Document: leaflet MAH GENERIC_PL 25174-0009 change

• leaflet MAH GENERIC_PL 25174-0009
• leaflet MAH GENERIC_PL 39655-0016

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(cefuroxime sodium)

Read all of this leaflet carefully before you start taking this medicine.

■    Keep this leaflet. You may need to read it again.

■    If you have further questions, ask your doctor or pharmacist.

■This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their

symptoms are the same as yours.

■    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Cefuroxime is and what it is used for

2.    Before you use Cefuroxime

3.    How to use Cefuroxime

4.    Possible side effects

5.    How to store Cefuroxime

6.    Further informaiton

The name of your medicine is Cefuroxime 750mg Powder for Injection or Cefuroxime 1.5g Powder for Injection or Infusion but will be referred to as Cefuroxime or as Cefuroxime injection throughout this leaflet.

1.    WHAT CEFUROXIME IS AND WHAT IT IS USED FOR

Cefuroxime injection is an antibiotic which helps the body fight infections by destroying certain bacteria that causes them.

Cefuroxime injection is used to treat many different types of infections including:

•    bronchitis, pneumonia and any other chest infections;

•    cystitis and kidney infections;

•    pelvic inflammatory diseases;

•    gonorrhoea;

•    ear, nose and throat infections

•    skin, soft tissue, bone and joint infections;

•    meningitis.

Your doctor may also give it to you before an operation to protect you from infection.

2.    BEFORE YOU USE CEFUROXIME

Your doctor or nurse will make sure it is safe for you to have Cefuroxime injection.

Do not take Cefuroxime if you:

•    are allergic (hypersensitive) to Cefuroxime or any of the other ingredients of Cefuroxime listed in section 6.

•    have ever had an allergic reaction to antibiotics such as penicillin or cephalosporins. An allergic reaction may include a rash, itching, swelling or breathing difficulties.

Take special care with Cefuroxime and tell your doctor if:

•    you have kidney problems or are on dialysis

•    you have jaundice (yellowing of the skin and eyes), low blood protein

•    this injection is for a premature baby

•    you are on a low sodium diet because Cefuroxime injection contains significant quantities of sodium

This medicine can alter the results of some blood tests e.g. blood cross-matching and blood sugar tests for diabetes. It is important to tell the doctor that you are taking this medicine if you have to have any of these tests.

Unlike certain cephalosporin antibiotics, Cefuroxime does not usually cause a false positive result when the urine is tested for sugar.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Cefuroxime may interfere with

•    diuretics (water tablets) e.g. furosemide

•    aminoglycoside antibiotics e.g. gentamicin and neomycin

•    other antibiotics e.g. probenacid.

In some cases your doctor will arrange further monitoring, but this is routine and nothing to worry about. Using Cefuroxime with food and drink

Cefuroxime injection can be used at any time of the day without regard to food intake.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Cefuroxime is not known to harm the unborn child but, like all medicines, it will only be given to a pregnant woman if it is really needed. Your doctor will decide this.

Breast-feeding is not recommended whilst taking Cefuroxime as small amounts of Cefuroxime may enter the milk. .

Driving and using machines

Cefuroxime is not known to affect the ability to drive or operate machinery.

Important Information about some of the ingredients of Cefuroxime injection

Each 750mg vial contains 36.75mg sodium; each 1.5g vial contains 73.5mg sodium. To be taken into consideration by patients on a controlled sodium diet.

3. HOW TO USE CEFUROXIME

Your doctor will decide which dose you need. Your doctor or nurse will inject the Cefuroxime injection into a muscle or into a vein. In some cases, it may be added to a ‘drip' intravenous infusion.

Cefuroxime Injection is made up by adding the following amount of sterile water or other recommended diluting solution:

On reconstitution, product must be mixed vigorously for at least 90 seconds prior to withdrawing into the syringe; and if not given immediately, again just prior to administration.

Usual doses

Adults: Most adults need 750mg three or four times a day but for more severe infections this may be increased to 1.5g three or four times a day. If you have kidney trouble, you may be given the lower dose just once or twice a day.

•    Your doctor may give you 1.5g of Cefuroxime injection before surgery to protect you from infection. You may get further doses of 750mg of Cefuroxime injection after the operation.

•    If you have a joint replacement operation, Cefuroxime may be mixed in the cement which is used.

Infants and children: Most need 60mg for each kilogram of their body weight each day. This will be divided into three or four doses.

Newborn babies: Most need 30 to 100mg for each kilogram of their body weight each day. This will be divided into three or four doses.

•    If you or a child is being treated for meningitis, larger doses of Cefuroxime injection may be needed.

For the treatment of gonorrhoea:

•    1.5g should be given as a single dose. This may be given as 2 x 750mg injections into different sites e.g. each buttock.

For the treatment of pneumonia:

•    A twice daily dose of 1.5g injection should be given for 48-72 hours, followed by a twice daily dose of 500mg cefuroxime axetil oral therapy for 7 days.

For the treatment of acute exacerbations of chronic bronchitis:

•    A twice daily dose of 750mg injection should be given for 48-72 hours, followed by a twice daily dose of 500mg cefuroxime axetil oral therapy for 5-7 days.

If you take more Cefuroxime than you should:

It is most unlikely that you will be given too much medicine by the nurse or doctor. Your doctor and nurse will be monitoring your progress, and checking the medicine that you are given. Always ask if you are not sure why you are getting a dose of medicine.

If you forget to take Cefuroxime:

Your doctor or nurse have instructions when to give you your medicine. It is most unlikely that you will not be given the medicine as it has been prescribed. If you think that you may have missed a dose then talk to your nurse or doctor. It is important that the course of treatment your doctor has prescribed is taken. You may start to feel better but it is important not to stop taking this medicine, until the doctor advises, otherwise your condition may get worse again.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Cefuroxime can cause side effects, although not everybody gets them.

Some people may be allergic to antibiotics; if any of the following rare side effects occur soon after having your injection, tell your doctor immediately:

•    Loss of consciousness

•    Sudden wheeziness and chest tightness or breathing difficulties

•    Swelling of the eyelids, face or lips

•    Severe skin rashes that can peel or blister

•    Fever

Other side effects are classified according to the following frequencies:

-    Very common (in more than 1 in 10 patients)

-    Common (in more than 1 in 100 but less than 1 in 10 patients)

-    Uncommon (in more than 1 in 1000 but in less than 1 in 100 patients)

-    Rare (in more than 1 in 10,000 but less than 1 in 1000 patients)

-    Very rare (in less than 1 in 10,000 patients including reports of isolated cases)

Common:

•    Changes in liver enzymes

•    Inflammation or pain at the site of injection

Uncommon:

•    Diarrhoea which contains blood or mucous

Laboratory tests have shown that Cefuroxime can also cause changes in the blood, such as a decrease in blood haemoglobin concentrations (may result in anaemia), decreases in white blood cell counts (with an increased risk of infection), decreases in the very tiny blood cells called platelets (resulting in bruising and prolonged bleeding) and increases in the numbers of a type of white blood cells (eosinophils).

Like other medicines used to treat meningitis, Cefuroxime may take some time in clearing up the infection. As a result of this, hearing loss caused by meningitis has occurred in a few patients after using cefuroxime.

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 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 reach and sight of children.

The un-opened dry powder should be stored below 30°C. Store in the original package.

From a microbiological point of view, the reconstituted solution should be used immediately. If not used immediately, the reconstituted solution should be stored at 2-8°C for no longer than 24 hours.

Do not use Cefuroxime after the expiry date which is stated on the label and carton after EXP.

The expiry refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMAITON What Cefuroxime injection contains

Cefuroxime injection contains the active ingredient Cefuroxime Sodium. There are no other ingredients.

What Cefuroxime looks like and contents of the pack

Cefuroxime 750 mg powder for injection is a white or off-white powder which forms:

•    an off-white, opaque suspension for intramuscular use when reconstituted with 3ml of Water for Injections.

•    a yellowish, clear solution for intravenous use when reconstituted with 6ml of Water for Injections.

Cefuroxime 1.5 g powder for injection or infusion is a white or off-white powder which forms:

•    a yellowish, clear solution for intravenous injection when reconstituted with 15 ml of Water for Injections.

•    a yellowish, clear solution for intravenous infusion when reconstituted with 50 ml of Water for Injections.

Cefuroxime 750 mg powder for injection is available in 10 ml vials in packs of 1,5 or 100 vials.

Cefuroxime 1.5 g powder for injection or infusion is available in 20 and 100 ml vials in packs of 1, 10 or 20 vials.

Not all pack sizes may be marketed.

Rare:

•    Thrush infections

•    Easy bruising (thrombocytopenia)

•    Changes in how the liver and kidneys function

Very rare:

•    Headache, joint pain, generally feeling unwell (Pseudomembranous colitis)

•    Inflammation of the kidneys

Marketing Authorisation Holder and Manufacturer

Laboratorio Reig Jofre, S.A.

Gran Capitan, 10 08970 Sant Joan Despi,

Barcelona, Spain

This leaflet was last revised in May 2015.