SUXAMETHONIUM ETHYPHARM 50 mg/mL Injectable Solution and Perfusion Solution

Introduction

Package Leaflet: Information for the User

Suxamethonium Ethypharm 50 mg/ml Solution for Injection and Infusion EFG

Suxamethonium chloride dihydrate

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, nurse or operating theatre staff.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, nurse or operating theatre staff. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Suxamethonium Ethypharm is and what it is used for
2. What you need to know before you are given Suxamethonium Ethypharm
3. How Suxamethonium Ethypharm is given
4. Possible side effects
5. Storage of Suxamethonium Ethypharm
6. Contents of the pack and other information

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

Suxamethonium Ethypharm contains a medicine called suxamethonium chloride dihydrate. It belongs to a group of medicines called muscle relaxants.

Suxamethonium Ethypharm is used:

• to relax muscles during surgical operations in adults and children

Ask your doctor if you want a more detailed explanation of this medicine.

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

You should not be given Suxamethonium Ethypharm:

• if you are allergic to suxamethonium chloride dihydrate or any of the other ingredients of this medicine (listed in section 6)
• if your doctor has told you that you have a problem with the activity of an enzyme called cholinesterase (cholinesterase is an enzyme that breaks down acetylcholine)
• if you or someone in your family has a history of abnormal body temperature (hyperthermia)
• if you have high levels of potassium in your blood (hyperkalemia)
• if you or someone in your family has a condition that causes muscle weakness (congenital myotonia or myotonic dystrophy)
• if you have muscle weakness and loss of muscle tissue (Duchenne muscular dystrophy)

Warnings and precautions

A qualified anaesthetist will give you this medicine, together with other medicines to help you sleep. A ventilation machine will be used to help you breathe.

Tell your doctor, nurse or operating theatre staff before you are given this medicine if:

• you have an infection that causes muscle stiffness (tetanus)
• you have tuberculosis
• you are not feeling well
• you have a fever
• you have cancer
• you have a blood disease called anaemia
• if you do not have a proper diet or are unable to absorb nutrients from food (malnutrition)
• you have severe liver or kidney problems
• you have a disease where your body attacks itself (autoimmune disease) such as a disease of the thyroid gland (myxoedema)
• you have diseases that cause joint problems (collagen disease)
• you have heart problems (including heart attacks, heart disease or irregular heartbeat)
• you are receiving or have recently received a blood treatment called plasmapheresis
• you have had a head injury
• if you are recovering from a major injury or severe burns
• if you have had a spinal cord injury, nerve damage or sudden muscle loss
• you have a muscle disease, for example myasthenia gravis
• you have recently had an eye injury
• you have glaucoma
• you have ever had an allergic reaction to any muscle relaxant given as part of a surgical operation (see also "Allergic reactions")
• if you have been bedridden for a long time
• if you have a severe blood infection (sepsis)

Allergic reactions

Severe allergic reactions can occur, even if you have never been exposed to muscle relaxants before. In most cases, they are characterised by a rash (redness of the skin) or hives, generalised or limited to the injection site, which then becomes complicated by difficulty breathing, swelling, dizziness, rapid heartbeat, sweating and loss of consciousness. See also section 4 Possible side effects.

The appearance of the first signs implies the definitive interruption of the administration of Suxamethonium, even if the product has not been fully administered, and requires the administration of symptomatic treatment.

Children

Special attention or additional monitoring should be paid to infants and children receiving suxamethonium. If any of the warnings and precautions listed above apply to you or your child, consult your doctor.

Using Suxamethonium Ethypharm with other medicines

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

• anti-arrhythmics (medicines used to alter the heart rhythm), e.g. lidocaine, procaine and cocaine
• antibacterials (medicines capable of killing bacteria), e.g. neomycin, vancomycin and polymyxin B
• anticholinesterases (medicines used to treat muscle problems), such as neostigmine
• ecothiopate, a medicine used to treat high pressure in the eye (glaucoma)
• metoclopramide, a medicine used to prevent nausea or vomiting
• 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 Alzheimer's disease
• ACE inhibitors
• antiepileptics (medicines used to prevent convulsive seizures), e.g. carbamazepine and phenytoin
• antineoplastics (medicines used to treat cancer), e.g. cyclophosphamide and tretamine
• benzodiazepines (medicines that help you relax), e.g. diazepam and midazolam
• calcium channel blockers (medicines that reduce the strength of the heart), e.g. nifedipine, verapamil or dantrolene
• cardiac glycosides (medicines that increase the contraction of the heart muscles), e.g. digoxin
• cytotoxics (a type of medicine used to treat cancer), e.g. cyclophosphamide and thiotepa
• general anaesthetics (medicines used to put you to sleep during a surgical operation), e.g. propofol, fentanyl-droperidol citrate 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 been recently exposed to pesticides, e.g. parasiticidal dips for sheep.

Tell your doctor if you have recently received a blood transfusion.

If you are unsure whether you should be given this medicine, consult your doctor or nurse.

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.

Driving and using machines

Do not drive or use machines immediately after you have been operated on because it may be dangerous. Your doctor will tell you how long you should wait before you can drive and use machines.

3. How Suxamethonium Ethypharm is given

You will be given Suxamethonium Ethypharm as an injection into a vein (intravenously).

Your doctor will decide the correct dose and duration of treatment for your operation, which will depend on:

• your body weight;
• the degree of muscle relaxation required;
• the expected response to the medicine.

Suxamethonium Ethypharm will always be given under carefully controlled conditions. If you have any other questions about the use of this medicine, ask your doctor.

Adults, elderly patients and adolescents over 12 years

Via intravenous injection:

1 mg per kilogram of body weight.

Administration of supplementary doses of 50% to 100% of the initial dose, given at intervals of 5 to 10 minutes, will maintain muscle relaxation.

Via intravenous infusion (drip):

0.1-0.2% solution, at a rate of 2.5 to 4 mg per minute.

The maximum total dose is 500 mg.

Children from 1 to 12 years

Via intravenous injection:

1-2 mg per kilogram of body weight.

Infants (less than 1 year): 2 mg per kilogram of body weight.

If you are given too much Suxamethonium Ethypharm

Since this medicine will be given to you in a hospital, it is unlikely that you will be given too much or too little; however, tell your doctor or nurse if you have any concerns.

4. Possible side effects

Like all medicines, Suxamethonium Ethypharm can cause side effects, although not everybody gets them. If you experience any side effects, talk to your doctor, nurse or other hospital staff, even if they are not listed in this leaflet.

On very rare occasions, a sudden and severe allergic reaction to suxamethonium chloride can occur. If you experience any of the following symptoms, tell your doctor or nurse immediately:

• difficulty breathing, wheezing or breathing problems
• swelling of the eyelids, face, lips, tongue or other parts of the body
• rash, itching or hives on the skin
• fainting

There are other serious side effects that you and your doctor should watch for.

You must tell your doctor or nurse immediately if you experience any of the following symptoms:

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

• abdominal cramps or pain, nausea or feeling "full"
• visible muscle spasms under the skin
• muscle pain after the operation; your doctor will monitor you for this

Common (may affect up to 1 in 10 people)

• severe allergic reaction with difficulty breathing, swelling, dizziness, rapid heartbeat, sweating and loss of consciousness (anaphylactic shock).
• increased pressure of the fluid in the eye which can cause headache or blurred vision
• redness of the skin
• rash
• high levels of potassium in the blood
• increased or decreased heart rate
• proteins in the blood or urine due to muscle damage
• muscle damage that can cause your muscles to hurt or feel soft, stiff or weak. Your urine may also be dark, reddish or brown in colour

Uncommon (may affect up to 1 in 100 people)

• abnormal heart rhythm
• heart problems including changes in the way your heart beats or your heart stops beating
• breathing difficulties or temporary loss of breathing
• difficulty opening your mouth

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

• high body temperature

Other side effects include:

Frequency not known: cannot be estimated from the available data

• excessive saliva production
• high/low blood pressure

Reporting of side effects

If you experience 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 Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Suxamethonium Ethypharm

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

Do not receive suxamethonium chloride injection or infusion after the expiry date which is stated on the carton and on the label of the ampoule after EXP. The doctor or nurse will check that the expiry date has not been exceeded before giving you the injection. The expiry date is the last day of the month shown.

Store in a refrigerator (between 2°C and 8°C). Do not freeze.

Store in the original packaging to protect from light.

Once opened, this medicine should be used immediately.

Do not use this medicine if you notice any change in colour or if it contains particles.

Medicines should not be disposed of via wastewater or household waste. Your doctor or nurse will dispose of any unused medicines.

6. Contents of the pack and other information

Composition of Suxamethonium Ethypharm

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

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

Appearance and packaging of the product

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Ethypharm

194 Bureaux de la Colline, Bâtiment D

92213 Saint-Cloud CEDEX

France

Manufacturer:

Macarthys Laboratories Limited t/a Martindale Pharma

Bampton Road, Harold Hill,

Romford, Essex RM3 8UG

United Kingdom

Or

ETHYPHARM,

Chemin de la Poudriere, GRAND QUEVILLY, 76120, France

Or

ETHYPHARM,

Zone Industrielle de Saint-Arnoult, CHATEAUNEUF EN THYMERAIS, 28170, France

This medicine is authorised in the Member States of the EEA under the following names:

Belgium: Suxamethonium chloride Ethypharm 50 mg/ml solution injectable ou pour perfusion

Denmark: Suxamethonium chloride dihydrate "Ethypharm"

Spain: Suxametonio Ethypharm 50 mg/ml solución inyectable y para perfusión EFG

Finland: Suxamethonium Ethypharm 50 mg/ml injektio-/infuusioneste, liuos

Ireland: Suxamethonium Chloride 50mg/ml Solution for Injection/Infusion

Netherlands: Suxamethoniumchloride Ethypharm 50 mg/ml oplossing voor injectie/infusie

Norway: Suxamethonium chloride dihydrate Ethypharm 50 mg/ml injeksjons-/infusjonsvæske, oppløsning

Sweden: Suxamethonium Ethypharm 50mg/ml injektions-/infusionsvätska, lösning

United Kingdom: Suxamethonium Chloride 50mg/ml Solution for Injection/Infusion

Date of last revision of this leaflet: May 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Medicines Agency (AEMPS) http://www.aemps.gob.es/

This information is intended only for healthcare professionals:

Suxamethonium Ethypharmis used for muscle relaxation during general anaesthesia.

Dosage and administration

Via intravenous injection

Adults and adolescents over 12 years

The dose depends on body weight, the degree of muscle relaxation required, the route of administration and the individual patient's response.

To achieve endotracheal intubation, suxamethonium chloride is normally given intravenously at a dose of 1 mg/kg. With this dose, muscle relaxation will be achieved, usually within 30 to 60 seconds and will last for about 2 to 6 minutes. Higher doses will produce longer-lasting muscle relaxation, but doubling the dose does not necessarily mean that the duration of relaxation will be doubled. Administration of supplementary doses of suxamethonium chloride, 50% to 100% of the initial dose, at intervals of 5 to 10 minutes, will maintain muscle relaxation during short surgical operations under general anaesthesia.

The total dose of suxamethonium chloride should not exceed 500 mg.

Infants and young children are more resistant to suxamethonium than adults.

Children from 1 to 12 years

1-2 mg/kg via intravenous injection.

Infants, less than 1 year

2 mg/kg via intravenous injection.

Via intravenous infusion

Suxamethonium chloride can be given via intravenous infusion as a 0.1-0.2% solution, diluted in 5% glucose solution or sterile isotonic saline solution, at a rate of 2.5 to 4 mg per minute. The infusion rate should be adjusted according to the individual patient's response.

Elderly patients

As for adults.

Elderly patients may be more susceptible to cardiac arrhythmias, especially if they are also taking digitalis medicines (see section 4.4).

Form of administration:

Via bolus injection or infusion.

Overdose

The manifestations of a suxamethonium overdose are profound and prolonged muscle paralysis with respiratory depression. Assisted ventilation is required.

The use of neostigmine and other cholinesterase inhibitors should be avoided, as they prolong the depolarising effect of suxamethonium chloride.

The decision to use neostigmine to reverse the phase II block induced by suxamethonium depends on medical judgment in each individual case. Monitoring of neuromuscular function will provide valuable information regarding this decision. If neostigmine is used, its administration should be accompanied by appropriate doses of an anticholinergic such as atropine.

Incompatibilities

This medication should not be mixed with other medications except those mentioned in Special precautions for disposal and other handling.

Suxametonio Ethypharm is acidic in nature and should not be mixed with solutions with a high degree of alkalinity, such as barbiturates, for example.

Special precautions for disposal and other handling

Use once and discard any remaining solution.

Suxametonium chloride can be administered by intravenous infusion as a 0.1-0.2% solution, diluted in 5% glucose solution or sterile isotonic saline solution, at a rate of 2.5 to 4 mg per minute. The infusion rate should be adjusted according to the individual patient's response.