floxapen syrup - GSK Australia
Transcription
floxapen syrup - GSK Australia
FLOXAPEN® SYRUP Flucloxacillin Consumer Medicine Information What is in this leaflet? Please read this leaflet carefully before you give FLOXAPEN. This leaflet answers some common questions about FLOXAPEN. 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. Sometimes new risks are found even when a medicine has been used for many years. Your doctor has weighed the expected benefits of your child taking FLOXAPEN against the risks this medicine could have for your child. FLOXAPEN works by killing the bacteria that cause these infections. FLOXAPEN will not work against infections caused by viruses such as colds or the flu. Your doctor may have prescribed FLOXAPEN for another reason. Ask your doctor if you have any questions about why FLOXAPEN has been prescribed for your child. There is no evidence that FLOXAPEN is addictive. Before you give FLOXAPEN Do not give FLOXAPEN if: • If you have any concerns about your child taking this medicine, ask your doctor or pharmacist. Keep this leaflet until your child has finished the course of FLOXAPEN. You may need to read it again. What is FLOXAPEN used for? FLOXAPEN contains flucloxacillin as the active ingredient. FLOXAPEN belongs to a group of medicines called penicillins. FLOXAPEN is used to treat infections caused by bacteria. These infections may affect the chest (pneumonia), the bones (osteomyelitis), or the skin and fleshy tissues. FLOXAPEN can also be used to treat infected burns or other infected wounds. ® FLOXAPEN SYRUP • • • Your child has had an allergic reaction to flucloxacillin, other penicillins or similar types of antibiotics (such as cephalosporins) or any of the ingredients contained in FLOXAPEN. The ingredients are listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include skin rash, itching, difficulty in breathing and swelling of the face or tongue. Your child has previously experienced liver problems after taking FLOXAPEN or any other medicines. the expiry date (EXP) printed on the pack has passed. the packaging is torn or shows signs of tampering. Tell your doctor if: • • your child is allergic to foods, dyes, preservatives or any other medicines. Your child has ever had an allergic reaction (such as a • • rash) to antibiotics or other substances in the past. your child has any kidney or liver problems. The dose of FLOXAPEN may need to be changed or your child may need to be given an alternative medicine. Your child is taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop. In particular tell your doctor or pharmacist if your child is taking any of the following: medicines which are used to treat gout (eg. probenecid). other antibiotics. These may interfere with the actions of FLOXAPEN. Some medicines may affect the way other medicines work. Your doctor or pharmacist will be able to tell you what to do when taking FLOXAPEN with other medicines. How do I give FLOXAPEN? Follow the directions given to you by your doctor and pharmacist. Their directions may differ from the information contained in this leaflet. Please read the direction label carefully. If you have any concerns about how to give this medicine talk to your doctor or pharmacist. How much FLOXAPEN to give: Give FLOXAPEN as directed by your doctor or pharmacist. The dose given depends on your child’s weight. [1] A dose of FLOXAPEN is usually given four times daily How to give FLOXAPEN: Shake the syrup well. Measure the dose accurately with a marked spoon, dropper or measure. Make sure the whole dose is swallowed each time. FLOXAPEN should be given half an hour to an hour before meals or on an empty stomach. Space the doses as evenly as possible throughout the day. For example, if your child is taking FLOXAPEN four times a day, give a dose about every six hours. How long to give FLOXAPEN for: Keep giving FLOXAPEN until the course is finished or for as long as your doctor tells you. Do not stop giving FLOXAPEN just because your child feels better as the infection can return Do not stop giving FLOXAPEN, or change the dose without first checking with your doctor. If you forget to give FLOXAPEN: Centre (telephone 131126) for advice, if you think your child or anyone else may have taken too much FLOXAPEN, even if there are no signs of discomfort or poisoning. If you are not sure what to do, contact your doctor, pharmacist or nearest hospital. While you are giving FLOXAPEN Things you must do: Tell your doctor if, for any reason, you have not given the medicine exactly as directed. Otherwise, your doctor may think that it was not working as it should and change your child’s treatment unnecessarily. Tell your doctor, dentist or pharmacist your child is taking FLOXAPEN, before starting any other medicines. Some medicines may affect the way other medicines work. Tell your doctor if the symptoms of your child’s infection become worse, or do not improve within a few days of starting FLOXAPEN. Give the missed dose as soon as you remember. Then give the next dose at the time it is normally due. Do not give two doses within three hours of each other. Things you must not do: Do not try to make up for missed doses by giving more than one dose at a time. Giving more than the prescribed dose can increase the chance of unwanted side effects. Do not use FLOXAPEN to treat any other complaints unless your doctor says to. What do I do if I give too much FLOXAPEN? (Overdose) Immediately telephone your doctor or Poisons Information ® FLOXAPEN SYRUP Do not give this medicine to anyone else, even if their symptoms seem similar to your child’s. What are the sideeffects? Check with your doctor as soon as possible if you think your child is experiencing any side effects or allergic reactions due to taking FLOXAPEN, even if the problem is not listed below. Like other medicines, FLOXAPEN can cause some side-effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention. MILD EFFECTS • Tell your doctor if you notice any of the following that are troublesome or ongoing: diarrhoea (several loose bowel motions per day). indigestion. feeling sick or being sick. white furry sore tongue and mouth (oral thrush). sore and itchy vagina and/ or discharge (vaginal thrush). MORE SERIOUS EFFECTS • Tell your doctor immediately if you notice any of the following during or for up to several weeks after taking FLOXAPEN: itching, rash. dark urine or pale stools. yellowing of the skin and eyes (jaundice). severe stomach cramps. severe watery or bloody diarrhoea. These may be symptoms of rare but serious side effects and require urgent medical attention. • Stop giving FLOXAPEN and contact a doctor immediately or take your child to the emergency department of your nearest hospital if any of the following happens: Wheezing, swelling of the limbs, lips/mouth or throat, difficulty in breathing, hayfever, lumpy rash (hives) or severe skin reactions or fainting. These reactions are signs of a severe allergic reaction to FLOXAPEN. Allergy to FLOXAPEN is rare. [2] • Other rare events that - have been reported with FLOXAPEN include: blood disorders. inflammation of the liver (hepatitis). inflammation of the kidney (nephritis). FLOXAPEN can cause serious liver damage which may be prolonged. The reaction is more frequent in the elderly and those who take it for more than 14 days. Remember, you should tell the doctor or pharmacist as soon as possible if any of these, or any other unusual events or problems occur during or after treatment with FLOXAPEN. This is not a complete list of all possible side-effects. Others may occur in some people and there may be some side-effects not yet known. Tell your doctor or pharmacist if you notice any side effects from your child’s medicine which are not mentioned here. Do not be alarmed by this list of possible side-effects. Your child may not experience any of them. How do I store FLOXAPEN? Keep the bottle in the refrigerator where the temperature stays between 2 and 8°C. Keep this medicine where children cannot reach it, such as in a locked cupboard. Do not leave in a car, on a window sill or in the bathroom. Heat and dampness can destroy some medicines. Do not use any syrup left in the bottle after it has been open for 14 days. Ask your pharmacist ® FLOXAPEN SYRUP what to do with any doses that are left over. Product description What FLOXAPEN looks like: FLOXAPEN is available as syrups containing; - 125mg of flucloxacillin in 5mL (FLOXAPEN syrup) Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition. FLOXAPEN syrups come in the following packs: - FLOXAPEN syrup - (AUST R11148). FLOXAPEN forte syrup (AUST R11147). or 250mg of flucloxacillin in 5mL (FLOXAPEN forte syrup) - Ingredients: The information provided applies only to FLOXAPEN®. FLOXAPEN contains the active ingredient flucloxacillin. FLOXAPEN syrups also contain the following inactive ingredients: xanthum gum, citric acid, sodium benzoate and sodium citrate. The syrups also contain sugar (sucrose), sodium saccharin, menthol dry 600061e, blood orange 600001e and tutti-frutti 51.880/AP05.51 as flavourings. FLOXAPEN is also available as capsules. ®FLOXAPEN is a trademark of the GlaxoSmithKline Group of Companies. This leaflet is subject to copyright. FLOXAPEN Syrup Issue 2. Prepared on 23rd June 2003. Each 5mL of FLOXAPEN forte syrup contains approximately 0.25mmoL of magnesium and 2.7g of sucrose. Each 5mL of FLOXAPEN syrup contains approximately 0.12mmoL of magnesium and 2.9g of sucrose. FLOXAPEN syrups do not contain lactose, gluten, tartrazine or any other azo dyes. Manufacturer: Your FLOXAPEN is made by: GlaxoSmithKline Australia Pty Ltd 1061 Mountain Highway Boronia Victoria, 3155 Australia. Tel: (03) 9721 6000 Where to go for further information: [3]