Cefuroxime 500mg Film-Coated Tablets
Package Leaflet: Information for the patient
Cefuroxime 250 mg and 500 mg film coated tablets
cefuroxime
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, pharmacist or nurse.
- 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, pharmacist or nurse. 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
The Cefuroxime tablets contain Cefuroxime.
This 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 tablets are 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)
Your doctor may test the type of bacteria causing your infection and monitor whether the bacteria are sensitive to cefuroxime tablets during your treatment.
Other medicines and Cefuroxime tablets
Tell your doctor or pharmacist if you are taking any other medicines, if you've started taking any recently or you start taking new ones. 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 tablets work.
Probenecid Oral anticoagulants
• Tell your doctor or pharmacist if you are
taking any medicine like this.
Contraceptive pills
Cefuroxime tablets may reduce the effectiveness of the contraceptive pill. If you are taking the contraceptive pill while you are being treated with Cefuroxime tablets you also need to use a barrier method of contraception (such as condoms). Ask your doctor for advice.
Pregnancy and 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 tablets against the risk to your baby.
Driving and use of machines
Cefuroxime tablets can make you dizzy and have other side effects that make you less alert.
• Don't drive or use machines if you do not feel well.
3. How to take Cefuroxime tablets
Always take this medicine exactly as your doctor or pharmacist has told you to. Check with your doctor or pharmacist if you are not sure.
Take Cefuroxime tablets after food. This will help to make the treatment more effective.
Swallow Cefuroxime tablets whole with some water.
Don't chew, crush or split the tablets — this may make the treatment less effective.
The usual dose
Adults
4. Possible side effects
2. What you need to know before you take Cefuroxime tablets
Do not take Cefuroxime tablets:
• 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, don't take Cefuroxime tablets until you have checked with your doctor.
Take special care with Cefuroxime tablets
The usual dose of Cefuroxime tablets is 250 mg to 500 mg twice daily depending on the severity and type of infection.
Children
The usual dose of Cefuroxime tablets is 10 mg/kg (to a maximum of 125 mg) to 15 mg/kg (to a maximum of250 mg) twice daily depending on: the severity and type of infection
Cefuroxime tablets 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.
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 tablets 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 tablets 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 tablets for a long time.
• Severe diarrhoea (Pseudomembranous colitis). Medicines like Cefuroxime tablets 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 tablets 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.
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).
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 protect the environment.
6. Contents of the pack and other information
What Cefuroxime tablets contain
• The active substance is cefuroxime (present as Cefuroxime axetil). Each tablet contains 250 mg or 500 mg of cefuroxime.
• The other ingredients are microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulphate, colloidal anhydrous silica, calcium stearate, calcium carbonate crospovidone, hypromellose E464, titanium dioxide E171, propylene glycol E1520, FD &C blue no. 1 aluminium lake E133.
What Cefuroxime tablets look like and contents of the pack
Cefuroxime 250mg film coated tablets
Blue colour capsule shaped biconvex film coated tablets with '204' debossed on one side and plain on other side.
They are packaged in aluminium foil blister packs, enclosed in a carton. Each pack contains 2, 6,10,12, 14,24 and 50 tablets.
Cefuroxime 500mg film coated tablets
Blue colour capsule shaped biconvex film coated tablets with '203' debossed on one side and plain on other side.
They are packaged in aluminium foil blister packs, enclosed in a carton. Each pack contains 2,6, 10,12,14,24 and 50 tablets.
Not all packs may be marketed.
Marketing authorisation holder and manufacturer
Marketing Authorisation Holder:
Alkem Pharma GmbH GutenbergstraBe 13,
24941 Flensburg Germany
Manufacturer:
Wave Pharma Limited 4th Floor Cavendish House,
369 Burnt Oak Broadway, Edgware,
Middlesex HA8 5AW, United Kingdom
This leaflet was last revised in 08/2015
Cefuroxime tablets 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 (such as candida) and severe diahorrea (pseudomembranous colitis) while you are taking Cefuroxime tablets. 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 tablets 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 tablets.
If you take more Cefuroxime tablets than you should
If you take too much Cefuroxime tablets you may have neurological disorders, in particular you may be more likely to have fits (seizures).
• Don't delay. Contact your doctor or your nearest hospital emergency department immediately. If possible, show them the Cefuroxime tablets pack.
If you forget to take Cefuroxime tablets
Don't take an extra dose to make up for a missed dose. Just take your next dose at the usual time.
If you stop taking Cefuroxime tablets
It is important that you take the full course of Cefuroxime tablets. Don't 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.
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 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.
Store below 250C.
PT 2541