Retalex^® Solution for Injection is a medicine which acts as a muscle relaxant.

Retalex^® 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. 

Do not use Retalex^® 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 Retalex^® 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 Retalex^®, 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. 

Retalex^® 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.

Your baby would be closely monitored if you breast-feed within 24 hours of being given Retalex^®. 

Driving and using machines 

Do not drive or use machines within 24 hours of being given Retalex^®. 

Retalex^® 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 adults , the children will be given over the age of one month. 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. 

Retalex^® 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 Retalex^® Solution for Injection than you should be given

Retalex^® 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.

Like all medicines, Retalex^® 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.

Keep out of the sight and reach of children. 

Do not use Retalex^® Solution for Injection after the expiry date which is stated on the vial label and carton. 

The vials should be stored in a refrigerator (2 – 8°C) , Do not freeze and

protect from light.