Package Insert: Information for the Patient

Cefotaxime Normon 250 mg Powder and Diluent for Injectable Solution EFG

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, 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 package insert. See section 4.

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

2. What you need to know before starting to use Cefotaxime Normon

3. How to use Cefotaxime Normon

4. Possible adverse effects

5. Storage of Cefotaxime Normon

6. Contents of the package and additional information

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

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

- Respiratory infections.

- Otorhinolaryngological infections.

- Renal and urinary tract infections.

- Skin and soft tissue infections.

- Bone and joint infections.

- Gynecological infections, including gonorrhea.

- Abdominal infections (including peritonitis).

- Meningitis.

- Blood poisoning (sepsis).

- Inflammation of the heart (endocarditis).

- Lyme disease (especially in stages II and III) (infection primarily caused by tick bites).

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

Do not use Cefotaxima Normon

- If you are allergic to cefotaxime, other cephalosporins, or any of the other components of this medication (listed in section 6).

- If you have had a previous acute or severe hypersensitivity reaction to penicillin or other beta-lactam antibiotics. Penicillin with cephalosporins can cause cross-reactions.

- If you have ever had a severe skin rash or peeling, blisters, or mouth sores after taking cefotaxime or other cephalosporins.

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

The use of cefotaxime mixed with lidocaine for intramuscular injection is not indicated in children under 30 months of age. Please refer to the prospectus for the product containing lidocaine.

Warnings and precautions

Consult your doctor or pharmacist before starting to use cefotaxime:

• If you are allergic to penicillin or other beta-lactam antibiotics in any form (for known hypersensitivity reactions, see earlier in the section "Do not use Cefotaxima Normon").
• If you have an allergic reaction (e.g., hay fever, asthma, hives) or if you know your history. In this case, you have a higher risk of more severe hypersensitivity reactions (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 interrupted.
• If you experience severe or persistent diarrhea during treatment or several weeks after its completion. Inform your doctor immediately, as diarrhea in its most severe form (called pseudomembranous colitis) could be fatal and should be treated. Do not take any medication that limits intestinal activity.
• If you know you have kidney insufficiency. Inform your doctor in this case; if necessary, your dose may be adjusted. Your kidney function should be monitored.
• 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 kidney function, as these substances may increase the harmful effects on the kidneys and caution is needed.
• If you experience a movement disorder, seizures, confusion, or altered consciousness. These may be signs of what is called encephalopathy. There is a risk of these adverse effects occurring when high doses are administered, in cases of overdose, or if you have kidney 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 occur (see also section 4).
• - If you experience signs of a new infection (e.g., fungal membrane mucosa infection with redness and a white surface). The use of antibiotics can increase the amount of pathogens that are not sensitive to the medication used. Be vigilant to detect 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-induced eosinophilia and systemic symptoms (DRESS), generalized acute pustular exanthema (PEGA), have been associated with cefotaxime treatment. Stop taking cefotaxime and seek medical attention immediately 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 used recently, or may need to use any other medication.

Other antibiotics

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

Diuretics and potentially nephrotoxic medications

When cefotaxime is used concomitantly with medications that may have a nephrotoxic effect, such as aminoglycosides (other antibiotics) or medications with a high potential for dehydration (diuretics, such as furosemide), the nephrotoxic effect of these medications may be increased. If administered concomitantly, kidney function should be monitored (see section 2 "Warnings and precautions").

Probenecid

The simultaneous administration of probenecid results in an increase in cefotaxime serum concentration and, therefore, an extension of its effect because probenecid limits the renal elimination of cefotaxime. Inform your doctor if you are taking probenecid, especially if you have kidney insufficiency, so that, if necessary, your dose may be adjusted.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you 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 cefotaxime in pregnant women. Animal experiments did not show any teratogenic properties of cefotaxime.

However, cefotaxime 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.

Lactation

Cefotaxime is excreted in breast milk in small amounts. If you receive cefotaxime during breastfeeding, it may cause intestinal flora alterations with diarrhea, fungal growth, and also may cause sensitization. Your doctor will decide whether to interrupt breastfeeding or interrupt cefotaxime treatment, considering the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and operating machines

According to previous experience, cefotaxime at low and medium doses has no effect on concentration or reaction capacity.

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

Cefotaxima contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per vial, making it essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Unless your doctor indicates otherwise, the recommended dose is:

Adults and children over 12 years:The usual dosing regimen is 1 g of cefotaxime every 12 hours. In severe cases, the daily dose can be increased 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 dosing regimen:

For the treatment ofgonorrheain adults, a single dose of 0.5 g of cefotaxime should be administered intramuscularly. In less sensitive pathogens, a higher dose may be required. Before starting treatment, check for syphilis.

Forperioperative prophylaxis of infections, it is recommended to administer 1-2 g of cefotaxime 30-60 minutes before surgery. Less sensitive pathogens may require a higher dose. Before starting treatment, check for syphilis.

ForLyme disease, the daily dose is 6 g of cefotaxime (14-21 days). In most cases, the daily dose is divided into 3 fractional doses (2 g of cefotaxime 3 times a day), but in some cases, it has been administered in 2 fractional doses (3 g of cefotaxime 2 times a day). The dosing 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 cefotaxime and aminoglycosides without an antibiogram is indicated. When combined with aminoglycosides, renal function should be monitored.

In cases ofPseudomonas aeruginosainfection, combined treatment with other effective antibiotics againstPseudomonasmay 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.

Children under 12 years old andinfantsreceive 50-100 mg of cefotaxime (up to 150 mg) per kilogram of body weight daily, depending on the severity of the infection. The daily dose should be divided into 2 or more identical fractional doses, administered at 12 (6) hour intervals. In individual cases, especially in situations with vital risk, the daily dose can be increased to 200 mg of cefotaxime per kilogram of body weight.

Inpremature infants, it should be taken into account that renal function is not yet fully developed and should not exceed a daily dose of 50 mg of cefotaxime per kilogram of body weight.

Inpatients with severe renal insufficiency(creatinine clearance less than 10 ml/min), after the initial normal dose (the first dose at the start of treatment), the maintenance dose can be reduced to half the normal dose, maintaining the administration interval.

Patients on hemodialysis receive 1-2 g of cefotaxime daily, depending on the severity of the infection. Cefotaxime should be administered after dialysis on the day of dialysis.

Patients on peritoneal dialysis receive 1-2 g of cefotaxime daily, depending on the severity of the infection. Cefotaxime is not eliminated by peritoneal dialysis.

Cefotaxima Normon 250 mg is administered intravenously (in a vein).

Geriatric patients

In elderly patients, renal function should be closely monitored, and if necessary, the dose should be adjusted.

If you use more Cefotaxima Normon than you should

Betalactam antibiotics, including cefotaxime, can cause the so-called encephalopathies, which are accompanied by central nervous system excitation, myoclonus, seizures, confusion, altered consciousness, and movement disorders. This risk exists when higher doses are used, in cases of overdose, and in patients with renal dysfunction or who suffer from epilepsy or meningitis.

If cefotaxime 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 cefotaxime, 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 medication, so it is unlikely that you will not receive the medication following the instructions. If you think you have forgotten a dose, talk to your doctor or nurse.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience 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, including Quincke's edema and bronchospasm. If you experience chest tightness, dizziness, nausea, or weakness, they may be signs of a hypersensitivity reaction.
• Persistent severe diarrhea or blood in the stool due to possible life-threatening intestinal inflammation.
• Acute hemolytic anemia, change in urine color to a brownish-red.
• Acute renal failure.
• Flat, reddish patches, or circular or target-shaped patches on the chest, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin eruption, elevated body temperature, and lymph node enlargement (DRESS syndrome or drug hypersensitivity syndrome).
• Generalized, red, scaly skin eruption, with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular exanthema).

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

• Jaundice as a sign of possible hepatitis.
• Severe granulocytopenia, which may be detected by the appearance of acute signs of infection, as well as oral, nasal, pharyngeal, genital, and anal inflammation.
• Severe decrease in the number of all blood cells and bone marrow insufficiency. Acute signs of infection and inflammation (see above) may also appear, as well as bleeding, bruising (thrombocytopenia), fatigue, pallor, or difficulty breathing (anemia).

Inform your doctor or nurse if any of the following side 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 after intramuscular administration.

Common(may affect up to 1 in 10 people)

- Joint problems (e.g., swelling).

Rare(may affect up to 1 in 100 people)

- Eosinophilia (increase in eosinophil blood cells).

- 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.

- Renal function limitation, e.g., increased serum creatinine and urea concentrations.

- Fever.

- Inflammatory reactions in the injection area and vein inflammation (phlebitis/thrombophlebitis).

Unknown frequency(cannot be estimated from available data)

- Secondary infections 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).

- Central nervous system stimulation, alteration of consciousness, confusion, movement disorders, muscle spasms (encephalopathy symptoms, especially with high doses, in cases of overdose, or with renal function deterioration).

- Headache.

- Dizziness.

- Nausea, vomiting, abdominal pain.

- Interstitial nephritis (inflammation of the kidneys).

- Intolerance reactions in the form of feeling hot 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, decreased white blood cells, increased liver enzymes, difficulty breathing, and joint pain. These symptoms correspond partially to the symptoms of the underlying disease in patients being treated.

Reporting side effects

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

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 25°C.

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

Reconstituted vials maintain their chemical and physical stability during 8 to 25°C and for 24 hours in a refrigerator (2°C-8°C).

From a microbiological standpoint, it is recommended to use the solutions immediately after preparation. If you do not administer immediately, the time and conditions under which they can be stored will be the responsibility of the user and should normally not exceed 24 hours at 2°C-8°C, unless the reconstitution was performed under controlled and validated aseptic conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Cefotaxime Normon 250 mg Composition

The active ingredient is cefotaxime (as cefotaxime sodium).

Each vial contains 250 mg of cefotaxime (as cefotaxime sodium).

Each ampoule of solvent contains water for injection.

Appearance of the product and contents of the package

Cefotaxime Normon 250 mg is presented as a white or slightly yellowish powder in a transparent glass vial with a rubber stopper and sealed with an aluminum capsule and a glass ampoule containing 2 ml of solvent.

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

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos (Madrid)

Spain

Last review date of this leaflet:June 2024

The detailed 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 solely for healthcare professionals

Common information for the following presentations:

Cefotaxime Normon 250 g powder and solvent for injection EFG

Cefotaxime Normon 500 g powder and solvent for injection EFG

Cefotaxime Normon 1 g powder and solvent for injection EFG

Cefotaxime Normon 2 g powder and solvent for injection and for infusion EFG

Intravenous injection

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

Intravenous infusion

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

For a rapid intravenous infusion, dilute in 40 ml of water for injection or a sodium chloride isotonic solution, and infuse by intravenous route for 20 minutes.

For a slow intravenous infusion, dissolve in 100 ml of a sodium chloride isotonic solution or a glucose solution, and infuse by intravenous route for 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 injection. Then, the injection should be administered by deep intragluteal injection. Pain during intramuscular injection can be avoided by dissolving 1 g of cefotaxime in 4 ml or 500 mg in 2 ml of lidocaine 1% (see section 2Do not use Cefotaxime Normon). Intravascular injection should be avoided, as lidocaine administered by intravascular route may cause restlessness, tachycardia, conduction abnormalities, vomiting, and confusion. The commercial presentationCefotaxime Normon 1 g powder and solution for intramuscular injection EFGincludes the lidocaine ampoule for intramuscular administration inside.

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

Cefotaxime is not compatible with:

• sodium bicarbonate solution,
• infusion solutions with a pH greater than 7,
• aminoglycosides.

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