Prospect: information for the user

Cefuroxima Aurovitas 500 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist or nurse.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist or nurse, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Cefuroxima Aurovitas

3.How to take Cefuroxima Aurovitas

4.Possible adverse effects

5.Storage of Cefuroxima Aurovitas

6. Contents of the package and additional information

Cefuroxima Aurovitas is an antibiotic used in both adults and children. It works by eliminating the bacteria that cause infections. It belongs to a group of medications calledcephalosporins.

Cefuroxima Aurovitas is used to treat infections of:

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

Cefuroxima Aurovitas may also be used to:

• treat Lyme disease (infection transmitted by ticks)

Your doctor may analyze the type of bacteria causing your infection and monitor whether the bacteria are sensitive to Cefuroxima Aurovitas during treatment.

Do not take Cefuroxima Aurovitas

• If you are allergictoany cephalosporin antibioticor 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 skin 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 Aurovitasuntil you have consulted with your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cefuroxima Aurovitas.

Children

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

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

Be especially careful with Cefuroxima Aurovitas:

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 Aurovitas may affect the results of blood sugar levels or theTest of Coombs. If you need a blood test:

→Inform the person performing the testthat you are taking Cefuroxima Aurovitas.

Taking Cefuroxima Aurovitas with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or would need to take any other medicine.

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

Probenecid

Oral anticoagulants

→Inform your doctor or pharmacistif you are taking any of these types of medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Consult your doctor before taking Cefuroxima Aurovitas:

• 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 Aurovitas against the risk to your child.

Driving and operating machinery

Cefuroxima Aurovitasmay cause dizzinessand other adverse effects that may impair your ability to be alert.

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

Cefuroxima Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

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 Aurovitas after meals.This will help make the treatment more effective. Swallow the Cefuroxima Aurovitas tablets whole with water.

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

Recommended dose

Adults and children with a weight of 40 kg or more

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

Children weighing less than 40 kg

Children weighing less than 40 kg should preferably be treated with oral cefuroxima suspension or in sachets.

The recommended dose of Cefuroxima Aurovitas is 10 mg/kg of the child's weight (up to a maximum of 250 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 Aurovitas is not recommended for children under 3 months,since 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 Aurovitas than you should

If you take too much Cefuroxima Aurovitas you may experience neurological disturbances, particularly you may have a higher probability of havingepileptic seizures (convulsions).

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

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

If you forgot to take Cefuroxima Aurovitas

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

If you interrupt the treatment with Cefuroxima Aurovitas

It is essential that you complete the entire Cefuroxima Aurovitas treatment.Do not interrupt 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 other doubts about the use of this medication, ask your doctor or pharmacist.

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 Cefuroxima Aurovitas experienced an allergic reaction or a potentially severe skin reaction. The symptoms of these reactions include:

• generalized eruption, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome),
• chest pain in the context of allergic reactions, which can be a symptom of an allergy-induced heart attack (Kounis syndrome),
• severe allergic reaction.The signs includeskin eruption with itching, swelling,sometimes of the face or mouth, causingdifficulty breathing,
• skin eruption,which can causeblistering,appearing assmall dots(dark spot in the center surrounded by a lighter area, with a dark ring around the edge),
• widespread skin eruptionwithblistering and skin peeling.(These can be symptoms ofStevens-Johnson syndromeortoxic epidermal necrolysis).

Other symptoms to be aware of while taking Cefuroxima Aurovitas:

• fungus infections.Medicines like Cefuroxima Aurovitas can cause an increase in the growth of fungi (Candida) in the body that can lead to fungus infections (such as mouth ulcers). This side effect is more likely to occur if Cefuroxima Aurovitas has been taken for a prolonged period,
• severe diarrhea (pseudomembranous colitis).Medicines like Cefuroxima Aurovitas can 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 eruption while taking Cefuroxima Aurovitas to treat Lyme disease. This is known as theJarisch-Herxheimer reaction. The symptoms usually last for a few hours to a day.

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

Common side effects

These may affectup to 1 in 10people:

• fungus infections (such asCandida).
• 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

These may affectup to 1 in 100people:

• vomiting
• skin eruptions

Uncommon side effects that may appear in blood tests:

• decrease in the number of platelets in the blood (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 eruptions (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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute toproviding more information about the safety of this medicine.

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.

This medication does not require special conservation conditions.

Store in the original packaging to protect from light.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

Cefuroxima Aurovitas Composition

-The active ingredient is cefuroxima

Cefuroxima Aurovitas 500 mg film-coated tablets contain 601.44 mg of cefuroxima axetil equivalent to 500 mg of cefuroxima.

-The other components (excipients) are:

Tablet core:microcrystalline cellulose (E460), croscarmellose sodium, sodium lauryl sulfate, hydrogenated vegetable oil (hydrogenated cottonseed oil) and anhydrous colloidal silica.

Tablet coating:hypromellose, titanium dioxide (E171), macrogol 400.

Appearance of the product and packaging contents

Film-coated tablet.

Cefuroxima Aurovitas 500 mg:

Film-coated tablets, capsule-shaped, white to off-white in color, marked with “A34” on one side and smooth on the other. The size is 20.1 mm x 8.6 mm.

Cefuroxima Aurovitas film-coated tablets are available in blisters and white opaque PEAD bottles. The PEAD bottle also contains silica gel as a desiccant.

Packaging sizes:

Blister:6, 8, 10, 12, 14, 15, 16, 20, 24, 30, 50, 100, and 500 film-coated tablets.

PEAD bottle:20, 60, and 500 film-coated tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Germany:Cefuroxim PUREN 500 mg Filmtabletten

Ireland:Cefuroxime Aurobindo 500 mg film-coated tablets

Poland:Cefuroxime Axetil Aurovitas

Portugal:Cefuroxima Aurobindo

Romania:Cefuroxima Atb 500 mg film-coated tablets

Spain:Cefuroxima Aurovitas 500 mg film-coated tablets

Last review date of this leaflet:November 2024

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)