Cefuroxime axetil aurovitas

Package leaflet: Information for the user

Cefuroxime Axetil Aurovitas, 500 mg, film-coated tablets
Cefuroximum
Please read all of this leaflet carefully before you start taking this medicine, because it contains
important information for you.

• 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 personally. 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, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Cefuroxime Axetil Aurovitas is and what it is used for
2. What you need to know before you take 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 Cefuroxime Axetil Aurovitas is and what it is used for

Cefuroxime Axetil Aurovitas is an antibiotic used in adults and children. It 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
• the sinuses
• the middle ear
• the lungs or chest
• the urinary tract
• the skin and soft tissues

Cefuroxime Axetil Aurovitas may also be used:

• in the treatment of early-stage Lyme disease (a tick-borne infection).

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

2. Important information before using Cefuroxime Axetil Aurovitas

When not to take Cefuroxime Axetil Aurovitas:

• if the patient is allergic (hypersensitive) to cephalosporin antibiotics or to any of the other ingredients of this medicine (listed in section 6).
• if the patient has ever experienced a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotics (penicillins, monobactams, or

carbapenems).

• if the patient has ever developed severe skin rash, skin peeling, blisters, and/or oral ulcers after treatment with cefuroxime or other cephalosporin antibiotics. → If any of the above apply, the patient should not take Cefuroxime Axetil Aurovitas without consulting a doctor.

Warnings and precautions
Before starting treatment with Cefuroxime Axetil Aurovitas, discuss this 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 have not been established.
During treatment with Cefuroxime Axetil Aurovitas, be alert for symptoms such as allergic reactions, fungal infections (e.g. candidiasis), or severe diarrhoea (pseudomembranous colitis). This will help reduce the risk of complications. See "Symptoms to be aware of" in section 4.
Special caution is needed when using Cefuroxime Axetil Aurovitas:
Severe skin adverse reactions have occurred during cefuroxime treatment, such as:
Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). If any symptoms associated with severe skin reactions described in section 4 are observed, medical advice should be sought immediately.
Blood tests
Cefuroxime Axetil Aurovitas may affect the results of blood sugar tests and the blood test known as the Coombs test. If the patient is to undergo blood tests, they should:
→ inform the person taking the sample that they are taking Cefuroxime Axetil Aurovitas.
Cefuroxime Axetil Aurovitas and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or might take in the future.
Medicines that reduce stomach acid (e.g. antacids used to treat heartburn) may affect the action of Cefuroxime Axetil Aurovitas.

• Probenecid.
• Oral anticoagulants. → If the patient is taking any of the above (or similar) medicines, they should inform their doctor or pharmacist.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Inform the doctor before taking Cefuroxime Axetil Aurovitas:

• if the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant,
• if the patient is breastfeeding. The doctor will assess whether the benefits of using Cefuroxime Axetil Aurovitas during pregnancy or breastfeeding outweigh any potential risks to the baby.

Driving and operating machinery
Cefuroxime Axetil Aurovitas may cause dizziness and other adverse effects that may impair alertness.
→ The patient should not drive or operate machinery if they do not feel well.
Cefuroxime Axetil Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to use Cefuroxime Axetil Aurovitas

This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Cefuroxime Axetil Aurovitas should be taken after a meal. This will help increase the
effectiveness of treatment. Cefuroxime Axetil Aurovitas tablets should be swallowed whole with
water.
Do not chew, crush, or divide the tablets – this may reduce the effectiveness of treatment.
Cefuroxime Axetil Aurovitas coated tablets should not be crushed and are therefore not
suitable for use in patients who cannot swallow tablets. In children, an available oral suspension formulation containing cefuroxime may be used.
Recommended dose
Adults and children weighing 40 kg or more
The usual dose of Cefuroxime Axetil Aurovitas is 250 mg to 500 mg twice
daily, 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 cefuroxime in the form of an oral suspension or sachets. The usual dose of Cefuroxime Axetil Aurovitas is 10 mg/kg body weight
(not exceeding 250 mg) to 15 mg/kg body weight (not exceeding 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,
as the safety and efficacy of the medicine have not been established in this age group.
Depending on the disease and the patient's response to treatment, the initial dose may be
adjusted or more than one treatment course may be required.
Patients with kidney problems
If the patient has impaired kidney function, the doctor may adjust the dosage of the medicine.
→ If this applies to the patient, they should inform the doctor.
Taking more than the recommended dose of Cefuroxime Axetil Aurovitas
If a patient takes more than the recommended dose of Cefuroxime Axetil Aurovitas, neurological
disorders may occur, particularly an increased risk of seizures (epileptic fits).
→ Medical advice should be sought immediately or emergency services contacted. If possible, the
Cefuroxime Axetil Aurovitas packaging should be shown.
Missing a dose of Cefuroxime Axetil Aurovitas
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
Stopping treatment with Cefuroxime Axetil Aurovitas
It is important not to shorten the prescribed duration of treatment with Cefuroxime Axetil Aurovitas. Do not stop treatment without consulting a doctor, even if the patient feels better. Shortening the recommended treatment period may lead to recurrence of the illness.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Conditions to be aware of
In a small number of people taking Cefuroxime Axetil Aurovitas, an allergic reaction or potentially severe skin reaction has been reported. Symptoms may include:

• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Chest pain associated with an allergic reaction, which may be a sign of allergy-induced heart attack (Kounis syndrome).
• Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or lips, which may make breathing difficult.
• Skin rash, which may develop into blisters and appear as small rings (a dark spot in the center surrounded by a lighter ring and a dark ring at 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 conditions to be aware of during treatment with Cefuroxime Axetil Aurovitas:

• Fungal infections. Medicines such as Cefuroxime Axet il Aurovitas may cause overgrowth of yeast (Candida) in the body, which may lead to fungal infection (e.g. thrush). The risk of this adverse reaction is higher if Cefuroxime Axetil Aurovitas is used for a prolonged period.
• Severe diarrhoea ( Pseudomembranous colitis ). Medicines such as Cefuroxime Axetil Aurovitas may cause inflammation of the colon (large intestine), resulting in severe diarrhoea, usually with blood and mucus, abdominal pain, and fever.
• Jarisch-Herxheimer reaction. When Cefuroxime Axetil Aurovitas is used to treat Lyme disease (borreliosis), some patients may experience high temperature (fever), chills, muscle and headache pain, and skin rash. This is known as the Jarisch-Herxheimer reaction. These symptoms usually last from several hours to one day. → If any of these symptoms occur, contact a doctor or nurse immediately.

Common adverse reactions:
These may affect no more than 1 in 10 people:

• fungal infections (e.g. candidiasis)
• headache
• dizziness
• diarrhoea
• nausea
• stomach pain.

Common adverse reactions that may be revealed in blood tests:

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

Uncommon adverse reactions:
These may affect no more than 1 in 100 people:

• vomiting
• skin rashes.

Uncommon adverse reactions that may be revealed in blood tests:

• reduced platelet count (cells involved in blood clotting)
• reduced white blood cell count (leukopenia)
• positive Coombs test.

Other adverse reactions
Other adverse reactions occur in a very small number of patients, but the exact frequency is unknown:

• severe diarrhoea (pseudomembranous colitis)
• allergic reactions
• skin reactions (including severe)
• high temperature (fever)
• yellowing of the whites of the eyes or skin
• hepatitis.

Adverse reactions that may be revealed in blood tests:

• excessive breakdown of red blood cells (haemolytic anaemia).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

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 outer carton and blister pack following the abbreviation "EXP". The expiry date refers to the last day of the stated month.
There are no special temperature storage requirements for this medicine. Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package 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.
• Other ingredients are:
• Tablet core: microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, hydrogenated vegetable oil (containing cottonseed oil), and colloidal anhydrous silica.
• Tablet 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, capsule-shaped film-coated tablets, embossed with the code "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 in HDPE bottles with a cardboard outer carton. The HDPE bottle also contains silica gel as a desiccant.
Pack sizes:
Blister packs: 6, 8, 10, 12, 14, 15, 16, 20, 24, 30, 50, 100 or 500 film-coated tablets.
HDPE bottles: 20, 60 or 500 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer

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

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

This medicinal product is authorised 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