FRESENIUS

KABI

Anexo 6.00 do PT.G.087

Package Leaflet: Information for the user

Cefuroxime 750 mg

powder for solution for injection/infusion

Cefuroxime

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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 pharmacist.

•    If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Cefuroxime is and what it is used for

2.    What you need to know before you use Cefuroxime

3.    How to use 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 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 use 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.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using 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 for¹) 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 (diuretic), 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 to use Cefuroxime

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 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).

•    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, pharmacist 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

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This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last revised in Mar 2014

UK-IE V002 7966787XX

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