PATIENT INFORMATION LEAFLET

CEFOTAXIME TORLAN 500 mg powder and solvent for solution for injection EFG

Cefotaxime (as cefotaxime sodium)

Read this leaflet carefully before you start using the medicine.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

This medication belongs to a group of antibiotics called cephalosporins.

Cefotaxima TORLAN 500 mg is indicated for infections caused by bacteria sensitive to cefotaxima, such as:

• otolaryngological infections,
• lower respiratory tract infections, including worsening of chronic bronchitis, bacterial pneumonia,
• renal and urinary tract infections,
• genital infections (pelvic inflammatory disease, prostatitis, gonorrhea),
• septicemia/bacteremia (infection due to the presence of bacteria in the blood),
• endocarditis (inflammation of the membrane lining the inside of the heart),
• meningitis (except those caused by Listeria) and other central nervous system infections,
• ostearticular infections,
• skin and soft tissue infections,
• abdominal cavity infections (peritonitis, biliary tract infections).

Do not use CEFOTAXIMA TORLAN 500 mg

• If you are allergic (hypersensitive) to cefotaxime, to other cephalosporins, or to any of the other components of CEFOTAXIMA TORLAN 500 mg.
• If you have ever had a severe skin rash or peeling of the skin, blisters, or mouth sores after taking cefotaxime or other cephalosporins.

Do not use CEFOTAXIMA TORLAN 500 mg or inform your doctor if any of them affect you

Be especially careful with CEFOTAXIMA TORLAN 500 mg

• If you are allergic to penicillins and/or beta-lactam antibiotics. Consult your doctor if you have had any type of allergy to any medication before starting treatment with Cefotaxima TORLAN 500 mg.
• If you have had any type of immediate allergic reaction to cephalosporins. In case of doubt, the first administration should be performed in the presence of a doctor.
• In case of diarrhea, especially if it is severe, persistent, and/or bloody during or after treatment with Cefotaxima TORLAN 500 mg, consult your doctor as it may be a symptom of associated disease caused by the germ Clostridium difficile.
• Consult your doctor at any discomfort, especially if you have been treated with Cefotaxima TORLAN 500 mg injectable for a long time, to rule out another infection by resistant germs (superinfection), or if you have itching/irritation in the genitals to rule out an inflammation in the area due to the germ Candidaspp.
• If you need to be treated for a period exceeding 10 days, it is likely that your doctor will consider the convenience of a blood test to rule out the appearance of neutropenia (decrease in the number of white blood cell neutrophils).
• Some tests such as the Coombs test and glucosuria may be positive without actually being so, due to treatment with this medication
• If you are going to undergo any diagnostic test (blood test, urine...) inform your doctor that you are being treated with this medication as it may alter the results.
• 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 using cefotaxime and seek medical attention immediately if you observe any of the symptoms described in section 4 related to these severe skin reactions.

Use of other medications

Inform your doctor or pharmacist if you are using, or have recently used other medications, including those purchased without a prescription, homeopathic, herbal remedies, and other health-related products as it may be necessary to interrupt treatment or adjust the dose of one of them. Cefotaxima TORLAN should not be administered simultaneously with:

• medications whose active ingredient is probenecid (for the treatment of gout) as it increases the concentration of cefotaxime in the blood.
• with nephrotoxic medications (that produce kidney toxicity), especially aminoglycosides as it potentiates kidney toxicity, so your doctor should monitor its function.
• oral contraceptives, as the use of Cefotaxima TORLAN 500 mg may reduce their effectiveness.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

In case of pregnancy, your doctor will decide whether to use this medication.

Women in lactation period should consult their doctor before using this medication, as cefotaxime passes into breast milk.

Driving and operating machinery

No adverse effects on driving or operating machinery have been reported or documented for Cefotaxima TORLAN 500 mg. However, be cautious and avoid tasks that require special attention until you know how you tolerate the medication.

Important information about some of the components of CEFOTAXIMA TORLAN 500 mg

Patients with low-sodium diets should note that this medication contains 25.25 mg (1.10 mmol) of sodium per dose.

Follow exactly the administration instructions for CEFOTAXIMA TORLAN 500 mg as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

This medication can be administered intramuscularly by injection or intravenously by slow injection.

Remember that administration should be performed by medical personnel.

Your doctor will indicate the duration of treatment with Cefotaxima TORLAN 500 mg, do not discontinue treatment before.

As a general rule, treatments should be prolonged for at least 3 days after the disappearance of clinical symptoms of the infection. Remember to request the administration of your medication.

The usual dose is:

Adults and adolescents (12 to 18 years):The usual dosing regimen is 1 g of cefotaxine every 12 hours.

In severe cases, the daily dose may be increased to 12 g. If the dose is greater than 2g, or if Cefotaxima TORLAN 1,000 mg is administered more than 2 times a day, the CEFOTAXIMA TORLAN 2,000 mg powder and solvent for injectable solution and for infusion EFG presentation is recommended. In these cases, if the daily dose is 4 g, it may be divided into 2 doses of 2 g each, administered at 12-hour intervals. If higher doses are necessary, the interval should be reduced.

Pediatric population (less than 12 years):According to the severity of the infection, 50-150 mg/kg/day divided into 2, 3, or 4 doses depending on the severity of the infection.

Presentations with 1% hydrochloride lidocaine as a solvent should only be used in children over 30 months.

Patients with renal insufficiency:

In patients with reduced renal function, the maintenance dose should be reduced to half.

The initial dose depends on the sensitivity of the pathogen and the severity of the infection.

Patients undergoing hemodialysis:

1 to 2 g per day, depending on the severity of the infection. Cefotaxima TORLAN should be administered after the dialysis session on the day of hemodialysis.

If you estimate that the action of Cefotaxima TORLAN 500 mg is too strong or too weak, inform your doctor or pharmacist.

If you use more CEFOTAXIMA TORLAN 500 mg than you should:

Consult your doctor immediately or go to the nearest hospital. In case of overdose, particularly in patients with renal insufficiency, encephalopathy (deterioration of consciousness, abnormal movements, and seizures) may occur.

In case of accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service. Telephone 91 562 04 20 indicating the medication and the amount used.

If you forgot to use CEFOTAXIMA TORLAN 500 mg:

Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with CEFOTAXIMA TORLAN 500 mg:

Do not discontinue treatment before completing it, as the desired effect will not be achieved. It is very important to treat infections for the recommended time, otherwise it may worsen.

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

Like all medicines, CEFOTAXIMA TORLAN 500 mg may cause side effects, although not everyone will experience them.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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

• Flat red 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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

• Generalized red and scaly skin eruption, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular exanthema).

The following side effects have been reported according to the frequencies detailed below:

Frequent: at least 1 in 100 patients

Occasional: at least 1 in 1,000 patients

Rare: at least 1 in 10,000 patients

Very rare: less than 1 in 10,000 patients

Frequency unknown: cannot be estimated from available data

Blood and lymphatic system disorders:

Rare:Decreased white blood cell count (neutropenia) and hemolytic anemia (decreased red blood cell count).

Very rare:Decreased granulocytes (agranulocytosis), particularly if cefotaxime is administered for prolonged periods.

Frequency unknown:Eosinophilia (increased eosinophil count) and thrombocytopenia (decreased platelet count), reversible when treatment is suspended.

Immune system disorders:

Very rare:Severe skin reactions, including anaphylaxis, which can be life-threatening.

Nervous system disorders:

Occasional:At high doses, particularly in patients with renal insufficiency, encephalopathy (deterioration of consciousness, abnormal movements, and seizures) may occur.

Cardiac disorders:

Frequency unknown:Arrhythmia (abnormal heart rhythm) in the case of rapid intravenous central injection.

Gastrointestinal disorders:

Frequent:Nausea, vomiting, abdominal pain, or diarrhea.

Diarrea may be a symptom of enterocolitis (inflammation of the small intestine and colon), which may be accompanied by blood in the stool. There is a particular form of enterocolitis that can occur with antibiotics.

Hepatobiliary disorders:

Occasional:Increased liver enzymes and/or bilirubin. Hepatitis (inflammation of the liver) with yellowing of the skin, mucous membranes, or eyes.

Skin and subcutaneous tissue disorders:

Frequent:Rash, pruritus, and, less frequently, urticaria, skin irritation, and pruritus.

Frequency unknown:Vesicular eruptions (skin eruptions in the form of blisters), as with other antibiotics of this type.

Renal and urinary disorders:

Occasional:Decreased kidney function (increased creatinine) in patients receiving aminoglycoside medications concurrently.

Transient elevation of urea nitrogen has also been observed.

Very rare:Interstitial nephritis (allergic kidney inflammation).

Reproductive and breast disorders:

Occasional:Candidiasis (infection by Candida fungi), vaginitis (inflammation of the vaginal mucosa).

General disorders and administration site conditions:

Frequent:Phlebitis (inflammation of the vein wall) and pain at the injection site, which can be avoided by administering Cefotaxima TORLAN at a slower rate (3 to 5 minutes).

Other

Fever.

Especially in the case of prolonged treatment, other infections caused by organisms not sensitive to Cefotaxima TORLAN (cefotaxime) may occur.

In the case of borreliosis (infection by Borrelia), a Jarisch-Herxheimer reaction (inflammatory reaction) may occur in the first few days, and after several weeks, symptoms similar to those of the disease may appear.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Keep out of reach and sight of children.

Store in the original packaging to protect it from light.

Do not store at a temperature above 25°C.

The reconstituted solution with the solvent is stable for 3 hours at a temperature not exceeding 25°C and for 6 hours if stored in a refrigerator (2-8°C).

Do not use CEFOTAXIMA TORLAN 500 mg after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Cefotaxima TORLAN 500 mg Composition

The active ingredient is cefotaxime (as cefotaxime sodium).

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

The other components are: water for injection preparations.

Product Appearance and Packaging Contents

CEFOTAXIMA TORLAN 500 mg is presented in the form of powder, white or almost white, or slightly yellowish, and injectable solution solvent. It is presented in boxes with 1 vial with 500 mg of cefotaxima powder and 1 ampoule of 2 ml of water for injection preparations as solvent and clinical packaging with 100 vials and 100 ampoules of solvent.

Other Presentations

CEFOTAXIMA TORLAN 1.000 mg powder and injectable solution solvent for intravenous infusion EFG: box with 1 vial + 1 ampoule of 4 ml of water for injection preparations. Clinical packaging with 100 vials + 100 ampoules.

CEFOTAXIMA TORLAN 1.000 mg powder and injectable solution solvent for intramuscular infusion EFG: box with 1 vial + 1 ampoule of 4 ml of lidocaine hydrochloride solution (40 mg/4 ml). Clinical packaging with 100 vials + 100 ampoules.

CEFOTAXIMA TORLAN 2.000 mg powder and injectable solution solvent for infusion and perfusion EFG: box with 1 vial + 1 ampoule of 10 ml of water for injection preparations. Clinical packaging with 100 vials + 100 ampoules.

Only some package sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

LDP-LABORATORIOS TORLAN, S.A.

Crta de Barcelona, 135-B

08290 Cerdanyola del Vallès

Barcelona

This leaflet was approved in: April 2024

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Warning: Use exclusively by a healthcare professional

This information is intended solely for doctors or healthcare professionals:

• -Stability of reconstituted cefotaxime solution:

After reconstitution, cefotaxime can be stored for up to 3 hours at a temperature below +25° C and up to 6 hours between +2 and +8°.

The slightly yellowish color of the solution does not indicate a change in the efficacy of the antibiotic, nor in its tolerance. Solutions with yellowish or brownish color should not be administered.

The stability of the cefotaxime solution at a concentration of 1g/250 ml is satisfactory in the following infusion liquids:

• Sodium chloride 0.9%

• Glucose 5%

• Ringer's solution

• Sodium lactate

• -How to prepare this medication

Cefotaxima TORLAN 500 mg will be administered according to the following instructions:

Intravenous Route

With the cefotaxime injection, venous wall inflammation reactions and pain at the injection site have been observed, which can be prevented by administering it more slowly (3 to 5 minutes).

Recently, some cases of life-threatening arrhythmia have been reported in patients who received cefotaxime intravenously through a central venous catheter, so it is recommended to administer it intravenously slowly over 3 to 5 minutes.

For intravenous injection: Cefotaxima TORLAN 500 mg is administered intravenously slowly over 3 to 5 minutes, after dilution in solvent, directly into the vein or through the distal end of the perfusion tube, after pinching the same.

If higher doses are required or if Cefotaxima TORLAN 1.000 mg is administered more than 2 times a day, it is recommended to use the CEFOTAXIMA TORLAN 2.000 mg powder and injectable solution and perfusion solvent EFG presentation.

For intravenous perfusion: Never use the ampoule of solvent included in the packaging that contains 10 ml of water for injection preparations.

For a rapid perfusion, 2 g of Cefotaxima TORLAN will be dissolved in 40 ml of water for injection preparations or in a conventional perfusion solution and perfused over a period of 20 minutes.

For a slow perfusion, 2 g of Cefotaxima TORLAN will be dissolved in 100 ml of isotonic saline solution or glucose and perfused over 50 to 60 minutes (other perfusion solutions may also be used, except those containing sodium bicarbonate).

Intramuscular Route

For intramuscular injection, the vial of Cefotaxima TORLAN 500 mg will be dissolved in the ampoule that comes with water for injection preparations and the freshly prepared solution will be injected into the gluteal region in deep intramuscular injection. The pain resulting from intramuscular injection can be reduced by dissolving Cefotaxima TORLAN 500 mg in 4 ml of lidocaine solution 1%.

Other presentations are available on the market that contain lidocaine Cefotaxima TORLAN 1.000 mg powder and injectable solution solvent for intramuscular infusion EFG

Never administer lidocaine to children under 30 months. It is recommended not to inject more than 4 ml in each gluteal region.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/