Prospect: information for the user

Suxametonio Ethypharm 50mg/ml injectable solution and for perfusion EFG

chloride of suxamethonium dihydrate

Read this prospect carefully beforethey administer this medication to you, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, nurse or members of the operating room staff.
• If you experience adverse effects, consult your doctor, nurse or members of the operating room staff, even if they do not appear in this prospect. See section4.

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

2.What you need to know before they administer Suxametonio Ethypharm

3.How to administer Suxametonio Ethypharm

4.Possible adverse effects

5.Storage of Suxametonio Ethypharm

6.Contents of the package and additional information

SuxametonioEthypharmcontains a medicine called suxamethonium chloride. It belongs to a group of medicines called muscle relaxants.

SuxametonioEthypharmis used:

• to relax muscles during surgical interventions in adults and children

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

Do not administerSuxametonio Ethypharm:

• if you are allergic to suxamethonium chloride or any of the other components of this medication (listed in section6)
• if your doctor has told you that you have a disorder of cholinesterase activity (cholinesterase is an enzyme that breaks down acetylcholine)
• if you or a family member has a history of abnormally high body temperature (hyperthermia)
• if you have abnormally high levels of potassium in your blood (hyperkalemia)
• if you or a family member has a disease that causes muscle weakness (congenital myotonia or myotonic dystrophy)
• if you have muscle weakness and muscle tissue loss (Duchenne muscular dystrophy)

Warnings and precautions

A qualified anesthesiologist will administer this medication, along with other medications to help you sleep. A ventilation device will be used to help you breathe.

Consult your doctor, nurse, or operating room staff before receiving this medication if:

• you have a muscle stiffness infection (tetanus)
• you have tuberculosis
• you are not feeling well
• you have a fever
• you have cancer
• you have a blood disorder called anemia
• if you do not have adequate nutrition or are unable to absorb nutrients from food (malnutrition)
• you have severe liver or kidney problems
• you have an autoimmune disease, such as a thyroid disease (myxedema)
• 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 received in the past a blood treatment called plasmapheresis
• you have had a head injury
• if you are recovering from a severe injury or severe burns
• if you have had a spinal cord injury, nerve damage, or sudden muscle loss
• you have a muscle disease, such as myasthenia gravis
• you have recently had an eye injury
• you have glaucoma
• you have had an allergic reaction to any muscle relaxant administered during a surgical procedure
• if you have been unable to walk for a prolonged period
• if you have a severe blood infection (sepsis)

Children

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

Use of Suxametonio Ethypharm with other medications

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

• antiarrhythmics (medications used to alter heart rhythm), p.eg., lidocaine, procaine, and cocaine
• antibiotics (medications capable of killing bacteria), p.eg., neomycin, vancomycin, and polymyxin B
• anticholinesterases (medications used to treat muscle problems), such as neostigmine
• ecotiopato, a medication used to treat high eye pressure (glaucoma)
• metoclopramide, a medication used to prevent nausea or vomiting
• fenelzine, a medication used to treat depression (monoamine oxidase inhibitor)
• promazine, a medication used to treat anxiety and agitation
• medications used to treat malaria, such as quinine and chloroquine
• tacrine, a medication used to treat Alzheimer's disease
• ACE inhibitors
• antiepileptics (medications used to prevent seizures), p.eg., carbamazepine and phenytoin
• antineoplastics (medications used to treat cancer), p.eg., cyclophosphamide and vincristine
• benzodiazepines (medications that help you relax), p.eg., diazepam and midazolam
• calcium channel blockers (medications that reduce heart force), p.eg., nifedipine, verapamil, or dantrolene
• cardiac glycosides (medications that increase heart muscle contraction), p.eg., digoxin
• citotoxics (a type of medication used to treat cancer), p.eg., cyclophosphamide and thiophosphamide
• general anesthetics (medications used to put you to sleep during a surgical procedure), p.eg., propofol, fentanyl citrate-droperidol, and ether
• magnesium salts (dietary supplements)
• medications that affect the nervous system (parasympathomimetics and sympathomimetics), p.eg., demecarium, neostigmine, donepezil, bambuterol

Inform your doctor if you have recently been exposed to pesticides, p.eg., sheep dips.

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

If you have any doubts about whether you should receive this medication, consult your doctor or nurse.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor before receiving this medication.

Driving and operating machinery

Do not drive or operate machinery immediately after surgery because it may be hazardous. Your doctor will tell you how long you should wait before driving and operating machinery.

You will receiveSuxamethonium Ethypharmas an injection into a vein (intravenously).

Your doctor will decide on the appropriate dose and treatment duration for your procedure, which will depend on:

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

Suxamethonium Ethypharmwill be administered in carefully controlled conditions. If you have any other questions about the use of this medication, consult your doctor.

Adults, elderly patients, and adolescents over 12years

By intravenous injection:

1mg per kilogram of body weight.

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

By intravenous infusion (drip):

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

The maximum total dose is 500mg.

Childrenfrom 1 to 12years

By intravenous injection:

1-2mg per kilogram of body weight.

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

If you are given too much Suxamethonium Ethypharm

Since this medication will be administered in a hospital, it is unlikely that you will receive an excessive or insufficient dose; however, inform your doctor or nurse if you have any doubts.

Like all medications, suxamethonium chloride for injection or infusion may cause side effects, although not everyone will experience them. If you experience any type of side effect, consult your doctor, nurse, or other relevant hospital staff member, even if it is a side effect that does not appear in this prospectus.

In very rare cases, a sudden and severe allergic reaction to suxamethonium chloride may occur. If you experience any of the following symptoms, inform your doctor or nurse immediately:

• difficulty breathing, wheezing, or respiratory problems
• swelling of the eyelids, face, lips, tongue, or other parts of the body
• skin rash, itching, or urticaria
• loss of consciousness

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

You must inform 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, nausea, or feeling full
• visible muscle spasms under the skin
• muscle pain after the procedure; your doctor will monitor for this

Common (may affect up to 1 in 10 people)

• increase in intraocular pressure that may cause headache or blurred vision
• skin redness
• skin rash
• high potassium levels in the blood
• increase or decrease in heart rate
• protein in the blood or urine due to muscle damage
• muscle damage that may cause your muscles to feel sore, soft, rigid, or weak. Urine may also be dark, reddish, or brown in color

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

• abnormal heart rhythm
• cardiac problems, including changes in heart rhythm or heart stopping
• transient respiratory difficulty or lack of breathing
• difficulty opening the mouth

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

• high body temperature

Other side effects include:

Unknown frequency: cannot be estimated from available data

• excessive saliva production
• high or low blood pressure

Reporting side effects

If you experience any type of side effect, consult your doctor, nurse, or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

This medication should not be administered with suxamethonium chloride injection or for infusion after the expiration date appearing on the box and ampoule label after CAD. The doctor or nurse will verify that the expiration date has not been exceeded before administering the injection. The expiration date is the last day of the month indicated.

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

Store in the original packaging to protect it from light.

Once opened, this medication must be used immediately.

Do not use this medication if you observe any change in color or if it contains particles.

Medications should not be disposed of through drains or in the trash. Your doctor or nurse will dispose of the medications that you no longer need. These measures will help protect the environment.

Composition of Suxamethonium Ethypharm

The active principle is dihydrate suxamethonium chloride50mg/ml.

The othercomponentsare hydrochloric acid (to adjust the pH) and water for injectable preparations.

Appearance of the product and contents of the package

Suxamethonium chloride injectable or for perfusion is a transparent and colorless solution supplied in a transparent glass vial of 2ml. Each vial of 2ml contains 100mg of dihydrate suxamethonium chloride (equivalent to 73.1mg of suxamethonium). Each boxcontains10vials.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Ethypharm

194 Bureaux de la Colline, Building D

92213 Saint- Cloud CEDEX

France

Responsible for manufacturing:

Macarthys Laboratories Limited t/a Martindale Pharma

Bampton Road, Harold Hill,

Romford, Essex RM3 8UG

United Kingdom

O

ETHYPHARM,

Chemin de la Poudriere, GRAND QUEVILLY,
76120,France

O

ETHYPHARM,

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

Ó

Fannin Limited,

Fannin House,

South County Business Park,

Dublin 18, D18 Y0C9,

Ireland

Last review date of this leaflet:March 2020

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

This information is intended solely for healthcare professionals:

Suxamethonium Ethypharm50mg/ml injectable solutionand for perfusion EFGis used for muscle relaxation during general anesthesia.

Dosage and administration

By intravenous injection

Adults and adolescents over 12years

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 administered by intravenous injection at a dose of 1mg/kg. With this dose, muscle relaxation will generally be achieved in 30 to 60seconds and will last for 2 to 6minutes. 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 at 50%, 75%, or 100%, at intervals of 5 to 10minutes, will maintain muscle relaxation during short surgical procedures performed under general anesthesia.

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

Newborns and small children are more resistant to suxamethonium than adults.

Children aged 1 to 12years

1-2mg/kg by intravenous injection.

Newborns, less than 1year

2mg/kg by intravenous injection.

By intravenous perfusion

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

Older adults

The same as adults.

Older adults may be more susceptible to cardiac arrhythmias, especially if they are also taking digitalis medications (seesection4.4).

Administration:

By intravenous bolus or perfusion.

Overdose

The manifestations of a suxamethonium overdose are deep 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 depolarizing effect of suxamethonium chloride.

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

Incompatibilities

This medicine should not be mixed with other medicinesexcept those mentioned inSpecial precautions for disposal and other manipulations.

Suxamethonium Ethypharm is an acidic substance and should not be mixed with solutions with a high degree of alkalinity, such as barbiturates.

Special precautions for disposal and other manipulations

Use once and eliminate any remaining solution.

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