Cefuroxime Alter 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cefuroxime Alter 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.

Contents of the leaflet

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

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

Cefuroxime Alter 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 Alter 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 Alter may also be used to:

• treat Lyme disease (an infection transmitted by ticks).
• Your doctor may identify the type of bacteria causing your infection and monitor whether the bacteria are sensitive to Cefuroxime Alter during treatment.

2. What you need to know before taking Cefuroxima Alter

Do not take Cefuroxima Alter:

• If you are allergic to cefuroxime (as acetyl) or to any cephalosporin antibiotic, or to any of the other ingredients of this medicine (listed in section 6).
• If you have ever had a severe allergic (hypersensitivity) reaction to any other type of beta-lactam antibiotic (penicillins, monobactams, and carbapenem derivatives).
• If you think this applies to you, do not take Cefuroxima Alter 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.

Take special care with Cefuroxima Alter

Serious 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 of the symptoms related to these serious skin reactions described in section 4.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Cefuroxima Alter.

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

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

If you need a blood test

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

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

Other medicines and Cefuroxima Alter

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 for treating heartburn) may affect the action of Cefuroxima Alter.

Probenecid

Oral anticoagulants

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

Oral contraceptives

Cefuroxima Alter may reduce the effectiveness of oral contraceptives. If you are taking an oral contraceptive while using Cefuroxima Alter, you should also use barrier contraceptive methods (such as condoms). Consult your doctor.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

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

??Check with your doctor that Cefuroxima Alter is suitable for you.

3. How to take Cefuroxima Alter

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

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

Swallow the Cefuroxima Alter tablets whole with water.

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

Recommended dose

Adults

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

Children

The recommended dose of Cefuroxima Alter 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

Cefuroxima Alter is not recommended for 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 Alter than you should

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

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or 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 Alter

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

If you stop taking Cefuroxima Alter

Do not stop treatment with Cefuroxima Alter without prior advice.

It is important that you complete the full course of treatment with Cefuroxima Alter. 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 return.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets them.

Symptoms to watch for

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

• Severe allergic reaction. Signs include skin rash with itching, swelling, sometimes of the face or mouth, causing difficulty breathing
• Skin rash, possibly causing blisters, appearing as 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 peeling skin. (These may be symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis)
• Generalized 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 a heart attack triggered by allergy (Kounis syndrome)

Other symptoms to watch for while taking cefuroxime:

• Fungal infections. Medicines such as Cefuroxima Alter may 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 diarrhoea (pseudomembranous colitis). Medicines such as Cefuroxima Alter may cause inflammation of the colon (large intestine), resulting in severe diarrhoea, 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 Alter to treat Lyme disease. This is known as Jarisch-Herxheimer reaction. Symptoms usually last from several 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 people:

• fungal infection (such as Candida)
• headache
• dizziness
• diarrhoea
• 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 people:

• vomiting
• skin rashes

Uncommon adverse effects that may appear in blood tests:

• decreased number of blood platelets (cells that help blood to clot)
• decreased 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 diarrhoea (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 (haemolytic anaemia)

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can 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 Alter

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 must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cefuroxime Alter

• 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-Disol SD-711), sodium lauryl sulfate, microcrystalline cellulose, colloidal anhydrous silica, hydrogenated vegetable oil, Opadry (hydroxypropylmethylcellulose, titanium dioxide, propan-1,2-diol (propylene glycol), brilliant blue FCF, carmine, indigo).

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

Marketing Authorization Holder

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

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 the most recent revision of this leaflet: February 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