Ceroxim

Package Leaflet: Information for the User

Ceroxim, 250 mg, Film-Coated Tablets

Ceroxim, 500 mg, Film-Coated Tablets

Cefuroxime

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• You should 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Ceroxim is and what it is used for
• 2. What you need to know before you take Ceroxim
• 3. How to take Ceroxim
• 4. Possible side effects
• 5. How to store Ceroxim
• 6. Contents of the pack and other information

1. What Ceroxim is and what it is used for

Ceroxim is an antibiotic that is used in adults and children. The medicine works by killing the bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Ceroxim is used to treat infections of:

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

This medicine may also be used to treat early stages of Lyme disease (borreliosis - an infection spread by ticks).

Your doctor may test the type of bacteria that is causing your infection and make sure that they are susceptible to Ceroxim during treatment.

2. What you need to know before you take Ceroxim

When not to take Ceroxim

• -if you are allergic to cefuroxime axetil 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 sores after taking cefuroxime or other cephalosporin antibiotics.

If any of the above applies to you, do not take Ceroxim without consulting your doctor.

Warnings and precautions

Before you start taking Ceroxim, talk to your doctor or pharmacist.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with cefuroxime treatment. If you get any of the symptoms listed in section 4, you should contact your doctor immediately.

Children

Ceroxim 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.

While taking Ceroxim, you should be aware of the following symptoms: allergic reactions, fungal infections (e.g. thrush) or severe diarrhea (pseudomembranous colitis). This will reduce the risk of complications. See “Special warnings and precautions for use” in section 4.

If you are going to have a blood test

Ceroxim may affect the results of a blood test to check your blood sugar levels and a test called Coombs test.

If you are going to have a blood test, tell the person taking the blood sample that you are taking Ceroxim.

Ceroxim and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and those you plan to take.

• Medicines that reduce the amount of acid in your stomach (e.g. antacids used to treat heartburn) may affect the way Ceroxim works.
• Probenecid (a medicine used to treat gout).
• Oral anticoagulants (blood thinners).

If you are taking any of these medicines, tell your doctor.

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.

Driving and using machines

Ceroxim may cause dizziness and other side effects that can affect your ability to concentrate.

Do not drive or operate machinery if you do not feel well.

Important information about some of the ingredients of Ceroxim

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to take Ceroxim

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Ceroxim should be taken after food. This will increase the effectiveness of the treatment.

Swallow the tablets whole with water. Do not chew, crush or break the tablets - this can reduce the effectiveness of the treatment.

Recommended dose

Adults

The recommended dose of Ceroxim is 250 mg to 500 mg twice daily, depending on the severity and type of infection.

Children

The recommended dose of Ceroxim 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.

Ceroxim 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.

Depending on the disease and how the child responds to treatment, the initial dose may be changed or more than one course of treatment may be necessary.

Patients with kidney disease

If you have kidney disease, tell your doctor. Your doctor may need to adjust the dose.

Take more Ceroxim than you should

If you take more Ceroxim than you should, you may experience nervous system problems, including an increased risk of seizures (convulsions).

Contact your doctor or the nearest hospital emergency department immediately. If possible, show them the pack of Ceroxim.

Miss a dose of Ceroxim

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

Stop taking Ceroxim

Do not stop taking Ceroxim without consulting your doctor.

It is important that you take all the prescribed Ceroxim tablets. Do not stop treatment, even if you feel better, without your doctor’s advice. Stopping treatment early may lead to a recurrence of the infection.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Special warnings and precautions for use

A small number of people taking Ceroxim have reported allergic reactions or potentially serious skin reactions. The symptoms may include:

• Severe allergic reaction. Symptoms include: raised and itchy rash, swelling, sometimes of the face or mouth, which may make breathing difficult.
• Rash on the skin, which may spread and look like small rings (a dark spot surrounded by a lighter ring with a dark ring around the edge).
• Widespread skin reactions with blisters and peeling skin (this may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread rash, high fever and enlarged lymph nodes (DRESS syndrome or drug 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 special warnings and precautions for use while taking Ceroxim include:

• Fungal infections. Medicines like Ceroxim can cause an overgrowth of yeast (Candida) in the body, which can lead to a fungal infection (e.g. thrush). The risk of this side effect is greater if Ceroxim is taken for a long time.
• Severe diarrhea (pseudomembranous colitis). Medicines like Ceroxim can cause inflammation of the colon (large intestine), which can lead to severe diarrhea, usually with blood and mucus, abdominal pain and fever.
• Jarisch-Herxheimer reaction. High fever, chills, muscle and headache, and rash during treatment of Lyme disease (borreliosis). 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 (e.g. thrush)
• Headache
• Dizziness
• Diarrhea
• Nausea
• Stomach pain

Common side effects seen in blood tests:

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

Uncommon side effects(may affect up to 1 in 100 people):

• Vomiting
• Rash

Uncommon side effects seen in blood tests:

• Decreased number of platelets (blood cells involved in blood clotting);
• Decreased number of white blood cells (leukopenia);
• Positive Coombs test result.

Other side effects

Other side effects have been reported in a small number of people, but the frequency of these side effects is not known:

• Severe diarrhea (pseudomembranous colitis)
• Allergic reactions
• Skin reactions (including severe reactions)
• High fever
• Yellowing of the whites of the eyes or skin
• Liver inflammation

Side effects seen in blood tests:

• Breakdown of red blood cells (hemolytic anemia)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system listed in the “Further information” section.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ceroxim

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.

There are no special storage requirements.

Do not use Ceroxim if you notice that the tablets are broken or damaged.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Ceroxim contains

The active substance is cefuroxime (as cefuroxime axetil). Each film-coated tablet contains 250 mg or 500 mg of cefuroxime.

The other ingredients are:

Tablet core:

Microcrystalline cellulose (PH101), microcrystalline cellulose (PH112), sodium croscarmellose, sodium lauryl sulfate, hydrogenated vegetable oil, colloidal anhydrous silica

Coating:

Opadry White OY-S-58910: hypromellose (5 cp), titanium dioxide (E 171), macrogol 400, talc

What Ceroxim looks like and contents of the pack

250 mg film-coated tabletsare white to off-white, capsule-shaped, with the numbers “250” engraved on one side and smooth on the other. The tablets are 15.0 mm long, 6.5 mm wide and 5.05 mm thick. They are packaged in PVC/Aclar/Aluminum blisters in a carton. The carton contains 10, 12, 14, 20 or 24 film-coated tablets.

500 mg film-coated tabletsare white to off-white, capsule-shaped, with the numbers “500” engraved on one side and smooth on the other. The tablets are 18.0 mm long, 9.0 mm wide and 6.95 mm thick. They are packaged in PVC/Aclar/Aluminum blisters in a carton. The carton contains 10, 12, 14, 20 or 24 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Ranbaxy (Poland) Sp. z o. o.

ul. Idzikowskiego 16

00-710 Warsaw

Manufacturer/Importer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH- Hoofddorp

Netherlands

Alkaloida Chemical Company Zrt.

4400 Tiszavasvári

Kabay János u. 29

Hungary

Terapia SA

Str. Fabricii nr 124

400 632 Cluj Napoca

Romania

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Netherlands: Cefuroxim SUN 250 mg filmomhulde tabletten

Cefuroxim SUN 500 mg filmomhulde tabletten

Czech Republic: Znobact 500 mg potahované tablety

Hungary: Ceroxim 500 mg filmtabletta

Germany: CEFUROX BASICS 250mg (500mg) Filmtabletten

Slovakia: Znobact 500 mg filmom obalené tablety

Spain: Cefuroxima SUN 500 mg comprimidos recubiertos con película EFG

Date of last revision of the leaflet:26.05.2023