10000000134945

Package Leaflet: Information for the Patient

cefuroxime axetil

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 or nurse.

•    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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Zinnat is and what it is used for

2.    What you need to know before you take Zinnat

3.    How to take Zinnat

4.    Possible side effects

5.    How to store Zinnat

6.    Contents of the pack and other information

1. What Zinnat is and what it is used for

Zinnat 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.

Zinnat is used to treat infections of:

•    the throat

•    sinus

•    middle ear

•    the lungs or chest

•    the urinary tract

•    the skin and soft tissues.

Zinnat 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 Zinnat during your treatment.

2. What you need to know before you take Zinnat

Do not take Zinnat:

•    if you are allergic to cefuroxime axetil or any cephalosporin antibiotics or any of the other ingredients of Zinnat (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 Zinnat until you have checked with your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Zinnat.

Children

Zinnat 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 diahorrea (pseudomembranous colitis) while you are taking Zinnat. 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

Zinnat 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 Zinnat.

Other medicines and Zinnat

Tell your doctor or pharmacist if you are taking,

have recently taken or might take any other

medicines.

Medicines used to reduce the amount of acid in

your stomach (e.g. antacids used to treat heartburn) can affect how Zinnat works. Probenecid Oral anticoagulants

^ Tell your doctor or pharmacist if you are

taking any medicine like this.

Contraceptive pills

Zinnat may reduce the effectiveness of the contraceptive pill. If you are taking the contraceptive pill while you are being treated with Zinnat you also need to use a barrier method of contraception (such as condoms).

Ask your doctor for advice.

Pregnancy and breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Zinnat 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.

Important information about some of the ingredients of Zinnat

Zinnat suspension contains sugar (sucrose). If you are diabetic you need to take this into account for your diet.

Zinnat suspension also contains aspartame, which is a source of phenylalanine. If you have an intolerance to aspartame or have a condition called phenylketonuria (PKU):

^ Check with your doctor that Zinnat is suitable for you.

3. How to take Zinnat

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

Shake the bottle before use.

Zinnat suspension can be diluted in cold fruit juices, or milk drinks but should be taken immediately.

Don't mix Zinnat with hot liquids.

For step-by-step instructions on how to make up Zinnat suspension see Instructions for reconstitution at the end of this leaflet.

The recommended dose Adults

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

Children

The recommended dose of Zinnat 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

•    the weight and age of the child, up to a maximum of 500 mg per day.

Zinnat 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 more Zinnat than you should If you take too much Zinnat 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 Zinnat pack.

If you forget to take Zinnat Do not take a double dose to make up for a forgotten dose. Just take your next dose at the usual time.

If you stop taking Zinnat

Don't stop Zinnat without advice It is important that you take the full course of Zinnat. 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.

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 Zinnat 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 Zinnat include:

•    fungal infections. Medicines like Zinnat 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 Zinnat for a long time.

•    severe diarrhoea (Pseudomembranous colitis). Medicines like Zinnat 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 Zinnat 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).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 Zinnat

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

Do not use this medince after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.

The suspension should be stored in a fridge at all times when not taking the medicine. Do not allow it to freeze. It can be kept in the fridge for up to 10 days.

Do not use Zinnat if it shows any sign of deterioration.

Don't 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 to protect the environment.

6. Contents of the pack and other information

What Zinnat contains

•    The active substance is 125 mg per 5 ml of cefuroxime (present as cefuroxime axetil).

•    The other ingredients are aspartame (E951), xanthan gum, acesulfame potassium, Povidone K30, stearic acid, sucrose, tutti fruitti flavour and purified water.

•    See section 2 for further important information about some of the ingredients of Zinnat.

What Zinnat looks like and contents of the pack

Zinnat Suspension 125 mg/5 ml is supplied in an amber, glass, multidose bottle. The bottle contains 70 ml of suspension. Your pharmacist will have made this up with water using the original granules that were supplied in the bottle. The bottle is contained within a carton. Marketing authorisation holder and manufacturer

Marketing Authorisation Holder: GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex UB11 1BT Manufacturer: Glaxo Wellcome Operations, Harmire Road, Barnard Castle,

Co. Durham DL12 8DT Other formats

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name    Zinnat Suspension

125 mg/5 ml

Reference number    10949/0094

This is a service provided by the Royal National

Institute of Blind People.

This leaflet was last revised in September 2015.

Zinnat is a registered trade mark of the GSK group of companies

© 2015 GSK group of companies. All rights reserved

Instructions for reconstitution

Directions for making up the suspension

1.    Shake the bottle to loosen the granules and remove the cap

2.    Add the amount of water stated on the bottle label, or as stated on the cup (if supplied), and replace the cap.

3.    Turn the bottle upside down and rock vigorously for at least 15 seconds.

4.    Turn the bottle the right way up and shake vigorously.

5.    Zinnat suspension, must be stored in the fridge between 2°C and 8°C.

6.    If using a dosing syringe, allow the reconstituted suspension to stand for at least one hour before taking the first dose.

For children who can't take Zinnat using a spoon,

a dosing syringe with a 5 ml graduation may be

supplied with the pack. If supplied, use the oral

dosing syringe to measure your dose accurately:

1.    Remove the bottle cap. Keep it safely.

2.    Hold the bottle firmly. Push the plastic adapter into the neck of the bottle.

3.    Insert the syringe firmly into the adapter.

4.    Turn the bottle upside down.

5.    Pull out syringe plunger until the syringe contains the first part of your full dose.

6.    Turn the bottle the correct way up. Remove the syringe from the adapter.

7.    Put the syringe into your mouth, placing the tip of the syringe against the inside of your cheek. Slowly push the plunger in, allowing time to swallow. Don't push too hard and squirt the liquid into the back of your throat or you may choke.

8.    Repeat steps 3 to 7 in the same way until you have taken your whole dose.

9.    Take the syringe out of the bottle and wash

it thoroughly in clean water. Let it dry completely before you use it again.

10.    Close the bottle tightly with the cap, leaving

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