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APO-AZITHROMYCIN TABLETS Contains the active ingredient azithromycin (as azithromycin dihydrate) Consumer Medicine Information

What is in this leaflet Ask your doctor if you have any If it has expired or is damaged, return questions about why azithromycin it to your pharmacist for disposal. has been prescribed for you. This leaflet answers some common If you are not sure whether you questions about Azithromycin. It Your doctor may have prescribed it should start taking this medicine, does not contain all the available for another reason. talk to your doctor. information. This medicine is not addictive. It does not take the place of talking to Before you start to take it your doctor or pharmacist. This medicine is not expected to Tell your doctor if you have All medicines have risks and affect your ability to drive a car or to any other medicines, foods, benefits. Your doctor has weighed operate machinery. preservatives or dyes. the risks of you taking Azithromycin Tell your doctor if you have any against the benefits they expect it Use in children other health problems, will have for you. There is not enough information to including: • any problems If you have any concerns about recommend the use of azithromycin taking this medicine, ask your tablets in children. • any heart problems, including doctor or pharmacist. abnormalities of the rhythm Keep this leaflet with your • diabetes, hereditary fructose medicine. Before you take this intolerance, glucose-galactose You may need to read it again. malabsorption or medicine sacchariseisomaltase deficiency • When you must not take it • muscle weakness What this medicine is Do not take azithromycin if you • low levels of potassium or used for are allergic to: magnesium in your blood • azithromycin Azithromycin is used to treat • if you are pregnant or if you plan • any other or to become pregnant or are infections in different parts of the (e.g., . Your doctor can body caused by . It is , discuss with you the risks and commonly used to treat . , benefits involved. Azithromycin is also used to prevent , If you have not told your doctor infections by a bacterium called ) about any of the above, tell them Mycobacterium Aviumintracellulare • any of the ingredients listed before you start taking Complex (MAC) in some people. at the end of this leaflet. azithromycin. Azithromycin is an , which Symptoms of an allergic reaction belongs to a group of medicines may include shortness of breath, Taking other medicines called azalides. The azalides are a wheezing or difficulty breathing; Tell your doctor or pharmacist if sub-class of a group of antibiotics swelling of the face, lips, tongue or you are taking any other called . other parts of the body, rash, itching medicines, including any that you or hives on the skin. Azithromycin works by killing or get without a prescription from a stopping the growth of bacteria Do not take this medicine if the pharmacy, supermarket or health causing your infection. expiry date (EXP) printed on the food shop. packaging has passed or if the Azithromycin will not work against packaging is torn or shows signs of viral infections such as colds or flu. Some medicines may interfere with tampering. Azithromycin or increase the risk of side effects. These include:

APO-AZITHROMYCIN TABLETS 1 • antacids (medicines used to treat pills, although this has not been How long to take it for indigestion) shown with azithromycin. Continue taking your medicine until • coumarin-type oral you finish the pack or until your anticoagulants (a medicine used doctor recommends. Do not stop to prevent blood clots) taking it because you are feeling How to take this better. • cyclosporin (a medicine used to medicine prevent organ transplant rejection Make sure you have enough to last or to treat certain problems with Follow all directions given to you over weekends and holidays. the immune system) by your doctor or pharmacist • digoxin (a medicine used to treat carefully. If you forget to take it abnormal heart rhythm or heart They may differ from the If you are taking your medicine for failure) information contained in this leaflet. three days or longer and you miss a • ergot derivatives (such as dose, take it as soon as you ergotamine, which is used to treat If you do not understand the remember (within a 24- hour period), migraines) instructions on the pack, ask your then continue as normal. doctor or pharmacist for help. • terfenadine or astemizole Do not take a double dose to make up for missed doses. (medicines used to treat allergies How much to take and hay fever) This may increase the chance of you The dose will depend on your experiencing side effects. • zidovudine, a medicine used to infection. treat patients with AIDS The usual dose to treat Chlamydia is If you are not sure what to do, check two 500 mg tablets taken as a single with your doctor or pharmacist. • diphenoxylate (Lomotil), a dose. medicine used to treat diarrhoea If you have trouble remembering to For other infections Azithromycin is take your medicine, ask your • some medicines used to treat usually taken once a day. Sometimes pharmacist for some hints to help you heart rhythm problems (heart the dose is taken once a week. Your remember. arrhythmia) such as amiodarone, doctor will decide the right dose for you. disopyramide, ibutilide and Do not stop taking your medicine or sotalol change your dosage without first • antipsychotic medicines used to checking with your doctor. If you take too much treat schizophrenia or bipolar (overdose) mania such as haloperidol, How to take it quetiapine and risperidone Swallow the tablets whole with Immediately telephone your doctor • medicines used to treat liquid. This medicine may be taken or Poisons Information Centre depression (antidepressants) such with or without food. (telephone in Australia - 13 11 26: as fluoxetine, sertraline and in New Zealand - 0800 POISONS If you are taking an antacid (e.g., venlafaxine or 0800 764 766) for advice if you Gastrogel, Mylanta), take it at least think that you or anyone else may • fluoroquinolone antibiotics such one hour before or two hours after have taken too much as ciprofloxacin, lomefloxacin, this medicine dose. Azithromycin. moxifloxacin and norfloxacin This will avoid any possible effect of Do this even if there are no signs of These medicines may be affected by the antacid on the absorption of discomfort or poisoning. You may Azithromycin or may affect how well azithromycin. it works. You may need different need urgent medical attention. amounts of your medicines, or you may need to take different medicines. When to take it While you are taking this Your doctor or pharmacist has more Take this medicine at the same time information on medicines to be each day. Taking it at the same time medicine careful with or to avoid while taking each day will have the best effect and Azithromycin. Things you must do Talk to your doctor about the need will also help you remember when to for additional contraception while take it. If the symptoms of your infection taking Azithromycin. This medicine may be taken with or do not improve within a few days, Some antibiotics may decrease the without food. or if they become worse, tell your effectiveness of some doctor.

APO-AZITHROMYCIN TABLETS 2 If you get severe diarrhoea, tell Do not give Azithromycin to • oral thrush - white furry, sore your doctor, pharmacist or nurse anyone tongue and mouth immediately. Do this even if it else, even if they have the same • vaginal thrush - sore and itchy occurs several weeks after you condition as you. vagina and/or white discharge have stopped taking your Do not use Azithromycin to treat • (feeling sick), loss of medicine. any other medical complaints unless appetite, , stomach pain, Diarrhoea may mean that you have a indigestion, wind, constipation, your doctor tells you to. serious condition affecting your diarrhoea bowel. You may need urgent medical • dizziness, headache, spinning care. Do not take any diarrhoea Things to be careful of sensation medicine without first checking with Be careful when driving or operating your doctor. machinery until you know how this • tiredness, drowsiness, fatigue muscle or joint aches If you get a sore, white mouth or medicine affects you. tongue while taking, or soon after Protect your skin when you are in • hearing loss or ringing in the ears stopping azithromycin, tell your the sun, especially between 10am • altered taste and smell. doctor. Also tell your doctor if you and 3pm. See your doctor immediately and get vaginal itching or discharge. Some macrolide antibiotics may before you take your next dose of This may mean you have a yeast cause your skin to be more sensitive Azithromycin if you notice any of infection called thrush. Sometimes to sunlight than it is normally. the following: the use of azithromycin allows yeast Exposure to sunlight may cause a • severe persistent diarrhoea (loose to grow and the above symptoms to skin rash, itching, redness or severe bowel motions) occur. Azithromycin does not work sunburn. against yeast. • fast or irregular heart beat If outdoors, wear protective If you become pregnant while clothing and use a 30+ sunscreen. • symptoms of sunburn such as taking Azithromycin, tell your If your skin does appear to be redness, itching, swelling or doctor. burning tell your doctor blistering which may occur more Tell your doctor immediately if immediately. quickly than normal during treatment with • decreased feeling or sensitivity, Azithromycin your baby develops especially in the skin irritability with feeding or starts • hives, itching or skin rash vomiting. Side effects • widespread body rash, fever and This may be a sign of a stomach swollen lymph nodes disorder in the infant. Tell your doctor as soon as possible If you are about to start any new if you do not feel well while you are • aggressive reaction, nervousness, medicines, tell your doctor and taking azithromycin or if you have agitation or anxiety pharmacist that you are taking any questions or concerns. • bleeding or bruising more easily Azithromycin. Like other medicines, Azithromycin than normal, reddish or purplish Tell any other doctors, dentists and can cause some side effects. If they blotches under the skin occur, most are likely to be minor pharmacists who are treating you • signs of frequent or worrying and temporary. However, some may that you are taking Azithromycin. be serious and need medical infections such as fever, severe attention. chills, sore throat or mouth ulcers Things you must not do Ask your doctor or pharmacist to • dark or blood in the urine or answer any questions you may Do not stop taking Azithromycin bowel motions have. or • severe upper stomach pain, often lower the dosage without checking Do not be alarmed by the following with nausea and vomiting. with your doctor. list of side effects. You may not These are serious side effects. You If you do not complete the full course experience any of them. may need urgent medical attention. prescribed by your doctor, all the Serious side effects are rare. organisms causing your infection While taking it If you experience any of the may not be killed. These organisms Tell your doctor or pharmacist if following, stop taking your may continue to grow and multiply you notice any of the following and medicine and contact your doctor so that your infection may not clear they worry you: completely or may return. immediately or go to the Accident

APO-AZITHROMYCIN TABLETS 3 and Emergency department at blood abnormalities) can only be “AZ250” on one side, and your nearest hospital. found when your doctor does tests “APO” on the other. from time to time to check your • Apo-Azithromycin 500mg • sudden signs of such as progress. rash, itching or hives on the skin, tablets are white, oval, swelling of the face, lips, tongue Do not be alarmed at this list of film-coated tablet Embossed or other parts of the body, possible side effects. “AZ500” on one side, and shortness of breath, wheezing or You may not experience any of them. “APO” on the other. trouble breathing • blisters or ulcers on the skin, in Available in blister of 2 tablets and the mouth or airways that may bottles of 30 and 500 tablets. occur after a period of fever Storage and disposal * Not all strengths, pack types and/or • diarrhoea, usually with blood and pack sizes may be available. mucus, stomach pain and fever Storage • yellowing of the eyes or skin, Keep your medicine in its original Ingredients also called jaundice packaging until it is time to take it. • chest pain If you take your medicine out of its Active Ingredient: • fainting original packaging it may not keep Each capsule contains either 250 mg well. or 500 mg of azithromycin (as • convulsions (fits) Keep your medicine in a cool dry dihydrate). These are very serious side effects. place where the temperature will stay You may need urgent medical They also contain the following attention or hospitalisation. These below 25°C. inactive ingredients: side effects are rare. Do not store your medicine, or any • calcium hydrogen phosphate other medicine, in the bathroom or dihydrate After finishing it near a sink. Do not leave it on a • hydroxypropyl cellulose window sill or in the car. Tell your doctor immediately if you • croscarmellose sodium Heat and dampness can destroy some notice any of the following side medicines. • magnesium stearate effects, particularly if they occur (intragranular) several weeks after stopping Keep this medicine where children treatment with azithromycin: cannot reach it. • magnesium stearate (extragranular) • severe stomach cramps A locked cupboard at least one-and- a-half metres above the ground is a • opadry II 31K58875 white • watery and severe diarrhoea, good place to store medicines. which may be bloody Apo-Azithromycin tablets do not contain lactose, sucrose, gluten or • fever, in combination with one or Disposal tartrazine. both of the above. If your doctor tells you to stop Azithromycin can cause some taking this medicine, or it has Sponsor bacteria, which are normally present passed its expiry date, ask your Apotex NZ Ltd in the bowel and normally harmless pharmacist what to do with any 32 Hillside Road to multiply and therefore cause the that is left over. above symptoms. You may need Wairau Valley, Auckland 0627 urgent medical attention. However, this side effect is rare. Telephone: (09) 444 2073 Do not take any medicine for this Product description Fax: (09) 444 2951 diarrhoea without first checking E-mail: with your doctor. [email protected] What it looks like Tell your doctor if you notice Apo-Azithromycin come in two anything else that is making you APO and APOTEX are registered strengths: feel unwell. trademarks of Apotex Inc • Apo-Azithromycin 250mg Other side effects not listed above may also occur in some patients. tablets are white, oval, film- This leaflet was last updated in Some of these side effects (for coated tablets. Embossed example certain liver conditions, and November 2018

APO-AZITHROMYCIN TABLETS 4