CEFUROXIME KERN PHARMA 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Cefuroxime Kern Pharma 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 or nurse.
• 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What is Cefuroxime Kern Pharma and what is it used for

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

Antibiotics are used to treat bacterial infections and do not work for viral infections such as flu or the common cold.

It is important to follow the instructions regarding the dose, intake, and duration of treatment indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after finishing the treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

Cefuroxime Kern Pharma is used to treat infections of:

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

Cefuroxime Kern Pharma can also be used to:

• treat Lyme disease (infection transmitted by ticks).

2. What you need to know before you take Cefuroxime Kern Pharma

Do not take Cefuroxime Kern Pharma:

• If you are allergic(hypersensitive) to cephalosporinsor to any of the other components 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 a severe skin rash or skin peeling, blisters, and/or ulcers in the mouth after treatment with cefuroxime or any other cephalosporin antibiotic.

• If you think this applies to you, do not take Cefuroxime Kern Pharmauntil you have consulted your doctor.

Be careful with Cefuroxime Kern Pharma

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.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cefuroxime Kern Pharma.

Cefuroxime is not recommended for children under 3 months, as the safety and efficacy for this age group are unknown.

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

If you need a blood test

Cefuroxime Kern Pharma may affect the results of blood sugar tests or the Coomb test. If you need a blood test:

• Tell the person performing the testthat you are taking cefuroxime.

Taking Cefuroxime Kern Pharma with other medicines

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.

Medicines used to reduce stomach acidity(e.g., antacidsto treat heartburn) may affect the mechanism of action of Cefuroxime.

Probenecid

Oral anticoagulants:

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

Contraceptive pill

Cefuroxime may reduce the effectiveness of the contraceptive pill. If you are taking the contraceptive pill while taking Cefuroxime Kern Pharma, you should also use barrier contraceptive methods(such as condoms). Consult your doctor.

Pregnancy, breastfeeding, and fertility

Consult your doctor before taking Cefuroxime Kern Pharma:

• 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 Cefuroxime against the risk to your child.

Driving and using machines

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

? Do not drive or use machineryif you do not feel well.

3. How to take Cefuroxime Kern Pharma

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

Take Cefuroxime Kern Pharma after meals.This will help make the treatment more effective.

Swallow the Cefuroxime Kern Pharma tablets whole with water.

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

Usual dose

Adults

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

Children

The usual dose of Cefuroxime 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.

Cefuroxime is not recommended for children under 3 months, as the safety and efficacy for this age group are unknown.

Depending on the disease and how you or your child respond 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 Cefuroxime Kern Pharma than you should

If you take too much Cefuroxime Kern Pharma, you may experience neurological disorders, in particular, you may have a higher risk of having seizures (convulsions).

? Do not delay.Contact your doctor or the emergency department of the nearest hospital immediately. If possible, show them the Cefuroxime Kern Pharma packaging.

You can also call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Cefuroxime Kern Pharma

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

Do not interrupt treatment with Cefuroxime Kern Pharma without prior advice.

It is important that you complete the entire treatment of Cefuroxime Kern Pharma.Do not interrupt it unless your doctor tells you to, even if you have started to feel better. If you do not complete the treatment cycle, the infection may recur.

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 experienced an allergic reaction or a potentially severe skin reaction. The symptoms of these reactions include:

• widespread rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome)

• chest painin the context of allergic reactions, which can be a symptom of allergy-induced heart attack (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 Cefuroxime can cause an increase in fungal growth (Candida) in the body, leading to fungal infections (such as thrush). This side effect is more likely to occur if cefuroxime has been taken for a prolonged period

• severe diarrhea(pseudomembranous colitis). Medicines like Cefuroxime can cause inflammation of the colon (large intestine), leading to 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 Cefuroxime Kern Pharma 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 (like 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 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
• liver inflammation (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 them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es.

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

5. Storage of Cefuroxime Kern Pharma

No special storage conditions are required.

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

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

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

6. Contents of the pack and further information

Composition of Cefuroxime Kern Pharma

• The active substance is cefuroxime. Each tablet contains 500 mg of cefuroxime (as cefuroxime axetil).
• The other components (excipients) are: pregelatinized corn starch, croscarmellose sodium (AC-Disol SD-711), sodium lauryl sulfate, microcrystalline cellulose, anhydrous colloidal silica, hydrogenated vegetable oil, Opadry.

Appearance of the product and packaging contents

Light blue film-coated tablets, biconvex, capsule-shaped.

Each pack contains 10, 15, and 20 film-coated tablets.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Date of the last revision of this leaflet:May 2023

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