Package Insert: Information for the Patient

Cefuroxima Sandoz 500 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Cefuroxima is an antibiotic used in adults and children. It acts by eliminating the bacteria that cause infections. It belongs to a group of medications called cephalosporins .

Cefuroxima is used to treat infections of:

• throat,
• nasal sinuses,
• middle ear,
• lungs or chest,
• urinary tract,
• skin and soft tissues.

Cefuroxima may also be used:

• to treat Lyme disease (a disease transmitted by parasites called ticks).

Do not take Cefuroxima Sandoz:

• if you are allergicto cefuroxima or to anycephalosporin antibioticor 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 type of beta-lactam antibiotic (penicillins, monobactam, 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.

?If you think this applies to you,do not take cefuroximauntil you have consulted your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take cefuroxima.

Cefuroxima is not recommended for use in children under 3 months, as its safety and efficacy have not been established in this age group.

While taking cefuroxima, be aware of symptoms such as allergic reactions, fungal infections (such ascandida) and severe diarrhea (pseudomembranous colitis). This will reduce the risk of possible complications. See “Symptoms to be aware of” in section 4.

Be especially careful with Cefuroxima Sandoz

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

If you need a blood test

Cefuroxima may affect the results of a test to determine blood glucose levels, or a test calledCoomb test.

If you need a blood test:

?Inform the person performing the testthat you are taking cefuroxima.

Other medicines and Cefuroxima Sandoz

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

This includes medicines that can be purchased without a prescription.

Medicines used toreduce the amount of acid in your stomach(such asantacidsused to treatheartburn) may affect the functioning of cefuroxima.

Probenecid

Oral anticoagulants

?Consult your doctor or pharmacistif you are taking any of these types of medicines.

Pregnancy, breastfeeding and fertility

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

Your doctor will consider the benefits of treating you with cefuroxima against the risk to your baby.

Driving and operating machinery

Cefuroximamay cause dizzinessand other adverse effects that make you less alert.

?Do not drive or operate machineryif you are not feeling well.

Cefuroxima Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

Take cefuroxima after meals. This will help make the treatment more effective.

Swallow cefuroxima tablets with some water.

Do not chew, crush, or break the tablets; this may make the tablets difficult to swallow and the treatment less effective.

The recommended dose is:

Adults

The usual dose of cefuroxima is 250 mg to 500 mg, twice a day, depending on the severity and type of infection.

Use in children and adolescents

The usual dose of cefuroxima is 10 mg/kg of child's weight (up to a maximum of 125 mg) to 15 mg/kg of child's weight (up to a maximum of 250 mg) twice a day, depending on the severity and type of infection.

Do not use cefuroxima in children under 3 months, as its safety and efficacy in this age group are unknown.

Depending on the disease and how you or your child responds to treatment, the initial dose may be changed or more than one treatment cycle may be needed.

Patients with kidney problems

If you have kidney problems, your doctor may change your dose.

?Inform your doctorif this affects you.

If you take more Cefuroxima Sandoz than you should

If you take too much cefuroxima, you may experience neurological disturbances, particularly an increased risk ofhaving seizures(convulsions).

?Do not delay. Contact your doctor or pharmacist immediately, go to the nearest emergency serviceor call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount useda.If possible, show them the Cefuroxima Sandoz packaging.

If you forget to take Cefuroxima Sandoz

Do not take a double dose to make up for the missed doses. Take the next dose at the usual time.

If you interrupt treatment with Cefuroxima Sandoz

Do not stop taking Cefuroxima Sandoz without prior advice.

It is essential that you complete the full treatment of Cefuroxima Sandoz.Do not stop taking it at least until your doctor advises you, even if you are already feeling better. If you do not complete the entire treatment, the infection may recur.

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

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

Stop taking cefuroxime and seek medical attention immediately if you notice any of the following symptoms:

• Flat red patches, in the shape of a target or circles, 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).
• A red, scaly, and widespread rash with bumps under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular exanthema).

Symptoms to be aware of

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

• Severe allergic reaction. Signs includeskin rash and itching, swelling, sometimes of the face or mouth causingdifficulty breathing,
• 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).

Other symptoms to be aware of while taking cefuroxime, may include:

• Fungal infections. Medicines like cefuroxime can cause a proliferation of fungi (Candida) in the body that can lead to fungal infections (such asvaginal candidiasis). This side effect is more frequent if you take cefuroxime for a long time,
• Severe diarrhea(clostridioides difficile). Medicines like cefuroxime can cause inflammation of the colon (large intestine), causing severe diarrhea, usually with blood and mucus, stomach pain, and fever,
• Jarisch-Herxheimer reaction. Some patients may experience high body temperature (fever), chills, headache, muscle pain, and skin rash while being treated with cefuroxime for Lyme disease. This is known as theJarisch-Herxheimer reaction. Symptoms usually last a few hours or up to a day.

?Contact your doctor immediately if you have any of these symptoms.

Common side effects

May affectup to 1 in 10people:

• Fungal infections (such asCandida),
• Headache,
• Dizziness,
• Diarrhea,
• Unpleasant sensation,
• Stomach pain.

Common side effects that may appear in blood tests:

• Increased levels of a type of white blood cell (eosinophilia),
• Increased levels of liver enzymes.

Uncommon side effects

May affect up to1 in 100people

• Nausea,
• Skin eruptions.

Uncommon side effects that may appear in blood tests:

• Decreased number of platelets in the blood (cells that help blood to clot),
• Decreased number of white blood cells,
• Positive Coomb's test.

Other side effects

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

• Severe diarrhea (clostridioides difficile),
• Allergic reactions,
• Skin reactions (which can be severe),
• High body temperature (fever),
• Yellowing of the white part of the eyes or skin,
• Inflammation of the liver (hepatitis).

Side effects that may appear in blood tests:

• Red blood cells that are destroyed very quickly (hemolytic anemia).

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 prospectus. You can also report them directly through the Spanish System for the 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.

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

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

Store in the original packaging to protect it from moisture.

This medication does not require any special storage temperature.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers 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 containers and medicines you no longer need. By doing so, you will help protect the environment.

Cefuroxima Sandoz Composition

• The active ingredient is cefuroxime. Each tablet contains 601.44 mg of cefuroxime axetil (equivalent to 500 mg of cefuroxime).
• The other components (excipients) are: sodium lauryl sulfate, copovidone, croscarmellose sodium (E468), magnesium stearate (E470B), anhydrous colloidal silica (E551), granulated mannitol (E421), microcrystalline cellulose (E460), crospovidone (E1202), talc (E553B), mannitol (E421), hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide (E171).

Product Appearance and Packaging Content

White to slightly yellowish, biconvex, and oblong coated tablets.

It is presented in carton packaging with blister(s) or strip(s) containing 8, 10, 12, 14, 15, 16, 20, 24, and 500 coated tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer:

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible Manufacturer

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

AustriaCefuroxim Sandoz 500 mg – Filmtabletten

BelgiumCefuroxim Sandoz 500 mg omhulde tabletten

Czech RepublicXorimax 500 mg potahované tablety

HungaryXorimax 500 mg bevont tabletta

LithuaniaXorimax 500 mg dengtos tabletes

LatviaXorimax 500 mg apvalkotas tabletes

NetherlandsCefuroximaxetil 500, omhulde tabletten 500 mg

PolandXorimax 500

SlovakiaXorimax 500 mg

Last review date of this leaflet:October2021

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/