Cefuroxime Eg

Package leaflet: Information for the user

Cefuroxime EG 250 mg film-coated tablets, 500 mg film-coated tablets

Cefuroxil
Please read this leaflet carefully before taking this medicine because it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are
the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor,
pharmacist, or nurse. See section 4.
Contents of this leaflet:

1. What Cefuroxime EG is and what it is used for
2. What you need to know before taking Cefuroxime EG
3. How to take Cefuroxime EG
4. Possible side effects
5. How to store Cefuroxime EG
6. Contents of the pack and other information

1. What Cefuroxime EG is and what it is used for

Cefuroxime EG is an antibiotic. It works by killing the bacteria that cause infections and belongs to a
group of medicines called cephalosporins.
Cefuroxime EG 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

Cefuroxime EG may also be used:

• to treat Lyme disease (an illness transmitted by parasites called ticks).

Your doctor may identify the type of bacteria causing the infection and check whether the bacteria are sensitive to
Cefuroxime EG during treatment.

2. What you need to know before taking Cefuroxima EG

Do not take Cefuroxima EG:

• if you are allergic to any antibiotic of the cephalosporin class or to any of the other ingredients of Cefuroxima EG (listed in section 6).
• if you have had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotics (penicillins, monobactams, and carbapenems). If you think this applies to you, do not take Cefuroxima EG before consulting your doctor.

Take special care with Cefuroxima EG
Be alert for certain symptoms such as allergic reactions, fungal infections (such as Candida) and severe diarrhoea (pseudomembranous colitis) while taking Cefuroxima EG. This will help reduce the risk of potential problems. See 'Conditions requiring caution' in section 4.
If you need blood tests
Cefuroxima EG may interfere with blood test results for blood sugar levels, or with a blood test known as the Coombs test. If you need blood tests:
Inform the person taking the sample that you are taking Cefuroxima EG.
Other medicines and Cefuroxima EG
Tell your doctor or pharmacist if you are taking any other medicines, if you have recently started taking any, or if you start taking new ones. This includes medicines you buy without a prescription.
Medicines used to reduce stomach acid (for example, antacids used to treat heartburn) may affect the activity of Cefuroxima EG.
Probenecid
Oral anticoagulants
Inform your doctor or pharmacist if you are taking any of these medicines.
Oral contraceptives
Cefuroxima EG may reduce the effectiveness of oral contraceptives. If you are taking an oral contraceptive while being treated with Cefuroxima EG, you should also use a barrier method of contraception (such as condoms). Please consult your doctor for advice.
Pregnancy, breast-feeding and fertility
Inform your doctor before taking Cefuroxima EG:

• if you are pregnant, think you may be pregnant, or are planning to become pregnant
• if you are breast-feeding.

Your doctor will assess the benefits of treatment with Cefuroxima EG against the risks to the baby.
Driving and using machines
Cefuroxima EG may cause dizziness and other side effects that may impair alertness.
Do not drive or operate machinery if you do not feel well.
Important information about some of the excipients in Cefuroxima EG
Cefuroxima EG tablets contain propyl and methyl parahydroxybenzoates. These excipients may cause allergic reactions (which may be delayed).

3. How to take Cefuroxime EG

Take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, consult your doctor or pharmacist.
Take Cefuroxime EG after meals. This will help make the treatment more effective.
Swallow the Cefuroxime EG tablets whole with water.
Do not chew, crush, or split the tablets – this may make the treatment less effective.

Recommended dose
The recommended dose of Cefuroxime EG is 250 mg to 500 mg twice daily, depending on the severity and type of infection.
Depending on the illness or your response to treatment, the initial dose may be adjusted or more than one course of treatment may be necessary.

Patients with kidney problems
If you have kidney problems, your doctor may adjust your dose.
Talk to your doctor if this applies to you.

If you take more Cefuroxime EG than you should
If you take too much Cefuroxime EG, you may experience neurological disturbances; in particular, you are more likely to have seizures.
Do not wait. Contact your doctor or the nearest hospital emergency department immediately. If possible, show them the Cefuroxime EG packaging.

If you forget to take Cefuroxime EG
Do not take a double dose to make up for the missed dose. Take the next dose at your usual time.

Do not stop taking Cefuroxime EG without advice
It is important to complete the full course of treatment with Cefuroxime EG. Do not stop unless your doctor tells you to, even if you feel better. If you do not complete the full course of treatment, the infection may return.

4. Possible side effects

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

Conditions requiring attention
A small number of people being treated with Cefuroxime EG experience an allergic reaction or a potentially serious skin reaction. Symptoms of these reactions include:

• Severe allergic reaction. Signs include raised, itchy rash, swelling, sometimes of the face or mouth, causing difficulty in breathing.
• Skin rash with blister-like spots resembling small targets (a dark spot in the centre surrounded by a pale area with a dark ring around the edge).
• Widespread rash with blistering and peeling of the skin. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis).

Other conditions requiring attention while taking Cefuroxime EG include:

• Fungal infections. Medicines such as Cefuroxime EG may cause overgrowth of fungi (Candida) in the body, which can lead to fungal infections (such as thrush). This side effect is more likely if you take Cefuroxime EG for a long time.
• Severe diarrhoea ( pseudomembranous colitis ). Medicines such as Cefuroxime EG may cause inflammation of the colon (large intestine), leading to severe diarrhoea, usually with blood and mucus, stomach pain, and fever.
• Jarisch-Herxheimer reaction. Some patients may experience high temperature (fever), chills, headache, muscle pain, and skin rash during treatment with Cefuroxime EG for Lyme disease. This is known as a Jarisch-Herxheimer reaction. Symptoms usually last for a few hours or up to one day.

Contact your doctor or nurse immediately if you experience any of these symptoms.

These may affect up to 1 in 10 patients:

• Fungal infections (such as Candida)
• Headache
• Dizziness
• Diarrhoea
• Nausea
• Stomach pain

Common side effects that may be detected by blood tests:

• Increase in a type of white blood cells (eosinophilia)
• Increase in liver enzymes

Uncommon side effects
These may affect up to 1 in 100 patients:

• Vomiting
• Skin rashes

Uncommon side effects that may be detected by blood tests:

• Decrease in the number of blood platelets (cells that help blood to clot)
• Decrease in the number of white blood cells
• Positive Coombs test

Other side effects
Other side effects have occurred in a very small number of people, but their 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
• Inflammation of the liver (hepatitis)

Side effects that may be detected by blood tests:

• Too rapid destruction of red blood cells (haemolytic anaemia)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the reporting system at: http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cefuroxime EG

Do not store above 30°C.
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 Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 Cefuroxime EG contains
The active substance is cefuroxime axetil.
Each film-coated tablet of Cefuroxime EG 250 mg contains 300.72 mg of cefuroxime axetil,
equivalent to 250 mg of cefuroxime.
Each film-coated tablet of Cefuroxime EG 500 mg contains 601.44 mg of cefuroxime axetil,
equivalent to 500 mg of cefuroxime.
The excipients are:
microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, hydrogenated vegetable oil, anhydrous colloidal silica, hypromellose, propylene glycol, titanium dioxide (E171), sodium benzoate, methyl parahydroxybenzoate, propyl parahydroxybenzoate.

Description of the appearance of Cefuroxime EG and package contents
Cefuroxime EG 250 mg – Film-coated tablets: 12 film-coated tablets of 250 mg
Cefuroxime EG 500 mg – Film-coated tablets: 6 and 12 film-coated tablets of 500 mg
The tablets are packaged in OPA/AL/PVC blisters.

Marketing Authorization Holder and Manufacturer
EG S.p.A. – Via Pavia, 6 – 20136 Milan, Italy
Manufacturer
Glaxo Wellcome Operations – Harmire Road - Barnard Castle - United Kingdom