Ceroxim

Package leaflet: Information for the user

Ceroxim, 250 mg, film-coated tablets
Ceroxim, 500 mg, film-coated tablets
Cefuroximum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, 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

1. What Ceroxim is and what it is used for
2. What you need to know before taking 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 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:

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

This medicine may also be used to treat early-stage Lyme disease (borreliosis – an infection transmitted by ticks).
Your doctor may test the type of bacteria causing your infection and monitor whether the bacteria are susceptible to Ceroxim during treatment.

2. Information before using Ceroxim

When not to use Ceroxim

• if the patient is allergic to cefuroxime axetil or other cephalosporin antibiotics, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotics (penicillins, monobactams or carbapenems);
• if the patient has ever developed severe skin rash or peeling of the skin, blisters and (or) mouth ulcers after treatment with cefuroxime or other antibiotics from the cephalosporin group.

If any of the above applies to the patient, Ceroxim must not be taken without consulting a doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ceroxim.
Severe skin adverse reactions have been reported with cefuroxime treatment, such as:
Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). If any of the symptoms related to severe skin reactions described in section 4 occur, seek immediate medical advice.
Children
Ceroxim is not recommended for use in children under 3 months of age, as the safety and efficacy of the medicine in this age group have not been established.
While taking Ceroxim, the patient should be alert for symptoms such as: allergic reactions, fungal infections (e.g. Candida), or severe diarrhoea (pseudomembranous colitis). This will reduce the risk of complications. See "Symptoms which need attention" in section 4.
If the patient is to undergo blood tests
Ceroxim may affect the results of blood glucose tests and the test known as the Coombs test. If the patient is to have blood tests, he or she should inform the person taking the blood sample that Ceroxim is being taken.
Ceroxim with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

• Medicines that reduce stomach acid (e.g. antacids used to treat heartburn) may affect the action of Ceroxim.
• Probenecid (a medicine used in the treatment of gout).
• Oral anticoagulant medicines (blood thinners).

If the patient is taking any of the medicines listed above, he or she should inform the doctor.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, thinks she may be pregnant or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Ceroxim may cause dizziness and other adverse effects that may impair concentration.
Do not drive or operate machinery if the patient does not feel well.
Important information about certain ingredients of Ceroxim
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Ceroxim

This medicine should always be used exactly as directed by the doctor. In case of doubt, consult your
doctor or pharmacist.
Ceroxim should be taken after a meal. This increases the effectiveness of treatment.
The tablets should be swallowed whole with water.
Do not chew, crush, or split the tablets – this may reduce the effectiveness of 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 (bw) (not exceeding 125 mg) to 15 mg/kg
bw (not exceeding 250 mg) twice daily, depending on the severity and type of infection.
The use of Ceroxim is not recommended in children under 3 months of age, as the safety and efficacy
of the medicine have not been established in this age group.
Depending on the disease and the child's response to treatment, the initial dose may be adjusted or
more than one treatment cycle may be required.

Patients with kidney disease
If the patient has kidney disease, they should inform their doctor. The doctor may adjust the dosage.

Taking more Ceroxim than recommended
If a patient takes more than the recommended dose, disturbances of the nervous system may occur,
particularly an increased risk of seizures ( epileptic seizures ).
In such a case, contact a doctor or the emergency department of the nearest hospital immediately. If
possible, show the medicine packaging.

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

Stopping treatment with Ceroxim
Do not stop taking Ceroxim without first consulting your doctor.
It is important to take all prescribed tablets of Ceroxim. Do not stop treatment without the doctor's
instruction, even if the patient feels better. Shortening the recommended duration of treatment may
lead to recurrence of the disease.
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.
Symptoms to be aware of
In a small number of people taking Ceroxim, 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 make breathing difficult.
• Skin rash that may develop into blisters and look like small rings (a dark spot surrounded by a lighter ring with a dark rim around the edge).
• Widespread skin lesions with blisters and peeling skin. (This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Extensive rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Chest pain associated with an allergic reaction, which may be a symptom of an allergy-induced heart attack (Kounis syndrome).

Other symptoms to be aware of during treatment with Ceroxim include:

• Fungal infections. Medicines such as Ceroxim may cause overgrowth of yeast (Candida) in the body, which may lead to fungal infection (e.g. candidiasis). The risk of this adverse reaction is higher if Ceroxim is used for a prolonged period.
• Severe diarrhoea (pseudomembranous colitis). Medicines such as Ceroxim may cause inflammation of the colon (large intestine), resulting in severe diarrhoea, usually with blood and mucus, abdominal pain, and fever.
• Jarisch-Herxheimer reaction. High temperature (fever), chills, muscle and headache, and rash during treatment for Lyme disease (Lyme disease). This is known as the Jarisch-Herxheimer reaction. These symptoms usually last from several hours to one day.

If any of these symptoms occur in a patient, contact a doctor or nurse immediately.
Common adverse reactions (may occur in up to 1 in 10 people):

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

Common adverse reactions observed 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 people):

• vomiting
• rash

Uncommon adverse reactions observed 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 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 temperature (fever)
• yellowing of the whites of the eyes or skin
• hepatitis

Adverse reactions observed 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, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw;
Tel.: 22 49 21 301
Fax: 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 Ceroxim

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the specified month.
There are no special storage conditions required.
Do not use Ceroxim tablets if the patient notices that the tablets are broken or damaged.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This 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
Film-coated tablets 250 mg are white to off-white, capsule-shaped, embossed with the digits "250" on one side and smooth on the other. The tablets are 15.0 mm in length, 6.5 mm in width, and 5.05 mm in thickness. They are packed in PVC/Aclar/Aluminum blisters in cardboard boxes. The box contains 10, 12, 14, 20, or 24 film-coated tablets.
Film-coated tablets 500 mg are white to off-white, capsule-shaped, embossed with the digits "500" on one side and smooth on the other. The tablets are 18.0 mm in length, 9.0 mm in width, and 6.95 mm in thickness. They are packed in PVC/Aclar/Aluminum blisters in cardboard boxes. The box 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
Poland

Manufacturer/Importer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The 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 European Economic Area countries 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