CLOXACILLIN NORMON 1 g POWDER FOR INJECTION AND INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Cloxacillin Normon 1 g Powder for Solution for Injection and Infusion EFG

Cloxacillin Sodium

Contents of the Package Leaflet:

1. What is Cloxacillin Normon and what is it used for
2. What you need to know before you take Cloxacillin Normon
3. How to take Cloxacillin Normon
4. Possible side effects
5. Storage of Cloxacillin Normon
6. Contents of the pack and further information

1. What is Cloxacillin Normon and what is it used for

Cloxacillin Normon 1 g is presented in a vial with powder for solution for injection.

Cloxacillin Normon is indicated for the treatment of the following infections caused by sensitive germs:

• Infections of the skin and soft tissues.
• 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 parts of the heart).
• Meningitis (inflammation of the meninges).

2. What you need to know before you take Cloxacillin Normon

Do not use Cloxacillin Normon

If you are allergic (hypersensitive) to penicillins or other beta-lactams or to any of the other components of Cloxacillin Normon.

Warnings and precautions

• If you are allergic to cephalosporins, as there may be a cross-allergic reaction.
• In newborns with jaundice (evidenced by yellow color of the skin).
• If you have kidney dysfunction (kidney damage), due to the risk of neurotoxicity (nerve damage).
• If you have restricted sodium intake, as each gram of Cloxacillin Normon 1 g powder for solution for injection contains 52.8 mg of sodium.

This medicine 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 medicines and Cloxacillin Normon

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Some medicines may influence the action of others.

Cloxacillin Normon interacts with the following medicines:

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using a medicine.

Pregnancy

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

Breastfeeding

Cloxacillin Normon is excreted in breast milk. Its use during the breastfeeding period will be carried out with caution.

Driving and using machines

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

Important information about some of the components of Cloxacillin Normon

This medicine contains 52.8 mg of sodium (main component of table salt/kitchen salt) in each vial. This is equivalent to 2.71% of the maximum daily sodium intake recommended for an adult.

3. How to take Cloxacillin Normon

Follow exactly the administration instructions of Cloxacillin Normon indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to use your medicine. Your doctor will indicate the duration of your treatment with cloxacillin. Do not stop treatment before. If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

Cloxacillin Normon is administered intravenously.

The doctor will decide which posology is suitable for each type of pathology.

Adults and children over 12 years:the recommended dose in adults is 500 mg to 1 g every 6-8 hours. These doses are guidelines and may be increased when the severity of the process requires it.

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 use more Cloxacillin Normon than you should

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

If you forget to take Cloxacillin Normon

Do not take a double dose to make up for forgotten doses.

If you stop treatment with Cloxacillin Normon

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

4. Possible side effects

Like all medicines, Cloxacillin Normon can cause side effects, although not everybody gets them:

Hypersensitivity reactions:skin alterations, interstitial nephritis (kidney inflammation). Rarely, other reactions such as angioneurotic edema (extensive swelling of the face), anaphylaxis (unusual or exaggerated allergic reaction that occurs with hypotension and bronchospasm that makes breathing difficult), and serum sickness (allergic reaction to serum) have been reported.

Gastrointestinal tract alterations:diarrhea, nausea, and vomiting that are usually mild and transient and do not require treatment to be stopped. The persistence of diarrhea should make one consider the possibility of pseudomembranous colitis.

Blood alterations:rare cases of neutropenia (decrease in the number of white blood cells) and platelet dysfunction have been reported.

Central nervous system alterations:at very high doses, convulsions may appear. Hepatic function alterations:jaundice (evidenced by yellow color of the skin) and hepatitis. Local reactions:cases of phlebitis (venous inflammation) may occur.

Other adverse reactions:oral candidiasis.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cloxacillin Normon

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

Do not use Cloxacillin Normon after the expiry date stated on the packaging after CAD. The expiry date is the last day of the month indicated.

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

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Cloxacillin Normon

The active substance is cloxacillin sodium. Each vial contains 1 g of cloxacillin sodium.

Appearance of the product and contents of the packaging

Cloxacillin Normon 1 g is presented as a powder for solution for injection, with each pack containing 1 vial.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

OTHER PRESENTATIONS

Cloxacillin Normon 500 mg powder for solution for injection and infusion EFG.

Date of the last revision of this leaflet: February 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

THIS INFORMATION IS INTENDED ONLY FOR HEALTHCARE PROFESSIONALS

Information for the doctor:

In case of overdose, carry out symptomatic and maintenance treatment. Peritoneal dialysis or hemodialysis is not effective.

Precautions in parenteral administration

Intravenous administration: The vial is reconstituted with 20 ml of water for injections. Inject slowly over 3-4 minutes.

For administration in continuous infusion, the reconstituted powder in 20 mL of water for injections will be 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 infusion in the hospital.

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

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