Prospect: information for the user

Cefuroxima Normon 250 mg powder and solvent for injectable solution EFG

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor, pharmacist, or nurse.

-If you experience adverse effects, consult your doctor or nurse, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to use Cefuroxima Normon

3.How to use Cefuroxima Normon

4.Possible adverse effects

5Storage of Cefuroxima Normon

6. Contents of the package and additional information

Cefuroxima Normon is an antibiotic used in both adults and children. It works by eliminating the bacteria that cause infections. It belongs to the group of medications known ascephalosporins.

Cefuroxima Normon is used to treat infectionsof:

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

Cefuroxima Normon is also used for:

• preventing infections during surgical procedures.

Do not use Cefuroxima Normon:

• If you are allergic(hypersensitive)to cephalosporinsor to any of the other components of this medication (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 cefuroxima or any other cephalosporin antibiotic.

Be especially careful with Cefuroxima Normon

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

Consult your doctor beforestarting treatment with cefuroxima; if you consider this may affect you, this medication should not be administered to you.

Warnings and precautions

You should be aware of certain symptoms such as allergic reactions and gastrointestinal disturbances, like diarrhea, while receiving cefuroxima. This will reduce the risk of possible complications. See (“Symptoms to be aware of”) in section 4. If you have had any allergic reaction to other antibiotics, such as penicillin, you may also be allergic to cefuroxima.

If you need blood or urine tests

Cefuroxima may affect the results in the determination of sugar in urine and blood (Coombs test). If you are undergoing tests:

Inform the person taking the samplethat you are receiving cefuroxima.

Use of Cefuroxima Normon with other medications

Inform your doctor or pharmacist if you are taking another medication, if you have taken recently or may have to take any other medication.

Some medications may affect the way cefuroxima acts, or make it more likely that you may have adverse effects. These include:

• aminoglycoside antibiotics,
• “urine-voiding” medications (diuretics), such as furosemide,
• probenecid,
• oral anticoagulants.

Consult your doctorif you think this may affect you. You may need additional reviews to monitor renal function while taking cefuroxima.

Birth control pill

Cefuroxima may reduce the effectiveness of the birth control pill. If you are taking the birth control pill while being treated with cefuroxima, you should use additional barrier methods (such as condoms). Ask your doctor for advice.

Pregnancy, breastfeeding, and fertility

Inform your doctor before being treated with cefuroxima:

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

Your doctor will assess the benefit of being treated with cefuroxima against the risk to your child.

Driving and operating machinery

Do not drive or operate machinery if you are not feeling well.

Cefuroxima Normon contains sodium

This medication containsless than 23 mg of sodium (1 mmol) per vial; this is,essentially “sodium-free”.

Two vials of this medication contain 28 mg of sodium(main component of table salt/for cooking). This is equivalent to 1.4 % of the recommended daily maximum sodium intake for an adult.

Cefuroxima is usually administered by a doctor or nurse..It can be administered throughintravenous injectiondirectly into a vein or into a muscle.

The normal dose

Your doctor will decide on the optimal dose of cefuroxima for you, based on:

Newborns (0 - 3 weeks)

For each kilogram of the newborn's weight,30 to100 mg of cefuroxima will be administered per day, divided into two or three doses.

Infants (over 3 weeks) and children

For each kilogram of the baby's or child's weight,30 to100 mg of cefuroxima will be administered per day, divided into three or four doses.

Adults and adolescents

750 mg to 1,500 mg of cefuroxima sodium twice, three or four times a day.

Patients with kidney problems

If you have a kidney problem, your doctor may adjust your dose.Consult with your doctorif you are affected by this problem.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Symptoms to be aware of

A small number of people who received cefuroxime presented an allergic reaction or a potentially severe skin reaction. The symptoms of these reactions include:

• Generalized rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Chest pain in the context of allergic reactions, which can be a symptom of an allergic-induced heart attack (Kounis syndrome).

• Severe allergic reaction. The signs includeskin rash with itching, swelling, sometimes on the face or mouth, causingdifficulty breathing,
• Skin rash,which may causeblistering,appearing assmall dots(dark spot in the center surrounded by a lighter area, with a dark ring around the edge),
• Widespread skin rash,withblistering and skin peeling.(These may be symptoms ofStevens-Johnson syndromeortoxic epidermal necrolysis),
• Fungal infectionsin rare cases, medicines like cefuroxime can cause an overgrowth of fungi (Candida) in the body that may lead to fungal infections (such as mouth ulcers). This side effect is more likely to occur 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 side effects

May affectup to 1 in 10 people:

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

Contact your doctorif you experience any of these symptoms.

Frequent side effects that may appear in blood tests:

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

Frequent side effects

May affectup to 1 in 100 people:

• Skin rash, itching, hives,
• Diarrhea, nausea, stomach pain.

Contact your doctorif you experience any of these symptoms.

Frequent side effects that may appear in blood tests:

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

Other side effects

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

• Fungal infections,
• High temperature (fever),
• Allergic reactions,
• Colon inflammation (large intestine), causing diarrhea, usually with blood and mucus,
• Stomach pain,
• Inflammation in the kidneys and blood vessels,
• Rapid destruction of red blood cells (hemolytic anemia),
• Skin rash, which may cause blistering, appearing as small dots (dark spot in the center surrounded by a lighter area, with a dark ring around the edge) erythema multiforme.

Contact your doctorif you experience any of these symptoms.

Frequent side effects that may appear in blood tests:

• Decreased platelet count in the blood (cells that help blood to clot - thrombocytopenia),
• Increased levels of urea nitrogen and creatinine in the blood.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: https//www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Maintain this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Store below 25 °C.

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

For the storage conditions of the reconstituted/diluted powder, see “INFORMATION FOR THE HEALTHCARE PROFESSIONAL” at the end of the leaflet.

Medicines should not be disposed of through the drains or in the trash. Deposit the containers and medicines that you do not need in the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines that you do not need. In this way, you will help protect the environment.

Cefuroxima Normon Composition

The active ingredient is cefuroxime sodium.

Each vial of 250 mg contains 271 mg of cefuroxime sodium equivalent to 250 mg of cefuroxime.

The ampoule of solvent contains water for injection preparations.

Appearance of Cefuroxima Normon and packaging contents

Cefuroxime sodium is a white or almost white powder.

It is presented in type II glass vials of 8 ml capacity, closed with a chlorobutyl rubber stopper of gray color and sealed with a "flip-off" capsule.

Packaging of 1 vial and 1 ampoule of solvent.

Marketing authorization holder and manufacturer responsible

Laboratorios Normon, S.A.

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

Last review date of this leaflet: July 2023

INFORMATION FOR THE HEALTHCARE PROFESSIONAL

Reconstitution instructions

For single use. Discard unused solution.

Intramuscular use

Add 1 ml of water for injection to cefuroxime 250 mg (see "Volumes of addition 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 injection using at least 2 ml for cefuroxime 250 mg. Gently shake to obtain a transparent solution. For intravenous infusions of short duration (e.g., up to 30 minutes) See "Volumes of addition 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 is increased by the displacement factor of the resulting drug in the listed concentrations in mg/ml.

Compatibilidad

Cefuroxima de sodio is compatible with aqueous solutions containing up to 1% of lidocaine hydrochloride.

The stability of cefuroxima de sodio in sodium chloride 0.9% solution for injection p/v and in glucose 5% solution for injection is not affected by the presence of hydrocortisone phosphate sodium.

Conservación de cefuroxima inyectable

Store below 25 °C.

Store the vial in the outer packaging to protect it from light.

Solution reconstituted: From a microbiological point of view, once opened, the product should be used immediately. If not used immediately, the storage times in use and the conditions prior to use are the responsibility of the user and should not normally be greater than 25 °C protected from light , unless the reconstitution was performed in controlled and validated conditions.

Incompatibilidades

The solutions containing cefuroxima should not be mixed with or added to solutions containing other products that are not mentioned above (See "Compatibilidad").

Cefuroxima in powder for injection should not be mixed in the same syringe with aminoglycoside antibiotics.

The pH of sodium bicarbonate injection 2.74% p/v significantly affects the color of the solutions and is therefore not recommended for the dilution of cefuroxima in powder for injection.