CEFUROXIME CODRAMOL 250 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Cefuroxime Codramol 250 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 Codramol and what is it used for
2. What you need to know before you take Cefuroxime Codramol
3. How to take Cefuroxime Codramol
4. Possible side effects
5. Storage of Cefuroxime Codramol
6. Contents of the pack and other information

1. What is Cefuroxime Codramol and what is it used for

Cefuroxime Codramol 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.

Cefuroxime Codramol is used to treat infections of:

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

Cefuroxime Codramol can also be used to:

• treat Lyme disease (an infection transmitted by ticks).
• Your doctor may analyze the type of bacteria causing your infection and check if the bacteria are sensitive to Cefuroxime Codramol during treatment.

2. What you need to know before you take Cefuroxime Codramol

Do not take Cefuroxime Codramol:

• If you are allergicto cefuroxime (such as axetil) or to any other cephalosporin antibiotic or 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 think this applies to you, do not take Cefuroxime Codramol until you have consulted your doctor.
• If you have ever developed a severe skin rash or peeling of the skin and/or mouth ulcers after treatment with cefuroxime or any other cephalosporin antibiotic.

Be cautious with Cefuroxime Codramol

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 immediate medical attention 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 Codramol.

Cefuroxime Codramol is not recommended for children under 3 monthsas 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 Codramol. This will reduce the risk of possible complications. See “Symptoms to be aware of”in section 4.

If you need a blood test

Cefuroxime Codramol may affect the results of blood sugar tests or the Coombs test. If you need a blood test:

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

Other medicines and Cefuroxime Codramol

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., antacidsfor treating heartburn) may affect the action of Cefuroxime Codramol.

Probenecid

Oral anticoagulants

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

Contraceptive pill

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

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

Check with your doctorthat Cefuroxime Codramol is suitable for you.

3. How to take Cefuroxime Codramol

Always take this medicine exactly as your doctor or pharmacist has told you.If you are not sure, check with your doctor or pharmacist.

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

Swallow the Cefuroxime Codramol tablets whole with water.

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

Recommended dose

Adults

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

Children

The recommended dose of Cefuroxime Codramol 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 Codramol 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 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 Cefuroxime Codramol than you should

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

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Cefuroxime Codramol

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

If you stop taking Cefuroxime Codramol

Do not stop taking Cefuroxime Codramol without prior advice.

It is important that you complete the entire treatment of Cefuroxime Codramol.Do not stop 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.

If you have any further questions on 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 serious 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 peeling of the skin. (These can be symptoms of Stevens-Johnson syndromeor toxic epidermal necrolysis)
• widespread rash, high body temperature, and swollen lymph nodes(DRESS or drug hypersensitivity syndrome)
• chest pain in the context of allergic reactions, which can be a symptom of allergy-induced heart attack (Kounis syndrome)

Other symptoms to be aware of while taking cefuroxime:

• fungal infections. Medicines like Cefuroxime Codramol 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 Codramol 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 Codramol to treat Lyme disease. This is known as a 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 10 people:

• 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 100 people:

• vomiting
• skin rashes

Uncommon side 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 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 they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es.

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

5. Storage of Cefuroxime Codramol

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 which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cefuroxime Codramol

• The active substance is cefuroxime. Each tablet contains 250 mg of cefuroxime (as cefuroxime axetil).

The other ingredients (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, or 20 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Farmalider, S.A.

C/ La Granja, 1 3ª Planta

1. Alcobendas. Madrid

Spain

Manufacturer:

Farmalider, S.A.

C/ Aragoneses 2

28108 Alcobendas

Madrid

or

Laboratorios Atral, S.A.

Rua da Estação 1 e 1A

2600-726 Castanheira do Ribatejo

Portugal

or

Toll Manufacturing Services, S.L.

C/ Aragoneses, 2

28108 Alcobendas

Madrid

Date of last revision of this leaflet: February 2023

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