Cefuzime is used to treat infections of:

· the throat

· sinus

· middle ear

· the lungs or chest

· the urinary tract

· the skin and soft tissues.

Cefuzime can also be used:

· to treat Lyme disease

1. What this product is and what it is used for

Cefuzime 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.

Cefuzime is used to treat infections of:

· the throat

· sinus

· middle ear

· the lungs or chest

· the urinary tract

· the skin and soft tissues.

Cefuzime 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 Cefuzime during your treatment.

2. What you need to know before you use this product

Don’t take Cefuzime :

· if you are allergic to any cephalosporin antibiotics or any of the other ingredients of Cefuzime (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 Cefuzime until you have checked with your doctor.

Take special care with Cefuzime

Cefuzime is not recommended for children aged less than 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 diahorrea (pseudomembranous colitis) while you are taking Cefuzime. 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

Cefuzime 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 Cefuzime.

Other medicines and Cefuzime

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.

· Medicines used to reduce the amount of acid in your stomach (e.g. antacids used to treat heartburn) can affect how Cefuzime works.

· Probenecid

· Oral anticoagulants

Tell your doctor or pharmacist if you are taking any medicine like this.

Contraceptive pills

Cefuzime may reduce the effectiveness of the contraceptive pill. If you are taking the contraceptive pill while you are being treated with Cefuzime 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 Cefuzime:

· 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 Cefuzime against the risk to your baby.

Driving and using machines

Cefuzime 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

3. How to use this product.

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 Cefuzime after food. This will help to make the treatment more effective.

Swallow Cefuzime 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 Cefuzime is 250 mg to 500 mg twice daily depending on the severity and type of infection.

Children

The usual dose of Cefuzime 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

Cefuzime is not recommended for children aged less than 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 Cefuzime

If you take too much Cefuzime 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 Cefuzime pack.

If you forget to take Cefuzime

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 Cefuzime without advice

It is important that you take the full course of Cefuzime. 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. 1.

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 Cefuzime 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 Cefuzime include:

· fungal infections. Medicines like Cefuzime 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 Cefuzime for a long time.

· Severe diarrhoea (Pseudomembranous colitis). Medicines like Cefuzime 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 Cefuzime 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.