Furocef

Package Leaflet: Information for the Patient

Furocef, 250 mg, Film-Coated Tablets

Furocef, 500 mg, Film-Coated Tablets

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.
• In case of any doubts, 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 not listed in this package leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Furocef and what is it used for

Furocef is an antibiotic used in adults, adolescents, and children with a body weight of over 40 kg.
The medicine works by killing the bacteria that cause infections. Furocef belongs to a group of medicines called cephalosporins.
Furocef is used to treat infections of:

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

Furocef may also be used:

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

2. Important information before taking Furocef

When not to take Furocef

• if the patient is allergic to cefuroxime, any other cephalosporin antibioticor 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 peeling of the skin, 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 takeFurocef without consulting a doctor.

Warnings and precautions

Before starting to take Furocef, 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 treatment. If the patient notices any of the symptoms related to severe skin reactions described in section 4, they should seek medical advice immediately.
During treatment with Furocef, 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.

Blood tests

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

Furocef and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take, including those obtained without a prescription.
The patient should tell their doctor or pharmacistif they are taking:

• medicines that reduce the amount of stomach acid(e.g. antacids used to treat heartburn) may affect the action of Furocef.
• probenecid.
• oral anticoagulants (blood thinners).

Furocef with food and drink

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

Pregnancy, breastfeeding, and fertility

The patient should inform their doctor before taking Furocef:

• if they are pregnant, think they may be pregnant, or plan to become pregnant,
• if they are breastfeeding.

The doctor will assess whether the benefits of taking Furocef during pregnancy and breastfeeding outweigh the risks to the baby.

Driving and using machines

Furocef 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.

Furocef contains sodium

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

3. How to take Furocef

This medicine should always be taken exactly as advised by the doctor or pharmacist.If the patient has any doubts, they should consult their doctor or pharmacist.
Furocef should be taken after a meal. This will help increase the effectiveness of the treatment. The tablets should be swallowed with water.
The tablets should not be chewed, crushed, or divided- this may reduce the effectiveness of the treatment.

Usual dose

Adults, adolescents, and children (≥40 kg)

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

Use in children

Furocef 250 mg and 500 mg film-coated tablets are not suitable for use in young children with a body weight below 40 kg.
The usual dose of Furocef 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 disease

If the patient has kidney disease, their doctor may change the dose of Furocef.
If this applies to the patient, they should tell their doctor.

Taking more Furocef than prescribed

If the patient takes more Furocef than prescribed, they may experience neurological disorders, including an increased risk of seizures(epileptic fits).
The patient should contact their doctor or emergency services immediately.If possible, they should show the Furocef packaging.

Missing a dose of Furocef

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 Furocef

The patient should not stop taking Furocef without consulting their doctor. It is important not to shorten the prescribed treatment period with Furocef.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, Furocef can cause side effects, although not everybody gets them.

Symptoms to watch out for

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

• widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or hypersensitivity syndrome),
• chest pain associated with an allergic reaction, which may be a sign of an allergic myocardial infarction (Kounis syndrome),
• severe allergic reactionwith symptoms such as: raised, itchy rash, swelling, sometimes of the face or lips, 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 rashes with blisters and peeling skin(this may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis),
• fungal infections. Medicines like Furocef 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 Furocef is taken for a long time.
• severe diarrhea(pseudomembranous colitis). Medicines like Furocef 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 Furocef to treat Lyme disease (borreliosis), some patients may experience a high fever, chills, muscle and headache, and a rash on the skin. 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(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 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)
• 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 the patient experiences any side effects, including any not listed in this package leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products)
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Furocef

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 after "EXP". The expiry date refers to the last day of the month.
The batch number is stated on the packaging after "Lot".
No special precautions for storage are necessary.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Furocef contains

• The active substance is cefuroxime. Furocef, 250 mg, film-coated tablets Each film-coated tablet contains 250 mg of cefuroxime, equivalent to 300.715 mg of cefuroxime axetil. Furocef, 500 mg, film-coated tablets Each film-coated tablet contains 500 mg of cefuroxime, equivalent to 601.43 mg of cefuroxime axetil.
• The other ingredients are: microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, colloidal anhydrous silica, calcium stearate, calcium carbonate, and crospovidone (type A) in the tablet core, and hypromellose 6cp, titanium dioxide (E 171), propylene glycol, and brilliant blue FCF (E 133) in the tablet coating. See section 2 "Furocef contains sodium".

What Furocef looks like and contents of the package

Furocef 250 mg, film-coated tablets: blue, biconvex, film-coated tablets in the shape of a capsule with the inscription "204" on one side and smooth on the other; dimensions: 15.1 mm x 8.1 mm
Furocef 500 mg, film-coated tablets: blue, biconvex, film-coated tablets in the shape of a capsule with the inscription "203" on one side and smooth on the other; dimensions: 19.1 mm x 9.1 mm
Packaging:10, 12, 14, 15, 16, 20, or 24 film-coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information on the names of medicinal products in other EU member states, the patient should contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the package leaflet:18.08.2023