Ceroxim

Leaflet attached to the packaging: information for the user

Ceroxim, 125 mg/5 ml, powder for oral suspension

Ceroxim, 250 mg/5 ml, powder for oral suspension

Cefuroxime

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Ceroxim and what is it used for

Ceroxim 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.

Ceroxim is used to treat infections:

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

Ceroxim may also be used:

• to treat early stages of Lyme disease (borreliosis - an infection transmitted by ticks).

The doctor may check what type of bacteria caused the infection in the patient and check during treatment whether the bacteria are sensitive to Ceroxim.

2. Important information before taking Ceroxim

When not to take Ceroxim:

• if the patient is allergic to cefuroxime axetil, to any other cephalosporin antibiotic, 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 antibiotic (penicillins, monobactams, or carbapenems);
• if the patient has ever had a severe skin rash or skin peeling, blisters, and (or) ulcers of the mouth after taking cefuroxime or other cephalosporin antibiotics.

If any of the above applies to the patient, they should not take Ceroximwithout consulting a doctor.

Warnings and precautions

Before starting to take Ceroxim, the patient should discuss it with their doctor or pharmacist. Severe skin reactions, such as:

Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with cefuroxime. If the patient notices any of the symptoms related to severe skin reactions described in section 4, they should seek medical advice immediately.

Children

Ceroxim is not recommended for use in children under 3 months, as the safety and efficacy of the medicine in this age group are not known. During treatment with Ceroxim, the patient should be aware of the possibility of allergic reactions, fungal infections (e.g., thrush), and severe diarrhea (pseudomembranous colitis). This will reduce the risk of complications. See “Symptoms to watch for”in section 4.

Blood tests

Ceroxim may affect the results of blood sugar tests and a blood test called the Coombs test. If the patient is to have a blood test, they should:

tell the person taking the blood samplethat they are taking Ceroxim.

Ceroxim and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are taking, have recently taken, or might take.

• Medicines that reduce the amount of acid in the stomach(e.g., antacids used to treat heartburn) may affect the action of Ceroxim.
• Probenecid.
• Oral anticoagulants (blood thinners). If the patient is taking any of the above (or similar) medicines, they should tell their doctor or pharmacist.

Oral contraceptives

Ceroxim may reduce the effectiveness of oral contraceptives. If the patient is taking oral contraceptives while taking Ceroxim, they should also use mechanical methods of contraception(e.g., condoms). If in doubt, the patient should consult their doctor.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Ceroxim may cause dizzinessand other side effects that can impair the patient's alertness. The patient should not drive or operate machineryif they do not feel well.

Important information about some of the ingredients of Ceroxim

Ceroxim, powder for oral suspension, contains sugar (sucrose)

5 ml of the ready-to-use oral suspension 125 mg/5 ml contains 2.7819 g of sucrose. 5 ml of the ready-to-use oral suspension 250 mg/5 ml contains 2.4998 g of sucrose. This should be taken into account in patients with diabetes.

Ceroxim, powder for oral suspension, contains glucose (maltodextrin component)

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Ceroxim, powder for oral suspension, contains aspartame (E 951)

The medicine contains 8 mg of aspartame in each 5 ml of the ready-to-use suspension. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion. If the patient does not tolerate aspartame or has phenylketonuria, they should:

ask their doctorif they can take Ceroxim.

Ceroxim, powder for oral suspension, contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 5 ml of suspension, which means that it is considered “sodium-free”.

Ceroxim, powder for oral suspension, contains mannitol

The medicine may have a slight laxative effect.

Ceroxim, powder for oral suspension, contains sodium benzoate (E 211)

The medicine contains 5 mg of sodium benzoate per 5 ml of suspension, which corresponds to 1 mg/ml.

Ceroxim, powder for oral suspension, contains benzyl alcohol

The medicine contains 0.45 mg of benzyl alcohol per 5 ml of suspension, which corresponds to 0.09 mg/ml. Benzyl alcohol may cause allergic reactions. Pregnant or breastfeeding women should consult their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis). Patients with liver or kidney disease should consult their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis). The medicine should not be given to small children (under 3 years) for more than a week without the advice of a doctor or pharmacist.

Ceroxim, powder for oral suspension, contains ethanol

This medicine contains 0.001 mg of alcohol (ethanol) per 5 ml of suspension, which is equivalent to 0.0002 mg/ml. The amount of alcohol in 5 ml of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce noticeable effects. Ceroxim, powder for oral suspension, contains flavoring substances - citral, geraniol, and citronellol.

3. How to take Ceroxim

This medicine should always be taken as directed by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist. Ceroxim should be taken after a meal. This will help increase the effectiveness of the treatment. Before use, the bottle should be shaken. Ceroxim suspension can be diluted with cold fruit juice or a milk drink, but it should be taken immediately after preparation. Ceroxim should not be mixed with hot liquids. Detailed instructions for preparing Ceroxim suspension can be found at the end of the leaflet (see Instructions for preparing the suspension).

Recommended dose

Adults

The recommended dose of Ceroxim is 250 mg to 500 mg twice a day, 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 a day, depending on:

• the severity and type of infection
• the child's body weight and age, not more than 500 mg per day.

Ceroxim is not recommended for use in children under 3 months, 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 the patient has kidney problems, the doctor may change the dose of Ceroxim. If this applies to the patient, they should tell their doctor. The measuring cup provided with the packaging is intended for accurate dosing. The measuring cup can be used to measure or administer the medicine (instead of a spoon).

Taking a higher dose of Ceroxim than recommended

If the patient takes a higher dose of Ceroxim than recommended, they may experience neurological disorders, in particular, an increased risk of seizures (epileptic fits). The patient should immediately contact a doctor or call an emergency number. If possible, they should show the packaging of Ceroxim.

Missing a dose of Ceroxim

The patient should not take a double dose to make up for a missed dose. They should take the next dose at the usual time.

Stopping treatment with Ceroxim

The patient should not stop taking Ceroxim without their doctor's advice.

It is important not to shorten the prescribed treatment period with Ceroxim. The patient should not stop treatment without their doctor's advice, even if they feel better. Shortening the recommended treatment period may lead to a recurrence of the disease. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

Symptoms to watch for

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

• Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or lips, which can make breathing difficult.
• Skin rash, which can develop into blistersand 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 - Lyell's disease).
• Widespread rash, high fever, and swollen lymph nodes(DRESS syndrome or drug hypersensitivity syndrome).
• Chest pain associated with an allergic reaction, which can be a sign of a heart attack caused by an allergy (Kounis syndrome).

Other symptoms to watch for while taking Ceroxim

• Fungal infections. Medicines like Ceroxim can cause an overgrowth of yeast (Candida) in the body, leading to a fungal infection (e.g., thrush). The risk of this side effect is higher 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. When taking Ceroxim to treat Lyme disease (borreliosis), some patients may experience a high fever, chills, muscle and headache, and a rash. This is called a Jarisch-Herxheimer reaction. These symptoms usually last from a few hours to a day.

If the patient experiences any of these symptoms, they should immediately contact their doctor or nurse. Common side effects (may occur in up to 1 in 10 patients):

• fungal infections (e.g., thrush)
• headache
• dizziness
• diarrhea
• nausea
• stomach pain

Common side effects that may be detected in blood tests:

• increased white blood cell count (eosinophilia)
• increased liver enzyme activity

Uncommon side effects

May occur in less than 1 in 100 patients:

• vomiting
• skin rashes

Uncommon side effects that may be detected in blood tests:

• decreased platelet count (thrombocytopenia)
• decreased white blood cell count (leukopenia)
• positive Coombs test result

Other side effects

Other 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 ones)
• high fever
• yellowing of the whites of the eyes or skin
• liver inflammation

Side effects that may be detected in blood tests:

• rapid breakdown of red blood cells (hemolytic anemia)

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. 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: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: 22 49-21-301, Fax: 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, more information can be collected on the safety of the medicine.

5. How to store Ceroxim

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. The powder should be stored at a temperature below 25°C. Protect from moisture. The prepared suspension should be stored in a refrigerator at a temperature between 2°C and 8°C for no more than 10 days. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ceroxim contains

• The active substance of the medicine is cefuroxime in the form of cefuroxime axetil (in a mixture: crystalline cefuroxime axetil, hypromellose phthalate, copolymer of methacrylic acid and ethyl acrylate). 5 ml of the prepared suspension contains 125 mg or 250 mg of cefuroxime.
• Other ingredients are:
• sucrose, aspartame (E 951), xanthan gum, silica dioxide (Syloid Al-1 FP), sodium citrate, sodium benzoate (E 211), Tutti Frutti flavor [51.880/AP05.51; containing, among others, sodium, corn maltodextrin, propylene glycol (E 1520), benzyl alcohol, ethanol, citral, geraniol, and citronellol], peppermint flavor (517 SD; containing modified starch), sodium chloride, mannitol (Pearlitol SD 200). See also the composition of the mixture with the active substance above.

Other important information about some of the ingredients of Ceroxim, see section 2.

What Ceroxim looks like and what the packaging contains

Powder for oral suspension. The powder is white to cream-colored. After adding water, a white to cream-colored suspension is formed. Ceroxim is available in bottles containing powder for the preparation of 50 ml or 100 ml of oral suspension with a strength of 125 mg/5 ml or 250 mg/5 ml. A measuring cup is provided with the bottle, allowing for the measurement of 22 ml, 23 ml, 42 ml, or 44 ml of water. After turning it over, it can be used to measure or administer 2.5 ml, 5 ml, or 10 ml of the prepared suspension.

Marketing authorization holder and manufacturer

Marketing authorization holder Ranbaxy (Poland) Sp. z o.o. ul. Idzikowskiego 16 00-710 Warsaw Tel. +48 22 642 07 75 Manufacturer Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87 2132 JH Hoofddorp Netherlands Date of last revision of the leaflet: -------------------------------------------------------------------------------------------------------------------------------

Instructions for preparing the suspension

Ceroxim, 125 mg/5 ml

Bottle for preparing 50 ml of suspension Before adding water, the bottle should be shaken several times to loosen and aerate the powder. Then, 23 ml of boiled, cooled water should be measured into a separate container (the provided measuring cup can be used for measurement). Slowly add about half of the previously measured water to the powder in the bottle and shake well. Slowly add the rest of the water and shake until a uniform suspension is obtained. The prepared suspension should be stored in the refrigerator. Before use, leave at room temperature for about 5 minutes, then shake vigorously until the suspension is liquefied. Shake before each use. Bottle for preparing 100 ml of suspension Before adding water, the bottle should be shaken several times to loosen and aerate the powder. Then, 44 ml of boiled, cooled water should be measured into a separate container (the provided measuring cup can be used for measurement). Slowly add about half of the previously measured water to the powder in the bottle and shake well. Slowly add the rest of the water and shake until a uniform suspension is obtained. The prepared suspension should be stored in the refrigerator. Before use, leave at room temperature for about 5 minutes, then shake vigorously until the suspension is liquefied. Shake before each use.

Ceroxim, 250 mg/5 ml

Bottle for preparing 50 ml of suspension Before adding water, the bottle should be shaken several times to loosen and aerate the powder. Then, 22 ml of boiled, cooled water should be measured into a separate container (the provided measuring cup can be used for measurement). Slowly add about half of the previously measured water to the powder in the bottle and shake well. Slowly add the rest of the water and shake until a uniform suspension is obtained. The prepared suspension should be stored in the refrigerator. Before use, leave at room temperature for about 5 minutes, then shake vigorously until the suspension is liquefied. Shake before each use. Bottle for preparing 100 ml of suspension Before adding water, the bottle should be shaken several times to loosen and aerate the powder. Then, 42 ml of boiled, cooled water should be measured into a separate container (the provided measuring cup can be used for measurement). Slowly add about half of the previously measured water to the powder in the bottle and shake well. Slowly add the rest of the water and shake until a uniform suspension is obtained. The prepared suspension should be stored in the refrigerator. Before use, leave at room temperature for about 5 minutes, then shake vigorously until the suspension is liquefied. Shake before each use.