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Atracurium Besilate 10mg/ml solution for Injection/Infusion

Active Ingredient:
atracurium besilate
Company:  
hameln pharma ltd See contact details
ATC code: 
M03AC04
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL)
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 23 Mar 2026
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 25215/0032.

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Atracurium Besilate 10mg/ml solution for Injection/Infusion

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Atracurium besilate 10 mg/ml solution for injection/infusion

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, pharmacist or nurse.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

1. WHAT ATRACURIUM IS AND WHAT IT IS USED FOR

Atracurium belongs to a group of medicines called muscle relaxants. It is used to relax muscles during surgery.

Atracurium is used:

  • during surgery, other procedures and in intensive care
  • during general anaesthesia to ease tracheal intubation (a tube into the windpipe) and controlled ventilation

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ATRACURIUM
You should not be given Atracurium:
  • if you are allergic to atracurium besilate or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, difficulty of breathing or swelling of the face, lips, throat or tongue. You may know this from earlier experience.

Warnings and precautions

Before you receive Atracurium, tell your doctor if you have:

  • a disease that affects the muscles and/or their nervous control (neuromuscular disease such as myasthenia gravis or Eaton-Lambert syndrome)
  • a severe electrolyte disorder
  • cancer spread widely from a primary source (carcinomatosis)
  • a sensitivity to histamine
  • asthma-like symptoms (a history of allergy, asthma or bronchospasm)
  • burns
  • lack of adequate circulatory filling (hypovolaemia)

Children:

The use of Atracurium is not recommended in neonates (children under the age of one month). In the case of necessary treatment in newborn or premature newborn the dose has to be significantly lowered. Ask your doctor if you have any further questions.

Other medicines and Atracurium

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines This is especially important with the following medicines as they may interact with your Atracurium:

  • 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. furosemide, thiazides, acetazolamide and mannitol)
  • medicines used to control blood pressure, angina or other heart problems (e.g. propranolol, oxprenolol diltiazem, nicardipine, nifedipine and verapamil)
  • antiepileptic medicines (e.g. carbamazepine, phenytoin)
  • drugs used to treat rheumatism (e.g. chloroquine, d-penicillamine)
  • corticosteroids (used to treat inflammation)
  • trimetaphan, hexamethonium (used to lower blood pressure during surgery)
  • dantrolene (a muscle relaxant)
  • magnesium sulphate
  • ketamine (an anaesthetic drug)
  • lithium, chlorpromazine (treatment of mental illness)
  • quinine (treatment of malaria or leg cramps)

It may still be all right for you to be given Atracurium and your doctor will be able to decide what is suitable for you.

Pregnancy and breast-feeding

Atracurium should not be given to pregnant women unless medically justified. Mothers should stop breast-feeding for 24 hours after receiving Atracurium. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

After you have been given Atracurium, you must not drive, operate machinery, or work in dangerous situations. You should not go home alone and should not drink alcohol until fully recovered.

3. HOW ATRACURIUM IS GIVEN

Atracurium must only be given by an experienced doctor under carefully controlled conditions.

Dosage

Atracurium is used during procedures that require that the patient is fully anaesthetized (unconscious), or heavily sedated.

The dosing will be worked out by the doctor. Atracurium must be given only by injection directly into a vein (intravenous use). Atracurium must not be injected into a muscle.

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

4. POSSIBLE SIDE EFFECTS

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

The following side effects have been reported:

Common (may affect up to 1 in 10 people)

  • tachycardia (rapid heartbeat)
  • temporary hypotension (low blood pressure)
  • wheezing
  • bronchospasm (asthma-like symptoms)
  • skin flushing
  • urticaria (nettle rash)

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

  • myasthenia and/or myopathy (weak or non-working muscles)
  • severe allergic reactions including shock, circulatory failure and heart attack in patients receiving atracurium with one or more anaesthetic drugs
  • seizures (fits) when taken with other drugs in at-risk patients
  • laryngospasm (spasm of the vocal cords)

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 the Yellow Card Scheme at: 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
  • Keep this medicine out of sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the label and the carton after "Exp". The expiry date refers to the last day of that month.
  • Store in a refrigerator (2°C -8°C). Do not freeze. Keep the ampoules in the outer carton in order to protect from light.
  • After first opening the medicinal product should be used immediately.
  • Shelf life of prepared infusion solutions for infusion: Chemical and physical in-use stability has been demonstrated in Sodium Chloride Intravenous Infusion BP for up to 24 hours at 30°C and in other common infusion fluids for up to 4 or 8 hours, respectively (see Dilution instructions at the end of this leaflet ‘The following information is intended for healthcare professionals only)’. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
  • The product should be inspected visually prior to administration (also after dilution.) Do not use Atracurium if you notice the solution is not clear, colourless and free of particles or if the container is damaged.
  • Any unused solution from opened ampoules should be discarded.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Atracurium contains

The active substance is atracurium besilate.

1 ml of Atracurium contains 10 mg of atracurium besilate.

One ampoule with 2.5 ml solution contains 25 mg atracurium besilate

One ampoule with 5.0 ml solution contains 50 mg atracurium besilate.

The other ingredients are water for injections and benzenesulfonic acid.

What Atracurium looks like and the content of the pack

Atracurium is a clear and colourless solution for injection/infusion.

3 ml or 5 ml clear glass ampoules

Box of 5 ampoules with 2.5 or 5 ml

Box of 10 ampoules with 2.5 or 5 ml

Box of 5 x 10 ampoules with 2.5 or 5 ml

Not all pack sizes may be marketed.

Marketing authorisation holder
hameln pharma ltd
Nexus
Gloucester Business Park
Gloucester
GL3 4AG
United Kingdom

Manufacturer
Siegfried Hameln GmbH
Langes Feld 13
31789
Hameln
Germany

hameln rds s.r.o.
Horná 36
900 01
Modra
Slovakia

This medicinal product is authorised in the Member States of the EEA under the following names:

DE: Atracurium-hameln 10 mg/ml Injektions-/Infusionslösung

NL: Atracurium-hameln 10 mg/ml oplossing voor injectie/infusie

ES: Besilato de Atracurio-hameln 10 mg/ml solución inyectable y para perfusión EFG

SE: Atracurium-hameln 10 mg/ml injektions-/infusions vätska, lösning

UK: Atracurium besilate 10 mg/ml solution for injection/infusion

This leaflet was last revised in June 2025

44487/28/25

hameln pharma ltd
Company image
Address
Nexus, Gloucester Business Park, Gloucester, GL3 4AG, UK
WWW
https://www.hameln-pharma.com
Telephone
+44 (0)1452 621 661
Fax
+44 (0)1452 632 732
Medical Information e-mail
[email protected]