Prospect: information for the user

Cefoxitina NORMON 1 g powder and solvent for injectable solution and for infusion EFG

Cefoxitina (as cefoxitina sodium)

Cefoxitina belongs to a group of antibiotics known as cephalosporins.

It is indicated for the treatment of infections caused by sensitive microorganisms located in respiratory tracts, urinary tracts and genitals, abdomen, blood (septicemia), bones and joints, skin and soft tissues, burns or infected wounds, as well as for the prevention of infections in surgery.

Do not use Cefoxitina NORMON

• If you are allergic (hypersensitive) to cefoxitina or to other cephalosporins or to any of the other components of this medication (listed in section 6).

Take special care with Cefoxitina NORMON

• If you have an allergy to beta-lactam antibiotics (such as penicillin) cross-allergy may occur.
• If you experience diarrhea while receiving treatment with cefoxitina, as it may be due to a special type of colitis, called pseudomembranous colitis (inflammation of the large intestine area), which may be severe. In these cases your doctor will decide whether to discontinue cefoxitina administration and initiate appropriate treatment.
• If you have any kidney disease, your doctor may need to adjust the dose of cefoxitina you should receive.
• If you are restricted from taking salt, as each gram of cefoxitina NORMON contains 53.81 mg of sodium.
• If you are receiving long-term treatment with cefoxitina, overinfections may occur.
• If you are to undergo any blood tests, inform the healthcare staff that you are receiving this medication, as cefoxitina may interfere with the results.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Cefoxitina NORMON.

Use of Cefoxitina NORMON with other medications

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

Some medications may influence the action of others.

Cefoxitina should not be administered simultaneously with aminoglycosides (other antibiotics).

In case of doubt, consult your doctor or pharmacist.

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

In the case of breastfeeding, your doctor will decide whether to use this medication. Consult your doctor or pharmacist before using a medication.

Driving and operating machinery

Cefoxitina generally does not alter the ability to drive vehicles or operate machinery.

Cefoxitina Normon contains sodium

This medication contains 53.81 mg of sodium (2.34 mmol) (main component of table salt/for cooking) in each gram. This is equivalent to 2.69% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Cefoxitina will be administered intravenously. Remember to use your medication.

Your doctor will indicate the appropriate dose and duration of your treatment with cefoxitina. Do not suspend or prolong it, as the desired effect will not be achieved.

If you estimate that the action of this medication is too strong or weak, inform your doctor or pharmacist.

The usual dose is:

Adults:uncomplicated infections: 1 g every 6-8 hours by intravenous injection. For moderately severe or severe infections, 1 g every 4 hours or 2 g every 6-8 hours by intravenous injection is recommended. In case of life-threatening infections, 2 g every 4 hours or 3 g every 6 hours by intravenous injection may be administered.

A dose reduction may be necessary if you have any kidney disease. Inform your doctor in this case so that the dose can be adjusted accordingly.

Use in children

Children over 3 months: 80-160 mg/kg of body weight per day divided into 4-6 equal doses. In case of kidney disease, your doctor may need to reduce the dose.

Cefoxitina is not recommended for children under 3 months.

Surgical prophylaxis

Cefoxitina administration should be performed between 30 and 60 minutes before surgery, and interrupted within 24 hours. The following guidelines are recommended:

Adults:2 g by intravenous injection 30 or 60 minutes before surgery and then 2 g every 6 hours.

Children (over 3 months):30-40 mg/kg 30 or 60 minutes before surgery and then 2 g every 6 hours.

Patients undergoing cesarean section:A single dose of 2 g by intravenous injection may be administered at the time of umbilical cord ligation, or 3 doses of 2 g may be administered, with the first dose at the time of umbilical cord ligation and the remaining two doses at 4 and 8 hours after the first dose, respectively.

If you use more Cefoxitina NORMON than you should

Consult your doctor or pharmacist immediately. In case of overdose or accidental administration/ingestion, consult the Toxicological Information Service (Tel. 91 562 04 20), indicating the product and the amount administered/ingested. Bring this leaflet with you.

Information for the doctor:In case of overdose, treatment will be symptomatic and according to medical judgment. Cefoxitina is eliminated by hemodialysis.

If you forgot to use cefoxitina NORMON

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

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Frequent Adverse Effects (may affect up to 1 in 10 patients):

• Allergic Reactions:The most common manifestation is the appearance of varied skin lesions. Other possible reactions include itching, facial swelling, and difficulty breathing.
• Gastrointestinal Alterations:Nausea, vomiting, and diarrhea.

Less Frequent Adverse Effects (may affect up to 1 in 100 patients):

• Blood Alterations:Decreased levels of some blood cells, such as red blood cells and white blood cells, have been reported.

Rare Adverse Effects (may affect up to 1 in 1000 patients):

• Liver Alterations:Transient increases in liver enzymes (transaminases) have been rarely reported.
• Kidney Alterations:In some cases, increased creatinine levels in the blood have been observed, indicating kidney dysfunction.

Adverse Effects of Unknown Frequency (cannot be estimated from available data):

• CARDIOVASCULAR Alterations:Hypotension (low blood pressure).

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 86°F (30°C).

Reconstituted solutions maintain their stability for 24 hours at room temperature and for 4 days at 8°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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Cefoxitina NORMON:

• The active ingredient is cefoxitina (sodium). Each vial contains 1 g of cefoxitina (sodium). Each ampoule of solvent contains water for injection preparations.

Appearance of the product and contents of the packaging

Cefoxitina NORMON 1 g powder and solvent for injectable solution and for infusion EFG is presented in a vial with powder and solvent for injectable solution. Each package contains a vial of cefoxitina powder and an ampoule with 10 ml of injection water.

Once reconstituted with its solvent, the solution contains 100 mg of cefoxitina per ml.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

This information is intended solely for healthcare professionals:

For intravenous administration, the contents of the vial are dissolved in the 10 ml of solvent from the accompanying ampoule (water for injection). It can be administered intravenously slowly over 3 to 5 minutes, after dilution in the solvent. For continuous intravenous infusion, the resulting solution can be diluted again in a standard infusion solution (5% glucose, 0.9% sodium chloride, 5% glucose and 0.9% sodium chloride, or 5% glucose with the addition of 0.02% sodium bicarbonate).

It is not recommended to mix cefoxitina sodium with other medications.

Last review date of this leaflet: July 2022

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