Cefuroxime 250mg Tablets
Package Leaflet: Information for the User
Zinnat® 250 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 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 side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
See section 4.
• The name of this medicine is Zinnat® 250 mg Tablets but will be referred to as Zinnat throughout the remainder of this leaflet.
• Zinnat® 250 mg Tablets are also available in other strengths.
What is in this leaflet:
1) What Zinnat is and what it is used for
2) What you need to know before you take Zinnat
3) How to take Zinnat
4) Possible side effects
5) How to store Zinnat
6) Contents of the pack and other information
1) WHAT ZINNAT IS AND WHAT IT IS USED FOR
Zinnat 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.
Zinnat is used to treat infections of:
• the throat
• sinus
• middle ear
• the lungs or chest
• the urinary tract
• the skin and soft tissues.
Zinnat 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 Zinnat during your treatment.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZINNAT Do not take Zinnat:
• if you are allergic to cefuroxime axetil or any cephalosporin antibiotics or any of the other ingredients of Zinnat (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 Zinnat until you have checked with your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Zinnat.
Children
Zinnat 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 Zinnat. 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
Zinnat 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 Zinnat.
Other medicines and Zinnat
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Medicines used to reduce the amount of acid in your stomach
(e.g. antacids used to treat heartburn) can affect how Zinnat works.
Probenecid
Oral anticoagulants
-^Tell your doctor or pharmacist if you are taking any medicine like this.
Contraceptive pills
Zinnat may reduce the effectiveness of the contraceptive pill. If you are taking the contraceptive pill while you are being treated with Zinnat you also need to use a barrier method of contraception (such as condoms). Ask your doctor for advice.
Pregnancy and breast-feeding and fertility
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.
Driving and using machines
Zinnat 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.
Important information about some of the ingredients of Zinnat
• This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. This may cause allergic reactions (which could be delayed).
3) HOW TO TAKE ZINNAT
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 Zinnat after food. This will help to make the treatment more effective.
Swallow Zinnat tablets whole with some water.
Don’t chew, crush or split the tablets — this may make the treatment less effective.
The recommended dose
Adults
The recommended dose of Zinnat is 250 mg to 500 mg twice daily depending on the severity and type of infection.
Children
The recommended dose of Zinnat 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
Zinnat 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 Zinnat than you should
If you take too much Zinnat 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 Zinnat pack.
If you forget to take Zinnat
Do not take a double dose to make up for a forgotten dose. Just take your next dose at the usual time.
POM
If you stop taking Zinnat Don’t stop Zinnat without advice
It is important that you take the full course of Zinnat. 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 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 Zinnat 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).
Other conditions you need to look out for while taking Zinnat include:
• fungal infections. Medicines like Zinnat 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 Zinnat for a long time.
• severe diarrhoea (Pseudomembranous colitis). Medicines like Zinnat 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 Zinnat 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).
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 ZINNAT
• Keep out of the sight and reach of children.
• Do not store above 25oC.
• Store in the original packaging in order to protect from light.
• Do not use your tablets after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of the month.
• If your medicine becomes discoloured or shows any sign of deterioration, return it to your pharmacist.
• Medicine should not be disposed via wastewater or household waste. Ask your pharmacist how to dispose of medicine no longer required. These measures will help to protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Zinnat contains:
Each film coated tablet contains 250 mg cefuroxime as cefuroxime axetil. The other ingredients are:
Tablet Core: microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulphate, hydrogenated vegetable oil and silica colloidal anhydrous.
Tablet Coat: hypromellose, propylene glycol, 0.07 mg methyl-4-hydroxybenzoate E218, 0.06 mg propyl-4-hydroxybenzoate E216 and Opaspray white M-1-7120 (hypromellose, titanium dioxide E171, sodium benzoate E211 and “Industrial Methylated Spirits 74 OP”)
What Zinnat looks like and contents of the pack
Zinnat 250 mg Tablets are white, film-coated, capsule-shaped tablets, plain on one side and engraved with ‘GXES7' on the other.
Zinnat 250 mg Tablets are available in blister packs of 14 tablets.
Manufactured by
Glaxo Wellcome Operations,
Barnard Castle, uK.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall, WS9 8ER.
Repackaged by MPT Pharma Ltd.
Leaflet dated 27th January 2016 Leaflet coded xxxxxxxxxxxxxxx
PL: 33532/0618
Zinnat® is a registered trademark of GlaxoSmithKline group of companies.
Cefuroxime 250 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 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 side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
See section 4.
• The name of this medicine is Cefuroxime 250 mg Tablets but will be referred to as Cefuroxime throughout the remainder of this leaflet.
• Cefuroxime 250 mg Tablets are also available in other strengths.
What is in this leaflet:
1) What Cefuroxime is and what it is 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 IT IS 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).
Your doctor may test the type of bacteria causing your infection and monitor whether the bacteria are sensitive to Cefuroxime during your treatment.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEFUROXIME
Do not take Cefuroxime:
• if you are allergic to cefuroxime axetil or any cephalosporin
antibiotics or any of the other ingredients of Cefuroxime (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 until you have checked with your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before 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.
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. 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.
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.
Contraceptive pills
Cefuroxime may reduce the effectiveness of the contraceptive pill. If you are taking the contraceptive pill while you are being treated with Cefuroxime you also need to use a barrier method of contraception (such as condoms). Ask your doctor for advice.
Pregnancy and breast-feeding and fertility
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.
Driving and using machines
Cefuroxime 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.
Important information about some of the ingredients of Cefuroxime
• This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. This may cause allergic reactions (which could be delayed).
3) HOW TO TAKE CEFUROXIME
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 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 recommended dose
Adults
The recommended dose of Cefuroxime is 250 mg to 500 mg twice daily depending on the severity and type of infection.
Children
The recommended 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).
^Don’t 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 a double dose to make up for a forgotten dose. Just take your next dose at the usual time.
If you stop taking Cefuroxime Don’t stop Cefuroxime without advice
It is important that you take the full course of Cefuroxime. 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 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 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).
Other conditions you need to look out for while taking Cefuroxime include:
• 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
• 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).
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 out of the sight and reach of children.
• Do not store above 25oC.
• Store in the original packaging in order to protect from light.
• Do not use your tablets after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of the month.
• If your medicine becomes discoloured or shows any sign of deterioration, return it to your pharmacist.
• Medicine should not be disposed via wastewater or household waste. Ask your pharmacist how to dispose of medicine no longer required. These measures will help to protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Cefuroxime contains:
Each film coated tablet contains 250 mg cefuroxime as cefuroxime axetil. The other ingredients are:
Tablet Core: microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulphate, hydrogenated vegetable oil and silica colloidal anhydrous.
Tablet Coat: hypromellose, propylene glycol, 0.07 mg methyl-4-hydroxybenzoate E218, 0.06 mg propyl-4-hydroxybenzoate E216 and Opaspray white M-1-7120 (hypromellose, titanium dioxide E171, sodium benzoate E211 and “Industrial Methylated Spirits 74 OP”)
What Cefuroxime looks like and contents of the pack
Cefuroxime 250 mg Tablets are white, film-coated, capsule-shaped tablets, plain on one side and engraved with ‘GXES7' on the other.
Cefuroxime 250 mg Tablets are available in blister packs of 14 tablets.
Manufactured by
Glaxo Wellcome Operations,
Barnard Castle, UK.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall, WS9 8ER.
Repackaged by MPT Pharma Ltd.
Leaflet dated 27th January 2016 Leaflet coded xxxxxxxxxxxxxxx
PL: 33532/0618
POM