CEFUROXIME KRKA 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Cefuroxima Krka 500 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Cefuroxima Krka is an antibiotic used in adults, adolescents, and children over 40 kg. It works by killing the bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Cefuroxima Krka is used to treat infections of:

• throat
• nasal sinuses
• middle ear
• lungs or chest
• urinary tract
• skin and its structures.

Cefuroxima Krka is also used to:

• treat Lyme disease (infection transmitted by ticks).

2. What you need to know before you start taking Cefuroxima Krka

Do not take Cefuroxima Krka

• If you are allergicto cefuroxime, to cephalosporin antibioticsor 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 carbapenem derivatives).
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth ulcers after treatment with cefuroxime or any other cephalosporin antibiotic.

If you think this applies to you, do not take Cefuroxima Krkauntil you have consulted your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cefuroxima Krka

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

You should be alert to certain symptoms such as allergic reactions, fungal infections (such as Candida), and severe diarrhea (pseudomembranous colitis) while taking Cefuroxima Krka. This will reduce the risk of possible complications. See “Symptoms to be aware of” in section 4.

If you need a blood test

Cefuroxima Krka may affect the results of blood sugar tests or the Coomb test.

If you need a blood test, inform the person performing the testthat you are taking cefuroxime.

Other medicines and Cefuroxima Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription.

Tell your doctor or pharmacistif you are taking:

• Medicines used to reduce stomach acidity(e.g., antacids to treat heartburn) may affect the mechanism of action of Cefuroxima Krka,

• probenecid,

• oral anticoagulants.

Using Cefuroxima Krka with food and drinks

Take Cefuroxima Krka after food.This will help the treatment to be more effective.

Pregnancy, breastfeeding, and fertility

Consult your doctor before taking Cefuroxima Krka:

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

Your doctor will weigh the benefits of being treated with Cefuroxima Krka against the risks to your child.

Driving and using machines

Cefuroxima Krka may cause dizzinessand cause other side effects that may impair your ability to be alert.

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

Cefuroxima Krka contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose unit; it is essentially "sodium-free".

3. How to take Cefuroxima Krka

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Take Cefuroxima Krka after meals. This will help the medicine to be more effective. Swallow the Cefuroxima Krka tablets whole with water.

Do not chew, crush, or divide the tablets– this may make the treatment less effective.

Usual dose

Adults, adolescents, and children (≥40 kg)

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

Use in children

Children

Cefuroxima Krka is not suitable for the treatment of children under 40 kg.

The usual dose of Cefuroxima Krka is 10 mg/kg of the child's weight (up to a maximum of 125 mg) to 15 mg/kg of the child's weight (up to a maximum of 250 mg) twice a day, depending on:

• the severity and type of infection

Depending on the disease and how you or your child responds to treatment, the initial dose may be adjusted or it may be necessary to administer more than one treatment cycle.

Patients with kidney problems

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

Consult your doctorif you are affected by this problem.

If you take more Cefuroxima Krka than you should

If you take too much Cefuroxima, you may experience neurological disorders, in particular, you may have a higher probability of having epileptic seizures (convulsions).

Do not delay. Contact your doctor or the emergency department of the nearest hospital immediately. If possible, show them the package of this medicine.

In case someone has ingested many tablets at once or if you think a child has ingested some, inform your doctor directly or go to the emergency department of the nearest hospital or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Cefuroxima Krka

Do not take a double dose to make up for forgotten doses. Simply continue with the next dose as usual.

If you stop taking Cefuroxima Krka

Do not stop taking Cefuroxima Krka without prior indication. It is important that you complete the entire treatment of Cefuroxima Krka. Do not interrupt it unless your doctor indicates it, even if you have started to feel better. If you do not complete the treatment cycle, the infection may recur.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Symptoms to be aware of

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

• widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).
• chest pain in the context of allergic reactions, which can be a symptom of allergy-induced myocardial infarction (Kounis syndrome).
• severe allergic reaction. The signs include skin rash with itching, swelling, sometimes of the face or mouth, causing difficulty breathing.
• skin rash,which can cause blisters,resembling small targets(dark spot in the center surrounded by a lighter area, with a dark ring around the edge).
• widespread skin rashwith blisters and skin peeling.(These can be symptoms of Stevens-Johnson syndromeor toxic epidermal necrolysis)
• fungal infections.Medicines like Cefuroxima Krka can cause an increase in fungal growth (Candida) in the body, which can lead to fungal infections (such as thrush). This side effect is more likely to occur if you have taken Cefuroxima Krka for a prolonged period.
• severe diarrhea (pseudomembranous colitis).Medicines like Cefuroxima Krka can cause inflammation of the colon (large intestine), which produces severe diarrhea, usually accompanied by blood and mucus, stomach pain, and fever.
• Jarisch-Herxheimer reaction.Some patients may experience an increase in body temperature (fever), chills, headache, muscle pain, and skin rash while taking Cefuroxima Krka to treat Lyme disease. This is known as Jarisch-Herxheimer reaction.The symptoms usually last from a few hours to a day.

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

Common side effects

May affect up to 1 in 10patients:

• fungal infection (such as Candida)
• headache
• dizziness
• diarrhea
• nausea
• stomach pain.

Common side effects that may appear in blood tests:

• increase in the count of a type of white blood cell (eosinophilia)
• increase in liver enzyme levels.

Uncommon side effects:

May affect up to 1 in 100patients:

• vomiting
• skin rashes.

Uncommon side effects that may appear in blood tests:

• decrease in the number of platelets in the blood (cells that help blood to clot)
• decrease in the number of white blood cells
• positive Coomb test.

Other side effects

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

• severe diarrhea (pseudomembranous colitis)
• allergic reactions
• skin rashes (which can be severe)
• high fever
• yellowing of the whites of the eyes or skin
• inflammation of the liver (hepatitis).

Side effects that may appear in blood tests:

• Rapid destruction of red blood cells (hemolytic anemia).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website (www.aemps.gob.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cefuroxima Krka

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

Do not use this medicine after the expiry date which is stated on the carton, after “EXP”. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cefuroxima Krka

• The active substance is cefuroxime.

Each tablet contains 500 mg of cefuroxime, equivalent to 601.43 mg of cefuroxime axetil.

• The other ingredients are: microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, anhydrous colloidal silica, calcium stearate, calcium carbonate, and crospovidone (Type A) in the core and hypromellose (6 cp), titanium dioxide (E171), propylene glycol, and brilliant blue FCF (E133) in the coating.

Appearance of the product and pack contents

Film-coated tablets with a capsule shape, biconvex, blue in color, marked with “203” on one side and smooth on the other side. The size is 19.1 mm x 9.1 mm.

It is available in packs containing 8, 10, 12, 14, 15, 16, 20, or 24 film-coated tablets in blisters.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto,

Šmarješka cesta 6,

8501 Novo mesto, Slovenia

You can obtain further information on this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L.

C/ Anabel Segura, 10,

28108 Alcobendas, Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:August 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (www.aemps.gob.es).