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APO-Flucloxacillin Flucloxacillin sodium Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet Your doctor may have prescribed this while you were taking medicine for another reason. flucloxacillin or another This leaflet answers some common This medicine is available only with . questions about flucloxacillin. It does a doctor©s prescription. Examples of liver reactions include not contain all the available This medicine is not addictive. hepatitis and jaundice (yellowing of information. It does not take the the eyes or skin). There is not enough information to place of talking to your doctor or Do not take this medicine after the pharmacist. recommend the use of this medicine for children under the age of 2 years expiry date printed on the pack or All medicines have risks. Your if the packaging is torn or shows doctor has weighed the risks of you signs of tampering. using this medicine against the Do not use this medicine in your benefits they expect it will have for Before you take this eyes. you. medicine If it has expired or is damaged, return If you have any concerns about it to your pharmacist for disposal. taking this medicine, ask your WARNING: Flucloxacillin can If you are not sure whether you doctor or pharmacist. cause severe liver damage, should start taking this medicine, particularly in older patients and Keep this leaflet with the medicine. talk to your doctor. those who take it for more than 14 You may want to read it again. days. Before you start to take it When you must not take it Tell your doctor if you have to any other medicines, Do not take this medicine if you What this medicine is foods, preservatives or dyes. used for are allergic to: Tell your doctor if you have or · flucloxacillin Flucloxacillin is used to treat have had any of the following · penicillin infections in different parts of the medical conditions: body caused by bacteria. It belongs · antibiotics · liver problems or jaundice to a group of medicines called · beta-lactam antibiotics including (yellowing of the skin or eyes) . and · kidney problems · any of the ingredients listed at the · asthma, hayfever, eczema or How it works end of this leaflet. other allergic conditions. Flucloxacillin is an antibiotic that Symptoms of an allergic reaction Tell your doctor if you are works by killing the bacteria that are may include: pregnant or you plan to become causing your infection. · shortness of breath pregnant or are breastfeeding. Flucloxacillin will not work against · wheezing or difficulty breathing Your doctor can discuss with you the infections caused by viruses, such as risks and benefits involved. colds or flu. · swelling of the face, lips, tongue, throat or other parts of the body The active ingredient Flucloxacillin Ask your doctor if you have any passes into breast milk and there is a · , itching or on the skin questions about why this medicine possibility that your baby may be has been prescribed for you. Do not take this medicine if you affected. have had a reaction affecting your

APO-FLUCLOXACILLIN 1 If you have not told your doctor If you do not understand the If you are not sure what to do, ask about any of the above, tell them instructions on the box, ask your your doctor or pharmacist. before you start taking this doctor or pharmacist for help. If you have trouble remembering to medicine. take your medicine, ask your How much to take pharmacist for some hints to help you Taking other medicines For most infections, the usual dose remember. Tell your doctor and pharmacist if for adults is 250 mg every 6 hours. If you take too much you are taking any other For children 2-10 years: half adult medicines, including any that you dose. (overdose) get without a prescription from Immediately telephone your doctor your pharmacy, supermarket or How to take it or the Poisons Information Centre health food shop. Swallow the capsules whole with a (telephone 13 11 26) for advice, or Tell your doctor or pharmacist if full glass of water. go to Accident and Emergency at you are taking this medicine in your nearest hospital, if you think combination with paracetamol, When to take it that you or anyone else may have particularly if you have impaired taken too much of this medicine. kidney function. Take this medicine at the same Do this even if there are no signs of Some medicines and flucloxacillin time each day. discomfort or poisoning. may interfere with each other. This Taking it at the same time each day You may need urgent medical includes: will have the best effect. It will also attention. help you remember when to take it. · , a medicine If you take too much flucloxacillin, commonly used to treat gout Take flucloxacillin on an empty you may get diarrhoea and . · some antibiotics may decrease the stomach, for example, half to one effectiveness of some birth hour before meals and at bedtime. control pills, although this has not Food can interfere with the been shown with flucloxacillin. absorption of flucloxacillin. While you are taking Talk to your doctor about the this medicine need for additional contraception How long to take it for while taking flucloxacillin. Continue taking this medicine until Things you must do These medicines may be affected by you finish the pack, or for as long If you are about to be started on any this medicine or may affect how well as your doctor tells you. new medicine, remind your doctor it works. You may need different Do not stop taking this medicine, and pharmacist that you are taking amounts of your medicines, or you even if you feel better after a few this medication. may need to take different medicines. days, unless advised by your Tell any other doctors, dentists and Your doctor and pharmacist have doctor. pharmacists who treat you that you more information on medicines to be Your infection may not clear are taking this medicine. careful with or avoid whilst taking completely if you stop taking your this medicine. If you become pregnant while taking medicine too soon. this medicine, tell your doctor Other medicines not listed above immediately. may also interact with flucloxacillin. If you forget to take it Keep all of your doctor©s If it is almost time to take your appointments so that your progress next dose, skip the dose you missed can be checked. and take your next dose when you Your doctor may occasionally do How to take this are meant to. medicine tests (such as liver function tests) to Otherwise, take it as soon as you make sure the medicine is working Follow all directions given to you remember, and then go back to and to prevent side effects. taking your medicine as you would by your doctor and pharmacist If your symptoms do not improve normally. carefully. within a few days, or if they become They may differ from the Do not take a double dose to make worse, tell your doctor. up for missed doses. information contained in this leaflet. If you develop jaundice (yellowing This may increase the chance of you of the eyes or skin), tell your doctor experiencing side effects. immediately. Do this even if it

APO-FLUCLOXACILLIN 2 occurs several weeks after you If you stop taking it suddenly, your The above list includes the more have stopped taking flucloxacillin. condition may worsen. common side effects of your Jaundice may mean that you have a medicine. serious condition affecting your liver. Things to be careful of Tell your doctor as soon as possible You may need urgent medical care. if you notice any of the following: Be careful when driving or operating If you get severe diarrhoea, tell machinery until you know how this · tiredness, headaches, being short your doctor or pharmacist medicine affects you. of breath when exercising, immediately. Do this even if it dizziness and looking pale occurs several weeks after you (possible anaemia). have stopped taking flucloxacillin. The above list includes serious side Diarrhoea may mean that you have a Side effects effects that may require medical serious condition affecting your attention. Tell your doctor or pharmacist as bowel. You may need urgent medical If any of the following happen, stop soon as possible if you do not feel care. Do not take any diarrhoea taking your medicine and contact well while you are taking medicine without checking with your your doctor immediately or go to flucloxacillin. doctor. Accident and Emergency at your If you get a sore, white mouth or Flucloxacillin treats infections in nearest hospital, even if they occur tongue while taking or soon after most people, but it may have several weeks after stopping stopping flucloxacillin, tell your unwanted side effects in some treatment with flucloxacillin: doctor. Also tell your doctor if you people. All medicines can have side · allergic reaction, symptoms pf get vaginal itching or discharge. effects. Sometimes they are serious, which include swelling of the most of the time they are not. You This may mean you have a fungal face, lips, tongue or other parts of may need medical attention if you get infection called thrush. Sometimes, the body; shortness of breath, some of the side effects. the use of flucloxacillin allows fungi wheezing or troubled breathing; to grow and the above symptoms to Do not be alarmed by the following skin rash, itching or hives occur. Flucloxacillin does not work lists of side effects. You may not · red, scaly rash with bumps under against fungi. experience any of them. the skin and blisters If you get severe skin reactions Ask your doctor or pharmacist to · watery and severe diarrhoea, with painful red areas, large answer any questions you may have. which may also be bloody blisters, peeling of skin layers; IMPORTANT: Flucloxacillin can · severe stomach cramps fever, chills, aching muscles, cause severe liver damage, which feeling unwell (signs of drug can make the skin and whites of · frequent infections such as fever, reaction with eosinophiliaand the eyes turn yellow in colour. This chills, sore throat or mouth ulcers systemic symptoms (DRESS), is more likely to occur in older · convulsions or fits and acute generalised patients particularly those over 55 · yellowing of the eyes or skin exanthematous pustulosis (AGEP), years of age and those who take it (jaundice) Stevens-Johnson Syndrome or for more than 14 days. · bleeding or bruising more easily toxic epidermal necrolysis), stop Immediately contact your doctor if than normal taking this medicine immediately you notice any yellowing of your · painful, swollen joints and tell your doctor. eyes or skin. · aching muscles, muscle Tell your doctor or pharmacist if Things you must not do tenderness or weakness, not you notice any of the following: caused by exercise Do not take any medicine for · nausea diarrhoea without first checking · irregular heart beat · feeling sick or vomiting with your doctor or pharmacist. · dark or cloudy urine, blood in the Do not take this medicine to treat · stomach upset, diarrhoea urine. any other complaints unless your · a mild rash The above list includes very serious doctor tells you to. · oral thrush (white, furry sore side effects. You may need urgent Do not give your medicine to anyone tongue and mouth) medical attention or hospitalisation. else, even if they have the same · vaginal thrush (sore and itchy condition as you. Tell your doctor or pharmacist if vagina and/or vaginal discharge). notice anything that is making you Do not stop taking your medicine or feel unwell. lower the dosage without checking with your doctor.

APO-FLUCLOXACILLIN 3 Other side effects not listed above Disposal may occur in some patients. If your doctor tells you to stop This leaflet was prepared in taking this medicine or the expiry December 2020. After stopping Flucloxacillin date has passed, ask your Tell your doctor if your skin and/ pharmacist what to do with any or eyes have turned yellow medicine that is left over. (jaundice) whilst or soon after you finish taking flucloxacillin. Tell your doctor immediately if you notice any of the following side Product description effects, even if they occur up to several weeks after finishing What it looks like treatment with flucloxacillin: 250 mg capsule (blister pack): Size 2 · watery and severe diarrhoea, capsule with blue cap and blue body which may also be bloody printed with "F250". AUST R · severe abdominal cramps or 226382 stomach cramps 500 mg capsule (blister pack): Size 0 · fever, in combination with one or capsule with blue cap and blue body both of the above printed with "F500". AUST R These are rare but serious side 226374 effects. Flucloxacillin can change the Pack sizes of 24 and 48 capsules. bacteria (which are normally present * Not all strengths and/or pack sizes in the bowel and are harmless) to may be available. multiply and therefore cause the above symptoms. You may need urgent medical attention. Ingredients Each contains 250 mg & 500 mg of flucloxacillin (as sodium) as the active ingredient. Storage and It also contains the following: · magnesium stearate Storage · titanium dioxide Keep your tablets in the pack until · indigo carmine it is time to take them. · methyl hydroxybenzoate If you take the tablets out of the pack they may not keep well. · propyl hydroxybenzoate Keep your medicine in a cool dry · gelatin place where the temperature will · shellac stay below 25°C. · isopropyl alcohol Do not store this medicine or any · ethanol other medicine in the bathroom or near a sink. Do not leave it on a This medicine does not contain window sill or in the car. gluten, lactose, sucrose, tartrazine and other azo dyes. Heat and dampness can destroy some medicines. Sponsor Keep it where children cannot Apotex Pty Ltd reach it. 16 Giffnock Avenue A locked cupboard at least one-and- a-half metres above the ground is a Macquarie Park NSW 2113 good place to store medicines. APO and APOTEX are registered trade marks of Apotex Inc.

APO-FLUCLOXACILLIN 4