Cefuroxime Axetil Aurovitas

Leaflet accompanying the packaging: information for the user

Cefuroxime Axetil Aurovitas, 500 mg, film-coated tablets

Cefuroxime

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Cefuroxime Axetil Aurovitas and what is it used for
• 2. Important information before taking Cefuroxime Axetil Aurovitas
• 3. How to take Cefuroxime Axetil Aurovitas
• 4. Possible side effects
• 5. How to store Cefuroxime Axetil Aurovitas
• 6. Contents of the pack and other information

1. What is Cefuroxime Axetil Aurovitas and what is it used for

Cefuroxime Axetil Aurovitas is an antibiotic used in adults and children. The medicine works by killing the bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Cefuroxime Axetil Aurovitas is used to treat infections of:

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

Cefuroxime Axetil Aurovitas may also be used:

• to treat early stages of Lyme disease (borreliosis - an infection spread by ticks).

Your doctor may perform tests to determine the type of bacteria causing the infection and monitor whether the bacteria are sensitive to Cefuroxime Axetil Aurovitas during treatment.

2. Important information before taking Cefuroxime Axetil Aurovitas

When not to take Cefuroxime Axetil Aurovitas:

• if you are allergic (hypersensitive) to cephalosporin antibiotics or 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 or

carbapenems).

• if you have ever had a severe skin rash or skin peeling, blisters, and (or) mouth ulcers after taking cefuroxime or other cephalosporin antibiotics. → If any of these conditions apply to you, you should not take Cefuroxime Axetil Aurovitas without consulting your doctor.

Warnings and precautions

Before taking Cefuroxime Axetil Aurovitas, discuss it with your doctor or pharmacist.

Children

Cefuroxime Axetil Aurovitas is not recommended for use in children under 3 months of age

because the safety and efficacy of the medicine in this age group are not known.
During treatment with Cefuroxime Axetil Aurovitas, pay attention to whether the following symptoms occur: allergic reactions, fungal infections (e.g., thrush), and severe diarrhea (pseudomembranous colitis). This will reduce the risk of complications. See "Symptoms to watch out for" in section 4.
Be particularly careful when taking Cefuroxime Axetil Aurovitas:
Severe skin reactions have occurred with cefuroxime treatment, such as:
Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). If you notice any symptoms related to severe skin reactions described in section 4, seek medical attention immediately.

Blood tests

Cefuroxime Axetil Aurovitas may affect the results of blood tests for sugar in the blood and a blood test called the Coombs test. If you are going to have blood tests, you should:
→ tell the person taking the blood samplethat you are taking Cefuroxime Axetil Aurovitas.

Cefuroxime Axetil Aurovitas and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
Medicines that reduce stomach acid(e.g., antacids used to treat heartburn) may affect the action of Cefuroxime Axetil Aurovitas.

• Probenecid.
• Oral anticoagulants. → If you are taking any of these (or similar) medicines, you should tell your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should inform your doctor before taking Cefuroxime Axetil Aurovitas:

• if you are pregnant, think you may be pregnant, or are planning to become pregnant,
• if you are breastfeeding. Your doctor will assess whether the benefits to you of taking Cefuroxime Axetil Aurovitas during pregnancy and breastfeeding outweigh the risks to your baby.

Driving and using machines

Cefuroxime Axetil Aurovitas may cause dizzinessand other side effects that can impair your alertness.
→ You should not drive or operate machineryif you do not feel well.

Cefuroxime Axetil Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Cefuroxime Axetil Aurovitas

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Cefuroxime Axetil Aurovitas should be taken after a meal.This will help increase the effectiveness of the treatment. Swallow the tablets whole with water.
Do not chew, crush, or break the tablets- this may reduce the effectiveness of the treatment.
The film-coated tablets of Cefuroxime Axetil Aurovitas should not be crushed and are therefore not suitable for patients who have difficulty swallowing tablets. For children, a cefuroxime suspension is available on the market.

Recommended dose

Adults and children over 40 kg body weight

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

Children under 40 kg body weight

Children under 40 kg should be treated with cefuroxime in the form of an oral suspension or sachets. The usual dose of Cefuroxime Axetil Aurovitas is 10 mg/kg body weight (not more than 250 mg) to 15 mg/kg body weight (not more than 250 mg) twice daily, depending on:

• the severity and type of infection.

Cefuroxime Axetil Aurovitas is not recommended for use in children under 3 months of age,
because the safety and efficacy of the medicine in this age group are not known.
Depending on the disease and how the patient responds to treatment, the initial dose may be changed or more than one treatment cycle may be necessary.

Patients with kidney problems

If you have kidney problems, your doctor may change the dose of Cefuroxime Axetil Aurovitas.
→ If this applies to you, you should tell your doctor.

Taking more than the recommended dose of Cefuroxime Axetil Aurovitas

If you take more than the recommended dose of Cefuroxime Axetil Aurovitas, you may experience neurological disorders, in particular, an increased risk of seizures (epileptic fits).
→ You should contact a doctor or call an emergency immediately.If possible, show the packaging of Cefuroxime Axetil Aurovitas.

Missing a dose of Cefuroxime Axetil Aurovitas

Do not take a double dose to make up for a forgotten dose.Take the next dose at the usual time.

Stopping treatment with Cefuroxime Axetil Aurovitas

It is important not to shorten the prescribed treatment period with Cefuroxime Axetil Aurovitas. Do not stop treatment without your doctor's advice, even if you feel better. Shortening the recommended treatment period may lead to a recurrence of the disease.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cefuroxime Axetil Aurovitas can cause side effects, although not everybody gets them.

Symptoms to watch out for

A small number of people taking Cefuroxime Axetil Aurovitas have reported an allergic reaction or potentially severe skin reaction. Their symptoms may be:

• Widespread rash, high fever, and swollen lymph nodes (DRESS or hypersensitivity syndrome).
• Chest pain associated with an allergic reaction, which may be a sign of an allergic myocardial infarction (Kounis syndrome).
• Severe allergic reaction.Symptoms include: raised, itchy rash, swelling,sometimes of the face or mouth, which may make breathing difficult.
• Rash on the skin,which can develop into blistersand look like small rings(a dark spot in the center surrounded by a lighter border with a dark ring around the edge).
• Widespread skin lesions with blisters and peeling skin.(This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis - Lyell's disease).

Other symptoms to watch out for while taking Cefuroxime Axetil Aurovitas:

• Fungal infections.Medicines like Cefuroxime Axetil Aurovitas can cause an overgrowth of yeast (Candida) in the body, leading to a fungal infection (e.g., thrush). The risk of this side effect is higher if Cefuroxime Axetil Aurovitas is taken for a long time.
• Severe diarrhea (pseudomembranous colitis).Medicines like Cefuroxime Axetil Aurovitas can cause inflammation of the colon (large intestine), leading to severe diarrhea, usually with blood and mucus, abdominal pain, and fever.
• Jarisch-Herxheimer reaction.When taking Cefuroxime Axetil Aurovitas to treat Lyme disease (borreliosis), some patients may experience a high fever, chills, muscle and headache, and rash on the skin. This is known as a Jarisch-Herxheimer reaction. These symptoms usually last from a few hours to a day. → If you experience any of these symptoms, you should contact your doctor or nurse immediately.

Common side effects:

These may occur in more than 1 in 10 people:

• fungal infections (e.g., thrush)
• headache
• dizziness
• diarrhea
• nausea
• stomach pain.

Common side effects that may be seen in blood tests:

• increased white blood cell count (eosinophilia)
• increased liver enzyme activity.

Uncommon side effects:

These may occur in more than 1 in 100 people:

• vomiting
• skin rashes.

Uncommon side effects that may be seen in blood tests:

• decreased platelet count (thrombocytopenia)
• decreased white blood cell count (leukopenia)
• positive Coombs test result.

Other side effects

Other side effects occur in a small number of patients, but the frequency is unknown:

• severe diarrhea (pseudomembranous colitis)
• allergic reactions
• skin reactions (including severe)
• high fever
• yellowing of the whites of the eyes or skin
• inflammation of the liver.

Side effects that may be seen in blood tests:

• rapid breakdown of red blood cells (hemolytic anemia).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cefuroxime Axetil Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Cefuroxime Axetil Aurovitas contains

• The active substance is cefuroxime. Cefuroxime Axetil Aurovitas 500 mg contains 601.44 mg of cefuroxime axetil equivalent to 500 mg of cefuroxime.
• The other ingredients are:
• Core:microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, hydrogenated vegetable oil (contains cottonseed oil), and anhydrous colloidal silica.
• Coating:hypromellose 5cP, titanium dioxide (E 171), macrogol 400.

What Cefuroxime Axetil Aurovitas looks like and contents of the pack

Film-coated tablet.
Cefuroxime Axetil Aurovitas, 500 mg:
White or almost white film-coated tablets in the shape of a capsule with the inscription "A34" on one side and smooth on the other.
Tablet size: 20.0 mm x 8.6 mm.
Cefuroxime Axetil Aurovitas film-coated tablets are available in blisters and HDPE bottles in a carton. The HDPE bottle contains a desiccant.
Pack sizes:
Blister: 6, 8, 10, 12, 14, 15, 16, 20, 24, 30, 50, 100, or 500 film-coated tablets.
HDPE bottle: 20, 60, or 500 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lok. 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany:
Cefuroxim PUREN 250 mg/500 mg Filmtabletten
Ireland:
Cefuroxime Aurobindo 250 mg/ 500 mg film-coated tablets
Poland:
Cefuroxime Axetil Aurovitas
Portugal:
Cefuroxima Aurobindo
Romania:
Cefuroxima Atb 250 mg/500 mg comprimate filmate
Spain:
Cefuroxima Aurovitas 250 mg/500 mg comprimidos recubiertos con película EFG

Date of last revision of the leaflet: 10/2024