Bioracef

Package leaflet: Information for the patient

Bioracef, 125 mg, film-coated tablets
Bioracef, 250 mg, film-coated tablets
Bioracef, 500 mg, film-coated tablets
Cefuroximum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, 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 of the leaflet

1. What Bioracef is and what it is 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 Bioracef is and what it is used for

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

• Throat
• Sinuses
• Middle ear
• Lungs or chest
• Urinary tract
• Skin and soft tissues

Bioracef may also be used:

• In the treatment of early-stage Lyme disease (borreliosis – an infection transmitted by ticks).

2. Important information before using Bioracef

When not to use Bioracef

• if the patient is allergic to cephalosporin antibiotics or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever experienced 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, skin peeling, blisters, and/or oral ulcers following treatment with cefuroxime or other cephalosporin antibiotics.

If any of the above conditions apply to the patient, the patient should not take Bioracef without
consulting a doctor.
Warnings and precautions
Before starting treatment with Bioracef, discuss this with your doctor or pharmacist.
Do not crush coated tablets; therefore, they are not suitable for patients who cannot swallow tablets.
During treatment with Bioracef, be vigilant for symptoms such as allergic reactions, fungal infections (e.g. candidiasis), and severe diarrhoea (pseudomembranous colitis). This may help reduce the risk of complications. See “Symptoms to watch for” in section 4.
Serious skin reactions have occurred during treatment with cefuroxime, including: Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). If any of the symptoms associated with serious skin reactions described in section 4 occur, seek immediate medical advice from a doctor.
Blood tests
Bioracef may affect the results of blood glucose tests and the blood test known as the Coombs test. If the patient is due to have blood tests, they should
inform the person taking the sample that they are taking Bioracef.
Other medicines and Bioracef
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take. This includes medicines 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 helps to increase the effectiveness of treatment.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The doctor will assess whether the benefits to the patient of using Bioracef during pregnancy and breastfeeding outweigh any potential risks to the child.
Driving and using machines
Bioracef may cause dizziness and other adverse effects that may impair alertness.
The patient should not drive or operate machinery if they do not feel well.
Bioracef contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free".

3. How to use Bioracef

This medicine should always be taken exactly as prescribed by your doctor. If you have any
doubts, consult your doctor or pharmacist.
Dosage
Adults
The usual dose of Bioracef ranges from 250 mg to 500 mg twice daily, depending on the severity
and type of infection.
Children above 5 years of age
The usual dose of Bioracef ranges from 10 mg/kg body weight (not exceeding 125 mg) to
15 mg/kg body weight (not exceeding 250 mg) twice daily, depending on the severity and type
of infection.
Depending on the disease and the patient's response to treatment, the initial dose may be adjusted
or more than one treatment cycle may be required.
Patients with kidney problems
If the patient has impaired kidney function, the doctor may adjust the dosage of the medicine.
If this applies to the patient, they should inform the doctor.
Method of administration
Bioracef tablets should be swallowed whole with water.
Do not chew, crush, or split the tablets – this may reduce the effectiveness of treatment.
Taking more than the recommended dose of Bioracef
If a patient takes more than the recommended dose of Bioracef, neurological disturbances may
occur, particularly increasing the risk of seizures (epileptic fits).
Seek immediate medical attention or call emergency services. If possible, show the Bioracef
packaging to the healthcare provider.
If a dose of Bioracef is missed
Do not take a double dose to make up for the missed dose. Take the next dose at the usual time.
Stopping treatment with Bioracef
It is important not to shorten the prescribed duration of treatment with Bioracef. Do not stop
treatment without consulting your doctor, even if you feel better. Shortening the recommended
treatment period may lead to recurrence of the infection.
If you have any further questions regarding the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Symptoms to be aware of
In a small number of people taking Bioracef, an allergic reaction or potentially severe skin reaction has been reported. Symptoms may include:

• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug-induced hypersensitivity syndrome);
• Chest pain associated with an allergic reaction, which may be a symptom of an allergy-induced heart attack (Kounis syndrome);
• Severe allergic reaction. Symptoms include: raised, itchy rash , swelling , sometimes of the face or lips, which may make breathing difficult ;
• Skin rash, which may develop into blisters and look like small rings (a dark spot in the center surrounded by a lighter ring and a dark ring around the edge);
• Widespread skin lesions with blisters and peeling of the epidermis. (This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis - Lyell's disease);
• Fungal infections. Medicines such as Bioracef may cause overgrowth of yeast ( Candida ) in the body, leading to fungal infection (e.g. candidiasis). The risk of this adverse reaction is higher if Bioracef is used for a prolonged period;
• Severe diarrhoea (pseudomembranous colitis). Medicines such as Bioracef may cause inflammation of the colon (large intestine), resulting in severe diarrhoea, usually with blood and mucus, abdominal pain, and fever;
• Jarisch-Herxheimer reaction. During treatment with Bioracef for Lyme disease (borreliosis), some patients may experience high temperature (fever), chills, muscle and headache pain, and skin rash. 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 (occur in no more than 1 in 10 patients):

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

Common adverse reactions that may be revealed in blood tests:

• increased number of white blood cells (eosinophilia)
• increased liver enzyme activity.

Uncommon adverse reactions (occur in no more than 1 in 100 patients):

• vomiting
• skin rashes.

Uncommon adverse reactions that may be revealed in blood tests:

• decreased number of platelets (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 (frequency cannot be estimated from available data):

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

Adverse reactions that may be revealed in blood tests:

• excessive breakdown of red blood cells (haemolytic anaemia).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Bioracef

Keep the medicine out of sight and reach of children.
Store in the original packaging to protect from light and moisture.
Do not store at temperatures 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 stated month.
The marking on the packaging following "EXP" indicates the expiry date, and following "Lot" or "LOT" indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the package and other information

What Bioracef contains

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

What Bioracef looks like and contents of the pack
White to cream-colored, elongated, biconvex tablets with a uniform surface.
The pack contains 10 or 14 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
POLPHARMA Pharmaceutical Works S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
tel. 22 + 48 364 61 01
Manufacturer
POLPHARMA Pharmaceutical Works S.A.
Production Plant in Duchnice
Ożarowska Street 28/30, 05-850 Ożarów Mazowiecki
POLPHARMA Pharmaceutical Works S.A.
Pelplińska Street 19, 83-200 Starogard Gdański