PATIENT INFORMATION LEAFLET

Atracurium Besylate 10mg/ml Injection

Atracurium Besylate

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE.

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

1.    WHAT ATRACURIUM BESYLATE INJECTION IS AND WHAT IT IS USED FOR

Atracurium Besylate injection belongs to a group of medicines called muscle relaxants.

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 baby.

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.

2.    BEFORE YOU ARE GIVEN ATRACURIUM BESYLATE INJECTION

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 acetazolamide.

•    Magnesium sulphate which has various uses including the treatment of some heart disorders.

•    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 machinery.

3.    HOW ATRACURIUM BESYLATE INJECTION IS GIVEN TO YOU

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.

4.    POSSIBLE SIDE EFFECTS

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: 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 BESYLATE INJECTION

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.

6.    FURTHER INFORMATION

The active substance is Atracurium Besylate. There is 10mg of Atracurium Besylate in 1ml of the injection.

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,

Ireland.

Manufacturer

MercuryPharma International Ltd., 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland.

This leaflet was last revised in October 2013