Cefuroxime Normon 750 mg powder and solvent for injection solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cefuroxime Normon 750 mg powder and solvent for injectable solution EFG

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Cefuroxime Normon is an antibiotic used in both adults and children. It works by eliminating the bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dosage, frequency, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of down the sink or in the household waste.

Cefuroxime Normon is used to treat infections of:

• the lungs or chest,
• the urinary tract,
• the skin and soft tissues,
• the abdomen.

Cefuroxime Normon is also used to:

• prevent infections during surgical procedures.

2. What you need to know before using Cefuroxime Normon

Do not use Cefuroxime Normon:

• If you are allergic (hypersensitive) to cephalosporins or to any of the other ingredients of this medicine (listed in section 6).
• If you have ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotic (penicillins, monobactams, and carbapenems).
• If you have ever developed severe skin rash or peeling, blisters and/or mouth ulcers after treatment with cefuroxime or any other cephalosporin antibiotic.

Take special care with Cefuroxime Normon

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with cefuroxime treatment. Seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Talk to your doctor before starting treatment with cefuroxime; if you think this may affect you, Cefuroxime Normon should not be administered.

Warnings and precautions

Be alert for certain symptoms such as allergic reactions and gastrointestinal disorders, such as diarrhea, while receiving cefuroxime. This will reduce the risk of potential complications. See (“Symptoms to be aware of”) in section 4. If you have previously had an allergic reaction to other antibiotics, such as penicillin, you may also be allergic to cefuroxime.

If you need blood or urine tests

Cefuroxime may affect test results for glucose in blood and urine tests (Coombs test). If you are having tests:

Inform the person taking the sample that you are receiving cefuroxime.

Using Cefuroxime Normon with other medicines

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

Some medicines may affect how cefuroxime works, or increase the likelihood of adverse effects. These include:

• aminoglycoside antibiotics,
• "medicines used to increase urination" (diuretics), such as furosemide,
• probenecid,
• oral anticoagulants.

Consult your doctor if you think this may affect you. You may need additional monitoring to assess kidney function while taking cefuroxime.

Oral contraceptives

Cefuroxime may reduce the effectiveness of oral contraceptives. If you are taking oral contraceptives while being treated with cefuroxime, you should also use barrier contraceptive methods (such as condoms). Ask your doctor for advice.

Pregnancy, breastfeeding, and fertility

Inform your doctor before being treated with cefuroxime:

• if you are pregnant, think you may be pregnant, or plan to become pregnant,
• if you are breastfeeding.

Your doctor will assess the benefit of treating you with cefuroxime against the potential risk to your child.

Driving and use of machines

Do not drive or operate machinery if you do not feel well.

Cefuroxime Normon contains sodium

This medicine contains 42 mg of sodium (the main component of table/cooking salt) per vial. This corresponds to 2.1% of the maximum daily intake of sodium recommended for an adult.

3. How to use Cefuroxime Normon

Cefuroxime is normally administered by a doctor or nurse. It may be given as an injection directly into a vein or into a muscle.

Normal dose

Your doctor will decide the optimal dose of cefuroxime for you, based on: the severity and type of infection, whether you are being treated with other antibiotics, your weight and age, and how well your kidneys are functioning.

Newborns (0 - 3 weeks)

Per kg of the newborn's body weight, 30 to 100 mg of cefuroxime per day will be administered, divided into two or three doses.

Infants (over 3 weeks) and children

Per kg of the infant's or child's body weight, 30 to 100 mg of cefuroxime per day will be administered, divided into three or four doses.

Adults and adolescents

750 mg to 1,500 mg of cefuroxime sodium two, three, or four times a day.

Patients with kidney problems

If you have kidney problems, your doctor may adjust your dose. Consult your doctor if you are affected by this condition.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Symptoms to watch for

A small number of people who received cefuroxime have experienced an allergic reaction or a potentially serious skin reaction. Symptoms of these reactions include:

• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

• Chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (Kounis syndrome).

• Severe allergic reaction. Signs include skin rash with itching, swelling, sometimes of the face or mouth, causing difficulty breathing,

• Skin rash, possibly causing blisters, appearing as small targets (a dark spot in the center surrounded by a lighter area, with a dark ring around the edge),

• Widespread skin rash, with blisters and peeling of the skin. (These may be symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis),

• Fungal infections. Rarely, medicines such as cefuroxime may cause overgrowth of fungi (Candida) in the body, leading to fungal infections (such as thrush). This side effect is more likely if you have been treated with cefuroxime for a prolonged period.

Contact a doctor or nurse immediately if you experience any of these symptoms.

Frequent adverse effects

May affect up to 1 in 10 people:

• Pain at the injection site, swelling, and redness along the vein.

Contact your doctor if you experience any of these symptoms.

Frequent adverse effects that may appear in blood tests:

• Increase in certain substances (enzymes) produced by the liver,
• Changes in white blood cell count (neutropenia or eosinophilia),
• Low levels of red blood cells (anemia).

Uncommon adverse effects

May affect up to 1 in 100 people:

• Skin rash, itching, hives (wheals),
• Diarrhea, nausea, stomach pain.

Contact your doctor if you experience any of these symptoms.

Uncommon adverse effects that may appear in blood tests:

• Low levels of white blood cells (leucopenia),
• Increased bilirubin (a substance produced by the liver),
• Positive Coombs test.

Other adverse effects

Other adverse effects have occurred in a very small number of people, but their exact frequency is unknown:

• Fungal infections,
• High temperature (fever),
• Allergic reactions,
• Inflammation of the colon (large intestine), causing diarrhea, usually with blood and mucus,
• Stomach pain,
• Inflammation of the kidney and blood vessels,
• Rapid destruction of red blood cells (hemolytic anemia),
• Skin rash, possibly causing blisters, appearing as small targets (a dark spot in the center surrounded by a lighter area, with a dark ring around the edge) — erythema multiforme.

Contact your doctor if you experience any of these symptoms.

Adverse effects that may appear in blood tests:

• Decrease in the number of blood platelets (cells that help blood to clot — thrombocytopenia),
• Increased levels of blood urea nitrogen and serum creatinine in the blood.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cefuroxime Normon

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

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

Store below 25 °C.

Keep the vial in the outer packaging to protect from light.

For storage conditions of the reconstituted/diluted powder, see "INFORMATION FOR HEALTHCARE PROFESSIONALS" at the end of the leaflet.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cefuroxime Normon

The active substance is cefuroxime sodium.

Each 750 mg vial contains 813 mg of cefuroxime sodium equivalent to 750 mg of cefuroxime.

The solvent ampoule contains water for injections.

Appearance of Cefuroxime Normon and contents of the pack

Cefuroxime sodium is a white or almost white powder.

It is supplied in 17 ml colourless type II glass vials, closed with a grey chlorobutyl rubber stopper and sealed with a "flip-off" cap.

Pack: 1 vial and 1 solvent ampoule.

Marketing Authorization Holder and Manufacturer

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

Date of the most recent review of this leaflet: July 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging.

You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/62908/P_62908.html

INFORMATION FOR HEALTHCARE PROFESSIONALS

Reconstitution instructions

For single use only. Discard any unused solution.

Intramuscular use

Add 3 ml of solvent to cefuroxime 750 mg powder for injectable solution (see Table "Volumes to be added and concentrations of the solution, which may be useful when fractional doses are required").

Gently shake to obtain an opaque suspension.

Intravenous use

Dissolve in water for injections using at least 6 ml for cefuroxime 750 mg powder. Gently shake to obtain a clear solution.

Table: Volumes to be added and concentrations of the solution, which may be useful when fractional doses are required

** The resulting volume of the cefuroxime solution in the reconstitution medium increases by the drug displacement factor resulting in the concentrations listed in mg/mL.

Compatibility

Sodium cefuroxime is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride.

The stability of sodium cefuroxime in 0.9% sodium chloride injection solution and in 5% glucose injection solution is not affected by the presence of sodium hydrocortisone phosphate.

Storage of injectable cefuroxime:

Store below 25 °C.

Keep the vial in the outer packaging to protect from light.

Reconstituted solution: From a microbiological standpoint, once opened, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and normally should not exceed storage at temperatures above 25 °C protected from light, unless reconstitution has been carried out under controlled and validated conditions.

Incompatibilities

Solutions containing cefuroxime must not be mixed with or added to solutions containing other products not previously mentioned (see “Compatibility”).

Cefuroxime for injectable solution powder must not be mixed in the same syringe with aminoglycoside antibiotics.

The pH of 2.74% p/v sodium bicarbonate injection solution considerably affects the color of solutions; therefore, this solution is not recommended for the dilution of cefuroxime for injectable solution powder.