Suxamethonium Chloride 50mg/ml Solution for Injection/Infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or member of the operating theatre staff.
• If you get any side effects, talk to your doctor, nurse, or member of the operating theatre staff. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Suxamethonium Chloride 50 mg/ml Solution for Injection / Infusion is and what it is used for
2. What you need to know before you are given Suxamethonium Chloride 50 mg/ml Solution for Injection / Infusion
3. How Suxamethonium Chloride 50 mg/ml Solution for Injection / Infusion is given
4. Possible side effects
5. How to store Suxamethonium Chloride 50 mg/ml Solution for Injection / Infusion
6. Contents of the pack and other information

• you are allergic to suxamethonium chloride, or any of the other ingredients of this medicine (listed in section 6)
• your doctor has told you that you suffer from abnormal cholinesterase activity (cholinesterase is an enzyme that breaks down acetylcholine)
• you or any of your family have a history of abnormally high body temperature (hyperthermia)
• you have abnormally high levels of potassium in your blood (hyperkalaemia)
• you or any of your family have a disease causing weakness of the muscles (myotonia congenita or dystrophia myotonica)
• you have muscle weakness and wasting of muscle tissue (Duchenne muscular dystrophy)

This medicine will be given to you by a qualified anaesthetist, along with other medicines to help you sleep. Ventilation equipment will be used to help you breathe.

Talk to your doctor, nurse or member of the operating theatre staff before having this medicine if you:

• are suffering from an infection that causes muscle stiffness (tetanus)
• are suffering from tuberculosis
• feel unwell
• have a fever
• have cancer
• suffer from a blood disease known as anaemia
• suffer from a lack of proper nutrition or an inability to absorb nutrients from food (malnutrition)
• have serious liver or kidney problems
• suffer from a disease caused by the body attacking itself (autoimmune disease) such as a disease of the thyroid gland (myxoedema)
• suffer from diseases that cause problems with the joints (collagen disease)
• suffer from heart problems (including heart attacks, heart disease or an irregular heart beat)
• are having or have had in the past treatment to your blood known as plasmapheresis therapy
• have had any head injuries
• are recovering from major trauma or severe burns
• have suffered a spinal cord injury, nerve injury or sudden muscle wasting
• have a muscle disease, for example, myasthenia gravis
• recently had an eye injury
• have glaucoma
• ever had an allergic reaction to any muscle relaxant which was given as part of an operation
• have not been able to walk for a long period of time
• have severe blood poisoning (sepsis)

Extra care or monitoring must be carried out on infants and children given suxamethonium. If any of the above apply to you or your child, please consult your doctor.

Tell your doctor, nurse or other relevant hospital staff member if you are taking or have recently taken any other medicines

• anti-arrhythmics (drugs used to alter the rhythm of the heart) e.g. lidocaine, procaine and cocaine.
• antibacterials (drugs able to kill bacteria) e.g. neomycin, vancomycin and polymyxin B
• anticholinesterases (drugs used to treat muscle problems) such as neostigmine
• ecothiopate, a medicine used to treat raised pressure in the eye (glaucoma)
• metoclopramide, a medicine used to stop you feeling or being sick
• phenelzine, a medicine used to treat depression (monoamine oxidase inhibitor)
• promazine, a medicine used to treat restlessness and agitation
• medicines used to treat malaria such as quinine and chloroquine
• tacrine, a medicine used to treat Alzheimers disease
• ACE inhibitors
• antiepileptics (drugs used to stop fits) e.g. carbamazepine and phenytoin
• antineoplastics (drugs used to treat cancer) e.g. cyclophosphamide and tretamine
• benzodiazepines (drugs which help you to relax) e.g. diazepam and midazolam
• calcium-channel blockers (drugs which reduce the strength of the heart) e.g. nifedipine, verapamil or dantrolene.
• cardiac glycosides (drugs which increase heart muscle contraction) e.g. digoxin
• cytotoxics (a type of medicine used to treat cancer) e.g. cyclophosphamide and thiotepa
• general anaesthetics (drugs used to put you to sleep for surgery) e.g. propofol, fentanyl citrate-droperidol (Innovar) and ether
• magnesium salts (a dietary supplement)
• medicines that affect the nervous system (parasympathomimetics and sympathomimetics) e.g. demecarium, neostigmine, donepezil, bambuterol.

Tell your doctor if you have recently been exposed to pesticides e.g. sheep dip.

Tell your doctor if you have recently had a blood transfusion

If you have any doubts about whether this medicine should be administered to you, consult your doctor or nurse.

If you are pregnant or breast-feeding, think you may be pregnant ask your doctor for advice before this medicine is given to you.

Do not drive or operate machinery immediately after having been operated on because it can be dangerous.

Your doctor will tell you how long you should wait before you can drive and use machinery.

By intravenous injection:

1mg per kilogram of bodyweight

Supplementary doses of around 50% to 100% of the initial dose given at 5 to 10 minute intervals will maintain muscle relaxation.

By intravenous infusion (drip):

0.1-0.2% solution, 2.5 to 4mg per minute

The maximum total dose is 500 mg.

Children 1 to 12 years

By intravenous injection:

1-2mg per kilogram of bodyweight.

Infants (under 1 year): 2mg per kilogram.

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 nurse if you have any concerns.

Very common (may affect more than 1 in 10 people)

• abdominal cramps or pain and a feeling of nausea or “fullness”
• visible twitching of muscle under the skin
• muscle pain after the operation - your doctor will monitor you for this.

Common (may affect up to 1 in 10 people)

• raised pressure of fluid in the eye which may cause headache or blurred vision
• skin flushing
• skin rash
• high level of potassium in your blood
• speeding up or slowing down of your heart rate
• protein in the blood or urine due to muscle damage
• muscle damage which may make your muscles ache or feel tender, stiff and weak. Your urine may also look dark or be red or cola coloured.

Rare (may affect up to 1 in 1,000 people)

• abnormal heart rhythm
• heart problems including changes in the way in which your heart beats or your heart stopping beating
• difficulty in breathing or temporary loss of breath
• difficulty in opening your mouth.

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

• high body temperature.

Other side effects include:

Not known: frequency cannot be estimated from the available data

• excessive production of saliva
• high/low blood pressure

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is suxamethonium chloride dihydrate 50 mg/ml.

The other ingredients are hydrochloric acid ( for pH adjustment), water for injections.

Suxamethonium Chloride injection / infusion is a clear, colourless solution supplied in a clear glass 2ml ampoule. Each 2 ml ampoule contains 100 mg of suxamethonium chloride dihydrate (equivalent to 73.1 mg of Suxamethonium). 10 ampoules are packed in one carton.