Leaflet: information for the user

Cefuroxima Kern Pharma 500 mg film-coated tablets

Read this leaflet carefully before you start taking this medicine,because 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 or pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before starting to take Cefuroxima Kern Pharma

3.How to take Cefuroxima Kern Pharma

4.Possible side effects

5.Storage of Cefuroxima Kern Pharma

6.Contents of the pack and additional information

Cefuroxima 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 medications called cephalosporins .

Cefuroxima Kern Pharma is used to treat infections of:

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

Cefuroxima Kern Pharma can also be used to:

• treat Lyme disease (infection transmitted by ticks).

Do not take CefuroximaKern Pharma:

• 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.

• Do not takeCefuroximaKern Pharmauntil you have consulted with your doctor.

Be especially careful with CefuroximaKern Pharma

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 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 CefuroximaKern Pharma

Cefuroximais not recommended for children under 3 months, as thesecurity and efficacy for this age group have not been established.

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

If you need blood tests

CefuroximaKern Pharmamay affect the results of blood sugar levels or theCoomb test.If you need a blood test:

• Inform the person performing the testthat you are takingcefuroxima.

Taking CefuroximaKern Pharmawith other medications

Inform your doctor or pharmacist if you aretaking, have taken recentlyor may need to take any other medication. This includes medications purchased without a prescription.

Medications used toreduce stomach acidity(e.g.antacidsfor treatingheartburn) may affect the mechanism of action ofCefuroxima.

Probenecid

Oral anticoagulants:

?Inform your doctor or pharmacistif you are taking any medication of this type.

Birth control pill

Cefuroximamay reduce the effectiveness of the birth control pill. If you are taking the birth control pill while takingCefuroximaKernPharmayou should use additional barrier methods (such as condoms). Consult your doctor.

Pregnancy, breastfeeding, and fertility

Consult your doctor before takingCefuroximaKern Pharma:

• 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 withCefuroximaagainst the risk to your child.

Driving and operating machinery

Cefuroximamay cause dizzinessand other adverse effects that may impair your ability to be alert.

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

Follow exactly the administration instructionsof this medicationindicated by your doctoror pharmacist.In case of doubt, consult your doctor or pharmacist again.

TakeCefuroximaKern Pharmaafter meals.This will help make the treatment more effective.

Swallow the tablets ofCefuroximaKern Pharmawhole with water.

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

Usual dose

Adults

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

Children

The usual dose ofCefuroximais 10 mg/kg of the child's weight (up to a maximum of 125 mg) to15 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

Cefuroximais not recommended for children under 3 months, as the safety and efficacy for this patient group is unknown.

Depending on the disease and how you or your child responds to the 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 CefuroximaKern Pharmathan you should

If you take too muchCefuroximaKern Pharmayou may experience neurological disturbances, particularly you may have a higher probability of havingseizures (epileptic attacks).

?Do not delay.Immediately contact your doctor or the emergency department of the nearest hospital. If possible, show them the packaging ofCefuroximaKern Pharma.

You can also call the Toxicological Information Service on telephone91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take CefuroximaKern Pharma

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

Do not interrupt the treatment with CefuroximaKern Pharmawithout prior advice.

It is essential that you complete the entire treatment ofCefuroximaKern Pharma.Do not interrupt it unless your doctor tells you to, even if you start to feel better. If you do not complete the treatment cycle, the infection may recur.

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

Symptoms to be aware of

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

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

Frequent side effects

May affectup to 1 in 10patients:

• fungus infections (such asCandida)
• headache
• dizziness
• diarrhea
• nausea
• stomach pain.

Frequent 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.

Rare side effects

May affectup to 1 in 100patients:

• vomiting
• skin rashes.

Rare side effects that may appear in blood tests:

• decrease in the number of platelets in the blood (cells that help blood to clot)
• decreasein 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 (colitis pseudomembranosa)
• 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

No requires special conditions for conservation.

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

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

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofCefuroximaKern Pharma

• The active ingredient is cefuroxima. Each tablet contains 500 mg of cefuroxima (as cefuroxima axetilo).
• The other components (excipients) are: pregelatinized cornstarch (cornstarch), croscarmelosa sodium (AC-Disol SD-711), sodium laurilsulfate, microcrystalline cellulose, anhydrous colloidal silica, hydrogenated vegetable oil, Opadry.

Appearance of the product and content of the packaging

Tablets coated with a clear blue film, biconvex, with a capsule shape.

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

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Last review date of this leaflet:May 2023

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es