Prospect: information for the user

Zennux 10 mg/ml injectable solution in pre-filled syringe

suxamethonium chloride anhydrous

Read this prospect carefully before this medicine is administered to you, as 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, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

Zennux belongs to a group of medications called muscle relaxants.

Its effect is to block the connection between nerves and certain muscles, which relaxes these muscles by temporarily paralyzing them.

It is used in adults and in pediatric populations over 12 years old in general anesthesia or emergency cases.

Zennux is administered during the insertion of a tube into the trachea (endotracheal intubation), if a person needs assistance with breathing. During this procedure, it is necessary for the muscles used for breathing to be paralyzed.

You should not be givenZennux:

-if you are allergic to suxamethonium or any of the other components of this medication (listed in section6).

-if you are a conscious patient;

-if you or a family member has had a negative reaction to an anesthetic in the past, such as malignant hyperthermia;

-if you have a deficiency of an enzyme called pseudocholinesterase that breaks down suxamethonium in the body;

-if you have high levels of potassium in your blood (hyperkalemia);

-if you have had a severe accident, surgery, or severe burns;

-if you have had aspinal cord injury, nerve injury, or sudden muscle loss;

-if you have been immobile for a long period of time, such as for the treatment of a bone fracture or prolonged bed rest;

-if you have muscle weakness or muscle tissue loss (e.g. Duchenne muscular dystrophy);

-if you or a family member has a disease that causes muscle weakness (congenital myotonia, myotonic dystrophy);

-if you have recently had eye injuries;

-if you have a condition caused by excessive pressure in the eye (glaucoma), unless the potential benefit is greater than the potential risk to the eye.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before Zennux is administered:

-if you have ever had an allergic reaction to any muscle relaxant that has been given to you during an operation;

-if you have myasthenia gravis, a disease that causes severe muscle weakness, or any other nerve or muscle disease;

-if you are pregnant or have given birth in the last six weeks;

-if you have tetanus, an infection that occurs through wound contamination;

-if you have tuberculosis or other severe or long-term bacterial infections.

-if you have a long-term disease that has weakened you.

-if you have a blood disease known as anemia.

-if you are malnourished or unable to absorb nutrients from food (malnutrition).

-if you have liver or kidney problems;

-if you have a disease caused by the body attacking itself (autoimmune disease) such as thyroid gland disease (mixedema);

-if you have diseases that cause joint problems (collagen diseases);

-if you have or have had a blood treatment known as plasma exchange therapy.

-if you have recently had a cardiopulmonary bypass.

Children

Zennux is not recommended for children under 12 years old because the sub-graduated syringe does not allow for an exact administration of the product in this population.

Special care should be taken when administering this medication to children over 12 years old.

Other medications andZennuxwith

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication.

Particularly, inform your doctor, pharmacist, or nurse if you are taking or being treated with any of the following:

-psychiatric medications (e.g. phenelzine, promazine);

-anticancer medications (e.g. cyclophosphamide, thiophosphamide, irinotecan);

-anesthetic medications (e.g. ketamine, halothane, enflurane, desflurane, propofol);

-local anesthetic medications (e.g. lidocaine, procaine, procainamide);

-a medication used to treat or prevent nausea and vomiting (metoclopramide);

-medications used to treat Alzheimer's disease or myasthenia gravis (cholinesterase inhibitors such as donepezil, edrophonium, galantamine, neostigmine, pyridostigmine, rivastigmine, and tacrine);

-medications for asthma or other respiratory problems (e.g. bambuterol, terbutaline);

-organic substances containing phosphorus;

-a medication used to reduce bleeding (aprotinin);

-estrogens and oral contraceptives containing estrogen;

-a medication to contract the uterus (oxytocin);

-medications used to treat inflammatory diseases (steroids such as for rheumatism, etc.);

-medications used to treat arrhythmias (antiarrhythmic agents such as e.g. quinidine, verapamil);

-some antibiotics used to treat bacterial infections (e.g. lincosamides, polymyxins, and aminoglycosides);

-antiepileptic medications used to stop seizures (e.g. carbamazepine and phenytoin);

-a beta-blocker medication used to reduce heart rate (esmolol);

-a medication used to suppress the immune response (azathioprine);

-a medication used to control overexcitement and/or depression (lithium);

-magnesium salts;

-medications that increase heart muscle contractions (cardiac glycosides such as digoxin);

-a medication used to treat high eye pressure, i.e. glaucoma (ecotiopato).

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before this medication is administered.

Zennux should only be used during pregnancy if your doctor decides that the benefits for you are greater than any risk to the unborn baby.

Care should be taken after the administration of suxamethonium to pregnant or postpartum patients.

The elimination of suxamethonium in breast milk is unknown. However, no effects are expected in newborns/infants, as suxamethonium is rapidly metabolized to an inactive metabolite.

Driving and operating machines

It may be hazardous to drive or operate machines too soon after receiving this medication. Your doctor will tell you how long to wait before you can drive or use machines.

Zennuxcontains sodium.

This medication contains 27.9 mg of sodium (main ingredient of table salt). This is equivalent to 1.4% of the recommended daily sodium intake for an adult.

You will never have to administer this medication yourself. It will always be administered by a qualified healthcare professional.

Your doctor will decide the dose you will receive. This depends on your personal needs, body weight, and the amount of muscle relaxation required.

Zennux will be administered to you in the form of an injection into your vein (intravenous use).The preloaded syringe is not suitable for use with a syringe pump.

If you are given more Zennux than you should

Since this medication will always be administered under carefully controlled conditions, it is unlikely that you will be given more than necessary. In the event of an overdose, the muscle will remain relaxed for longer than necessary.

If you have any doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Very Frequent (may affect more than 1 in 10 people):

• Visible muscle contractions under the skin

• Muscle pains after the operation - your doctor will monitor this.

Frequent (may affect up to 1 in 10 people)

• Allergic reactions: itching, urticaria, collapse

• Increased pressure in the eye that may cause headache or blurred vision

• Increased pressure in the stomach

• Increased or decreased heart rate

• Low blood pressure

• Proteins in the blood or urine due to muscle injuries

• High potassium levels in the blood

• Skin redness

• Rash

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

• Respiratory difficulty

• Elevated body temperature.

• Difficulty opening the mouth.

Unknown (frequency cannot be estimated from available data)

• Swelling (angioedema)

• Cardiac arrest

• High or low blood pressure

• Excessive saliva production

• Excessive mucus production

• Temporary air loss

• Muscle injuries

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse 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 after the expiration date that appears on the pre-filled syringe label, the blister pack, and the box. The expiration date is the last day of the month indicated.

Store in refrigerator (2?°C – 8?°C).

Do not freeze.

Store the pre-filled syringe in the closed blister pack until use.

The medication must be used immediately after opening.

This medication can be stored for a short period of time at temperatures not exceeding 25 °C. In any case, once removed from the refrigerator, the medication must be discarded after 30 days.

Do not use this medication if you observe visible signs of deterioration.

Any pre-filled syringe, even partially used, must be disposed of properly after use. Medications should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Zennux

• The active ingredient is suxamethonium chloride.

Each milliliter of injectable solution contains 10 mg of anhydrous suxamethonium chloride (as 11 mg of dihydrate suxamethonium chloride).

Each pre-filled syringe of 10 ml contains 100 mg of anhydrous suxamethonium chloride (as 110 mg of dihydrate suxamethonium chloride).

• The other components are: sodium chloride, succinic acid, sodium hydroxide or hydrochloric acid (for pH adjustment), water for injectable preparations.

Appearance of the product and contents of the package

Zennux is a clear, colorless injectable solution, in a 10 ml pre-filled syringe of polipropylene, individually packaged in a transparent blister pack. Cartons of 1 or 10 pre-filled syringes.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratoire Aguettant

1 rue Alexander Fleming

69007 Lyon

France

Manufacturer

Laboratoire Aguettant

1, rue Alexander Fleming

69007 LYON

France

Laboratoire Aguettant

Lieu Dit Chantecaille

07340 Champagne

France

Local representative:

Aguettant Ibérica S.L.

Parc Científic de Barcelona

Baldiri Reixac, 4-8 (Torre I)

08028 Barcelona

Last review date of this leaflet: December 2024.

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

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This information is intended solely for healthcare professionals:

Instructions for use:

The pre-filled syringe is not suitable for use with a syringe pump.

Please prepare the syringe carefully as follows

The pre-filled syringe must be used on a single patient. Dispose of the syringe after use. Do not reuse the syringe.

The medicine must be visually inspected to detect particles and discoloration before administration. Only a clear, colorless, particle-free, and precipitate-free solution should be used.

The medicine should not be used if the safety seal of the syringe is broken.

The external surface of the syringe is sterile until the blister pack is opened. Do not open the blister pack until the time of use.

When handled using an aseptic method, this medicine can be placed on a sterile field once it has been removed from the blister pack.

1) Remove the sterile pre-filled syringe from the blister pack.

6) Connect the syringe to a device or a needle. Push the plunger slowly to inject the required volume.