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.

• 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. Do not pass it on to others. It may harm them, even if their symptoms 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. 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. It 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. 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 taking Ceroxim, you should tell your doctor if:

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with cefuroxime. 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, as its safety and effectiveness have not been established in this age group.

While taking Ceroxim, you should be aware of the following:

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 Blood Tests

Ceroxim may affect the results of a blood test for sugar in your blood (glucose) and a test called the Coombs test.

If you are going to have a blood test, tell the person taking your blood 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 stomach acid (e.g. antacids used to treat heartburn) may affect the action of Ceroxim.
• Probenecid (a medicine used to treat gout).
• Oral anticoagulants (blood thinners).

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

Pregnancy, Breast-feeding and Fertility

If you are pregnant, think you might be pregnant, are planning to become pregnant or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and Using Machines

Ceroxim may cause dizziness or other side effects that may 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

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

3. How to Take Ceroxim

Always take Ceroxim exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

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

Swallow the tablets whole with water. Do not chew, crush or break them.

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, as its safety and effectiveness have not been established in this age group.

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

Patients with Kidney Disease

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

Overdose

If you take more Ceroxim than you should, you may experience neurological disorders, particularly an increased risk of seizures (convulsions).

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

Missed Dose

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

Stopping Treatment

Do not stop taking Ceroxim without consulting your doctor.

It is important that you complete the course of treatment, even if you start to feel better. Stopping treatment too soon may result in the infection returning.

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.

Side Effects to Look Out For

A small number of people taking Ceroxim have reported an allergic reaction or potentially serious skin reaction. The symptoms may be:

• Severe allergic reaction. Symptoms include: raised and itchy rash, swelling, sometimes of the face or mouth, which may make it difficult to breathe.
• Rash on the skin that may develop into blisters and look like small rings (a dark spot surrounded by a lighter ring with a dark ring around the edge).
• Widespread skin rash 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 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 Side Effects to Look Out For 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), leading to severe diarrhea, usually with blood and mucus, abdominal pain and fever.
• Jarisch-Herxheimer reaction. High fever (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 (thrombocytopenia);
• decreased number of white blood cells (leukopenia);
• positive Coombs test.

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)
• high fever (fever)
• yellowing of the whites of the eyes or skin
• inflammation of the liver.

Side effects seen in blood tests:

• rapid breakdown of red blood cells (hemolytic anemia).

Reporting Side Effects

If you experience any side effects, talk to your doctor or pharmacist or nurse. You can also report side effects directly via the national reporting system listed in the "Further information" section.

Reporting 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 (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

United Kingdom: Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard

Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, E-mail: [[email protected]](mailto:[email protected])

Malta: ADR Reporting, Website: www.medicinesauthority.gov.mt/adrportal

5. How to Store Ceroxim

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

Do not use Ceroxim 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 conditions.

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), croscarmellose sodium, 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 "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 "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