CEFOTAXIME NORMON 500 mg POWDER AND SOLVENT FOR INJECTION

Introduction

Package Leaflet: Information for thepatient

Cefotaxima Normon 500 mg powder and solvent for solution for injection EFG

Read all of this leaflet carefully before you start using 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 or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

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

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

This medicine belongs to a group of antibiotics called cephalosporins, used to combat bacteria.

Cefotaxima is indicated in severe, acute, and chronic bacterial infections caused by pathogens sensitive to cefotaxima:

• Respiratory infections.
• Otorhinolaryngological infections.
• Renal and urinary tract infections.
• Infections of the skin and soft tissues.
• Infections of bones and joints.
• Gynecological infections, including gonorrhea.
• Abdominal infections (including peritonitis).
• Meningitis.
• Blood poisoning (sepsis).
• Heart inflammation (endocarditis).
• Lyme disease (especially in stages II and III) (infection mainly caused by tick bites).

Additionally, for the prevention of infections after surgical interventions in patients with a higher risk of infections.

2. What you need to know before you use Cefotaxima Normon

Do not use Cefotaxima Normon

• If you are allergic to cefotaxima, other cephalosporins, or any of the other components of this medicine (listed in section 6).
• If you have previously had an acute or severe hypersensitivity reaction to penicillin or other beta-lactam antibiotics. Penicillin and cephalosporins can cause cross-reactions.
• If you have ever suffered from a severe skin rash, peeling, blisters, or ulcers in the mouth after taking cefotaxima or other cephalosporins.

Do not take Cefotaxima Normon or inform your doctor if any of these apply to you.

The use of cefotaxima mixed with lidocaine for intramuscular injection is not indicated in children under 30 months of age. The instructions for the preparation of the product containing lidocaine must be followed.

Warnings and precautions

Consult your doctor or pharmacist before starting to use cefotaxima:

• If you are allergic to penicillin or other beta-lactam antibiotics in any form (for contraindications due to known hypersensitivity reactions, see above in the section "Do not use Cefotaxima Normon").
• If you have an allergic reaction (e.g., hay fever, bronchial asthma, hives) or if you are known to have one. In this case, you have a higher risk of more severe hypersensitivity reactions (which can be fatal in exceptional cases). If you experience a feeling of chest tightness, or feel dizzy, sick, or weak, these may be signs of a hypersensitivity reaction (see section 4).
• If a hypersensitivity reaction occurs, treatment should be discontinued.
• If you experience severe or persistent diarrhea during treatment or for several weeks after its completion. Inform your doctor immediately, as diarrhea in its most severe form (called pseudomembranous colitis) could be life-threatening and requires treatment. Do not take any medication that limits intestinal activity.
• If you know you have kidney failure. Inform your doctor in this case; if necessary, they may adjust your dose. It is essential to monitor your kidney function.
• If you receive concomitant or subsequent treatment with aminoglycosides (other antibiotics), probenecid (for gout), or other medications that can cause kidney damage. A doctor should monitor your kidney function, as these substances can increase the harmful effects on the kidneys, and caution is needed.
• If you experience movement disorders, have seizures, or confusion, or have altered consciousness. These may be signs of what is called encephalopathy. There is a risk of these adverse effects when high doses are administered, in case of overdose, or if you have kidney failure. If these reactions occur, consult your doctor immediately.
• If your treatment lasts more than 7 to 10 days. In this case, blood tests should be performed because changes in the blood may appear (see also section 4).
• If you have signs of a new infection (e.g., fungal infection of the mucous membranes with redness and a white surface). The use of antibiotics can increase the amount of pathogens that are not sensitive to the used medication. Be vigilant for signs of a new infection and inform your doctor if necessary.

Be careful with Cefotaxima Normon

• Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported with cefotaxima treatment. Stop taking cefotaxima and seek immediate medical attention if you observe any of the symptoms described in section 4 related to these severe skin reactions.

Other medicines and Cefotaxima Normon

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Other antibiotics

The concomitant use of some antibiotics may reduce the effect of cefotaxima. Inform your doctor if you are taking or have recently taken other antibiotics.

Diuretics and potentially kidney-damaging medicines

When cefotaxima is used in conjunction with medicines that may have a harmful effect on the kidneys, such as aminoglycosides (other antibiotics) or medicines with a high capacity to cause dehydration (diuretics, such as furosemide), it may increase the harmful effect on the kidneys of these medicines. If administered concomitantly, kidney function should be monitored (see section 2 "Warnings and precautions").

Probenecid

The simultaneous administration of probenecid leads to an increase in the concentration of cefotaxima in the serum and, therefore, to the extension of its effect, because probenecid limits the elimination of cefotaxima by the kidneys. Inform your doctor if you are taking probenecid, especially if you have kidney failure, so that, if necessary, they can adjust your dose.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

There are insufficient data on the use of cefotaxima in pregnant women. Animal experiments did not show signs of teratogenic properties of cefotaxima.

However, cefotaxima should only be used during pregnancy, especially in the first trimester, after a strict evaluation of the risks and benefits of treatment by a specialist.

Breastfeeding

Cefotaxima is excreted in breast milk only in small amounts. If you receive cefotaxima during breastfeeding, it may cause changes in the intestinal flora with diarrhea, fungal growth, and may also cause sensitization. The doctor will decide whether it is necessary to interrupt breastfeeding or discontinue treatment with cefotaxima, considering the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and using machines

According to previous experience, cefotaxima in low and medium doses does not have any effect on concentration or reaction ability.

If you experience side effects such as dizziness or encephalopathy, which can be associated with seizures, confusion, altered consciousness, and movement disorders, you should not drive or use machines.

Cefotaxima Normon contains sodium

This medicine contains 25.3 mg (1.10 mmol) of sodium (the main component of table salt/cooking salt) per dose. This is equivalent to 1.27% of the maximum recommended daily sodium intake for an adult.

3. How to use Cefotaxima Normon

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

The dose, method of administration, and time intervals between injections depend on the dose, sensitivity of the pathogen, severity of the infection, and the patient's condition.

Unless your doctor considers otherwise, the recommended dose is:

Adults and children over 12 years:the usual dosage is 1 g of cefotaxima every 12 hours. In severe cases, the daily dose can be increased up to 12 g. Daily doses up to 6 g can be divided into at least two fractional doses administered at 12-hour intervals. Higher daily doses should be divided into at least 3-4 fractional doses with administration intervals of 6 or 8 hours.

The following table can be considered a guideline for administration:

For the treatment of gonorrheain adults, a single dose of 0.5 g of cefotaxima should be administered intramuscularly. In less sensitive pathogens, a dose increase may be necessary. Before starting treatment, check for the presence of syphilis.

For perioperative prophylaxis of infections, administration of 1-2 g of cefotaxima 30-60 minutes before surgery is recommended. Less sensitive pathogens may require a higher dose. Before starting treatment, check for the presence of syphilis.

For Lyme disease, the daily dose is 6 g of cefotaxima (for 14 to 21 days). In most cases, the daily dose is divided into 3 fractional doses (2 g of cefotaxima 3 times a day), but in some cases, it has been administered in 2 fractional doses (3 g of cefotaxima 2 times a day). The dosage recommendations are not based on comparative clinical trials but on observations of individual patients.

Combined treatment

In severe infections that pose a vital risk, combined treatment with cefotaxima and aminoglycosides without an antibiogram is indicated. When combined with aminoglycosides, kidney function should be monitored.

In cases of Pseudomonas aeruginosainfection, combined treatment with other antibiotics effective against Pseudomonasmay also be indicated.

For the prophylaxis of infections in patients with a weakened immune system, combined treatment with other appropriate antibiotics may also be indicated.

Infants and children up to 12 yearsreceive 50 to 100 mg of cefotaxima (up to 150 mg) per kilogram of body weight daily, depending on the severity of the infection. The daily dose will be divided into 2 or more identical fractional doses, which will be administered at intervals of 12 (to 6) hours. In individual cases, especially in life-threatening situations, the daily dose can be increased to 200 mg of cefotaxima per kilogram of body weight.

In premature infants, it should be taken into account that kidney function is not yet fully developed, and the dose should not exceed 50 mg of cefotaxima per kilogram of body weight per day.

In patients with severe kidney failure(creatinine clearance less than 10 ml/minute), after the initial normal dose (the first dose at the start of treatment), the maintenance dose can be reduced to half of the normal dose, maintaining the administration interval.

Patient on hemodialysis receive 1 to 2 g of cefotaxima daily, depending on the severity of the infection. On the day of hemodialysis, cefotaxima should be administered after dialysis.

Patient on peritoneal dialysis receive 1 to 2 g of cefotaxima daily, depending on the severity of the infection. Cefotaxima is not eliminated by peritoneal dialysis.

Elderly patients

In elderly patients, kidney function should be carefully monitored, and the dose should be adjusted if necessary.

If you use more Cefotaxima Normon than you should

Beta-lactam antibiotics, including cefotaxima, can cause what is called encephalopathy, which is accompanied by central nervous system excitement, myoclonus, seizures, confusion, altered consciousness, and movement disorders. There is a risk of these adverse effects when high doses are used, in case of overdose, or in patients with impaired kidney function or who suffer from epilepsy or meningitis.

If cefotaxima is injected through a central venous catheter (CVC) too quickly (in less than 1 minute), it can cause a severe cardiac arrhythmia.

If you think you have received too much cefotaxima, talk to your doctor or medical staff immediately.

If you forget to use Cefotaxima Normon

Your doctor or nurse will have instructions on when to administer the medicine, so it is unlikely that you will not receive the medicine according to the instructions. If you think you have missed a dose, talk to your doctor or nurse.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Stop taking cefotaxime and inform your doctor immediately if you observe any of the following symptoms:

• Seizures (rare, may affect up to 1 in 100 people).
• Unknown frequency (cannot be estimated from available data):

• Severe acute hypersensitivity reactions and life-threatening allergic reactions, as well as swelling (Quincke's edema) and constriction of the airways (bronchospasm). If you experience chest tightness, or feel dizzy, sick, or weak, these could be signs of a hypersensitivity reaction.
• Severe persistent diarrhea or blood in the stool due to possible life-threatening intestinal inflammation.
• Decrease in red blood cells (hemolytic anemia), change in urine color (to a brownish-red color).
• Acute kidney failure.
• Red patches that are not raised, or circular or target-shaped patches on the chest, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread skin rash, high body temperature, and enlargement of lymph nodes (DRESS or drug hypersensitivity syndrome).
• Widespread skin rash, red and scaly, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Tell your doctor or nurse if you experience any of the following adverse effects with an unknown frequency (cannot be estimated from available data):

• Jaundice as a sign of possible hepatitis.
• Severe decrease in white blood cells (agranulocytosis), which can be detected by the appearance of acute signs of infection, as well as inflammation of the oral, nasal, pharyngeal, genital, and anal areas.
• Great decrease in the number of all blood cells and bone marrow failure. Signs of acute infection and inflammation (see above) may also appear, as well as bleeding, bruising (decrease in platelets), fatigue, pallor, or difficulty breathing (decrease in red blood cells).

Tell your doctor or nurse if any of the following adverse effects worsen or last for more than a few days:

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

• Pain at the injection site, also hardening due to intramuscular administration.

Common(may affect up to 1 in 10 people)

• Joint problems (e.g., swelling).

Uncommon(may affect up to 1 in 100 people)

• Increase in eosinophil blood cells (eosinophilia).
• Decrease in platelet count (thrombocytopenia) and certain white blood cells (leukopenia, granulocytopenia).
• Jarisch-Herxheimer reaction (see explanation below).
• Diarrhea.
• Loss of appetite.
• Increase in bilirubin (bile pigment in the blood) and liver enzymes in serum (SGOT, SGPT, γ-GT, alkaline phosphatase, LDH).
• Allergic reactions in the form of rash, itching, hives.
• Limited kidney function, e.g., increased concentrations of creatinine and urea in serum.
• Fever.
• Inflammatory reactions at the injection site and vein inflammation (phlebitis/thrombophlebitis).

Unknown frequency(cannot be estimated from available data)

• Superinfections caused by bacteria or fungi (e.g., in the mouth or vagina).
• Decrease in the number of certain white blood cells (neutropenia).
• Tachycardia, cardiac arrhythmia (after rapid administration through a central venous access).
• Excitation of the central nervous system, altered consciousness, confusion, movement disorders, muscle spasms (symptoms of encephalopathy, especially with high doses, in case of overdose, or with impaired renal function).
• Headache.
• Dizziness.
• Nausea, vomiting, abdominal pain.
• Kidney inflammation (interstitial nephritis).
• Intolerance reactions in the form of a sensation of heat or nausea with rapid intravenous administration.

Jarisch-Herxheimer Reaction

When starting treatment for spirochetal infections (e.g., Lyme disease), you may experience fever, chills, headache, and joint pain. After several weeks of treatment for Lyme disease, one or more of the following symptoms have been described: rash, itching, fever, decrease in white blood cells, increase in liver enzymes, difficulty breathing, and joint pain. These symptoms partially correspond to the underlying symptoms of the patients being treated.

Adverse Effect Notification

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

5. Storage of Cefotaxime Normon

Keep this medicine out of sight and reach of children.

Do not store at a temperature above 25°C.

Do not use this medicine after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

The reconstituted vials maintain their chemical and physical stability at 8 to 25 °C and for 24 hours in the refrigerator (2 °C-8 °C).

From a microbiological point of view, it is recommended to use the solutions immediately after preparation. If not administered immediately, the time and conditions under which they can be stored will be the responsibility of the user and should not normally exceed 24 hours at 2 °C-8 °C, unless the reconstitution has been carried out under controlled and validated aseptic conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Cefotaxime Normon 500 mg

The active ingredient is cefotaxime (as cefotaxime sodium).

Each vial contains 500 mg of cefotaxime (as cefotaxime sodium).

Each ampoule of solvent contains water for injectable preparations.

Appearance of the Product and Package Contents

Cefotaxime Normon 500 mg is presented in the form of a white or slightly yellowish powder contained in a transparent glass vial, with a rubber stopper and sealed with an aluminum cap and a glass ampoule with 2 ml of solvent.

The vials are supplied in boxes containing 1 vial or in clinical packages of 100 vials.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos (Madrid)

Spain

Date of the Last Revision of this Prospectus:June 2024

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

This information is intended only for healthcare professionals

Common Information for the Following Presentations:

Cefotaxime Normon 250 g powder and solvent for injectable solution EFG

Cefotaxime Normon 500 g powder and solvent for injectable solution EFG

Cefotaxime Normon 1 g powder and solvent for injectable solution EFG

Cefotaxime Normon 2 g powder and solvent for injectable solution and perfusion EFG

Intravenous Injection

Cefotaxime Normon 250 mg, 500 mg, 1 g, and 2 g are administered by slow intravenous injection over 3 to 5 minutes, after dilution in 2, 4, or 10 ml of solvent (water for injectable preparations).

Intravenous Perfusion

Reconstitute the 2 g vial in 10 ml of water for injectable preparations. Then:

For rapid intravenous perfusion, dilute in 40 ml of water for injectable preparations or an isotonic sodium chloride solution, and perfuse intravenously over 20 minutes.

For slow intravenous perfusion, dissolve in 100 ml of isotonic sodium chloride solution or a glucose solution, and perfuse intravenously over a period of 50 to 60 minutes.

Intramuscular Injection

Cefotaxime Normon 500 mg and 1 g:

For intramuscular injection, dissolve 500 mg of cefotaxime in 2 ml or 1 g of cefotaxime in 4 ml of water for injectable preparations. Then, the injection should be administered by deep intragluteal route. Pain during intramuscular injection can be avoided by dissolving 1 g of cefotaxime in 4 ml or 500 mg in 2 ml of 1% lidocaine (see section 2 Do not use Cefotaxime Normon). Intravascular injection should be avoided, as lidocaine administered intravascularly can cause restlessness, tachycardia, conduction anomalies, vomiting, and confusion. The commercial presentation Cefotaxime Normon 1 g powder and solution for intramuscular injectable solution EFGincludes a lidocaine ampoule for intramuscular administration.

Unless physical-chemical compatibility with other perfusion solutions has been demonstrated, the cefotaxime solution should be administered, in principle, separately from them.

Cefotaxime is not compatible with:

• Sodium bicarbonate solution.
• Perfusion solutions with a pH above 7.
• Aminoglycosides.

In general, cefotaxime should not be mixed or administered with other antibiotics or medicines in the same syringe. Cefotaxime should not be mixed with aminoglycoside antibiotics in the perfusion equipment or syringe.