Bioracef

Leaflet attached to the packaging: patient information

Bioracef, 125 mg, film-coated tablets

Bioracef, 250 mg, film-coated tablets

Bioracef, 500 mg, film-coated tablets

Cefuroxime

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

• 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 a specific person. 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 not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Bioracef and what is it used for

Bioracef is an antibiotic used in adults and children over 5 years of age. The medicine works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Bioracef 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.

Bioracef may also be used:

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

2. Important information before taking Bioracef

When not to take Bioracef

• if the patient is allergic to cephalosporin antibioticsor 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 treatment with cefuroxime or other cephalosporin antibiotics.

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

Warnings and precautions

Before starting treatment with Bioracef, the patient should discuss it with their doctor or pharmacist. The film-coated tablets should not be crushed and are therefore not suitable for patients who have difficulty swallowing tablets. During treatment with Bioracef, the patient should be aware of the following symptoms: allergic reactions, fungal infections (e.g. thrush), and severe diarrhea (pseudomembranous colitis). This will reduce the risk of complications. See "Symptoms to watch out for" in section 4. 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 treatment. If the patient notices any of the symptoms associated with severe skin reactions described in section 4, they should contact their doctor immediately.

Blood tests

Bioracef may affect the results of blood tests for sugar and the Coombs test. If the patient is to have a blood test, they should tell the person taking the blood samplethat they are taking Bioracef.

Bioracef and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, or have recently taken, and about any medicines they plan to take, including those obtained without a prescription.

• Medicines that reduce stomach acid(e.g. antacids used to treat heartburn) may affect the action of Bioracef.
• Probenecid.
• Oral anticoagulants (blood thinners).

Bioracef with food and drink

Bioracef should be taken after a meal.This will help increase the effectiveness of the treatment.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, or are planning to have a baby, they should ask their doctor or pharmacist for advice before taking this medicine. The doctor will assess whether the benefits of taking Bioracef during pregnancy and breastfeeding outweigh the risks to the baby.

Driving and using machines

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

Bioracef contains sodium

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

3. How to take Bioracef

This medicine should always be taken exactly as advised by the doctor. If the patient is unsure, they should ask their doctor or pharmacist. Dosage

Adults

The usual dose of Bioracef is 250 mg to 500 mg twice a day, depending on the severity and type of infection.

Children over 5 years of age

The usual dose of Bioracef 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. 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 Bioracef. If this applies to the patient, they should tell their doctor. Administration The Bioracef tablets should be swallowed whole with water. The tablets should not be chewed, crushed, or divided- this may reduce the effectiveness of the treatment.

Taking a higher dose of Bioracef than recommended

If the patient takes more Bioracef than they should, they may experience neurological disorders, in particular, the risk of seizures (epileptic fits) increases. The patient should contact their doctor or call the emergency services immediately. If possible, they should show the Bioracef packaging.

Missing a dose of Bioracef

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 Bioracef

It is important not to shorten the prescribed treatment period with Bioracef.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 questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

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

Symptoms to watch out for

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

• Widespread rash, high fever, and swollen lymph nodes(DRESS or drug hypersensitivity syndrome);
• Chest painassociated with an allergic reaction, which may be a sign of a heart attack caused by an allergy (Kounis syndrome);
• Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or lips, which may cause difficulty breathing;
• Rash on the skin, which may 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);
• Fungal infections.Medicines like Bioracef 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 Bioracef is taken for a long time;
• Severe diarrhea (pseudomembranous colitis).Medicines like Bioracef can cause inflammation of the colon (large intestine), leading to severe diarrhea, usually with blood and mucus, abdominal pain, and fever;
• Jarisch-Herxheimer reaction.During treatment with Bioracef for Lyme disease (borreliosis), some patients may experience a high fever, chills, muscle and headache, and rash. This is known as 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 contact their doctor or nurse immediately.

Common side effects(occurring in less than 1 in 10 patients):

• 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(occurring in less than 1 in 100 patients):

• 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 very small number of patients, but the exact frequency is unknown (the frequency cannot be estimated from the available data):

• severe diarrhea (pseudomembranous colitis)
• allergic reactions
• skin reactions (including severe)
• high fever
• yellowing of the whites of the eyes or skin
• liver inflammation.

Side effects that may be seen in blood tests:

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

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 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 gathered on the safety of the medicine.

5. How to store Bioracef

The medicine should be stored out of sight and reach of children. Store in the original packaging to protect from light and moisture. Do not store above 25°C. 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 notation on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Bioracef contains

• The active substance of Bioracef is cefuroxime. Each tablet contains 125 mg, 250 mg, or 500 mg of cefuroxime in the form of cefuroxime axetil.
• The other ingredients are: core: sodium glycolate starch, colloidal silicon dioxide, sodium croscarmellose, modified starch, sodium lauryl sulfate; coating: hypromellose, titanium dioxide, castor oil.

What Bioracef looks like and contents of the pack

The tablets are white to cream-colored, elongated, biconvex, with a smooth surface. The pack contains 10 or 14 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. 22 + 48 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A., Production Plant in Duchnice, ul. Ożarowska 28/30, 05-850 Ożarów Mazowiecki, Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański

Date of last revision of the leaflet: