Cefuroxime Aristo
Ask a doctor about a prescription for Cefuroxime Aristo
How to use 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 specifically for you. 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, tell 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 these 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 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 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, attention should be paid to whether the following complaints occur: allergic reactions, fungal infections (e.g. thrush), and severe diarrhea (pseudomembranous colitis). This will reduce the risk of complications. See "Complaints 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 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 the breastfed child experiences gastrointestinal problems (diarrhea, fungal infections) or rashes, breastfeeding should be discontinued and medical advice should be sought 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 considered "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 daily, 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 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 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 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.
The tablets should not be crushed or chewed.
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.
Seek medical advice 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 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.
Complaints 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 changes with blisters and peeling skin. (This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis).
Other complaints 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 greater 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 called a Jarisch-Herxheimer reaction. These symptoms usually last from a few hours to a day.
If you experience any of these symptoms, seek medical advice 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 (cells involved in blood clotting)
- 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
- liver inflammation.
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, tell 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:
Jerozolimskie Avenue 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.
Reporting side effects will help to gather 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).
- Other ingredients are: Tablet core: microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate Coating: hypromellose, titanium dioxide (E 171), hydroxypropyl cellulose, 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 Street 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:
- Country of registration
- Active substance
- Prescription requiredYes
- ImporterAristo Pharma GmbH
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to Cefuroxime AristoDosage form: Powder, 50 mgActive substance: cefuroximeManufacturer: Biopharma S.r.L. Laboratoires TheaPrescription requiredDosage form: Powder, 1.5 gActive substance: cefuroximeManufacturer: Zakłady Farmaceutyczne POLPHARMA S.A. Zakłady Farmaceutyczne POLPHARMA S.A. Oddział Produkcyjny w DuchnicachPrescription requiredDosage form: Powder, 250 mgActive substance: cefuroximeManufacturer: Zakłady Farmaceutyczne POLPHARMA S.A. Zakłady Farmaceutyczne POLPHARMA S.A. Oddział Produkcyjny w DuchnicachPrescription required
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