Cefuroxime Pensa 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

1. What Cefuroxima Pensa is and what it is used for

Cefuroxima Pensa is an antibiotic used in both adults and children. It works by killing 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 influenza or the common cold.

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

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

Cefuroxima Pensa 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

Cefuroxima Pensa may also be used to:

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

2. What you need to know before taking Cefuroxime Pensa

Do not take Cefuroxime Pensa:

• 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 peeling of the skin, blisters, and/or mouth ulcers after treatment with cefuroxime or any other cephalosporin antibiotic.

If you think any of the above apply to you, do not take Cefuroxime Pensa until you have consulted your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Cefuroxime Pensa.

Cefuroxime Pensa is not recommended for children under 3 months of age, as safety and efficacy have not been established in this age group.

You should be aware of certain symptoms such as allergic reactions, fungal infections (such as Candida), and severe diarrhea (pseudomembranous colitis) while taking Cefuroxime Pensa. This will help reduce the risk of possible complications. See "Symptoms to watch for" in section 4.

Take special care with Cefuroxime Pensa

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

If you need blood tests

Cefuroxime Pensa 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 Pensa with 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 for treating heartburn) may affect the action of Cefuroxime Pensa.

Probenecid

Oral anticoagulants

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

Oral contraceptives

Cefuroxime Pensa may reduce the effectiveness of oral contraceptives. If you are taking oral contraceptives while on Cefuroxime Pensa, you should also use barrier contraceptive methods (such as, for example, condoms). Consult your doctor.

Pregnancy, breastfeeding, and fertility

Consult your doctor before taking Cefuroxime Pensa:

• if you are pregnant, think you may be pregnant, or plan to become pregnant
• if you are breastfeeding.

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

Driving and using machines

Cefuroxime Pensa 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.

3. How to take Cefuroxime Pensa

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

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

Swallow the Cefuroxime Pensa tablets whole with water.

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

Usual dose

Adults

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

Children

The usual dose of Cefuroxime Pensa 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.

Cefuroxime Pensa is not recommended for children under 3 months of age, as 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 course of treatment 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 Cefuroxime Pensa than you should

If you take too much Cefuroxime Pensa, 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 Cefuroxime Pensa 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 Cefuroxime Pensa

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

Do not stop treatment with Cefuroxime Pensa without prior advice.

It is important that you complete the full course of treatment with Cefuroxime Pensa. 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 to watch for

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:

• 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 paler 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)

• Fungal infections. Medicines such as Cefuroxima Pensa 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 like Cefuroxima Pensa 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 Pensa to treat Lyme disease. This is known as a Jarisch-Herxheimer reaction. Symptoms usually last from several hours to one day.

• 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 an allergy-triggered heart attack (Kounis syndrome).

• 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
• diarrhoea
• nausea
• stomach pain.

Common adverse effects that may appear in blood tests:

• increase in the 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 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 type of adverse effect, consult your doctor or pharmacist, even if these effects are 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 Pensa

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 containers and any unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, 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 Cefuroxime Pensa

• 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, anhydrous colloidal silica, hydrogenated vegetable oil, Opadry.

Appearance of the product and contents of the pack

Film-coated tablets, light blue in colour, biconvex, capsule-shaped. Each carton contains 10, 15 or 20 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

Laboratorios Atral, S.A.

Rua de Estação, 42

Vala do Carregado, 2600-726 Castanheira do Ribatejo

Portugal

or

Toll Manufacturing Services, S.L.

c/Aragoneses, 2

28108 Alcobendas (Madrid)

or

Farmalider, S.A.

c/Aragoneses, 2

28108 Alcobendas (Madrid)

Date of the most recent review of this leaflet: February 2023

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