Cefoxitin Normon 1 g powder and solvent for solution for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Cefoxitin (as cefoxitin sodium)

Package leaflet contents:

1. What Cefoxitin NORMON is and what it is used for
2. What you need to know before using Cefoxitin NORMON
3. How to use Cefoxitin NORMON
4. Possible side effects
5. Storage of Cefoxitin NORMON
6. Contents of the pack and other information

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

Cefoxitin belongs to a group of antibiotics known as cephalosporins.

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

2. What you need to know before starting Cefoxitin Normon

Do not use Cefoxitin NORMON

• If you are allergic (hypersensitive) to cefoxitin or to other cephalosporins or to any of the other ingredients of this medicine (listed in section 6).

Take special care with Cefoxitin NORMON

• If you are allergic to beta-lactam antibiotics (such as penicillin), cross-allergy may occur.
• If you develop diarrhea during treatment with cefoxitin, as it may be due to a special type of colitis called pseudomembranous colitis (inflammation of the large intestine), which can be severe. In such cases, your doctor will decide whether cefoxitin should be discontinued and appropriate treatment initiated.
• If you have kidney disease, your doctor may need to adjust the dose of cefoxitin you receive.
• If your salt intake is restricted, because each gram of Cefoxitin NORMON contains 53.81 mg of sodium.
• If you are undergoing prolonged treatment with cefoxitin, superinfections may occur.
• If you need to undergo blood tests, inform healthcare personnel that you are being treated with this medicine, as cefoxitin may interfere with test results.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Cefoxitin NORMON.

Use of Cefoxitin NORMON with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Some drugs may affect the action of others.

Cefoxitin must not be administered simultaneously with aminoglycosides (other antibiotics).

If in doubt, consult your doctor or pharmacist.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

During pregnancy, your doctor will decide whether it is appropriate to use this medicine.

Breastfeeding

If you are breastfeeding, your doctor will decide whether it is appropriate to use this medicine. Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Cefoxitin generally does not affect the ability to drive or operate machinery.

Cefoxitin Normon contains sodium

This medicine contains 53.81 mg of sodium (2.34 mmol) (main component of table/cooking salt) per gram. This corresponds to 2.69% of the maximum daily intake of sodium recommended for an adult.

3. How to use Cefoxitin Normon

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. Cefoxitin will be administered to you intravenously. Remember to use your medicine as prescribed.

Your doctor will determine the appropriate dose and duration of your treatment with cefoxitin. Do not stop or extend the treatment, as this may prevent the expected effect from being achieved.

If you feel that the effect of this medicine is too strong or too 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 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 kidney disease. In such case, inform your doctor so that the dose can be appropriately adjusted.

Use in children

Children over 3 months of age: 80–160 mg/kg body weight per day, divided into 4–6 equal doses. If the child has kidney disease, the doctor may need to reduce the dose.

Cefoxitin is not recommended for use in children under 3 months of age.

Surgical prophylaxis

Cefoxitin should be administered between 30 and 60 minutes before surgery and discontinued within 24 hours after surgery. The following regimens are recommended:

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

Children (over 3 months of age): 30–40 mg/kg 30 or 60 minutes before surgery, followed by 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 clamping, or alternatively, three doses of 2 g: the first administered at the time of umbilical cord clamping, followed by two additional doses of 2 g given 4 and 8 hours after the first dose, respectively.

If you use more Cefoxitin Normon than you should

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

Information for the physician: In case of overdose, treatment will be symptomatic and at the physician's discretion. Cefoxitin is removed by hemodialysis.

If you forget to use Cefoxitin Normon

Do not use a double dose to make up for missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Frequent adverse effects (may affect up to 1 in 10 patients):

• Allergic reactions: the most common are skin lesions of varying appearance. Other possible reactions include itching, facial swelling, and difficulty breathing.
• Gastrointestinal disturbances: nausea, vomiting, and diarrhoea.

Uncommon adverse effects (may affect up to 1 in 100 patients):

• Blood disorders: a reduction in certain blood cells, such as red blood cells and white blood cells, has been reported.

Rare adverse effects (may affect up to 1 in 1,000 patients):

• Liver disorders: rarely, transient increases in liver enzymes (transaminases).
• Kidney disorders: in some cases, increased blood creatinine levels have been observed, indicating impaired kidney function.

Adverse effects of unknown frequency (cannot be estimated from available data):

• Cardiovascular disorders: hypotension (low blood pressure).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cefoxitin Normon

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

Do not store above 30 ºC.

Reconstituted solutions remain stable for 24 hours at room temperature and for 4 days at 8 ºC.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be handed over to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of Cefoxitin NORMON:

• The active substance is cefoxitin (sodium). Each vial contains 1 g of cefoxitin (sodium). Each solvent ampoule contains water for injections.

Appearance of the product and contents of the container

Cefoxitin NORMON 1 g powder and solvent for injectable solution and for infusion EFG is supplied as a powder vial and a solvent ampoule for injectable solution. Each pack contains one vial of cefoxitin powder and one ampoule containing 10 ml of water for injection.

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

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

This information is intended for healthcare professionals only:

For intravenous administration, the contents of the vial should be dissolved in the 10 ml of solvent provided in the accompanying ampoule (water for injections). It may be administered by slow intravenous injection over 3 to 5 minutes, after dilution with the solvent. For continuous intravenous infusion, the resulting solution may be further diluted in a standard infusion solution (5% glucose, 0.9% sodium chloride, 5% glucose and 0.9% sodium chloride, or 5% glucose with addition of 0.02% sodium bicarbonate).

Cefoxitin sodium should not be mixed with other medicinal products.

Date of the most recent review of this summary: July 2022

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