Package leaflet: Information for the user

Cefuroxime 125 mg and 500 mg Tablets (cefuroxime axetil)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    Keep this 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Cefuroxime Tablets are and what they are used for

2.    What you need to know before you take Cefuroxime Tablets

3.    How to take Cefuroxime Tablets

4.    Possible side effects

5.    How to store Cefuroxime Tablets

6.    Contents of the pack and other information

1.    What Cefuroxime Tablets are and what they are used for

Cefuroxime is an antibiotic used in adults and children. It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Cefuroxime is used to treat infections of:

•    the throat

•    sinus

•    middle ear

•    the lungs or chest

•    the urinary tract

•    the skin and soft tissues.

Cefuroxime can also be used:

•    to treat Lyme disease (an infection spread by parasites called ticks).

2.    What you need to know before you take Cefuroxime Tablets Do not take Cefuroxime Tablets:

•    if you are allergic to any other cephalosporin antibiotics or any of the other ingredients in this medicine (listed in section 6)

•    if you have ever had a severe allergic reaction to any other type of betalactam antibiotic (penicillins, monobactams and carbapenems).

If you think this applies to you, do not take Cefuroxime until you have checked with your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Cefuroxime Tablets

Cefuroxime is not recommended for children aged under 3 months, as the safety and effectiveness are not known in this age group.

You must look out for certain symptoms, such as allergic reactions, fungal infections REG0185085    Version 0.6    Approved    Page 1 of 6

(such as Candida) and severe diarrhoea (pseudomembranous colitis) while you are taking Cefuroxime. This will reduce the risk of any problems. See ‘Conditions you need to look out for’ in Section 4.

If you need a blood test

Cefuroxime can affect the results of a test for blood sugar levels, or a blood screen called the Coombs test. If you need a blood test:

• tell the person taking the sample that you are taking Cefuroxime.

Other medicines and Cefuroxime

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you can obtain without a prescription.

Medicines used to reduce the amount of acid in your stomach (e.g. antacids used to treat

heartburn) can affect how Cefuroxime works.

probenecid

oral anticoagulants

Tell your doctor or pharmacist if you are taking any other medicine like this.

Pregnancy, breast-feeding and fertility

Tell your doctor before you take Cefuroxime:

•    if you are pregnant, think you might be pregnant or are planning to become pregnant

•    if you are breastfeeding.

Your doctor will consider the benefit of treating you with Cefuroxime against the risk to your baby.

Driving and using machines

Cefuroxime can make you dizzy and have other side effects that make you less alert.

•    Do not drive or use machines if you do not feel well.

3. How to take Cefuroxime Tablets

Always take Cefuroxime Tablets exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Take Cefuroxime after food. This will help to make the treatment more effective.

Swallow Cefuroxime tablets whole with some water.

Do not chew, crush or split the tablets— this may make the treatment less effective.

The recommended dose is:

Adults

The usual dose of Cefuroxime is 250 mg to 500 mg twice daily depending on the severity and type of infection.

Use in children and adolescents

The usual dose of Cefuroxime is 10 mg/kg (to maximum of 125 mg) to 15 mg/kg (to a maximum of 250 mg) twice daily depending on:

•    the severity and type of infection

Cefuroxime is not recommended for children aged under 3 months, as the safety and effectiveness are not known in this age group.

Depending on the illness or how you or your child responds to treatment, the initial dose may be

changed or more than one course of treatment may be needed.

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Patients with kidney problems

If you have a kidney problem, your doctor may change your dose.

•    talk to your doctor if this applies to you.

If you take more Cefuroxime Tablets than you should

If you take too much Cefuroxime you may have neurological disorders, in particular you may be more likely to have fits (seizures).

•    do not delay. Contact your doctor or your nearest hospital emergency department immediately. If possible, show them the Cefuroxime pack.

If you forget to take Cefuroxime Tablets

Do not take a double dose to make up for a forgotten dose. Just take your next dose at the usual time.

Do not stop taking Cefuroxime Tablets without advice.

It is important that you take the full course of Cefuroxime. Do not stop unless your doctor advises you to - even if you are feeling better. If you do not complete the full course of treatment, the infection may come back.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Conditions you need to look out for

A small number of people taking Cefuroxime an allergic reaction or potentially serious skin

reaction.

Symptoms of these reactions include:

•    severe allergic reaction. Signs include raised and itchy rash, swelling, sometimes of the face or mouth causing difficulty in breathing

•    skin rash, which may blister, and looks like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge)

•    a widespread rash with blisters and peeling skin. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis)

•    fungal infections. Medicines like Cefuroxime can cause an overgrowth of yeast (Candida) in the body which can lead to fungal infections (such as thrush). This side effect is more likely if you take Cefuroxime for a long time

•    severe diarrhoea (Pseudomembranous colitis). Medicines like Cefuroxime can cause inflammation of the colon (large intestine), causing severe diarrhoea, usually with blood and mucus, stomach pain, fever

•    Jarisch-Herxheimer reaction. Some patients may get a high temperature (fever), chills, headache, muscle pain and skin rash while being treated with Cefuroxime for Lyme disease. This is known as the Jarisch-Herxheimer reaction. Symptoms usually last a few hours or up to one day.

Contact a doctor or nurse immediately if you get any of these symptoms.

Common side effects

These may affect up to 1 in 10 people:

•    fungal infections (such as Candida)

•    headache

•    dizziness

•    feeling sick

•    diarrhoea

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Stomach pain.

Common side effects that may show up in blood tests:

•    an increase in a type of white blood cell (eosinophilia)

•    an increase in liver enzymes.

Uncommon side effects

These may affect up to 1 in 100 people:

•    being sick

•    skin rashes.

Uncommon side effects that may show up in blood tests:

•    a decrease in the number of blood platelets (cells that help blood to clot)

•    a decrease in the number of white blood cells

•    positive Coomb’s 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 show up in blood tests:

•    red blood cells destroyed too quickly (haemolytic anaemia).

If you get any side effects

Tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Cefuroxime Tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information.

What Cefuroxime Tablets contain:

•    The active substance is cefuroxime (as axetil). Each tablet contains either 125 mg or 500 mg of cefuroxime

•    The other ingredients are microcrystalline cellulose, croscarmellose sodium, sodium REG0185a$®yl sulphate, caVkrida anhydrous Appcayedlcium stearate, calcium cabonatasand

crospovidone. The tablet coating contains hypromellose and propylene glycol and the colouring agent titanium dioxide (E171)

What Cefuroxime Tablets look like and contents of the pack

Cefuroxime 125 mg Tablets are white, caplet-shaped biconvex, film-coated tablets with a break line on one side and marked with CX125 on the other side.

Cefuroxime 500mg Tablets are white, caplet-shaped biconvex, film-coated tablets with a break line on one side and marked with CX500 on the other side. Cefuroxime Tablets are supplied in packs of 14 or 50 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

PLIVA Pharma Ltd,

Ridings Point,

Whistler Drive,

Castleford,

West Yorkshire,

WF10 5HX,

United Kingdom.

Manufacturer:

AWD Pharma GmbH & Co. KG, Leipziger Strasse 7-13, 01097 Dresden, Germany or PLIVA Krakow S.A., 80 Mogilska str, 31-546 Krakow, Poland.

This leaflet was last revised: March 2016 PL 10622/0167-0169