Skip to Content

UK Edition. Click here for US version.

CEFUROXIME 125MG FILM-COATED TABLETS

Active substance(s): CEFUROXIME AXETIL

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the patient
Cefuroxime 125 mg, 250 mg and 500 mg film-coated tablets

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

What Cefuroxime is 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 Film-coated Tablets 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

Don’t not take Cefuroxime:



if you are allergic (hypersensitive) to any cephalosporin antibiotics or any of the other
ingredients of this medicine (listed in section 6).
if you have ever had a severe allergic (hypersensitive) 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.

If you are not sure whether any of the above apply to you speak to your doctor or pharmacist before
taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Cefuroxime
You must look out for certain symptoms, such as allergic reactions, fungal infections (such as
candida) and severe diahorrea (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.
Children
Cefuroxime is not recommended for children aged under 3 months, as the safety and
effectiveness are not known in this age group.
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 medicine like this.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.

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

Always take this medicine 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 Film-coated Tablets whole with some water.
Do not chew, crush or split the tablets — this may make the treatment less effective.

The usual 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
The usual dose of Cefuroxime is 10 mg/kg (to a 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.
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 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
Do not take an double dose to make up for a forgotten dose. Just take your next dose at the
usual time.
If You stop taking Cefuroxime
Do not stop unless your doctor advises you to – even if you are feeling better. If you don't complete
the full course of treatment, the infection may come back..

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 get 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 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: may affect up to 1 in 10 people








fungal infections (such as Candida)
headache
dizziness
diarrhoea
feeling sick
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: 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.
Not known: frequency cannot be estimated from the available data








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 with unknown frequency that may show up in blood tests:
• red blood cells destroyed too quickly (haemolytic anaemia).
.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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

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 blister or outer packaging. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicinesvia 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 pac and other information

What Cefuroxime Film-coated Tablets contains:




The active substance is cefuroxime (as cefuroxime axetil).
The other ingredients in the tablet core are pregelatinised starch, croscarmellose sodium, sodium
laurilsulfate, microcrystalline cellulose, anhydrous colloidal silica and hydrogenated vegetable oil.
The other ingredients in the tablet coating are as follows:
Cefuroxime 125 mg Film-coated Tablets:
Hypromellose (E464), titanium dioxide (E171), propylene glycol (E1520).
Cefuroxime 250 mg and 500 mg Film-coated Tablets:
Hypromellose (E464), titanium dioxide (E171), propylene glycol (E1520), Brilliant Blue FCF
aluminium lake (E133), Indigo Carmine Aluminium Lake (E132).

What Cefuroxime Film-coated Tablets looks like and contents of the pack
Cefuroxime 125mg Film-coated Tablets are white to off-white coloured film-coated tablets engraved with
“125” on one side and “P124” on the other side.
Cefuroxime 250 mg Film-coated Tablets are light blue coloured film-coated tablets engraved with “250” on
one side and “P125” on on the other side.
Cefuroxime 500 mg Film-coated Tablets are light blue coloured film-coated tablets engraved with “500” on
one side and “P126” on the other side.
Your medicine is provided in blister packs. Pack sizes are as follows:
• Cefuroxime 125 mg Film-coated Tablets: 10, 12 and 14 tablets.
• Cefuroxime 250 mg Film-coated Tablets: 8, 10, 12, 14, 16, 20 and 24 tablets.
• Cefuroxime 500 mg Film-coated Tablets: 6, 8, 10, 12, 14, 16, 20 and 24 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer

Teva UK Limited, Eastbourne, BN22 9AG.
Manufacturers:
Teva UK Limited, Eastbourne, BN22 9AG
OR
Teva Czech Industries s.r.o., Ostravska 29, c.p. 305, 747 70 Opava, Komarov, Czech Republic
OR
Teva Operations Poland Sp. z o.o., Mogilska 80 Str. 31-546 Kraków
OR
Merckle GmbH,
Ludwig-Merckle-Straße 3,
89143 Blaubeuren,
Germany
This leaflet was last revised: February 2016
PL 00289/1185-1187

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide