Cefuroxime 250mg Film-Coated Tablets
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.
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
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 Krakow OR
Merckle GmbH,
Ludwig-Merckle-StraBe 3,
89143 Blaubeuren,
Germany
This leaflet was last revised: February 2016 PL 00289/1185-1187