Patient leaflet - Suxamethonium Chloride injection BP 100 mg / 2 ml

1. What Suxamethonium Chloride is and what it is used for

Suxamethonium Chloride 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 operations.

This medicine can also be used when a patient is put on a ventilator to control breathing. During this procedure, it is necessary for the muscles used for breathing to be paralysed. Suxamethonium Chloride can also reduce the intensity of muscle contractions associated with drug-induced convulsions or with electroconvulsive therapy (ECT).

2. What you need to know before you are given Suxamethonium Chloride

You should not be given Suxamethonium Chloride

if you are allergic to suxamethonium chloride, any other muscle relaxants or any of the other ingredients of this medicine (listed in section 6)
if you or your family have reacted badly to an anaesthetic before such as a very high body temperature (malignant hyperthermia)
if you have a deficiency of an enzyme, pseudocholinesterase which breaks down suxamethonium in the body
if you have had a major accident, operation or severe burns within the last three months
if you have not been able to move for a long time such as to allow a broken bone to mend or a long period of bed rest
if you have high levels of potassium in your blood (hyperkalaemia)
if you have recently had an eye injury
if you suffer from a problem caused by too much pressure in your eye called ‘glaucoma’
if you or any of your family have a disease of the muscles or nerves, such as a muscle wasting disease, paralysis, motor neurone disease, muscular dystrophy or cerebral palsy.

If any of the above apply to you or if you are not sure, talk to your doctor, nurse or member of the operating theatre staff before you are given Suxamethonium Chloride.

Warnings and precautions

Talk to your doctor, nurse or member of the operating theatre staff before you are given Suxamethonium Chloride:

if you are pregnant or have given birth in the last six weeks
if you have tetanus, an infection which occurs through wound contamination
if you have tuberculosis or other severe or long standing infection
if you have had any long standing illness which has left you weak
if you suffer from cancer
if you have decreased number of red blood cells or hemoglobin concentration, a condition known as anaemia
if you are undernourished
if you have liver or kidney problems
if you have auto-immune diseases, for example, multiple sclerosis
if you have an underactive thyroid gland, a condition known as myxoedema
if you have muscle disease, for example, myasthenia gravis
if you have recently had a blood transfusion or a heart-lung by pass
if you have been in contact with insecticides
if you have ever had an allergic reaction to any muscle relaxant which was given as part of an operation.
if you are suffering from an imbalance in your body's blood chemistry
if you have a bone injury or muscle tightness in the area of the injury
if you recently received radiation therapy
if you suffer from severe burns

If you are elderly (over 65 years) check with your doctor, nurse or pharmacist before having this medicine as it may be linked to a temporary problem with the rate or rhythm of the heartbeat, especially if you are also taking medicines similar to digitalis

Suxamethonium Chloride should only be used when absolutely essential in vulnerable patients

Make sure your doctor is aware of these situations before you are given this injection.

Children

Care should be taken before administering Suxamethonium Chloride to children.

Other medicines and Suxamethonium Chloride

Tell your doctor, nurse or other relevant hospital staff member if you are taking, have recently taken or might take any other medicines. This includes any herbal products or medicines bought without a prescription. This is because these medicines can affect how well Suxamethonium Chloride works or can cause side effects.

In particular tell your doctor, nurse or member of the operating theatre staff if you are taking any of the following:

anaesthetics such as propofol, ketamine, propanidid, lignocaine and procaine or other medicines used during surgery such as pain killers (morphine, pethidine and pancuronium) or drugs to reverse their effects (called morphine antagonists)
medicines used to treat Alzheimer's disease, such as donepezil, galantamine and tetrahydroaminoacridine (Tacrine hydrochloride)
medicines for raised pressure in the eye (glaucoma) such as ecothiophate eye drops
medicines for coughs, cold, sleeping or tablets for allergies
medicines used to treat malaria, containing chloroquine or quinine. Quinine is sometimes used for night cramps
oral contraceptives
medicines for treating asthma and other breathing conditions e.g. terbutaline, bambuterol
medicines containing metoclopramide (used to treat and prevent feeling or being sick)
medicines for treating cancer (cytotoxic drugs) such as cyclophosphamide, chlorethamine, tretamine and thiotepa
medicines for mental problems including phenelzine, lithium, chlorpromazine or promazine
medicines containing magnesium (such as some laxatives or antacids)
medicines containing oestrogens
medicines containing steroids (used for inflammatory conditions e.g. rheumatism etc)
oxytocin (to contract the womb)
some non-penicillin antibiotics (for infection) e.g. clindamycin, polymyxins, and aminoglycosides, vancomycin, piperacillin
medicines used to treat disturbances in heartbeat rhythm (antiarrhythmic drugs), angina or high blood pressure such as beta-blockers, verapamil, digoxin, procainamide or quinidine
aprotinin (to reduce bleeding)
medicines used to treat myasthenia gravis such as neostigmine, pyridostigmine, physostigmine and edrophonium (known as acetylcholinesterase inhibitors)
medicines used to control your blood pressure during surgery such as trimetaphan
medicines that can affect the way your body fights disease (immunosuppressants) such as azathioprine. These can be used to stop your body rejecting a transplanted organ or for ‘auto-immune’ diseases such as rheumatoid arthritis
medicines used to treat depression and/or anxiety SSRIs (selective serotonin reuptake inhibitors) including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram.

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 you are given this medicine.

Pregnancy

Suxamethonium Chloride should only be used during pregnancy when your doctor decides the benefits to you are greater than any possible risk to the unborn baby.

Breastfeeding

There is insufficient information to say whether this medicine passes in to breast milk. It is recommended not to breast feed for at least 24 hours following administration of Suxamethonium Chloride.

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 or use machinery.

Information on sodium content

Suxamethonium Chloride contains less than 1mmol sodium (23mg) per dose, i.e. essentially “sodium free”.

3

OW CHLORIDE GIVEN TO Y

3. How Suxamethonium Chloride will be given to you

You will never be expected to give yourself this medicine. It will always be given to you by a person who is qualified to do so.

Suxamethonium Chloride can be given:

as a single injection into your vein (intravenous bolus injection)
as a continuous infusion into your vein. This is where the drug is slowly given to you over a long period of time.

Your doctor will decide the way you are given the drug and the dose you will receive. It will depend on:

your age
your body weight
the amount of muscle relaxation you require
your expected response to the medicine.

It may be administered as an injection. The anaesthetist will make sure that you are asleep before this muscle relaxant is administered.

If you receive more Suxamethonium Chloride than you should

Suxamethonium Chloride will always be given under carefully controlled conditions. In case of an overdose, the muscle will stay relaxed for longer than required. However, if you think that you have been given more than you should tell your doctor or nurse immediately.

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

POSSIBLE SIDE EFFECTS

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you get any side effects, talk to your doctor, nurse or other relevant hospital staff member.

This includes any possible side effects not listed in this leaflet.

All medicines can cause allergic reactions although serious allergic reactions are very rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.

Inform your doctor or nurse immediately if you experience:

heart problems including changes in the way in which your heart beats or your heart stops beating
difficulty in breathing or temporary loss of breath

The following side effects have also been reported:

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
excessive production of saliva
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
speeding up or slowing down of your heart rate
skin flushing
skin rash
laboratory tests revealing high level of potassium in your blood
high/low blood pressure
laboratory tests revealing 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
difficulty in opening your mouth.

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

high body temperature.

5. HOW TO STORE

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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.

5. How to store Suxamethonium Chloride

Keep this medicine out of the sight and reach of children.

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. Do not use this medicine after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month.

Your doctor or nurse will know how to store this medicine properly.

Keep the ampoule in the outer carton in order to protect from light.

The ampoules containing the injection solution are stored in refrigerator in their original packaging at a temperature between 2° and 8°C. Do not freeze. Once opened, any unused liquid should be discarded.

Do not use if the ampoule is damaged or if the contents are discoloured or deteriorated.

The solution should not be mixed with any other drugs.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Suxamethonium Chloride contains

The active substance is Suxamethonium Chloride. There is 100mg of Suxamethonium Chloride in 2ml of the injection.
The other ingredients of the solution are sodium acetate and water for injections.

What Suxamethonium Chloride looks like and contents of the pack

Suxamethonium Chloride is a clear, colourless sterile solution. The solution is supplied in glass ampoule (small bottle). These ampoules are then packed into cardboard boxes. Each box contains 10 x 2ml ampoules.

Marketing Authorisation Holder

Mercury Pharmaceuticals Ltd,

Capital House, 85 King William Street,

London EC4N 7BL, UK.

Manufacturer

Antigen Pharmaceuticals Limited,

Roscrea,

Co. Tipperary,

Ireland.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: