Prospect: information for the user

Cloxacilina Normon 500 mg powder for injectable solution and for infusion EFG

Cloxacilina sodium

CloxacilinaNormon500 mg is presented in a vial with powder for injectable solution.

CloxacilinaNormonis indicated for the treatment of the following infections caused by sensitive pathogens:

• Soft tissue and skin infections.
• Mastitis (inflammation of the mammary gland).
• Osteoarticular infections such as septic arthritis (inflammation of joints due to infection) and osteomyelitis (bone inflammation due to infection).
• Sepsis (generalized infection).
• Endocarditis (inflammation of certain heart parts).
• Meningitis (inflammation of the meninges).

Do not use Cloxacilina Normon

If you are allergic (hypersensitive) to penicillins or other beta-lactam antibiotics or to any of the other components of Cloxacilina Normon.

Warnings and precautions

• If you have an allergy to cephalosporins, because there may be a cross-reaction allergy.
• In newborns with jaundice (which is evident by a yellow color on the skin).
• If you have renal dysfunction (kidney damage), due to the risk of neurotoxicity (damage to the nervous system).
• If you have restricted sodium intake, since each gram of Cloxacilina Normon 500 mg powder and solvent for injectable solution contains 50 mg.

This medication may interfere with the analytical determination of serum aspartate aminotransferase (AST) concentration, glucose determination in urine, protein determination in urine and plasma, and Coombs test.

Other medications and Cloxacilina Normon

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Some medications may influence the action of others.

Cloxacilina Normon interacts with the following medications:

• Bacteriostatic antibiotics (chloramphenicol, tetracycline, erythromycin, or sulfonamides): may decrease its action.
• Probenecid: decreases the elimination of cloxacilina.

Pregnancy and lactation

Consult your doctor or pharmacist before using a medication.

Pregnancy

The use of Cloxacilina Normon in pregnant women should only be considered when the potential benefits outweigh the potential risks associated with treatment.

Lactation

Cloxacilina Normon is excreted in breast milk. Its use during lactation will be carried out with caution.

Driving and operating machinery

There is no evidence of effects on the ability to drive vehicles or use hazardous machinery.

Important information about some of the components of Cloxacilina Normon

This medication contains 26.4 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 1.35% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions for Cloxacilina Normon as indicated by your doctor. Consult your doctor, pharmacist, or nurse if you have any doubts.

Remember to use your medication. Your doctor will inform you of the duration of your treatment with cloxacilina. Do not discontinue treatment prematurely. If you estimate that the action of this medication is too strong or too weak, inform your doctor, pharmacist, or nurse.

Cloxacilina Normonis administered via intravenous or intramuscular routes.

Your doctor will decide on the appropriate dosage for each type of pathology.

Adults and children over 12 years:The recommended dose for adults is 500 mg to1 gevery 6-8 hours. These doses are indicative and may be increased as needed to address the severity of the process.

Children over 2 years:The recommended dose is 12.5-25 mg/kg of body weight every 6-8 hours.

Children under 2 years:The recommended dose is 6.25-12.5 mg/kg of body weight every 6 hours.

If you take more Cloxacilina Normon than you should

Consult your doctor or pharmacist immediately. In case of overdose or accidental administration, contact the Toxicological Information Service (Tel. 91 562 04 20), indicating the product and the amount administered.

If you forget to take Cloxacilina Normon

Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with CloxacilinaNormon

If you have any other questions about the use of this product, ask your doctor, pharmacist, or nurse.

Like all medications, Cloxacilina Normonmay produce adverse effects, although not all people will experience them:

• Reactions of Hypersensitivity:skin changes, interstitial nephritis (kidney inflammation). Rarely, other reactions such as angioneurotic edema (extensive swelling of the face), anaphylaxis (unusual or exaggerated allergic reaction that includes hypotension and bronchial spasm that makes breathing difficult), serum disease (allergic reaction to serum) have been reported.
• Gastrointestinal Alterations:diarrhea, nausea, and vomiting that are generally mild and transient and do not require suspension of treatment. Persistent diarrhea should suggest the possibility of pseudomembranous colitis.
• Blood Alterations:Rarely, cases of neutropenia (decrease in white blood cell count) and platelet dysfunction have been reported.
• Central Nervous System Alterations:At very high dosesseizures may occur.Liver Function Alterations: jaundice (evidenced by yellow skin color) and hepatitis.Local Reactions:cases of phlebitis (venous inflammation) may occur.
• Other Adverse Reactions:oral candidiasis.

Reporting Adverse Effects

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

Keep this medication out of the sight and reach of children. Store in the original packaging.

Do not use Cloxacilina Normon after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

After reconstitution, the physical-chemical stability of the reconstituted product with water for injectable preparations has been demonstrated up to 6 hours at 25°C and 72 hours at 2-8°C. The physical-chemical stability has been demonstrated in use of the diluted solution with sodium chloride 9 mg/ml (0.9%) for injection or glucose 50 mg/ml (5%) in infusion bags or bottles for 6 hours at 25°C or 48 hours at 2-8°C. From a microbiological point of view, the product must be used immediately. If not used immediately, storage times and previous conditions before use are the responsibility of the user and are normally not to exceed 24 hours at 2-8°C unless the dilution/reconstitution has taken place in controlled and validated aseptic conditions.

Do not use this medication if you observe the presence of particles or if the reconstituted solution is cloudy.

Medications should not be thrown down the drain or in the trash.Deposit the containers and medications that you do not need in the SIGRE Pointof the pharmacy.In case of doubt, ask your pharmacist how to dispose of the containers and medications that you do not need. In this way, you will help to protect the environment.

Cloxacilina Normon Composition

The active ingredient is cloxacillin sodium. Each vial contains 500 mg of cloxacillin sodium.

Appearance of the product and contents of the packaging

Cloxacilina Normon 500 mg is presented in powder for injectable solution, containing each package a vial.

Marketing authorization holder and responsible manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

OTHER PRESENTATIONS

Cloxacilina Normon 1 gpowder for injectable solution and for EFG perfusion.

Last review date of this leaflet: February 2024

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 ONLY FOR HEALTH PROFESSIONALS

Information for the doctor

In case of overdose, perform symptomatic and supportive treatment. Peritoneal dialysis or hemodialysis are not effective.

Precautions for parenteral administration

Intravenous administration:The vial is reconstituted with 10 ml of water for injectable preparations. Inject slowly over 3-4 minutes.

For continuous infusion administration, the reconstituted powder in 10 mL of water for injectable preparations is removed from the vial and added to a 100 mL bag of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) for hospital infusion.

Intramuscular administration:The vial is reconstituted with 3.5 ml of water for injectable preparations.

Cloxacillin sodium should not be used in solutions containing protein hydrolysates, lipid suspensions, amino acids, blood, or serum. If it is compatible with most commonly used intravenous solutions (physiological saline or glucose solution).

The mixture of cloxacillin and aminoglycosides may cause substantial mutual inactivation, so they should not be mixed in the same container for administration.