood pressure or angina or other heart problems (e.g. propranolol, oxprenolol, diltiazem, nicardipine, nifedipine, trimetaphan, hexamethonium and verapamil)
  • antiepileptic medicines (e.g. carbamazepine, phenytoin)
  • drugs used to treat rheumatism (e.g. chloroquine, d-penicillamine)
  • corticosteroids administered into your vein (used in the treatment of allergic emergencies, severe asthma and septic shock)
  • inhalation anaesthetics (drugs to put you to sleep) (e.g. isoflurane, desflurane, sevoflurane and enflurane anaesthesia, halothane)
  • others you may recognise by name (e.g. dantrolene (used in anaesthesia), magnesium sulphate (used to treat eclampsia and pre-eclampsia in pregnant women and some heart problems), ketamine (used in anaesthesia), lithium (used to treat bipolar disorder), quinine (used to treat malaria and leg cramps) and chlorpromazine (used to treat some psychiatric disorders and nausea)).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Atracurium besilate should not be used during the first three months of pregnancy. It will not be used during the second and third trimesters unless your doctor advises that it is necessary.

Atracurium besilate can be used during a caesarean section.

Your baby would be closely monitored if you breast-feed within 24 hours of being given atracurium besilate.

Driving and using machines

Do not drive or use machines within 24 hours of being given atracurium besilate.

3. HOW TO USE ATRACURIUM BESILATE SOLUTION FOR INJECTION

Atracurium besilate is used during procedures which require you to be anaesthetised (unconscious) or heavily sedated. The amount given to you will depend upon the length of time you will be unconscious or heavily sedated and your body weight.

An initial dose of this medicine will be given to you of approximately 0.3 – 0.6 mg/kg of body weight, followed by a reduced dose at specific intervals. This standard dose will be given to children and adults. The rate this medicine is administered may vary depending on your age and if you suffer from any heart problems. You will be monitored during use with this medicine, and the dose will be adjusted if necessary.

Atracurium besilate will be given to you by an injection into a vein.

Children less than 1 month old should not have this medicine.

If you are given more Atracurium Besilate Solution for Injection than you should be given

Atracurium besilate will only be used by doctors who are appropriately skilled in its administration. As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much, however tell your doctor or a healthcare professional immediately if you have any concerns.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Atracurium Besilate Solution for Injection can cause side effects, although not everybody gets them.

If any of the following happen, tell the doctor immediately:

  • severe allergic reaction – you may get a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint
  • seizures (fits)
  • shock
  • heart failure
  • cardiac arrest

The above are rare or very rare serious side effects. You may need urgent medical attention.

If you experience any of the following tell your doctor as soon as possible:

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

  • rapid heart beat
  • slow heart beat
  • soreness at the injection site
  • wheezing
  • localised rash or itching of the skin
  • low blood pressure (hypotension)
  • high blood pressure (hypertension)
  • flushing of the skin

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

  • difficulty breathing
  • generalised rash or redness of the skin
  • hives

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

  • shortness of breath
  • spasm of the vocal cords
  • rapid swelling under the skin (angioneurotic oedema)
  • itching

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

  • low blood oxygen level (hypoxemia)

Not known (frequency cannot be estimated from the available data)

  • prolonged therapeutic action of the medicine
  • insufficient therapeutic action of the medicine
  • increased mucous secretions in the lungs
  • muscle weakness/tiredness or difficulty controlling your muscles

If any of the side effects gets 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via

Malta

ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal

UK

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE ATRACURIUM BESILATE SOLUTION FOR INJECTION

Keep out of the sight and reach of children.

Do not use Atracurium Besilate Solution for Injection after the expiry date which is stated on the ampoule label and carton.

The ampoules should be stored in a refrigerator (2 – 8°C) but not frozen.

The ampoules should be kept in the outer carton (in order to protect from light).

6. CONTENTS OF THE PACK AND FURTHER INFORMATION

What Atracurium Besilate Solution for Injection contains

The active substance is atracurium besilate

The other ingredients are benzenesulphonic acid and Water for Injections

What Atracurium Besilate Solution for Injection looks like and contents of the pack

This medicinal product is a solution for injection (a solution which can be given as an injection). It is a clear, colourless or faint yellow solution. Each millilitre (ml) of solution contains 10 milligrams (mg) of atracurium besilate.

This medicine is presented in glass containers (ampoules). The 2.5 ml and 5 ml ampoule are available in packs of 5. Not all presentations may be marketed.

Marketing Authorisation Holder

Hospira UK Limited
Horizon
Honey Lane
Hurley
Maidenhead
SL6 6RJ
UK

Manufacturer

Hospira UK Limited
Horizon
Honey Lane
Hurley
Maidenhead
SL6 6RJ
UK

Pfizer Service Company BVBA
Hoge Wei 10
1930 Zaventem
Belgium

This leaflet was last revised in 02/2019

Ref: gxAT 2_0