Leaflet: information for the user

Cefuroxima pensa 500 mg film-coated tablets

Read this 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 or pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Cefuroxima Pensa 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 calledcephalosporins.

Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or a cold.

It is essential to follow the instructions regarding the dose, administration, and duration of treatment as indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of the medication through the drain or in the trash.

Cefuroxima Pensa is used to treat infections of:

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

Cefuroxima Pensa may also be used to:

• treat Lyme disease (infection transmitted by ticks).

Do not take Cefuroxima Pensa:

• if you are allergic(hypersensitive)to cephalosporinsor 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 carbapenems).
• if you have ever developed severe skin rash or peeling, blisters, and/or mouth ulcers after treatment with cefuroxima or any other cephalosporin antibiotic

If you consider this applies to you,do not take Cefuroxima Pensauntil you have consulted with your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cefuroxima Pensa

Cefuroxima Pensa is not recommended for children under 3 months, as thesecurity and efficacy for this age group have not been established.

You should be aware of certain symptoms such as allergic reactions, fungal infections (such asCandida) and severe diarrhea (colitis pseudomembranosa) while taking Cefuroxima Pensa. This will reduce the risk of possible complications. See“Symptoms to be aware of”in section 4.

Be especially careful with Cefuroxima Pensa

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been associated with cefuroxima treatment. Seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

If you need blood tests

Cefuroxima Pensa may affect the results of blood sugar levels or theCoomb test.If you need a blood test:

• Inform the person performing the testthat you are taking cefuroxima.

Taking Cefuroxima Pensa with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes medications purchased without a prescription.

Medications used toreduce stomach acid(e.g.antacidsfor treatingheartburn) may affect the mechanism of action of Cefuroxima Pensa.

Probenecid

Oral anticoagulants

• Inform your doctor or pharmacistif you are taking any medication of this type.

Birth control pill

Cefuroxima Pensa may reduce the effectiveness of the birth control pill. If you are taking the birth control pill while taking Cefuroxima Pensa, you should use additionalbarrier methods(such as condoms). Consult your doctor.

Pregnancy, breastfeeding, and fertility

Consult your doctor before taking Cefuroxima Pensa:

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

Your doctor will assess the benefit of being treated with Cefuroxima Pensa against the risk to your child.

Driving and operating machinery

Cefuroxima Pensamay cause dizzinessand other adverse effects that may impair your ability to stay alert.

• Do not drive or operate machineryif you are not feeling well.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Swallow the Cefuroxima Pensa tablets whole with water.

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

Usual dose

Adults

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

Children

The usual dose of Cefuroxima Pensa 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

Cefuroxima Pensa is not recommended for children under 3 months, as the safety and efficacy for this patient group is 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 Cefuroxima Pensa than you should

If you take too much Cefuroxima Pensa you may experience neurological disturbances, particularly you may be more likely to haveseizures (epileptic fits).

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

You can also call the Toxicological Information Service on telephone 91 562 04 20, indicating the medication and the amount taken.

If you forgot to take Cefuroxima Pensa

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

Do not interrupt the Cefuroxima Pensa treatment without prior advice.

It is essential that you complete the entire Cefuroxima Pensa treatment.Do not interrupt it unless your doctor tells you to, even if you start feeling better. If you do not complete the treatment cycle, the infection may recur.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Symptoms to be aware of

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

• Severe allergic reaction. The signs includeskin rash with itching, swelling, sometimes on the face or mouth, causingdifficulty breathing
• Skin rash,which may causeblistering,which appear likesmall dots(dark spot in the center surrounded by a lighter area, with a dark ring around the edge)
• Widespread skin rashwithblistering and skin peeling.(These may be symptoms ofStevens-Johnson syndromeortoxic epidermal necrolysis)
• Fungal infections.Cefuroxime Pensa may cause an increase in fungal growth (Candida), in the body that may lead to fungal infections (such as mouth ulcers). This side effect is more likely to occur if cefuroxime has been taken for a prolonged period
• Severe diarrhea (Pseudomembranous colitis).Cefuroxime Pensa may cause inflammation of the colon (large intestine), which produces 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 Pensa to treat Lyme disease. This is known asJarisch-Herxheimer reaction. The symptoms usually last for a few hours to a day.

• Generalized rash,high body temperature, and swollen lymph nodes(DRESS syndrome or drug hypersensitivity syndrome).

• Chest pain in the context of allergic reactions, which may be a symptom of allergic-induced heart attack(Kounis syndrome).

• Contact a doctor or nurse immediately if you experience any of these symptoms.

Frequent side effects

May affectup to 1 in 10patients:

• Fungal infections (such asCandida)
• Headache
• Dizziness
• Diarrhea
• Nausea
• Stomach pain.

Frequent side effects that may appear in blood tests:

• Increased count of a type of white blood cell (eosinophilia)
• Increased levels of liver enzymes.

Less frequent side effects

May affectup to 1 in 100patients:

• Vomiting
• Skin rash.

Less frequent side effects that may appear in blood tests:

• Decreased number of platelets in the blood (cells that help blood to clot)
• Decreased 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 rash (which may be severe)
• High fever
• Yellowing of the white 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 type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

No special storage conditions are required.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Cefuroxima Pensa

• The active ingredient is cefuroxime. Each tablet contains 500 mg of cefuroxime (as cefuroxime axetil).

The other components (excipients) are: pregelatinized cornstarch (cornstarch), 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 packaging

Blue film-coated, biconvex, capsule-shaped tablets. Each box contains 10, 15, or 20 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

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)

Last review date of this leaflet:February 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es