Furocef

Package leaflet: Information for the patient

Furocef, 250 mg, film-coated tablets
Furocef, 500 mg, film-coated tablets
Cefuroximum
Please read carefully all the information in this leaflet before taking the 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 doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Furocef is and what it is 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 pack and other information

1. What Furocef is and what it is used for

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

Furocef may also be used:

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

2. Information before using Furocef

When not to take Furocef

• if the patient is allergic to cefuroxime, any other cephalosporin antibiotic, or 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 or peeling skin, blisters and/or oral ulcers after treatment with cefuroxime or other cephalosporin antibiotics.

If any of the above apply to the patient, Furocef must not be taken without consulting a
doctor.
Warnings and precautions
Before starting treatment with Furocef, discuss this with your doctor or pharmacist.
Severe skin reactions have occurred during treatment with cefuroxime, such as:
Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and
systemic symptoms (DRESS). If any symptoms related to severe skin reactions described in section 4 occur, medical advice must be sought immediately.
During treatment with Furocef, be alert for signs of allergic reactions, fungal infections (e.g. candidiasis), or severe diarrhoea (pseudomembranous colitis). This may reduce the risk of complications. See "Symptoms which require attention" in section 4.
Blood tests
Furocef 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, it is important to inform the person taking the blood sample
that Furocef is being taken.
Furocef with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription, as well as any medicines the patient plans to take.
Tell your doctor or pharmacist if the patient is taking:

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

Furocef with food and drink
Furocef should be taken after a meal. This helps increase the effectiveness of treatment.
Pregnancy, breastfeeding and fertility
Inform your doctor before taking Furocef:

• if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant,
• if the patient is breastfeeding.

The doctor will assess whether the benefits of using Furocef during pregnancy or breastfeeding outweigh the risks to the child.
Driving and operating machinery
Furocef may cause dizziness and other adverse effects that may impair alertness.
The patient should not drive or operate machinery if feeling unwell.
Furocef contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; this means the medicine is considered "sodium-free".

3. How to use Furocef

This medicine should always be used as directed by a doctor or pharmacist. If in
doubt, consult a doctor or pharmacist.
Furocef should be taken after a meal. This will help increase the effectiveness of treatment. Tablets should be
swallowed whole with water.
Do not chew, crush, or split the tablets – this may reduce the effectiveness of treatment.
Usual dose
Adults, adolescents, and children (≥40 kg)
The usual dose of Furocef ranges from 250 mg to 500 mg twice daily, depending on
the severity and type of infection.
Use in children
Furocef 250 mg and 500 mg, coated tablets, is not suitable for use in young children
weighing less than 40 kg.
The usual dose of Furocef is 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 disease
If the patient has kidney disease, the doctor may adjust the dosage of the medicine.
If this applies to the patient, the patient should inform the doctor.
Taking more than the recommended dose of Furocef
If the patient takes more than the recommended dose of Furocef, neurological disturbances
may occur, particularly increasing the risk of seizures (epileptic fits).
Seek immediate medical advice or call emergency services. If possible, show the
Furocef packaging to the healthcare provider.
Missed dose of Furocef
Do not take a double dose to make up for a missed dose. Take the next dose at the
usual time.
Stopping Furocef treatment
Do not stop treatment with Furocef without consulting a doctor. It is important not to
shorten the prescribed duration of Furocef treatment. Do not discontinue treatment without
medical advice, even if the patient feels better. Shortening the recommended treatment period may
lead to recurrence of the illness.
If you have any further questions about 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 Furocef, an allergic reaction or potentially severe skin reaction has been reported. Symptoms may include:

• 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 allergy-induced heart attack (Kounis syndrome),
• severe allergic reaction with symptoms such as: raised, itchy rash, swelling — sometimes of the face or lips — which may make breathing difficult ,
• skin rash , which may develop into blisters and appear as small rings (a dark spot in the center surrounded by a lighter ring with a dark edge),
• widespread rash with blisters and peeling skin (this may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis),
• fungal infections . Medicines such as Furocef may cause overgrowth of yeast ( Candida ) in the body, leading to fungal infection (e.g. thrush). The risk of this adverse reaction is higher if Furocef is used for a prolonged period.
• severe diarrhoea (pseudomembranous colitis). Medicines such as Furocef 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 Furocef for 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 several hours to one day. If any of these symptoms occur, contact your doctor or nurse immediately.

Common adverse reactions (may affect up to 1 in 10 patients):

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

Common adverse reactions that may be observed in blood test results:

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

Uncommon adverse reactions (may affect up to 1 in 100 patients):

• vomiting
• skin rashes.

Uncommon adverse reactions that may be observed in blood test results:

• decreased platelet count (cells involved in blood clotting)
• decreased white blood cell count (leukopenia)
• positive Coombs test.

Other adverse reactions
Other adverse reactions occur in a very small number of patients, but the exact frequency is unknown:

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

Adverse reactions that may be observed in blood test results:

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

Reporting of adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, inform your 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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Furocef

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
The batch number is indicated on the packaging after the abbreviation "Lot".
No special storage precautions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Doing so helps protect the environment.

6. Contents of the pack 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, magnesium stearate, calcium carbonate, and crospovidone (type A) in the tablet core; hypromellose 6 cP, 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 pack
Furocef 250 mg, film-coated tablets: blue, biconvex, capsule-shaped film-coated tablets, embossed with "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, capsule-shaped film-coated tablets, embossed with "203" on one side and smooth on the other; dimensions: 19.1 mm x 9.1 mm
Pack sizes: 10, 12, 14, 15, 16, 20 or 24 film-coated tablets in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For further information on the product names in other European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Tel. 22 57 37 500