Document: leaflet MAH GENERIC_PL 39655-0015 change

• leaflet MAH GENERIC_PL 30306-0160
• leaflet MAH GENERIC_PL 39655-0015

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PACKAGE LEAFLET: INFORMATION FOR THE USER Cefuroxime 250 mg and 750 mg powder for solution for injection Cefuroxime 1.5 g powder for solution for injection or infusion

Cefuroxime

Read all of this leaflet carefully before you start using 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 nurse.

-    If you get any side effects, talk to your doctor or nurse.

This includes any possible side-effects not listed in this leaflet.

What is in this leaflet:

1.    What Cefuroxime is and what it is used for

2.    What you need to know before you are given Cefuroxime

3.    How Cefuroxime is given

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 the bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Cefuroxime is used to treat infections of:

•    the lungs or chest

•    the urinary tract

•    the skin and soft tissue

•    the abdomen

Cefuroxime is also used:

•    to prevent infections during surgery

2.    WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CEFUROXIME

You must not be given Cefuroxime:

•    if you are allergic (hypersensitive) to any cephalosporin antibiotics or any of the other ingredients of Cefuroxime

•    if you have ever had a severe allergic (hypersensitive) reaction to any other type of betalactam antibiotic (penicillins, monobactams and carbapenems).

—^Tell your doctor before you start on Cefuroxime if you think that this applies to you. You must not be given Cefuroxime.

Take special care with Cefuroxime

You must look out for certain symptoms such as allergic reactions and gastrointestinal disorders such as diarrhoea while you are being given Cefuroxime. This will reduce the risk of possible problems. See ('Conditions you need to look out for') in section 4.

If you have had any allergic reaction to other antibiotics such as penicillin, you may also be allergic to Cefuroxime.

If you need a blood or urine test

Cefuroxime can affect the results of urine or blood tests for sugar and a blood test known as the Coombs test. If you are having tests:

—Tell the person taking the sample that you have been given Cefuroxime.

Other medicines and Cefuroxime

—Tell your doctor 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.

Some medicines may affect how cefuroxime works, or make it more likely that you'll have side effects. These include:

•    aminoglycoside-type antibiotics

•    water tablets (diuretics), such as furosemide

•    probenecid

•    oral anticoagulants

—Tell your doctor if this applies to you. You may need extra check-ups to monitor your renal function while you are taking Cefuroxime.

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

Tell your doctor before you are given 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 against the risk to your baby.

Driving and using machines

Don't drive or use machines if you do not feel well.

Important information about some of the ingredients of Cefuroxime

Cefuroxime contains sodium. You need to take this into account if you are on a controlled sodium diet.

3. HOW CEFUROXIME IS GIVEN

Cefuroxime is usually given by a doctor or nurse. It can

be given as a drip (intravenous infusion) or as an injection directly into a vein or into a muscle.

The usual dose

The correct dose of Cefuroxime for you will be decided by your doctor and depends on: the severity and type of infection, whether you are on any other antibiotics; your weight and age; how well your kidneys are working.

Newborn babies (0 - 3 weeks)

For every 1 kg the baby weighs, they'll be given 30 to 100 mg Cefuroxime per day divided in two or three doses.

Babies (over 3 weeks) and children

For every 1 kg the baby or child weighs, they'll be given

30 to 100 mg of Cefuroxime per day divided in three or four

doses.

Adults and adolescents

750 mg to 1.5 g of Cefuroxime per day divided into two, three or four doses. Maximum dose: 6 g per day.

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.

4. POSSIBLE SIDE-EFFECTS

Like all medicines, Cefuroxime 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 on rare occasions, 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.

—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:

•    injection site pain, swelling and redness along a vein.

—^Tell your doctor if any of these are troubling you.

Common side effects that may show up in blood tests:

•    increases in substances (enzymes) produced by the liver

•    changes in your white blood cell count (neutropenia or eosinophilia)

•    low levels of red blood cells (anaemia)

Uncommon side effects

These may affect up to 1 in 100 people:

•    skin rash, itchy, bumpy rash (hives)

•    diarrhoea, nausea, stomach pain —Tell your doctor if you get any of these.

Uncommon side effects that may show up in blood tests:

•    low levels of white blood cells (leucopenia)

•    increase in bilirubin (a substance produced by the liver)

•    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:

•    fungal infections

•    high temperature (fever)

•    allergic reactions

•    inflammation of the colon (large intestine), causing diarrhoea, usually with blood and mucus, stomach pain

•    inflammation in the kidney and blood vessels

•    red blood cells destroyed too quickly (haemolytic anaemia).

•    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) erythema multiformae.

—Tell your doctor if you get any of these.

Side effects that may show up in blood tests:

•    decrease in number of blood platelets (cells that help blood to clot - thrombocytopenia)

•    increase in levels of urea nitrogen and serum creatinine in the blood.

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/vellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE CEFUROXIME

Your doctor will store the unopened vial below 25°C. Once the powder has been mixed, the solution should be stored at 2-8°C and discarded after 24 hours.

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.

Your doctor or nurse will dispose of any medicine that is no longer required. These measures will help protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Cefuroxime contains:

The active substance in Cefuroxime Injection is cefuroxime as the sodium salt.

What Cefuroxime looks like and the contents of the pack

Cefuroxime is a white to faintly yellow powder.

It is supplied in 250 mg, 750 mg or 1.5 g glass vials with a rubber stopper

The vials are boxed individually and in packs of 2, 5, 10, 20, 30, 40 and 100 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Stravencon Ltd, Landmark House, 17 Hanover Square, Mayfair, London,

W1S 1HU, UK.

Manufacturer:

IPG Pharma Ltd, Atrium Court, The Ring, Bracknell, RG12 1BW, UK.

This leaflet was last revised in February 2014

A076/4

5% Dextrose and 0.225% Sodium Chloride Injection

10% Dextrose Injection

10% Invert Sugar in Water for Injection

Ringer's Injection USP

Lactated Ringer's Injection USP

M/6 Sodium Lactate Injection

Compound Sodium Lactate Injection BP

(Hartmann's Solution).

The stability of cefuroxime sodium in Sodium Chloride Injection BP 0.9% w/v and in 5% Dextrose Injection is not affected by the presence of hydrocortisone sodium phosphate.

Cefuroxime sodium has also been found compatible for 24 h at room temperature when admixed in i.v. infusion with:

Heparin (10 and 50 units/ml) in 0.9% Sodium Chloride Injection; Potassium Chloride (10 and 40 mEqL) in 0.9% Sodium Chloride Injection.

1

The resulting volume of the solution of cefuroxime in reconstitution medium is increased due the displacement factor of the drug substance resulting in the listed concentrations in mg/ml.

Compatibility

Cefuroxime sodium (5 mg/ml) in 5% w/v or 10% w/v xylitol injection may be stored for up to 24 h at 25^oC.

Cefuroxime sodium is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride.

Cefuroxime sodium is compatible with the following infusion fluids. It will retain potency for up to 24 hours at room temperature in:

Sodium Chloride Injection BP 0.9% w/v 5% Dextrose Injection BP

0.18% w/v Sodium Chloride plus 4% Dextrose Injection BP 5% Dextrose and 0.9% Sodium Chloride Injection 5% Dextrose and 0.45% Sodium Chloride Injection

2

Reconstituted solution to be added to 35 ml of compatible infusion fluid (see information on compatibility, below)