Ceroxim

Package Leaflet: Information for the User

Ceroxim, 125 mg/5 ml, Powder for Oral Suspension

Ceroxim, 250 mg/5 ml, Powder for Oral Suspension

Cefuroxime

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

• Keep this package 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 experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What Ceroxim is and what it is 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 package and other information

1. What Ceroxim is and what it is 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
• the sinuses
• the middle ear
• the lungs or chest
• the urinary tract
• the skin and soft tissues.

Ceroxim 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 caused your infection and check if the bacteria are sensitive to Ceroxim during treatment.

2. Important information before taking Ceroxim

When not to take Ceroxim:

• if you are allergic to cefuroxime axetil, any other cephalosporin antibiotic, 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, skin peeling, or blistering, or mouth ulcers after taking cefuroxime or other cephalosporin antibiotics.

If any of these apply to you, do not take Ceroximwithout consulting your doctor.

Warnings and precautions

Before taking Ceroxim, discuss it with your 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 you notice any symptoms of severe skin reactions (see section 4), seek medical advice immediately.

Children

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

Blood tests

Ceroxim may affect the results of blood tests for sugar and the Coombs test. If you are going to have a blood test, tell the person taking the sample that you are taking Ceroxim.

Ceroxim and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.

• Medicines that reduce stomach acid(e.g., antacids used to treat heartburn) may affect the action of Ceroxim.
• Probenecid.
• Oral anticoagulants (blood thinners). If you are taking any of these medicines, tell your doctor or pharmacist.

Oral contraceptives

Ceroxim may reduce the effectiveness of oral contraceptives. If you are taking oral contraceptives, use additional mechanical methods of contraception(e.g., condoms). If you have any doubts, consult your doctor.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Ceroxim may cause dizzinessand other side effects that can impair your ability to drive or operate machinery. Do not drive or operate machinery if you do not feel well.

Important information about some ingredients of Ceroxim

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

5 ml of the reconstituted suspension contains 2.7819 g of sucrose. 5 ml of the reconstituted suspension contains 2.4998 g of sucrose. This should be taken into account for patients with diabetes.

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

If you have previously been diagnosed with intolerance to some sugars, consult your 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 reconstituted 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 impaired elimination. If you do not tolerate aspartame or have phenylketonuria, ask your doctorif you 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 the suspension, which means it is essentially “sodium-free”.

Ceroxim, powder for oral suspension, contains mannitol

The medicine may have a mild laxative effect.

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

The medicine contains 5 mg of sodium benzoate per 5 ml of the suspension, which is equivalent 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 the suspension, which is equivalent 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 (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 (metabolic acidosis). Do not give to small children (under 3 years) for more than a week without consulting a doctor or pharmacist.

Ceroxim, powder for oral suspension, contains ethanol

This medicine contains 0.001 mg of ethanol (alcohol) per 5 ml of the suspension, which is equivalent to 0.0002 mg/ml. The amount of alcohol in 5 ml of the suspension is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have a noticeable effect.

Ceroxim, powder for oral suspension, contains flavoring agents - citral, geraniol, and citronellol.

3. How to take Ceroxim

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Ceroxim should be taken after a meal. This will help increase the effectiveness of the treatment. Shake the bottle well before use. Ceroxim suspension can be diluted with cold fruit juice or milk, but it should be taken immediately after preparation. Do not mix Ceroxim with hot liquids. Detailed instructions for preparing Ceroxim suspension can be found at the end of the package 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 children under 3 months of age, 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 you have kidney problems, your doctor may change the dose of Ceroxim. If this applies to you, tell your doctor. The measuring cup provided with the medicine is intended for accurate dosing. The measuring cup can be used to measure or administer the medicine (instead of a spoon).

Taking more Ceroxim than prescribed

If you take more Ceroxim than prescribed, you may experience neurological disorders, particularly an increased risk of seizures (epileptic fits). Contact your doctor or call emergency services immediately. If possible, show the packaging of Ceroxim.

Missing a dose of Ceroxim

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 unless your doctor tells you to.

It is important not to shorten the prescribed treatment period with Ceroxim. Do not stop treatment without your doctor's advice, even if you feel better. Shortening the recommended treatment period may lead to a recurrence of the disease. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Symptoms to look out for

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

• Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or mouth, which may make breathing difficult.
• Skin rash, which may develop into blisteringand look like small rings(a dark spot in the center surrounded by a lighter border with a dark ring around the edge).
• Widespread skin lesions 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 may be a sign of an allergic myocardial infarction (Kounis syndrome).

Other symptoms to look out for while taking Ceroxim

• Fungal infections. Medicines like Ceroxim can cause an overgrowth of yeast (Candida) in the body, leading to fungal infections (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 skin rash. This is known as 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 affect up to 1 in 10 people):

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

Common side effects that may be seen in blood tests:

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

Uncommon side effects

May affect up to 1 in 100 people:

• vomiting
• skin rashes

Uncommon side effects that may be seen in blood tests:

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

Other side effects

Other side effects occur in a small number of people, 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
• inflammation of the liver

Side effects that may 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 package leaflet, tell your 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, you can help provide more information on the safety of this medicine.

5. How to store Ceroxim

Keep the medicine out of the 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. Store the powder below 25°C. Protect from moisture. The reconstituted suspension should be stored in the 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package 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, methacrylic acid - ethyl acrylate copolymer). 5 ml of the reconstituted suspension contains 125 mg or 250 mg of cefuroxime.
• Other ingredients are:
• sucrose, aspartame (E 951), xanthan gum, silicon 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 ingredients of Ceroxim, see section 2.

What Ceroxim looks like and contents of the pack

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 inverting, it can be used to measure or administer 2.5 ml, 5 ml, or 10 ml of the reconstituted 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 package leaflet: -------------------------------------------------------------------------------------------------------------------------------

Instructions for preparing the suspension

Ceroxim, 125 mg/5 ml

Bottle for preparation of 50 ml suspension Before adding water, shake the bottle several times to loosen and aerate the powder. Then, measure 23 ml of boiled, cooled water (the provided measuring cup can be used) into a separate container. Add the water slowly to the powder in the bottle, shaking well. 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 fluid. Shake before each use. Bottle for preparation of 100 ml suspension Before adding water, shake the bottle several times to loosen and aerate the powder. Then, measure 44 ml of boiled, cooled water (the provided measuring cup can be used) into a separate container. Add the water slowly to the powder in the bottle, shaking well. 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 fluid. Shake before each use.

Ceroxim, 250 mg/5 ml

Bottle for preparation of 50 ml suspension Before adding water, shake the bottle several times to loosen and aerate the powder. Then, measure 22 ml of boiled, cooled water (the provided measuring cup can be used) into a separate container. Add the water slowly to the powder in the bottle, shaking well. 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 fluid. Shake before each use. Bottle for preparation of 100 ml suspension Before adding water, shake the bottle several times to loosen and aerate the powder. Then, measure 42 ml of boiled, cooled water (the provided measuring cup can be used) into a separate container. Add the water slowly to the powder in the bottle, shaking well. 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 fluid. Shake before each use.