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Active substance(s): ATRACURIUM BESYLATE

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Atracurium Besylate 10mg/ml Injection
Atracurium Besylate
However, please be aware that this may not always be possible because of your
medical condition.
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 become serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor
In this leaflet:
1. What Atracurium Besylate Injection is and what it is used for
2. Before you are given Atracurium Besylate Injection
3. How Atracurium Besylate Injection is given to you
4. Possible side effects
5. How to store Atracurium Besylate Injection
6. Further information
Atracurium Besylate injection belongs to a group of medicines called muscle
Their effect is to block the connection between the nerves and certain muscles, which
relaxes these muscles by temporarily paralysing them. This effect helps surgeons
when performing a wide range of operations including Caesarean section to deliver a
This medicine can also be used when a patient is put on a ventilator to control the
breathing. During this procedure, it is necessary for the muscles used for breathing to
be paralysed.
You should not be given Atracurium Besylate injection, if you know that you are allergic
to Atracurium Besylate, any other muscle relaxant or any of the other ingredients in
Atracurium Besylate Injection (listed in Section 6)
• You have reacted badly to an anaesthetic before.
Do not have Atracurium Besylate Injection if any of the above apply to you.
If you are not sure, talk to your doctor, nurse or pharmacist before you have
Atracurium Besylate Injection.
Your doctor will take special care if any of the following situations apply to you:
• You have muscle weakness, tiredness or difficulty in co-ordinating your movements
(myasthenia gravis)
• You have a neuromuscular disease, such as a muscle wasting disease, paralysis,
motor neurone disease or cerebral palsy which is disorder of posture, muscle tone
and movement resulting from brain damage.
• You have a burn which requires medical treatment
• You have ever had an allergic reaction to any muscle relaxant which was given as
part of an operation.
• You suffer from a condition called myasthenia gravis (which causes severe
weakness of the muscles and difficulty in co-ordinating your movements) or from
any other disease of nerves or muscles.
• You have been told that you have an electrolyte disorder (imbalance of salts in your
blood) or acidosis (too much acid in your blood and tissues).
• You have a history of any allergies or asthma.
• You suffer from severe problems affecting your heart or blood vessels.

Make sure your doctor is aware of these situations if it is not already obvious,
before you are given this injection.
This medicine is not recommended for use in children under the age of 1 month
because not enough experience has been gained in this age group.
If you are not sure if any of the above apply to you, talk to your doctor, nurse or
pharmacist before you are given Atracurium Besylate Injection.
Taking other medicines
Please tell your doctor if you are taking, or have recently taken, any other medicines.
This includes medicines obtained without a prescription. This is extremely important
because some medicines can strengthen or weaken the effects of others.
In particular, tell your doctor if you are taking any of the following:
• An antibiotic (for infection) including aminoglycosides (e.g. neomycin), polypeptides
(e.g. polymyxin), spectinomycin, tetracycline, lincomycin or clindamycin.
• A medicine to control an irregular heart beat, e.g. procainamide, quinidine or lidocaine.
• A beta-blocking medicine, which may be used to treat various conditions including
high blood pressure, angina and irregular heart beats, e.g. propranolol, oxprenolol
• A calcium-channel blocking agent, which may be used to treat high blood
pressure, angina and irregular heart beats.
• A diuretic (water tablet), e.g. furosemide, mannitol, hydrochlorothiazide and
• Magnesium sulphate which has various uses including the treatment of some heart
• The anti-depressant drug, lithium.
• Drugs for Alzheimer’s disease which is a kind of brain disease. (anticholinesterases
e.g. donepezil).
• Medicines used to treat conditions like high blood pressure and hypertensive crisis
(e.g. hexamethonium, trimetaphan)
• Anti-rheumatic drugs, e.g. chloroquine or D-penicillamine.
• Steroids, including corticosteroids for the treatment of asthma and other
inflammatory conditions.
• Chlorpromazine, used to treat sickness and various mental disorders.
• Anti-epileptic medicines, including phenytoin.
Pregnancy and breast feeding
Talk to your doctor before having this medicine if you are pregnant or are breastfeeding.
Atracurium Besylate should only be used during pregnancy when your doctor decides
the benefits to the patient are greater than any possible risk to the unborn baby.
There is insufficient information to say whether this medicine passes in to breast milk.
Driving and using machines
It can be dangerous to drive or operate machinery too soon after having had an
operation. Your doctor will tell you how long to wait before you can drive and use
The anaesthetist will decide on the most appropriate dose.
It may be administered either as an injection or as an infusion which is dripped into a
vein over a longer period of time. In both cases the anaesthetist will make sure that
you are asleep before this muscle relaxant is administered.
If you are given more Atracurium Besylate Injection than you should
As the injection will be administered by an anaesthetist, it is unlikely that you will be
given more than is necessary. In case of an overdose, the muscle will stay relaxed for
longer than required.
If you have any further questions on the use of this product ask your doctor.
Like all medicines Atracurium Besylate Injection can sometimes cause side-effects,
although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions

are very rare.
The following side effects have also been reported:
• sudden wheeziness, chest pain or chest tightness
• swelling of your eyelids, face, lips, mouth or tongue
• a lumpy skin rash or ‘hives’ anywhere on your body
• decrease in heart rate
• decrease in blood pressure
• a rash or redness of your skin
• wheezing or coughing.
• muscle weakness
• rhythmic muscle movement
Very rarely a severe allergic reaction can occur when given with one or more
anaesthetic agent.
When you wake up after the anaesthetic, if you notice any of the side effects
becoming serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor.
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:
By reporting side effects you can help provide more information on the safety of this medicine.
Your doctor or nurse will know how to store this medicine properly.
The ampoules containing the injection solution are stored in their original packaging
at a temperature between 2 and 8°C. The expiry date (EXP) is printed on the label and
the carton. The first 2 digits indicate the month and the remaining digits indicate the
year of expiry. The drug should not be used after this date.
The active substance is Atracurium Besylate. There is 10mg of Atracurium Besylate in 1ml of the
Other ingredients of the solution are benzenesulfonic acid, water for injections and nitrogen.
What Atracurium Besylate Injection looks like and contents of pack
Atracurium Besylate 10mg/ml Injection is a clear, sterile solution.
Each glass ampoule (small bottles) of 2.5ml, 5ml, 10ml or 25ml contains 25mg, 50mg, 100mg or
250mg respectively of the active ingredient, Atracurium Besylate. These ampoules are then packed
in to cardboard boxes. Each box would contain 2 ampoules (25ml ampoule), 5 ampoules (all four
volumes) or 10 ampoules (all four volumes). Each box contains an information leaflet for the patient
and one for the health professional.
Marketing authorization holder
Mercury Pharma International Ltd., 4045, Kingswood Road, City West Business Park, Co Dublin,
MercuryPharma International Ltd., 4045, Kingswood Road, City West Business Park, Co
Dublin, Ireland.
This leaflet was last revised in October 2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.