Cefuroxime Aristo

Leaflet accompanying the packaging: patient information

Cefuroxime Aristo, 250 mg, film-coated tablets

Cefuroxime Aristo, 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Cefuroxime Aristo and what is it used for

Cefuroxime Aristo contains the active substance cefuroxime. It 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 Aristo is used to treat infections of:

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

Cefuroxime Aristo may also be used:

• to treat Lyme disease (a bacterial infection spread by ticks, also known as borreliosis).

Your doctor may perform tests to determine the type of bacteria causing the infection and to check if the bacteria are sensitive to Cefuroxime Aristo during treatment.

2. Important information before taking Cefuroxime Aristo

When not to take Cefuroxime Aristo

• if you are allergic (hypersensitive) to cefuroxime or other 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 blistering of the skin, or peeling and (or) mouth ulcers after taking cefuroxime or other cephalosporin antibiotics.

If any of the above apply to you, do not take Cefuroxime Aristo until you have consulted your doctor.

Warnings and precautions

Before taking Cefuroxime Aristo, discuss it with your doctor or pharmacist.
Severe skin reactions, such as:
Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with cefuroxime treatment. If you notice any of the symptoms related to severe skin reactions described in section 4, seek medical advice immediately.

Children

Cefuroxime Aristo is not recommended for use in children under 3 months of age, as the safety and efficacy of the medicine in this age group are not known.
During treatment with Cefuroxime Aristo, pay attention to whether the following problems occur: allergic reactions, fungal infections (e.g. thrush), and severe diarrhea (pseudomembranous colitis). This will reduce the risk of complications. See "Problems to watch out for" in section 4.

If you are going to have blood tests

Cefuroxime Aristo may affect the results of blood tests for sugar and a blood test called the Coombs test. If you are going to have blood tests:
tell the person taking the blood sample that you are taking Cefuroxime Aristo.

Cefuroxime Aristo 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) may affect the action of Cefuroxime Aristo.

• probenecid
• oral anticoagulants (blood thinners). If you are taking such medicines, 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.
Do not take this medicine during pregnancy and breastfeeding, unless your doctor has explicitly advised you to do so.
If your breastfed baby experiences digestive problems (diarrhea, fungal infections) or rashes, stop breastfeeding and contact your doctor immediately.

Driving and using machines

Cefuroxime Aristo may cause dizziness and other side effects that may impair your alertness.
Do not drive or operate machinery if you do not feel well.

Cefuroxime Aristo contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".
You should discuss with your doctor whether Cefuroxime Aristo is suitable for you.

3. How to take Cefuroxime Aristo

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Recommended dose

Adults

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

Children

The usual dose of Cefuroxime Aristo is 10 mg/kg body weight (not more than 125 mg) to 15 mg/kg body weight (not more than 250 mg) twice a day, depending on:

• the severity and type of infection.

Cefuroxime Aristo is not recommended for use in children under 3 months of age, as 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 Aristo.
Tell your doctor if this applies to you.
Method of administration
Oral use.
Cefuroxime Aristo should be taken after a meal. This will help increase the effectiveness of the treatment.
The tablets should be swallowed whole with water.
[only for 250 mg strength]
The tablet can be divided into two equal parts.
Do not crush or chew the tablets.

Taking more Cefuroxime Aristo than prescribed

If you take more Cefuroxime Aristo than prescribed, you may experience neurological disorders, in particular, the risk of seizures (epileptic fits) increases.
Contact your doctor or the nearest hospital immediately. If possible, show them the packaging of Cefuroxime Aristo.

Missing a dose of Cefuroxime Aristo

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 Aristo

Do not stop taking Cefuroxime Aristo without consulting your doctor.
It is important to complete the full treatment cycle with Cefuroxime Aristo. Do not stop treatment, unless your doctor advises you to do so – even if you feel better. If you do not complete the full treatment cycle, the infection may return.
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 Aristo can cause side effects, although not everybody gets them.

Problems to watch out for

In a small number of patients taking Cefuroxime Aristo, an allergic reaction or potentially severe skin reaction has been reported. The symptoms may be:

• Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or mouth, which may make breathing difficult.
• Widespread rash, high fever, and enlarged lymph nodes (DRESS syndrome or hypersensitivity syndrome).
• Chest pain associated with an allergic reaction, which may be a sign of a heart attack caused by an allergy (Kounis syndrome).
• Skin rash, which may develop into blisters and 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).

Other problems to watch out for while taking Cefuroxime Aristo:

• Fungal infections. Medicines like Cefuroxime Aristo may cause an overgrowth of fungi (Candida) in the body, leading to a fungal infection (such as thrush). The risk of this side effect is higher if Cefuroxime Aristo is used for a long time.
• Severe diarrhea (pseudomembranous colitis). Medicines like Cefuroxime Aristo may 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 Aristo to treat Lyme disease (borreliosis), some patients may experience a high fever, chills, muscle and headache, and skin rash. 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, contact your doctor or nurse immediately.

Common side effects

May affect up to 1 in 10 people:

• fungal infections (such as 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

May affect up to 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 effectsOther side effects occur in a very small number of patients, but the exact 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 those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +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 Aristo

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month.
Do not store above 25°C.
Store in the original package to protect from light.
Do not use Cefuroxime Aristo if the tablets are cracked or show other visible signs of damage.
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 Aristo contains

• The active substance is cefuroxime. [250 mg]One film-coated tablet contains 250 mg of cefuroxime (as cefuroxime axetil). [500 mg]One film-coated tablet contains 500 mg of cefuroxime (as cefuroxime axetil).
• The other ingredients are: Tablet core: microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate Coating: hypromellose, titanium dioxide (E 171), hydroxypropylcellulose, microcrystalline cellulose, stearic acid

What Cefuroxime Aristo looks like and contents of the pack

[250 mg]
White to almost white, round, biconvex film-coated tablets with a diameter of 11 mm and a dividing line.
The tablets are packaged in PVC/PVDC/Aluminum blisters.
Pack sizes: 10, 12, 14, 16, 20, and 24 film-coated tablets.
The tablet can be divided into two equal doses.
[500 mg]
White to almost white, oval, biconvex film-coated tablets with dimensions of 9 mm x 18.5 mm.
The tablets are packaged in PVC/PVDC/Aluminum blisters.
Pack sizes: 10, 12, 14, 16, 20, and 24 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Aristo Pharma Sp. z o.o.
Baletowa 30
02-867 Warsaw
phone: +48 22 855 40 93
Manufacturer
Aristo Pharma GmbH
Wallenroder Strasse 8-10
13435 Berlin
Germany

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

Belgium
Cefuroxime Aristo
France
Cefuroxime Aristo
Germany
Cefuroxim Aristo
Poland
Cefuroxime Aristo
Portugal
Cefuroxima Aristo Pharma

Date of last revision of the leaflet: