Cefuroxime Pensa 250 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cefuroxime Pensa 250 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 others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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 Cefuroxime Pensa is and what it is used for

Cefuroxime 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 your treatment, return it to the pharmacy for proper disposal. Medicines should not be disposed of via the sink or in household waste.

Cefuroxime 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

Cefuroxime Pensa may also be used to:

• treat Lyme disease (a tick-borne infection).

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 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 carbapenems).
• if you have ever developed severe skin rash or peeling skin, blisters and/or mouth ulcers after treatment with cefuroxime or any other cephalosporin antibiotic.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take 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 alert for certain symptoms such as allergic reactions, fungal infections (such as Candida) and severe diarrhoea (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 severe 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 used to treat heartburn) may affect the action mechanism 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 might 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 child.

Driving and using machines

Cefuroxime Pensa 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 Cefuroxime Pensa

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. 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 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 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 forgotten doses. Simply continue with your next dose as usual.

Do not stop treatment with Cefuroxime Pensa without prior advice.

It is important that you complete the full course of Cefuroxime Pensa treatment. 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 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:

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

• Skin rash, which may cause blisters, appearing as small target-like spots (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)

• 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 a few hours to one day.

• 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 a heart attack triggered by allergy (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 they are adverse effects not listed in this leaflet. You may also report them directly through 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 refers to 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 collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cefuroxima Pensa

• The active substance is cefuroxime. Each tablet contains 250 mg of cefuroxime (as cefuroxime axetil).
• The other components (excipients) are: pregelatinized corn starch (corn starch), sodium croscarmellose (AC-Dosil SD-711), sodium lauryl sulfate, microcrystalline cellulose, colloidal anhydrous silica, hydrogenated vegetable oil, Opadry.

Appearance of the product and contents of the pack

Light blue, film-coated, biconvex, capsule-shaped tablets. Each box 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 of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es