PATIENT INFORMATION LEAFLET

CEFOTAXIME TORLAN 1,000 mg powder and solvent for solution for injection, intramuscular use 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 you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Cefotaxime belongs to a group of antibiotics called cephalosporins.

Cefotaxime TORLAN 1.000 mg intramuscular is indicated for infections caused by bacteria sensitive to cefotaxime, such as:

• Otorhinolaryngological infections,
• Lower respiratory tract infections, including worsening of chronic bronchitis, bacterial pneumonia,
• Renal and urinary tract infections,
• Genital infections (pelvic inflammatory disease, prostatitis, gonorrhea),
• Sepsis/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,
• Osteoarticular infections,
• Soft tissue and skin infections,
• Abdominal cavity infections (peritonitis, biliary tract infections).

Do not use CEFOTAXIMA TORLAN 1.000 mg intramuscular

• If you are allergic or have had an allergic reaction to cefotaxime, other cephalosporins, or any of the components of Cefotaxima TORLAN 1.000 mg intramuscular.
• If you are allergic or have had an allergic reaction to lidocaine or other local anesthetics of the amide type.
• If you have been diagnosed with severe heart failure or uncontrolled atrioventricular block.
• In children under 30 months.
• By intravenous route.
• 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 1000 mg or inform your doctor if any of them affect you

Be especially careful with CEFOTAXIMA TORLAN 1.000 mg intramuscular

• If you are allergic to penicillins and/or beta-lactam antibiotics. Consult your doctor if you have had an allergy to any medication before starting treatment with Cefotaxima TORLAN 1.000 mg intramuscular.
• If you have had an immediate allergic reaction to cephalosporins. In case of doubt, the first administration should be performed in the presence of a doctor.
• If you have diarrhea, especially if it is severe, persistent, and/or bloody during or after treatment with Cefotaxima TORLAN 1.000 mg intramuscular, consult your doctor as it may be a symptom of an associated disease caused by the germ Clostridium difficile.Clostridium difficile.
• Consult your doctor if you experience any discomfort, especially if you have been taking Cefotaxima TORLAN 1.000 mg intramuscular 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 inflammation in the area due to the germ Candida spp.Candidaspp.
• If you need to be treated for a period of more than 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 have any diagnostic tests (blood, 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 taking 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, 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.
• Nephrotoxic medications (which produce kidney toxicity), especially aminoglycosides, as it potentiates kidney toxicity, so your doctor should monitor your kidney function.
• Oral contraceptives, as the use of Cefotaxima TORLAN 1.000 mg intramuscular may reduce their effectiveness.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

During pregnancy, your doctor will decide whether to use this medication.

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

Driving and operating machinery

No information is available or known about how Cefotaxima TORLAN 1.000 mg intramuscular affects driving or operating machinery. Be careful not to perform tasks that require special attention until you know how you tolerate the medication.

Important information about some of the components of CEFOTAXIMA TORLAN 1.000 mg intramuscular

Patients with low-sodium diets should note that this medication contains 50.5 mg (2.20 mmol) of sodium per dose.

Cefotaxima TORLAN 1.000 mg intramuscular contains lidocaine to increase local tolerance of intramuscular administration, so it should not be used intravenously or in patients with a history of allergy to lidocaine.

Follow exactly the administration instructions for CEFOTAXIMA TORLAN 1.000 mg intramuscular indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

This medication, Cefotaxima TORLAN 1.000 mg intramuscular, will be administered to you via intramuscular injection

Remember that administration should be performed by medical personnel.

Your doctor will inform you of the duration of treatment with Cefotaxima TORLAN 1.000 mg intramuscular, 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.

The normal dose is:

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

In severe cases, the daily dose may be increased up to 12 g. If the dose is greater than 2g, it is recommended to administer the intravenous injection with water for injection or perfusion solvents. 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.

There are other presentations more suitable depending on the dose.

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 1.000 mg intramuscular is too strong or too weak, inform your doctor or pharmacist.

If you use more CEFOTAXIMA TORLAN 1.000 mg intramuscular 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. Phone 91 562 04 20 indicating the medication and the amount used.

If you forgot to use CEFOTAXIMA TORLAN 1.000 mg intramuscular

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 medications, CEFOTAXIMA TORLAN 1.000 mg intramuscular may cause adverse effects, although not all people will experience them.

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

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

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

Generalized, red, 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 adverse effects have been reported according to the frequencies detailed below:

Frequent: at least 1 in 100 patients

Infrequent: 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

Immune system disorders:

Very rare:allergic reactions in the skin and severe allergic reaction that may include difficulty breathing and even loss of consciousness (anaphylaxis) that may lead to anaphylactic shock (severe allergic reaction that may put your life at risk).

Skin and subcutaneous tissue disorders:

Frequent:eruption (exanthema), itching (pruritus), and with less frequency, rashes, skin irritation, and itching (urticaria).

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

Cardiac disorders:

Frequency unknown:arrhythmia (changes in the heart rate rhythm) in the case of rapid central intravenous administration.

Gastrointestinal disorders:

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

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

Hepatobiliary disorders:

Infrequent:increased liver enzymes and/or bilirubin. Hepatitis (inflammation of the liver) with yellow discoloration of the skin, mucous membranes, or eyes.

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 cefotaxima is administered for prolonged periods.

Frequency unknown:eosinophilia (increased eosinophils) and thrombocytopenia (decreased platelet count), reversible rapidly when treatment is suspended.

Renal and urinary disorders:

Infrequent:kidney function impairment (increased creatinine) especially if treated simultaneously with a type of medication called aminoglycosides.

A transient elevation of urea nitrogen has also been observed.

Very rare:interstitial nephritis (allergic kidney inflammation).

Reproductive and mammary disorders:

Infrequent:candidiasis (infection by Candida fungus), vaginitis (inflammation of the vaginal mucosa).

Nervous system disorders:

Infrequent:at high doses, particularly in patients with renal insufficiency, encephalopathy (deterioration of consciousness, abnormal movements, and convulsions) may appear.

Other:

Fever.

Especially in the case of prolonged treatment, other infections due to non-sensitive organisms to Cefotaxima TORLAN (cefotaxima) may appear.

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

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, 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 1.000 mg intramuscular after the expiration date appearing 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 point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Cefotaxima TORLAN 1.000 mg intramuscular Composition

The active ingredient is cefotaxime (as cefotaxime sodium).

Each vial contains 1.000 mg of cefotaxime (as cefotaxime sodium).

Each ampoule of lidocaine solution contains 40 mg of lidocaine hydrochloride.

The other components are: water for injection preparations.

Product appearance and packaging contents

Cefotaxima TORLAN 1.000 mg intramuscular 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 1.000 mg of cefotaxime powder and 1 ampoule of 4 ml of lidocaine hydrochloride (40mg/4ml) as solvent and clinical packaging with 100 vials and 100 ampoules of solvent.

Other presentations

Cefotaxima TORLAN 500 mg powder and injectable solution solvent EFG: box with 1 vial + 1 ampoule of 2 ml of water for injection preparations. Packaging with 100 vials + 100 ampoules.

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

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

Only some package sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

LDP-LABORATORIOS TORLAN, S.A.

Barcelona Highway, 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:

How to prepare this medication

You will be administered Cefotaxima TORLAN 1.000 mg intramuscular according to the following instructions:

For intramuscular injection, the vial of Cefotaxima TORLAN 1.000 mg intramuscular will be dissolved in the ampoule accompanying the lidocaine hydrochloride 1% solution and the freshly prepared solution will be injected into the gluteal region in deep intramuscular injection. As it contains lidocaine, the intravenous administration of Cefotaxima TORLAN 1.000 mg intramuscular is not permitted.

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

If the dose is greater than 2g, or if Cefotaxima TORLAN 1.000 mg intramuscular is administered more than 2 times a day, it is recommended to use the CEFOTAXIMA TORLAN 2.000 mg powder and injectable solution and for perfusion EFG presentation.

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/