CEFUROXIME TEVA-RATIO 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Cefuroxime Teva-ratio 500 mg Film-Coated Tablets EFG

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

Keep this package leaflet, as you may need to read it again.

• Save this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist or nurse.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

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

1. What is Cefuroxime Teva-ratio and what is it used for

Cefuroxime Teva-ratio is an antibiotic used in both adults and children. It works by eliminating the bacteria that cause infections. It belongs to a group of medications called cephalosporins.

Cefuroxime Teva-ratio is used to treat infections of:

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

Cefuroxime Teva-ratio can also be used to:

• treat Lyme disease (infection transmitted by ticks).

Your doctor may analyze the type of bacteria causing your infection and check if the bacteria are sensitive to Cefuroxime Teva-ratio during treatment.

2. What you need to know before taking Cefuroxime Teva-ratio

Do not take Cefuroxime Teva-ratio:

• If you are allergic to cefuroxime (such as axetil) or any other cephalosporin antibioticor 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 carbapenem derivatives).
• If you think this applies to you, do not take Cefuroxime Teva-ratio until you have consulted your doctor.

• 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.

Be cautious with Cefuroxime Teva-ratio

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 symptoms related to these severe skin reactions described in section 4.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cefuroxime Teva-ratio.

Children

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

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

If you need a blood test

Cefuroxime Teva-ratio 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.

Taking Cefuroxime Teva-ratio with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medication.

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

Probenecid

Oral anticoagulants

• Tell your doctor or pharmacistif you are taking any of these medications.

Contraceptive pill

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

Pregnancy, breastfeeding, and fertility

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

Your doctor will weigh the benefits of being treated with Cefuroxime Teva-ratio against the risks to your child.

Driving and using machines

Cefuroxime Teva-ratio 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.

Cefuroxime Teva-ratio contains sodium

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

3. How to take Cefuroxime Teva-ratio

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

Take Cefuroxime Teva-ratio after meals.This will help make the treatment more effective.

Swallow the Cefuroxime Teva-ratio tablets whole with water.

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

The recommended dose is:

Adults

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

Use in children

The recommended dose of Cefuroxime Teva-ratio 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 Teva-ratio is not recommended in children under 3 months, as 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 Teva-ratio than you should

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

• Do not delay. Contact your doctor immediately or go to the emergency department of the nearest hospital. If possible, show them the Cefuroxime Teva-ratio packaging.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Cefuroxime Teva-ratio

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

If you interrupt treatment with Cefuroxime Teva-ratio

Do not interrupt treatment with Cefuroxime Teva-ratio without prior advice.

It is essential to complete the entire treatment with Cefuroxime Teva-ratio.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.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Symptoms to be aware of

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

• 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).
• widespread rash, high body temperature, and swollen lymph nodes(DRESS syndrome or drug hypersensitivity syndrome).
• chest pain in the context of allergic reactions, which can be a symptom of allergy-induced myocardial infarction(Kounis syndrome).

Other symptoms to be aware of while taking cefuroxime:

• fungal infections. Medications like Cefuroxime Teva-ratio 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 an extended period.
• severe diarrhea (pseudomembranous colitis).Medications like Cefuroxime Teva-ratio 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 Cefuroxime Teva-ratio to treat Lyme disease. This is known as the 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 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaRAM.es.

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

5. Storage of Cefuroxime Teva-ratio

No special storage conditions are required.

Keep this medication out of sight and reach of children.

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

Medications should not be thrown down the drain or in the trash. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Cefuroxime Teva-ratio

• The active ingredient is cefuroxime. Each tablet contains 500 mg of cefuroxime (as axetil).
• The other components (excipients) are: pregelatinized starch (from corn), croscarmellose sodium (AC-Disol SD-711), lauryl sulfate sodium, 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, 20, or 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

Anabel Segura Street, Albatros Building B, 1st floor

28108 Alcobendas, Madrid (Spain)

Manufacturer:

Toll Manufacturing Services, S.L.

Aragoneses, 2

28108 - Alcobendas-Madrid

Spain

or

FARMALIDER S.A.

Aragoneses, 2

28108 - Alcobendas (Madrid)

Spain

or

Laboratórios Atral SA

Rua da Estação, 1 e 1A

2600-726 Castanheira do Ribatejo Portugal

Date of the last revision of this package leaflet: May 2023

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

http://www.aemps.gob.es

You can access detailed and updated information about this medication by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69956/P_69956.html.

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