Atracurium 10mg/ml Solution for Injection/Infusion

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 or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
• The full name of this medicine is Atracurium 10mg/ml Solution for Injection/Infusion but within the leaflet it will be referred to as Atracurium.

In this leaflet:

1 What Atracurium is and what it is used for
2 Before you use
3 How to use
4 Possible side effects
5 How to store
6 Further information

Do not use Atracurium if you:

• are allergic (hypersensitive) to atracurium, cisatracurium or benzenesulfonic acid.

Atracurium must not be injected intramuscularly.

Tell your doctor before using Atracurium if you have

• myasthenia gravis or Eaton-Lambert syndrome (muscle weakness, tiredness or difficulty in co-ordinating your movements)
• any neuromuscular diseases
• an electrolyte imbalance (changes to the body’s normal levels of certain chemicals)
• carcinomatosis (cancer that has spread to different parts of the body)
• allergy to any other muscle relaxant
• a recent burn that has required medical attention
• a history of asthma, hay fever or allergies that give you a rash, itching or shortness of breath (histamine hypersensitivity)
• heart diseases, low blood pressure or low blood volume.

Taking other medicines

Please tell your doctor, before you are given the injection, if you are taking or have recently taken any of the following medicines, including medicines obtained without a prescription. Especially:

• antibiotics (e.g. aminoglycosides, polymyxins, spectinomycin, tetracyclines, lincomycin, clindamycin and vancomycin)
• drugs used to treat disturbances in heart beat rhythm (antiarrhythmic medicines e.g. lidocaine, procainamide, quinidine)
• drugs used to treat high blood pressure, angina or other heart problems (e.g. propranolol, oxprenolol)
• drugs to help you lose body fluid (diuretics e.g. furosemide, thiazides and mannitol)
• other muscle relaxants such as pancuronium and suxamethonium
• drugs for arthritis or myasthenia gravis (e.g. D-penicillinamine, chloroquine)
• acetazolamide (for glaucoma)
• chloroquine (for malaria)
• dantrolene (for muscle rigidity)
• steroids (used to reduce inflammation in many diseases)
• chlorpromazine (for schizophrenia)
• lithium and medicines containing lithium salts (for depression)
• medicines containing magnesium sulphate (such as those used to treat indigestion and heart burn)
• phenytoin, carbamazepine (anti-epileptic)
• trimetaphan, hexamethonium (used to control blood pressure in surgery)
• inhaled anaesthetics (e.g. halothane, isoflurane or enflurane) or intravenous anaesthetics (e.g. ketamine) thiopentone or any alkaline agent.
• Medicines used in the treatment of Alzheimer’s disease (anticholinesterases e.g. donepezil)

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

There is no adequate data on the use of atracurium during pregnancy.

Atracurium should only be administered during pregnancy after careful risk benefit assessment. The use of the recommended dose in caesarean section showed no harmful effects on the newborn infants. Therefore Atracurium is also suitable for maintenance of muscle relaxation during caesarean section.

It is not known whether atracurium passes in to breast milk.

As precaution you should restart breast-feeding 24 hours after administration of Atracurium, when the effect of the medicine has worn off.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

You should not drive, operate machinery or work in exposed situations soon after having had an operation. The time factor will be decided by your doctor. You should be accompanied on your way home.

Alcohol

You should not drink alcohol until you have fully recovered for the affects of the anaesthetic.

Atracurium must not be injected intramuscularly.

Atracurium must only be given under carefully controlled conditions by or under the supervision of an experienced doctor.

Your doctor will decide on a dose and duration of Atracurium therapy which is right for your operation.

Adults and children aged one month or older:

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

Atracurium will be given to you initially as an injection into your vein (intravenously). The usual adult dosage for injection is 0.3 – 0.6mg per kilogram of body weight, depending on the depth and duration of muscle relaxation that is needed. If further doses are needed during the operation, the injection will be diluted in a bag of fluid and given to you as a slow infusion. The usual dose for infusion is 0.3 – 0.6mg per kilogram of body weight per hour.

The use of Atracurium in children aged less than 1 month is not recommended. In the case of necessary treatment in newborn or premature newborn the dose has to be significantly lowered.

If you use more Atracurium than you should

The effects of Atracurium are monitored carefully throughout your operation and in the unlikely event of you receiving too much, appropriate action can be taken promptly.

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

Your doctor will stop treatment with Atracurium at once if you experience the following very rare side effects:

• severe anaphylactic reactions including shock, circulatory failure and heart attack
• seizures in patients in ICUs who had been receiving Atracurium at the same time as other medicines.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

• Common (occurs in less than 1 in 10 users): fast heart beat, low blood pressure, wheezing, difficulty breathing, skin flushing, urticaria (hives).
• Very rare (occurs in less than 1 in 10,000 users): spasm of the vocal cords, muscle weakness (myasthenia) or muscle cramps (myopathy).

What Atracurium contains:

The active substance is: Atracurium besilate.

1ml solution contains 10mg atracurium besilate.

Each 2.5ml ampoule contains 25mg of Atracurium besilate.

Each 5ml ampoule contains 50mg of Atracurium besilate.

Each 25ml ampoule contains 250mg of Atracurium besilate.

The other ingredients are: Benzenesulphonic acid, Water for injection.

What Atracurium looks like and contents of the pack

Solution for injection and Concentrate for solution for infusion

Clear and colourless solution

Box of 1, 5 or 10 ampoules of 2.5ml

Box of 5x5 or 5x10 ampoules of 2.5ml

Box of 1, 5 or 10 ampoule of 5ml

Box of 5x5 or 5x10 ampoules of 5ml

Box of 1, 2 or 5 ampoules of 25ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Manufacturer: