Consumer Medicine Information

AVELOX™ TABLETS

(Moxifloxacin hydrochloride)

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about AVELOX tablets.

It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking AVELOX tablets against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

WHAT AVELOX IS USED FOR

AVELOX tablets are used in adults for the treatment of infections of the lungs, airways and sinuses. It can also be used to treat severe and complicated skin and skin structure infections that initially require intravenous therapy followed by oral treatment, complicated intra-abdominal infections including infections such as abscesses that also initially require intravenous therapy followed by oral treatment, and a condition called pelvic inflammatory disease which may occur in women due to infections of the female upper genital tract. However, your doctor may prescribe this medicine for another use. If you want more information, ask your doctor.

AVELOX tablets contain the active ingredient called moxifloxacin, which is an antibiotic belonging to a group of medicines called quinolones. These antibiotics work by killing the bacteria that are causing your infection.

AVELOX tablets are available by prescription only.

AVELOX is not addictive.

BEFORE YOU USE AVELOX

When you must not take it

Do not take AVELOX if you:

have an allergy to moxifloxacin, other medicines belonging to the quinolone chemical family (e.g. ciprofloxacin, norfloxacin, nalidixic acid) or any of the ingredients in AVELOX tablets listed at the end of this leaflet.
have abnormal heart rhythm (specifically, the medical condition known as "prolongation of the Q-T interval" or "prolonged Q-T syndrome").
are taking another medicine used to treat abnormal heart rhythm (e.g. medicines containing the active ingredient quinidine, procainamide, amiodarone or sotalol).
have low potassium levels in your body.
are pregnant or think you may be pregnant. It is not known if it is safe for you to take AVELOX tablets while you are pregnant. Drugs similar to AVELOX have caused joint disease in immature animals. Tell your doctor if you are or maybe pregnant.
you are breast-feeding. AVELOX is excreted in breast milk and there is a possibility that the breast-fed baby may be affected. Your doctor will tell you whether you should take AVELOX and temporarily stop breastfeeding while you are taking the tablets.

Do not give AVELOX to children and growing adolescents unless you are told by your doctor to do so.

Do not take your AVELOX tablets after the expiry date printed on the pack. The EXPIRY date is marked on the strip of tablets as well as on the label of the carton. For example, 11 09 refers to the eleventh month of 2009.

Do not take your tablets if the packaging is torn or show signs of tampering.

Before you start to take AVELOX

Tell your doctor if you:

or your family have a history of heart rhythm problems.
have low potassium levels.
have a previous known allergy to moxifloxacin or any other ingredients in AVELOX tablets, or to any other medicines that you have used in the past.
suffer or have suffered from fits (seizures, convulsions), have had a stroke, liver problems, or other medical problems.

Taking other medicines

Tell your doctor if you are taking any other medicines, including those that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may affect the way others work. Your doctor or pharmacist will be able to tell you what to do when taking AVELOX with other medicines.

Some medicines may interfere with the absorption of AVELOX. These medicines include:

antacids, multivitamins, mineral supplements and other medicines containing iron, zinc, magnesium, aluminium or calcium.
sucralfate, a medicine used to treat duodenal or stomach ulcers.
didanosine, a medicine used to treat viral infections. You can still take these medicines while you are taking AVELOX. However, you must take AVELOX at least 2 hours before or 4 hours after taking any of these medicines to make sure there is no problem with absorption.
AVELOX may have an effect on the electro-cardiogram (ECG - an electrical record of the activity of the heart) and may add to the effect of other medicines on the ECG. You should advise your doctor of any other medicines you are currently taking, particularly those affecting the heart rhythm.

Tell your doctor if you are taking warfarin, an anticoagulant medicine. You may still take Avelox. Your doctor may wish to perform INR testing and adjust your warfarin dose as appropriate.

HOW TO TAKE AVELOX

How much to take

Your doctor or pharmacist will tell you how much and how often you should take AVELOX.

The usual adult dosage for most infections is one 400 mg tablet once daily for 5 to 10 days.

You should not exceed the recommended dose your doctor has prescribed for you.

How to take it

Swallow the tablet whole with a glass of water or other fluid. Do not chew the tablets.

When to take it

AVELOX tablets are usually taken once a day.

Take your tablet at the same time each day. It can be taken with or without food. It is advisable to drink fluids liberally.

Do not take AVELOX at the same time as taking iron or zinc supplements (or multivitamins containing them), antacids or sucralfate. Taking AVELOX at the same time or even within two hours of taking these can interfere with the absorption of AVELOX and reduce its effectiveness in fighting the infection.

How long to take it

The length of treatment may vary from five to ten days depending on the type of infection.

Continue taking AVELOX until you have finished the blister pack or for as long as your doctor tells you.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.

Do not take a double dose to make up for the dose that you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone Australia 13 11 26; New Zealand 0800 POISON or 0800 764 766), or go to the accident and emergency department at your nearest hospital, if you think you or anyone else may have taken too much AVELOX. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

WHILE YOU ARE USING AVELOX

Things you must do

If you become pregnant while you are taking AVELOX, tell your doctor immediately.

Tell all doctors, dentists and pharmacists who are treating you that you are taking AVELOX. If you develop an allergic reaction e.g. a skin rash while taking AVELOX, even following a single dose, stop taking AVELOX and tell your doctor.

If you get severe diarrhoea, tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after you have stopped taking AVELOX. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any medications for diarrhoea without checking with your doctor.

Things you must not do

Do not give your AVELOX tablets to anyone else, even if they have the same condition as you.

Do not use AVELOX to treat other conditions unless your doctor tells you to. Do not stop taking your tablets because you are feeling better, unless your doctor told you to do so.

If you do not complete the full course prescribed by your doctor, some of the bacteria causing your infection may not be killed. These bacteria may continue to grow and multiply so that your infection may not clear up completely or it may return.

What to be careful of

Be careful driving or operating machinery until you know how AVELOX affects you.

AVELOX tablets may cause dizziness or faintness in some patients, especially after the first few doses. The ability to drive and/or operate machinery may be impaired. If you drink alcohol, dizziness or faintness may be worse.

SIDE EFFECTS

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking AVELOX.

AVELOX helps most people with bacterial infections, but it may have unwanted side effects. Sometimes they are serious; most of the time they are not. You may need to stop taking the tablets or have medical treatment if you get some of the serious side effects.

Tell your doctor if you notice any of the following:

headache
dizziness or lightheadedness
stomach upsets such as feeling sick (nausea), diarrhoea, heartburn or stomach pains
vomiting.

These are the more common side effects of AVELOX. They are usually mild and short-lived.

Tell your doctor immediately, or go to the accident and emergency department at your nearest hospital if you notice any of the following:

palpitations or fainting spells
severe skin rashes
swelling of the face, lips, mouth or throat
inflammation of the mouth
fainting
yellowing of the skin and eyes, also called jaundice
pain in liver area
severe watery or bloody diarrhoea, even if it occurs several weeks after taking your tablets
fits (seizures, convulsions).

These are serious side effects. If you have them, you may need urgent medical attention or hospitalisation.

The Achilles tendon (extending from the calf to the heel of the foot) or other tendons have been torn after therapy with quinolone antibiotics. Stop taking AVELOX and call your doctor if you feel any discomfort, pain or inflammation of this or any other tendon.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

AFTER USING AVELOX

Storage

Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the box or the blister pack they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 25°C. Do not leave the tablets in the car on hot days.

Keep your tablets where children cannot reach them.

Disposal

If your doctor tells you to stop taking AVELOX tablets or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

PRODUCT DESCRIPTION

What it looks like

AVELOX 400 mg tablets are dull red oblong, film-coated, convex tablets marked M 400 on top and BAYER on the bottom (available in blister packs of 5 tablets).

Ingredients

Active Ingredients per tablet:

AVELOX 400 - moxifloxacin (as hydrochloride) 400 mg

Inactive ingredients:

microcrystalline cellulose
croscarmellose sodium
lactose
magnesium stearate
ferric oxide
hypromellose
macrogol 4000
titanium dioxde

Manufacturer

BAYER HealthCare AG Germany

Distributor

Bayer Australia Limited
ABN 22 000 138 714
875 Pacific Highway
PYMBLE NSW 2073
Australia

Bayer New Zealand Ltd
3 Argus Place
Hillcrest, North Shore 0627
AUCKLAND, New Zealand

Australian Registration Number:

AVELOX 400 - AUST R 75766

Date of preparation:

July 2007

™Trademark of Bayer HealthCare AG, Germany

INFORMATION FOR CONSUMERS