Cefuroxime 250mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
CefUROXime 250mg 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, 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.
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 further information
1. What Cefuroxime Tablets are and what they are used for
Cefuroxime is an antibiotic used in adults and children. It belongs to a group of medicines that are called cephalosporins. These types of antibiotics are similar to penicillin.
Cefuroxime works by killing some types of bacteria that can cause various sorts of infections in people.
Like all antibiotics, cefuroxime is only able to kill some types of bacteria so is only suitable for treating some types of infection.
Cefuroxime is used to treat infections of:
• the throat
• sinuses
• middle ear
• the lungs or chest
• bronchitis and pneumonia
• the urinary tract (the bladder or kidneys)
• the skin, soft tissue and layers just under the skin
• gonorrhoea (a sexually transmitted disease) when it has not spread from the lower genital organs in men or women.
Cefuroxime can also be used:
• Lyme disease (an infection spread by parasites called ticks) when it is still in the early stages and to prevent later complications in people who are at least 12 years old
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 Cefuroxime Tablets
• 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
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 diarrhoea (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.
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 works.
Probenecid Oral anticoagulants
Tell your doctor or pharmacist if you are taking any medicine like this.
Pregnancy and breast-feeding and fertility
Tell your doctor before you take Cefuroxime Tablets:
• if you are pregnant, think you might be pregnant or are planning to become pregnant
• if you are breast-feeding.
Your doctor will consider the benefit of treating you with Cefuroxime Tablets against the risk to your baby. Driving and using 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 Cefuromixe 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.
Cefuroxime Tablets should be swallowed whole with water.
Don’t chew, crush or split the tablets — this may make the treatment less effective.
Keep taking the tablets for as long as your doctor tells you, even if you start to feel better.
Adults, including the elderly
• The usual dose of Cefuroxime Tablets is 250 mg to 500 mg twice daily depending on the severity and type of infection. 125 mg twice daily for urinary tract infections to 500 mg twice daily for chest infections.
• Gonorrhoea can be treated with a single dose of 1000 mg
• Lyme disease in people of at least 12 years old is usually treated with 500 mg twice daily for about 20 days.
Children
The usual dose of Cefuroxime Tablets 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 Tablets are 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 Tablets than you should
If you take too many 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.
Don’t stop Cefuroxime Tablets without advice
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.
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 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 side effects
These 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 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.
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 pack after EXP. The expiry date refers to the last day of that month.
Don’t 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 250 mg of cefuroxime.
• The other ingredients are microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulphate, colloidal anhydrous silica, calcium stearate, calcium carbonate and 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 250 mg Tablets are white, caplet-shaped biconvex, film-coated tablets with a break line on one side and marked with CX250 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:
TEVA UK Limited, Eastbourne, BN22 9AG.
Manufacturer:
Teva Operations Poland Sp. z.o.o., 80 Mogilska str, 31-546 Krakow, Poland.
This leaflet was last revised: February 2016 PL 00289/1608
This is a representation of an electronic record that was signed electronically and this
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE
Teva Pharmaceuticals Europe B.V uk-pil-clean-pl00289-1608
Approvals
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Signed by |
Meaning of Signature |
Server Date |
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Kristina Mills |
Regulatory Affairs Approval |
18-Mar-2016 10:42:46 AM |
REG0185215 Version 0.2 Approved Page 7 of 7