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

Cefuroxime

Read the Package Leaflet Carefully Before Taking the Medication, 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Package Leaflet Contents

• 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. Package contents 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 you are allergic to cephalosporin antibioticsor any other ingredient 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 or peeling of the skin, blisters, and (or) ulcers in the mouth after taking cefuroxime or other cephalosporin antibiotics.

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

Warnings and precautions

Before taking Bioracef, discuss it with your 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, pay attention to whether you experience symptoms such as 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. If you notice any symptoms associated with severe skin reactions described in section 4, seek medical attention immediately.

Blood tests

Bioracef 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 Bioracef.

Bioracef and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, including those obtained without a prescription. This includes:

• Medicines that reduce stomach acid(e.g., antacids used to treat heartburn)
• 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 you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine. Your 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 your ability to drive or operate machinery. Do not drive or operate machineryif you 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

Always take this medicine exactly as your doctor has told you.If you are unsure, ask your 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 you have kidney problems, your doctor may change the dose of Bioracef. If this applies to you, tell your doctor. Administration

Swallow the Bioracef tablets whole with water. Do not chew, crush, or divide the tablets- this may reduce the effectiveness of the treatment.

Taking more Bioracef than prescribed

If you take more Bioracef 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 them the Bioracef packaging.

Missing a dose of Bioracef

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

Stopping treatment with Bioracef

It is important not to shorten the prescribed treatment period with Bioracef.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, 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 potentially severe skin reaction. The symptoms may include:

• Widespread rash, high fever, and swollen lymph nodes(DRESS or hypersensitivity syndrome);
• Chest painassociated with an allergic reaction, which can 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 mouth, which can make breathing difficult;
• Skin rashthat can develop into blistersand look like small rings(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.When taking Bioracef to treat Lyme disease (borreliosis), some patients may experience 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(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 (cells involved in blood clotting)
• 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 (cannot be estimated from 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 you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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. 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 Bioracef

Keep the medicine out of the 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. 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents 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.
• The other ingredients are: core: sodium starch glycolate, 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, and biconvex, with a smooth surface. The package 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 package leaflet: