Cefuroxime Kern Pharma 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cefuroxime Kern Pharma 500 mg film-coated tablets EFG

Read the entire 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, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Cefuroxime Kern Pharma is and what it is 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 are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, frequency, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Cefuroxime Kern Pharma is used to treat infections of:

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

Cefuroxime Kern Pharma may also be used to:

• treat Lyme disease (an infection transmitted by ticks).

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

Do not take Cefuroxime Kern Pharma:

• If you are allergic (hypersensitive) to cephalosporins or 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 mouth ulcers after treatment with cefuroxime or any other cephalosporin antibiotic.

• If you consider this applies to you, do not take Cefuroxime Kern Pharma until you have consulted with your doctor.

Take special care 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 during treatment with cefuroxime. Seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Warnings and precautions

Talk to your doctor or pharmacist before taking Cefuroxime Kern Pharma.

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

You should be alert to certain symptoms such as allergic reactions, fungal infections (such as Candida), and severe diarrhoea (pseudomembranous colitis) while taking Cefuroxime. This will help reduce the risk of possible complications. See “Symptoms to which you should pay attention” in section 4.

If you need blood tests

Cefuroxime Kern Pharma may affect test results for blood sugar levels or the Coombs test. If you need a blood test:

• Inform the person performing the test that you are taking cefuroxime.

Taking Cefuroxime Kern Pharmawith other medicines

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

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

Probenecid

Oral anticoagulants:

? Inform your doctor or pharmacist if you are taking any medicine of this type.

Oral contraceptives

Cefuroxime may reduce the effectiveness of oral contraceptives. If you are taking oral contraceptives while using 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 might be pregnant, or are planning to become pregnant.
• If you are breastfeeding.

Your doctor will assess the benefit of treatment with Cefuroxime against the potential risk to your child.

Driving and using machines

Cefuroxime may cause dizziness and provoke other adverse effects that could impair your ability to remain alert.

? Do not drive or operate machinery if you do not feel well.

3. How to take Cefuroxima Kern Pharma

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

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

Swallow the Cefuroxima Kern Pharma tablets whole with water.

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

Recommended dose

Adults

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

Children

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

• the severity and type of infection

Cefuroximais not recommended in children under 3 months of age, as the safety and efficacy in this patient group are unknown.

Depending on the illness and how you or your child responds to treatment, the initial dose may be adjusted or more than one treatment course may be required.

Patients with kidney problems

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

? Consult your doctor if you are affected by this condition.

If you take more Cefuroxima Kern Pharam than you should

If you take too much Cefuroxima Kern Pharma, you may experience neurological disturbances, particularly an increased risk of epileptic seizures (convulsions).

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

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

If you forget to take Cefuroxima Kern Pharma

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

Do not stop treatment with Cefuroxima Kern Pharma without prior advice.

It is important that you complete the full course of treatment with Cefuroxima Kern Pharma. Do not stop unless instructed by your doctor, even if you start to feel better. If you do not complete the treatment course, the infection may recur.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Symptoms you should be aware of

A small number of people who have taken cefuroxime have experienced an allergic reaction or a potentially serious skin reaction. Symptoms of these reactions include:

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

• Chest pain in the context of allergic reactions, which may be a symptom of an allergic-triggered heart attack (Kounis syndrome)

• Severe allergic reaction. Signs include itchy skin rash, swelling, sometimes of the face or mouth, causing difficulty breathing

• Skin rash, possibly causing blisters, appearing like small targets (a dark spot in the center surrounded by a lighter area, with a dark ring around the edge)

• Widespread skin rash with blisters and skin peeling. (These may be symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis)

• Fungal infections. Medicines such as cefuroxime can cause increased growth of fungi (Candida) in the body, leading to fungal infections (such as thrush). This side effect is more likely if cefuroxime has been taken for a prolonged period

• Severe diarrhea (pseudomembranous colitis). Medicines such as cefuroxime can cause inflammation of the colon (large intestine), resulting in 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 Kern Pharma to treat Lyme disease. This is known as a Jarisch-Herxheimer reaction. Symptoms usually last from a few hours to one day.

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

Common adverse effects

May affect up to 1 in 10 patients:

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

Common adverse effects that may appear in blood tests:

• increased count of a type of white blood cells (eosinophilia)
• increased levels of liver enzymes

Uncommon adverse effects

May affect up to 1 in 100 patients:

• vomiting
• skin rashes

Uncommon adverse effects that may appear in blood tests:

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

Other adverse effects

Other adverse 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 may be severe)
• high fever
• yellowing of the whites of the eyes or skin
• inflammation of the liver (hepatitis)

Adverse effects that may appear in blood tests:

• rapid destruction of red blood cells (hemolytic anemia)

• Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse 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. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cefuroxima 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 (corn starch), sodium croscarmellose (AC-Dirol SD-711), sodium lauryl sulfate, microcrystalline cellulose, anhydrous colloidal silica, hydrogenated vegetable oil, Opadry.

Appearance of the product and contents of the pack

Light blue, biconvex, film-coated tablets with a capsule-like shape.

Each carton contains 10, 15, or 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 most recent revision of this leaflet: May 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es