PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SZ00901LT05A

Cefuroxime 125 mg Tablets Cefuroxime 250 mg Tablets

(Cefuroxime axetil)    ^ SANDOZ

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.

•    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 or pharmacist. 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 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).

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

Tell your doctor before you take 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

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.

Cefuroxime tablets contain aspartame

Cefuroxime 125 mg coated tablets contain 0.2 mg aspartame. Cefuroxime 250 mg coated tablets contain 0.3 mg aspartame.

If you have been told by your doctor that you have a metabolic disorder called phenylketonuria or if you are on a low-phenylalanine diet, contact your doctor before taking this medicinal product.

3. How to take Cefuroxime

2. What you need to know before you take Cefuroxime

Do not take Cefuroxime:

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

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 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.

Always take this medicine exactly as your doctor or pharmacist has told you. 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 usual dose

Adults

The usual dose of Cefuroxime is 250 mg to 500 mg twice daily depending on the severity and type of infection.

Children

The usual 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 too much Cefuroxime

If you take too much Cefuroxime you may have neurological disorders, in particular you may be more likely to have fits

(seizures).

Medicines used to reduce the amount of acid in your

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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

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 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.

5. How to store Cefuroxime

4. Possible side effects

Keep this medicine out of the sight and reach of children.

Store Cefuroxime in the original packaging in order to protect from moisture.

This medicinal product does not require any special temperature storage conditions.

Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.

Do not 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 protect the environment.

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. 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).

If you get any side effects

■^Tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

6. Contents of the pack and other information

What Cefuroxime contains

•    The active substance is: Cefuroxime.

Cefuroxime 125 mg Tablets contain 150.36 mg of cefuroxime axetil per tablet, equivalent to 125 mg of cefuroxime. Cefuroxime 250 mg Tablets contain 300.72 mg of cefuroxime axetil per tablet equivalent to 250 mg of cefuroxime.

•    The other ingredients (excipients) are:

Tablet core: sodium laurylsulfate, copovidone, croscarmellose sodium (E468), magnesium stearate (E470B), anhydrous colloidal silicon dioxide (E551), mannitol (E421), microcrystalline cellulose (E460), crospovidone (E1202) and talc (E553B).

Tablet coating: mannitol (E421), soluble (potato) starch, talc (E553B), titanium dioxide (E171) and aspartame (E951).

What Cefuroxime looks like and contents of the pack

Cefuroxime Tablets are coated.

Cefuroxime 125 mg Tablets are white to slightly yellowish capsule-shaped tablets.

Cefuroxime 250 mg Tablets are white to slightly yellowish capsule-shaped tablets with a break-line on both sides.

Cefuroxime 125 mg Tablets are available in carton boxes with blister(s) tear-off or strips containing 8, 10, 12, 14, 15, 20, 24 and 500 tablets.

Cefuroxime 250 mg Tablets are available in carton boxes with blister(s) tear-off or strips containing 8, 10, 12, 14, 15, 16, 20, 24 and 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sandoz Ltd,

Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK.

Manufacturer

Sandoz GmbH,

Biochemiestrasse 10, 6250 Kundl,

Austria.

This leaflet is last revised in 03/2013.

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