Xorimax 500

Package Leaflet: Information for the Patient

Xorimax 250, 250 mg, Chewable Tablets

Xorimax 500, 500 mg, Chewable Tablets

Cefuroxime

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

Keep this leaflet, you may need to read it again.
In case of further questions, ask your doctor or pharmacist.
This medicine has been prescribed to you personally. Do not pass it on to others.
The medicine may harm another person, 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 Xorimax and what is it used for
• 2. Important information before taking Xorimax
• 3. How to take Xorimax
• 4. Possible side effects
• 5. How to store Xorimax
• 6. Contents of the pack and other information

1. What is Xorimax and what is it used for

Xorimax is an antibiotic used in adults and children. It works bactericidally on microorganisms causing infections. It belongs to the group of so-called cephalosporins.
Xorimax is used to treat infections of the:
throat
sinuses
middle ear
lungs or infections within the chest cavity
urinary tract
skin and soft tissues.
Xorimax may also be used:
to treat Lyme disease (borreliosis - an infection transmitted by ticks).

2. Important information before taking Xorimax

When not to take Xorimax

if you are allergic to cefuroxime, to any other antibiotic from the cephalosporin group, 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 antibiotic (penicillins, monobactams, carbapenems).
if you have ever had a severe skin rash or skin peeling, blisters, and (or) ulcers of the mouth after treatment with cefuroxime or other cephalosporin antibiotics.
➔ If any of the above situations apply to you, do not take Xorimax without consulting your doctor first.

Warnings and precautions

Before taking Xorimax, discuss it with your doctor, pharmacist, or nurse.
Xorimax is not recommended for use in children under 3 months of age, as its safety and efficacy in this age group are not known.
While taking Xorimax, pay attention to whether certain symptoms appear, such as allergic reactions, fungal infections (e.g., with Candida), and severe diarrhea (pseudomembranous colitis). This observation will help reduce the risk of problems that may occur. You should read the section "What to be aware of" in section 4.

Be careful when taking Xorimax

Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have occurred with cefuroxime treatment.
If you notice any symptoms related to severe skin reactions described in section 4, seek medical attention immediately.

If you are going to have a blood test

Xorimax may interfere with blood sugar tests and a blood test known as the Coombs test.
If you are going to have such a test:
➔ tell the person taking the samplethat you are taking Xorimax.

Xorimax and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as medicines you plan to take, including those available without a prescription.
Medicines used to reduce stomach acid (e.g., antacids used to treat heartburn) may affect the action of Xorimax.
Probenecid
Oral anticoagulants
➔ If you are taking any of these medicines, tell your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Your doctor will weigh the benefits of treating you with Xorimax against the risks to your baby.

Driving and using machines

Xorimax may cause dizziness and other side effects that impair your attention.
➔ Do not drive or operate machinery if you feel unwell.

Xorimax chewable tablets contain sodium

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

3. How to take Xorimax

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Xorimax tablets should be taken after meals, as this will help increase the effectiveness of the treatment.
Xorimax tablets should be swallowed with water.
Do not chew, crush, or divide the tablets, as this may make them difficult to swallow and reduce the effectiveness of the treatment.

Recommended dose:

Adults and children over 40 kg

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

Children under 40 kg

Children under 40 kg should be treated with the oral suspension form of the medicine.
The recommended dose of Xorimax is 10 mg/kg body weight (up to 250 mg) to 15 mg/kg body weight (up to 250 mg) twice a day, depending on the severity and type of infection.
Xorimax is not recommended for use in children under 3 months of age, as its safety and efficacy in this age group are not known.
Depending on the type of disease or the patient's response to treatment, the doctor may change the initial dose of Xorimax or decide that more than one treatment cycle is necessary.

Patients with kidney problems

If you have kidney problems, your doctor may use a different dose of Xorimax.
➔ If this applies to you, tell your doctor.

Taking more than the recommended dose of Xorimax

Taking too much Xorimax may cause neurological disorders, especially increase the risk of seizures.
➔ Seek medical attention immediately or go to the emergency department of the nearest hospital. If possible, show the packaging of the medicine.

Missing a dose of Xorimax

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

Stopping Xorimax treatment

Do not stop taking Xorimax without your doctor's advice.
It is important to take the medicine until the end of the prescribed treatment cycle. Do not stop treatment early without your doctor's advice, even if you feel better. Stopping treatment too early may cause the infection to recur.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Xorimax can cause side effects, although not everybody gets them.

If you experience any of the following symptoms, stop taking cefuroxime and seek medical attention immediately:

Red, flat patches on the torso, resembling a target or circle, often with blisters in the center, skin peeling, ulcers of the mouth, throat, nose, genitals, and eyes. These severe skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) may be preceded by fever and flu-like symptoms.
Red, peeling, widespread rash with bumps under the skin and blisters, with fever. These symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis).

Side effects to be aware of

In a few patients taking Xorimax, an allergic reaction or skin reaction may occur, which can be severe. The symptoms may be:
severe allergic reaction. Symptoms include hives and itching, swellingsometimes involving the face or mouth and causing difficulty breathing.
widespread rash, high fever, and swollen 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).

Other side effects to be aware of when taking Xorimax

include:

fungal infections. Medicines like Xorimax can cause an overgrowth of Candida in the body, leading to fungal infections (such as thrush). This side effect is more likely if you take Xorimax for a long time.
severe diarrhea (pseudomembranous colitis). Medicines like Xorimax can cause colitis with severe diarrhea (usually with blood and mucus), abdominal pain, and fever.
Jarisch-Herxheimer reaction. In some patients taking Xorimax for Lyme disease, fever, chills, headache, muscle pain, and rash may occur. This phenomenon is called the 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 occur in less than 1 in 10 people:
fungal infections (e.g., thrush)
headache
dizziness
diarrhea
nausea
abdominal pain
Common side effects that can be seen in blood tests:
increase in a certain type of white blood cell (eosinophilia)
increase in liver enzyme activity

Uncommon side effects

May occur in less than 1 in 100 people:
vomiting
skin rashes
Uncommon side effects that can be seen in blood tests:
decrease in platelet count (cells that help blood clot)
decrease in white blood cell count
positive Coombs test

Other side effects

Other side effects have occurred in a very small number of people, but their exact frequency is not known:

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

Side effects that can 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, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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
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 Xorimax

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
Store in the original packaging to protect from moisture.
No special storage temperature instructions.
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 Xorimax contains

The active substance is cefuroxime.
One Xorimax 250 mg chewable tablet contains 300.72 mg of cefuroxime axetil, equivalent to 250 mg of cefuroxime.
One Xorimax 500 mg chewable tablet contains 601.44 mg of cefuroxime axetil, equivalent to 500 mg of cefuroxime.
The other ingredients (excipients) are:
sodium lauryl sulfate, copovidone, croscarmellose sodium, magnesium stearate, colloidal anhydrous silica, granulated mannitol, microcrystalline cellulose, crospovidone, and talc, hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide (E 171)

What Xorimax looks like and contents of the pack

Xorimax tablets are chewable.
Xorimax 250: white to light yellow, biconvex, oval-shaped chewable tablets with a score line on both sides.
Xorimax 500: white to light yellow, biconvex, oval-shaped chewable tablets.
The tablets are available in blisters or soft blisters, in cardboard boxes.
Packaging contains:
Xorimax 250: 10, 14, 16, or 20 tablets.
Xorimax 500: 10, 14, or 16 tablets.

Marketing authorization holder and manufacturer

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria
Cefuroxim Sandoz 250 mg - Filmtabletten
Cefuroxim Sandoz 500 mg - Filmtabletten
Belgium
Cefuroxim Sandoz 250 mg omhulde tabletten
Cefuroxim Sandoz 500 mg omhulde tabletten
Czech Republic
Xorimax 250 mg potahované tablety
Xorimax 500 mg potahované tablety
Hungary
Xorimax 250 mg bevont tabletta
Xorimax 500 mg bevont tabletta
Lithuania
Xorimax 500 mg dengtos tabletės
Latvia
Xorimax 500 mg apvalkotās tabletes
Netherlands
Cefuroximaxetil 250, omhulde tabletten 250 mg
Cefuroximaxetil 500, omhulde tabletten 500 mg
Poland
Xorimax 250
Xorimax 500
Slovakia
Xorimax 250 mg
Xorimax 500 mg
Spain
Cefuroxima Sandoz 500 mg comprimidos recubiertos EFG
United Kingdom (Northern Ireland)
Cefuroxime 250mg Tablets
Date of last revision of the leaflet: 03/2025
(logo of the marketing authorization holder)