® AVELOX TABLETS (AV•e•lox) moxifloxacin hydrochloride

Consumer Medicine Information

for Avelox IV, you should read • swelling of the face, lips, WHAT IS IN THIS this leaflet as well as it contains tongue or other parts of the LEAFLET information specific to the body tablets. • rash, itching or hives on the This leaflet answers some skin common questions about Avelox Avelox tablets contain the active ingredient moxifloxacin, which Do not take this medicine if tablets. you are pregnant or think you is an antibiotic belonging to a group of medicines called might be pregnant. It does not contain all of the It may affect your developing available information. It does not fluoroquinolones. These antibiotics work by killing the baby if you take it during take the place of talking to your pregnancy. It is not known if it is doctor or pharmacist. bacteria that are causing your infection. safe for you to take Avelox tablets while you are pregnant. All medicines have risks and Avelox tablets will not work Drugs similar to Avelox have benefits. Your doctor has caused joint disease in immature weighed the risks of you taking against infections caused by viruses such as colds or the flu. animals. Tell your doctor if you Avelox against the benefits they are or may be pregnant. expect it will have for you. Avelox tablets are available by prescription only. Do not take this medicine if If you have any concerns about Ask your doctor if you have any questions about why this you are breastfeeding. taking this medicine, ask your Avelox is excreted in breast milk doctor or pharmacist. medicine has been prescribed for you. and there is a possibility that your baby may be affected. Your Keep this leaflet with the Your doctor may have prescribed it for another reason. doctor will tell you whether you medicine. should take Avelox and You may need to read it again. temporarily stop breastfeeding while you are taking the tablets. BEFORE YOU TAKE WHAT AVELOX IS AVELOX Do not give Avelox to children USED FOR under 18 years of age. When you must not take it Avelox tablets are used in adults Do not take Avelox if you: for the treatment of infections of Do not take Avelox tablets if • have a condition called the lungs, airways and sinuses. you have an allergy to: ‘QT prolongation’ which is • moxifloxacin, the active a type of abnormal heart In women Avelox tablets can be ingredient in Avelox rhythm • used to treat a condition called any of the ingredients listed • are taking medicines used pelvic inflammatory disease at the end of this leaflet to treat arrhythmia – fast, which is an infection of the • other medicines belonging to slow or irregular heart female upper genital tract. the quinolone family (e.g. beat (e.g. quinidine, ciprofloxacin, norfloxacin, procainamide, amiodarone, In certain infections, you may nalidixic acid) sotalol) require treatment with Avelox IV Some of the symptoms of an • have a blood test that injection followed by a course of allergic reaction may include: shows lower than normal Avelox tablets e.g. severe and • shortness of breath potassium levels complicated skin and skin • structure infections, complicated wheezing or difficulty breathing Do not take this medicine after abdominal infections. the expiry date printed on the Even if you have read the pack and blister. Consumer Medicine Information The expiry date is printed on the AVELOX® TABLETS NZ CMI – CCDS22 Page 1 of 5 carton and on each blister after If you have not told your • didanosine, a medicine used “EXP” (e.g. 11 18 refers to doctor about any of the above, to treat viral infections November 2018). The expiry tell him/her before you are You can still take these date refers to the last day of that given Avelox. medicines while you are taking month. If it has expired return it Avelox. However, you must to your pharmacist for disposal. Taking other medicines take Avelox at least 2 hours

Tell your doctor if you are before, or 4 hours after taking Do not take this medicine if the taking any other medicines, any of these medicines to make packaging is torn or shows including those that you buy sure there is no problem with signs of tampering. absorption. If the packaging is damaged, without a prescription from return it to your pharmacist for your pharmacy, supermarket Your doctor or pharmacist will be disposal. or health food shop. able to tell you what to do when

Avelox may have an effect on taking AVELOX with other If you are not sure whether the electro-cardiogram (ECG - medicines. you should start taking this an electrical record of the medicine, talk to your doctor. activity of the heart) and may

add to the effect of other HOW TO TAKE Before you start to take it medicines on the ECG. You AVELOX Tell your doctor if you have should advise your doctor if you allergies to any other are taking any medicine that Follow all directions given to medicines, foods, preservatives might affect the heart rhythm. you by your doctor or or dyes. pharmacist carefully. In particular, tell your doctor if They may differ from the Tell your doctor if you: you are taking: information contained in this • or someone in your family • warfarin, a medicine used to leaflet. has a history of heart rhythm stop blood clots. Your doctor problems should perform INR testing If you do not understand the • are taking any medicine that and may adjust your warfarin instructions printed on the might affect heart rhythm dose pharmacist label, ask your (e.g. quinidine, procainamide, • medicines used to treat doctor or pharmacist for help. amiodarone, sotalol, abnormal heart rhythm (e.g. erythromycin, tricyclic quinidine, procainamide, How much to take antidepressants, amiodarone, sotalol) Your doctor or pharmacist will antipsychotics) • medicines that can affect the tell you how much and how • have low potassium levels heart rhythm (erythromycin, often you should take Avelox. • have had any condition tricyclic antidepressants,

affecting the brain, antipsychotics) It is important that you take the particularly if you have ever • corticosteroids full course of treatment that your had a seizure (‘fit’) These medicines may affect each doctor has prescribed for you. • other or increase the chance of have severe liver problems • you getting a side effect. have a condition called The usual adult dosage for

myasthenia gravis (a disease Avelox tablets for most Some medicines may interfere causing muscle weakness) infections is one 400 mg tablet with the absorption of Avelox • have or have had a mental once daily for 5 to 10 days. tablets. These medicines illness However, some types of include: • have diabetes infections may require longer • antacids, multivitamins, treatment. Your doctor will • have a history of tendon mineral supplements and determine the duration of time disease or disorder which was other medicines containing that you take the tablets related to treatment with iron, zinc, magnesium, depending on the type of fluoroquinolone antibiotics aluminium or calcium. infection you have. • • have ever been told that you sucralfate, a medicine used to have an aortic aneurysm treat duodenal or stomach You should not exceed the dose ulcers your doctor has prescribed for

AVELOX® TABLETS NZ CMI – CCDS22 Page 2 of 5 you. The risk of heart rhythm Otherwise, take it as soon as you If you get diarrhoea, tell your problems may increase with an remember, and then go back to doctor or pharmacist increase of the dose. taking it as you would normally. immediately. Do this even if it occurs several How to take it Do not take a double dose to weeks after you have stopped make up for the dose that you taking Avelox. Diarrhoea may Swallow the tablet whole with missed. mean that you have a serious water. Do not chew the tablet. condition affecting your bowel.

If you are not sure what to do, You may need urgent medical When to take it ask your doctor or pharmacist. care. Do not take any Avelox tablets are usually taken If you have trouble remembering medications for diarrhoea once a day. when to take your medicine, ask without checking with your your pharmacist for some hints. doctor. Take your tablet at the same time each day. It can be taken with or If you take too much Tell your doctor immediately if without food. It is advisable to (overdose) you feel any discomfort, pain, drink fluids liberally. swelling or inflammation of a Immediately telephone your tendon. doctor, or the Poisons Do not take Avelox at the same Medicines like Avelox have been Information Centre (New time as taking antacids reported to cause tendon damage Zealand: 0800 POISON or (containing magnesium, calcium, (especially the Achilles tendon). 0800 764 766), or go to the or aluminium), multivitamins This may occur even within the Accident and Emergency (containing iron or zinc), first 48 hours of treatment and up department at your nearest sucralfate (a medicine to treat to several months after hospital, if you think you or stomach ulcers) or didanosine (a completing treatment with anyone else may have taken medicine to treat viral Avelox. The risk of tendon too much Avelox. Do this even infections). damage may be increased in if there are no signs of elderly patients, during strenuous discomfort or poisoning. Taking these medicines at the physical activity, if you are You may need urgent medical same time as Avelox can currently being treated with a attention. interfere with the absorption of type of medicine called

Avelox tablets and reduce their corticosteroids, if you have effectiveness in fighting the WHILE YOU ARE reduced kidney function or have infection. received solid organ transplants. TAKING AVELOX You must take Avelox at least If you experience palpitations 2 hours before, or 4 hours after Things you must do (fast or irregular heart beat) or taking any of these medicines. Tell all doctors, dentists and fainting spells during the pharmacists who are treating period of treatment, tell your How long to take it you that you are taking Avelox doctor immediately.

The length of treatment with If you are about to be started Tell your doctor or nurse if Avelox tablets may vary you experience symptoms of depending on the type of on any new medicine, remind your doctor and pharmacist depression of self-endangering infection. The usual duration of behaviour. treatment is from five to ten that you are taking Avelox tablets. Avelox should be discontinued. days, but can be longer. Your doctor will determine the If you become pregnant while Tell your doctor or nurse if duration of time that you need to you are taking Avelox, tell you develop photosensitivity take the tablets. your doctor immediately. (getting sunburnt very easily). If you forget to take it Avoid exposure to ultraviolet If it is almost time for your next If you develop an allergic radiation and sunlight. Protect dose, skip the dose you missed reaction (e.g. a skin rash) while your skin when you are in the and take your next dose when taking Avelox, even following a sun, especially between 10am you are meant to. single dose, stop taking it and and 3pm. If you are outdoors, tell your doctor. wear protective clothing and use a 30+ sunscreen. AVELOX® TABLETS NZ CMI – CCDS22 Page 3 of 5

All medicines can have side These are serious side effects. If Tell your doctor or nurse as effects. Sometimes they are you have them, you may need soon as possible if you develop serious; most of the time they are urgent medical attention or pain, burning, tingling, not. You may need to stop taking hospitalisation. numbness or weakness in any the tablets or have medical part of the body. treatment if you get some of the In isolated instances, some serious side effects. serious adverse drug reactions If you experience sudden may be long-lasting (> 30 days) stomach, chest or back pain, Do not be alarmed by the and disabling; such as tendinitis, immediately seek medical help following lists of side effects. tendon rupture, musculoskeletal at an emergency department. You may not experience any of disorders, and other reactions them. affecting the nervous system Things you must not do including psychiatric disorders Ask your doctor or pharmacist and disturbance of senses. Do not give your Avelox tablets to answer any questions you to anyone else, even if they have may have. Avelox may cause rapid and the same condition as you. severe inflammation of the liver,

Tell your doctor if you notice which can lead to life- Do not change the dose. any of the following and they threatening liver failure

worry you: including fatal cases. Tell your Do not use Avelox to treat other • headache doctor immediately if you conditions unless your doctor • suddenly feel unwell or sick and tells you to. dizziness or lightheadedness • develop symptoms such as: nausea, vomiting • yellowing of the skin and in Do not stop taking your tablets • stomach pains, diarrhoea the whites of your eyes, also because you are feeling better, • thrush in the mouth (sore called jaundice unless your doctor told you to do creamy-yellow raised patches • so. If you do not complete the in mouth) or in the vagina pain in liver area • full course prescribed by your (itching, burning or thick dark urine doctor, some of the bacteria white discharge) • itchy skin causing your infection may not These are the more common side • tendency to bleed effects of Avelox. They are be killed. These bacteria may If you develop a skin reaction usually mild and short-lived. continue to grow and multiply so or blistering and/or peeling of that your infection may not clear the skin and/or mucosal Tell your doctor immediately, up completely or it may return. reactions contact your doctor or go to the Accident and immediately before you Emergency department at What to be careful of continue the treatment. your nearest hospital if you Be careful driving or operating notice any of the following: Tell your doctor or pharmacist machinery until you know how • allergic reactions such as skin if you notice anything that is Avelox affects you. rashes, swelling of the face, making you feel unwell. Avelox tablets may cause lips, mouth or throat Other side effects not listed dizziness or faintness in some • palpitations or fainting spells above may also occur in some patients. The ability to drive • watery or bloody diarrhoea, people. and/or operate machinery may be even if it occurs several weeks impaired. If you drink alcohol, after finishing your tablets dizziness or faintness may be AFTER TAKING • pain, swelling or rupture of a worse. AVELOX tendon

• fits (seizures, convulsions) Storage • SIDE EFFECTS pain, burning, tingling, Keep your tablets in the blister numbness or weakness that pack until it is time to take Tell your doctor or pharmacist starts or worsens on Avelox them. as soon as possible if you do • changes in your mood or If you take the tablets out of the not feel well while you are thoughts that worry you box or the blister pack they may taking Avelox. • sudden stomach, chest or back not keep well. pain

AVELOX® TABLETS NZ CMI – CCDS22 Page 4 of 5

Keep your tablets in a cool dry • magnesium stearate place where the temperature • ferric oxide red stays below 25oC. • hypromellose • macrogol 4000 Do not store Avelox or any • titanium dioxide other medicine in the bathroom, near a sink, or on a Supplier window-sill. Made in Germany for: Do not leave it in the car. Heat and damp can destroy some Bayer New Zealand Limited medicines. 3 Argus Place, Hillcrest North Shore, Auckland 0627 Keep your tablets where New Zealand children cannot reach them. Telephone: 0800 229 376 A locked cupboard at least one Date of preparation and a half metres above the ground is a good place to store 1 October 2019 medicines. Disposal See MEDSAFE website (www.medsafe.govt.nz) for If your doctor tells you to stop latest New Zealand Consumer taking AVELOX tablets or the Medicine Information. tablets have passed their expiry date, ask your ® Registered Trademark of Bayer pharmacist what to do with AG, Germany any that are left over. Return any unused medicine to your pharmacist.

PRODUCT DESCRIPTION

What it looks like Avelox 400 mg tablets are dull red oblong, film-coated, convex tablets marked with M 400 on one side and BAYER on the other side.

It is available in blister packs of 1 tablet and 5 tablets.

Not all forms and pack sizes may be marketed.

Ingredients

Active ingredient per tablet: moxifloxacin (as hydrochloride)

400 mg

Inactive ingredients:

• microcrystalline cellulose

• croscarmellose sodium • lactose AVELOX® TABLETS NZ CMI – CCDS22 Page 5 of 5