Cefuroxime aristo

Package leaflet: Information for the patient

Cefuroxime Aristo, 250 mg, film-coated tablets
Cefuroxime Aristo, 500 mg, film-coated tablets
Cefuroximum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Cefuroxime Aristo is and what it is 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 Cefuroxime Aristo is and what it is used for
Cefuroxime Aristo contains the active substance cefuroxime. It is an antibiotic used in adults and children. The medicine works by killing bacteria causing infections. It belongs to a group of medicines called cephalosporins.
Cefuroxime Aristo 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 Aristo may also be used:

• in the treatment of Lyme disease (a tick-borne infection known as borreliosis).

Your doctor may perform tests to identify the type of bacteria causing the infection and to monitor whether 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 to other cephalosporin antibiotics, or to 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 antibiotics (penicillins, monobactams, or carbapenems);
• if you have ever experienced severe skin rash, skin peeling, blisters, and/or oral ulcers after treatment with 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 starting treatment with Cefuroxime Aristo, discuss this with your doctor or pharmacist.
Severe skin reactions have occurred during treatment with cefuroxime, 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 immediate medical advice.
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 unknown.
During treatment with Cefuroxime Aristo, be alert for symptoms such as: allergic reactions, fungal infections (e.g. candidiasis), and severe diarrhoea (pseudomembranous colitis). This will help reduce the risk of complications. See "Symptoms to watch for" in section 4.
If you are undergoing blood tests
Cefuroxime Aristo may affect the results of blood sugar tests and a blood test known as the Coombs test. If you are scheduled for blood tests, inform the person taking the sample that you are taking Cefuroxime Aristo.
Cefuroxime Aristo and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Medicines that reduce stomach acid (e.g. antacids used to treat heartburn) may affect the action of Cefuroxime Aristo.

• probenecid
• oral anticoagulants. If you are taking such medicines, inform your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Do not use this medicine during pregnancy or breastfeeding unless your doctor clearly advises otherwise.
If your breastfed infant develops gastrointestinal problems (diarrhoea, fungal infections) or skin 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, meaning it is considered "sodium-free".
You should consult your doctor to confirm whether Cefuroxime Aristo is suitable for you.
3. How to take Cefuroxime Aristo
Always take this medicine exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose
Adults
The usual dose of Cefuroxime Aristo is 250 mg to 500 mg twice daily, depending on the severity and type of infection.
Children
The usual dose of Cefuroxime Aristo is 10 mg/kg body weight (not exceeding 125 mg) to 15 mg/kg body weight (not exceeding 250 mg) twice daily, 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 unknown.
Depending on the illness and your response to treatment, the initial dose may be adjusted or more than one treatment course may be required.
Patients with kidney problems
If you have kidney problems, your doctor may adjust the dosage.
Inform your doctor if this applies to you.
Method of administration
Oral use.
Cefuroxime Aristo should be taken after food. This helps to increase the effectiveness of treatment.
Cefuroxime Aristo tablets should be swallowed whole with water.
[for 250 mg strength only]
The tablet may 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 disturbances, particularly an increased risk of seizures (epileptic fits).
Contact your doctor or the nearest hospital department immediately. If possible, show the packaging of Cefuroxime Aristo.
Missing a dose of Cefuroxime Aristo
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
Stopping Cefuroxime Aristo
Do not stop taking Cefuroxime Aristo without consulting your doctor.
It is important to complete the full course of treatment with Cefuroxime Aristo. Do not stop treatment unless advised by your doctor – even if you feel better. If you do not complete the full course, the infection may return.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Reactions to be aware of
In a small number of patients taking Cefuroxime Aristo, an allergic reaction or potentially severe skin reaction has been reported. Symptoms may include:

• Severe allergic reaction. Symptoms include raised, itchy rash, swelling, sometimes of the face or lips, which may cause difficulty breathing.
• 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).
• Skin rash which may develop into blisters and appear as small rings (a dark spot in the center surrounded by a lighter ring with a dark edge).
• Widespread skin lesions with blisters and peeling of the outer layer of skin. (This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis).

Other symptoms to watch for during treatment with Cefuroxime Aristo:

• Fungal infections. Medicines such as Cefuroxime Aristo may cause overgrowth of yeasts (Candida) in the body, which may lead to fungal infection (such as thrush). The risk of this adverse reaction is higher if Cefuroxime Aristo is used for a prolonged period.
• Severe diarrhoea (pseudomembranous colitis). Medicines such as Cefuroxime Aristo may cause inflammation of the colon (large intestine), resulting in severe diarrhoea, usually with blood and mucus, abdominal pain, and fever.
• Jarisch-Herxheimer reaction. During treatment with Cefuroxime Aristo for Lyme disease (borreliosis), some patients may experience high fever, chills, muscle and headache, 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
May occur in up to 1 in 10 patients:

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

Common adverse reactions that may be revealed in blood tests:

• increased number of white blood cells (eosinophilia)
• increased liver enzyme activity.

Uncommon adverse reactions
May occur in up to 1 in 100 patients:

• vomiting
• skin rashes.

Uncommon adverse reactions that may be revealed in blood tests:

• reduced number of platelets (cells involved in blood clotting)
• reduced number of white blood cells (leukopenia)
• positive Coombs test result.

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 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 of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: +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.
Reporting adverse reactions helps provide more information on the safety of the 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 pack and cardboard box following EXP. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Store in the original packaging to protect from light.
Do not use Cefuroxime Aristo if the tablets are cracked or show any 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 packaging and other information

What Cefuroxime Aristo contains

• The active substance is cefuroxime. [250 mg] One coated tablet contains 250 mg of cefuroxime (as cefuroxime axetil). [500 mg] One coated tablet contains 500 mg of cefuroxime (as cefuroxime axetil).
• Other ingredients are:
  Tablet core: microcrystalline cellulose, sodium lauryl sulfate, sodium croscarmellose, 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 coated tablets, 11 mm in diameter, with a score line.
Tablets are packed in PVC/PVDC/Aluminium blisters.
Pack sizes: 10, 12, 14, 16, 20 and 24 coated tablets.
The tablet can be divided into two equal doses.
[500 mg]
White to almost white, oval, biconvex coated tablets, 9 mm x 18.5 mm in size.
Tablets are packed in PVC/PVDC/Aluminium blisters.
Pack sizes: 10, 12, 14, 16, 20 and 24 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa 30
02-867 Warsaw
Poland
Tel: +48 22 855 40 93

Manufacturer
Aristo Pharma GmbH
Wallenroder Strasse 8-10
13435 Berlin
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium Cefuroxime Aristo
France Cefuroxime Aristo
Germany Cefuroxim Aristo
Poland Cefuroxime Aristo
Portugal Cefuroxima Aristo Pharma