CEFOTAXIME NORMON 1 g POWDER AND SOLUTION FOR INTRAMUSCULAR INJECTION

2. What you need to know before taking Cefotaxima Normon

Do not use Cefotaxima Normon

• If you are allergic to cefotaxima, other cephalosporins, or any of the other components of this medication (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 package leaflet for the lidocaine-containing product should be consulted for preparation.

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 such a reaction. In this case, you have a higher risk of more severe hypersensitivity reactions (which can be fatal in exceptional cases). If you experience chest tightness, dizziness, nausea, or weakness, 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 (pseudomembranous colitis) can be life-threatening and requires treatment. Do not take any medication that limits intestinal activity.
• If you know you have renal insufficiency. Inform your doctor in this case; if necessary, they may adjust the dose. It is essential to monitor renal function.
• If you are receiving concomitant or subsequent treatment with aminoglycosides (other antibiotics), probenecid (for gout), or other medications that can cause kidney damage. A doctor should monitor your renal function, as these substances can increase the harmful effects on the kidneys, and caution is needed.
• If you experience movement disorders, seizures, or confusion, or have altered consciousness. These can 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 renal insufficiency. If these reactions occur, consult your doctor immediately.
• If your treatment lasts more than 7 to 10 days. In this case, blood control 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. Monitor for signs of a new infection and inform your doctor if necessary.

Be especially 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 Medications and Cefotaxima Normon

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

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 Medications that may be Harmful to the Kidneys

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

Probenecid

The simultaneous administration of probenecid results in an increase in cefotaxima serum concentration and, therefore, an extension of its effect, as probenecid limits the elimination of cefotaxima by the kidneys. Inform your doctor if you are taking probenecid, especially if you have renal insufficiency, so that, if necessary, they can adjust the 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 medication.

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 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 to interrupt breastfeeding or discontinue cefotaxima treatment, 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, do not drive or use machines.

Cefotaxima Normon contains Sodium

This medication contains 50.6 mg (2.20 mmol) of sodium (the main component of table salt/cooking salt) per dose. This is equivalent to 2.53% of the maximum recommended daily sodium intake for an adult.

3. How to use Cefotaxima Normon

Follow your doctor's instructions for administration of this medication exactly. If in doubt, consult your doctor or pharmacist again.

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

Unless your doctor decides 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 fractionated doses administered at 12-hour intervals. Higher daily doses should be divided into at least 3-4 fractionated 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. For 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 fractionated doses (2 g of cefotaxima 3 times a day), but in some cases, it has been administered in 2 fractionated 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, renal 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 fractionated doses, 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 renal 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 renal insufficiency(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.

Cefotaxima Normon 1 g is administered intramuscularly.

Elderly Patients

In elderly patients, renal 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 are called encephalopathies, which are 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 renal 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, speak 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 medication, so it is unlikely that you will not receive the medication according to the instructions. If you think you have missed a dose, speak to your doctor or nurse.

If you have any other questions about the use of this medication, 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 narrowing of the airways (bronchospasm). If you experience chest tightness, or feel dizzy, sick, or weak, these may 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, non-raised patches, 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 may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • Widespread skin rash, elevated body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).
  • Widespread, red, and scaly skin rash, 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.
• Sharp decrease in the number of all blood cells and bone marrow failure. Acute signs of infection and inflammation (see above), bleeding, bruising (decrease in platelets), fatigue, paleness, or difficulty breathing (decrease in red blood cells) may also appear.

Tell your doctor or nurse if any of the following adverse effects worsen or last 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)

• Increased blood eosinophils (eosinophilia).
• Decrease in platelet count (thrombocytopenia) and certain white blood cells (leukopenia, granulocytopenia).
• Jarisch-Herxheimer reaction (see explanation below).
• Diarrhea.
• Lack of appetite.
• Increased 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.
• Limitation of renal function, e.g., increased creatinine and urea concentrations 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).
• Excitement 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 feeling of heat or nausea with faster 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 treated patients.

Adverse Effect Reporting

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 them 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 the sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiration date stated 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 1 g

The active ingredient is cefotaxime (as cefotaxime sodium).

Each vial contains 1 g of cefotaxime (as cefotaxime sodium).

Each ampoule of solution contains water for injectable preparations.

Appearance of the Product and Package Contents

Cefotaxime Normon 1 g 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 4 ml of solution.

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.gob.es

This information is intended only for healthcare professionals.

Intramuscular Injection

The injection should be administered via deep intragluteal injection. Pain during intramuscular injection can be avoided by dissolving cefotaxime 1 g with the 4 ml of 1% lidocaine from the ampoule of solvent (see section 2 Do not take Cefotaxime Normon). Intravascular injection should be avoided, as lidocaine administered intravascularly can cause restlessness, tachycardia, conduction anomalies, vomiting, and confusion.

Cefotaxime 1g can also be reconstituted with 4 ml of water for injectable preparations, but it is more painful for intramuscular administration.

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

Cefotaxime is not compatible with:

• Sodium bicarbonate solution.
• Infusion 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 infusion equipment or syringe.