CLAVAM (Amoxicillin & Clavulanic Acid)

Consumer Medicine Information

What is in this leaflet? CLAVAM tablets work by killing If you are not sure whether you the bacteria that cause these should start taking CLAVAM Please read this leaflet carefully infections. CLAVAM tablets will tablets, talk to your doctor. before you take CLAVAM tablets. not work against infections caused by viruses such as colds or the flu. Tell your doctor if: This leaflet answers some common questions about CLAVAM tablets. Your doctor may have prescribed it • you have ever had an allergic It does not contain all of the for another reason. If you want reaction (such as a rash) to available information. more information ask your doctor. antibiotics or other substances in It does not take the place of talking This medicine is available only with the past. to your doctor or pharmacist. a doctor’s prescription. • you are allergic to foods, dyes, preservatives or any other All medicines have risks and There is no evidence that it is medicines. benefits. Sometimes new risks are addictive. found even when a medicine has • you have experienced liver been used for many years. Your problems after taking CLAVAM doctor has weighed the expected tablets or any other medicines. benefits of you taking CLAVAM Before you take • you have glandular fever tablets against the risks this CLAVAM Tablets (mononucleosis) or leukaemia. medicine could have for you. • you are pregnant or think you If you have any concerns about Do not take CLAVAM Tablets may be pregnant or are breast- taking this medicine, ask your if: feeding. Your doctor will doctor or pharmacist. discuss with you the possible • you have had an allergic risks and benefits of taking Keep this leaflet with the medicine. reaction to penicillin or similar CLAVAM tablets during You may need to read it again. types of antibiotics (such as pregnancy or while you are cephalosporins) or any of the breast- feeding. CLAVAM ingredients contained in tablets can pass to your baby CLAVAM tablets. The from breast milk. ingredients are listed at the end What are CLAVAM • you have any kidney or liver of this leaflet. Some of the tablets used for? problems. The dosage of symptoms of an allergic reaction CLAVAM tablets may need to be may include skin rash, itching, CLAVAM tablets contain two changed or you may need to be difficulty in breathing and active ingredients. One of these is a given an alternative medicine. penicillin called amoxycillin and swelling of the face or tongue. • you have to test your urine for the other is clavulanic acid. • you have previously sugar. CLAVAM tablets may CLAVAM tablets belong to the experienced liver problems after affect the results of these tests. penicillin group of antibiotics. taking CLAVAM tablets or any other medicines. • Tell your doctor or pharmacist if CLAVAM tablets are used for the you are taking any other • The expiry date (EXP) printed short term treatment of wide range medicines, including medicines on the pack has passed. of infections caused by bacteria. that you buy without a These infections may affect the • The packaging is torn or shows prescription from your chest (e.g. bronchitis or signs of tampering. pharmacy, supermarket or health pneumonia), bladder (e.g. cystitis), Do not give this medicine to anyone food shop. In particular tell your sinuses (e.g. sinusitis), the ears (e.g. else; your doctor has prescribed it doctor or pharmacist if you are otitis media) or the skin. specifically for you and your taking any of the following: condition. - warfarin or other medicines

CLAVAM Published by MIMS March 2021 1 used to prevent blood clots Space the doses as evenly as While you are taking - mycophenolate possible throughout the day. If you CLAVAM tablets - Medicines used to treat gout are taking CLAVAM tablets twice a (eg. probenecid or allopurinol). day, take a dose about every twelve Things you must do: - other antibiotics. These may hours. interfere with the actions of Take CLAVAM tablets exactly as CLAVAM tablets. How long to take it for: your doctor has prescribed. - The contraceptive pill. As with Keep taking CLAVAM tablets until Tell your doctor if, for any reason other antibiotics, you may need the course is finished or for as long you have not taken your medicine to use extra birth control as your doctor tells you. exactly as directed. Otherwise, your methods (eg. condoms) while doctor may think that it was not taking CLAVAM tablets. Do not stop taking CLAVAM tablets working as it should and change just because you feel better as the • Some medicines may affect the your treatment unnecessarily. way other medicines work. Your infection can return. Tell your doctor, dentist or doctor or pharmacist will be Do not stop taking, or change the pharmacist you are taking able to tell you what to do when dose without first checking with CLAVAM tablets before starting taking CLAVAM tablets with your doctor. any other medicines. Some other medicines. If you forget to take it: medicines may affect the way other medicines work. If your next dose is due within six Tell your doctor if the symptoms of hours, skip the dose you missed and your infection become worse, or do How to take CLAVAM take your next dose at the normal not improve within a few days of Tablets time. Otherwise, take the missed starting CLAVAM tablets. dose as soon as you remember and Follow the directions given to you then go back to taking your tablets by your doctor and pharmacist. Things you must not do: as directed by your doctor. Their directions may differ from the Do not give this medicine to anyone information contained in this leaflet. Do not take a double dose to make up for the dose that you else, even if their symptoms seem Please read the direction label have missed. similar to yours. carefully. If you have any concerns Taking more than the prescribed Do not use to treat any other about how to take this medicine dose can increase the chance of complaints unless your doctor says talks to your doctor or pharmacist. unwanted side-effects. to.

How much to take: Things to be careful of: Take as directed by your doctor or Alcohol should be avoided during Pharmacist. What do I do if I take too much? (Overdose) and for several days after treatment The usual dose of CLAVAM is with CLAVAM tablets. Some twice daily. Immediately telephone your people who drink alcohol while doctor or Poisons Information taking antibiotics similar to How to take it: Centre (telephone 131126) for CLAVAM tablets have experienced advice, if you think you or anyone adverse effects. Swallow the CLAVAM tablet with else may have taken too much, a full glass of water or other liquid. Be careful driving or operating even if there are no signs of machinery until you know how CLAVAM tablets can also be discomfort or poisoning. broken in half, but should not be CLAVAM tablets affect you. Symptoms of overdose include mild chewed. Generally, these tablets do not to severe nausea, vomiting, cramps CLAVAM tablets should be taken cause any problems with your and diarrhoea. immediately before or with the first ability to drive a car or operate mouthful of food. If you are not sure what to do, machinery. contact your doctor, pharmacist or CLAVAM tablets work best when However, as with many other nearest hospital. Be sure to show medicines, CLAVAM tablets may taken this way. It may also help to the doctor the CLAVAM pack. prevent stomach upsets. However, cause dizziness or tiredness in some CLAVAM tablets will still work if people. they are taken without food.

CLAVAM Published by MIMS March 2021 2 If you develop severe diarrhea - severe stomach cramps How do I store either when taking CLAVAM - severe watery or bloody CLAVAM tablets? tablets or within several weeks after diarrhoea treatment, tell your doctor as soon - unusual bleeding or bruising Keep your tablets in the original as possible. Do not take any These may be symptoms of rare pack until it is time to take them. If medication to stop the diarrhoea serious side-effects and require you take the tablets out of the pack (eg. Lomotil or Imodium). urgent medical attention. they may not keep well. • Stop taking CLAVAM tablets Keep the pack in a cool dry place. and immediately contact your Do not leave it in the car on a hot doctor or go to the emergency day. Do not store medicine in the What are the side- department of your nearest bathroom or near a sink. Heat and effects? hospital if any of the following dampness can destroy CLAVAM happens: tablets. Check with your doctor as soon Wheezing, hives, severe skin as possible if you think you are reaction, fainting, swelling of Store all medicines out of the reach experiencing any side-effects or limbs, face, lips, mouth or of children, such as in a locked allergic reactions due to taking throat, difficulty swallowing or cupboard. CLAVAM tablets, even if the problem is not listed below. breathing, joint discomfort or If your doctor tells you to stop swelling, swollen lymph glands, taking CLAVAM tablets or if the Like other medicines, CLAVAM nausea and vomiting or fever. expiry date has passed, ask your can cause some side-effects. If they These may be signs of an pharmacist what to do with any occur, they are most likely to be allergic reaction or other tablets that are left over. minor and temporary. However, reaction to CLAVAM tablets. some may be serious and need - Allergy to these antibiotics is medical attention. rare. Tell your doctor about any effect - Fits/seizures. Product description which is troublesome or ongoing. • Rare events that have been MILD EFFECTS reported with CLAVAM What they look like: • Tell your doctor if you notice tablets include: CLAVAM tablets come as White to any of the following that are - inflammation of the bowel off whit capsule shaped, biconvex, troublesome or ongoing: (colitis) film coated tablets debossed with - diarrhoea (several loose bowel - inflammation of the liver AM and CL separated by break line movements per day), (hepatitis) on one side and 1000 on other side. indigestion, pain in the stomach, - inflammation of the kidney (nephritis) feeling sick or being sick Other ingredients: - white, furry, sore tongue and - blood disorders mouth (oral thrush), abnormal - crystals in the urine CLAVAM tablets contain the taste (crystalluria) following inactive ingredients: - soreness or itching of the Remember, you should tell your Microcrystalline Cellulose, Sodium vagina or vaginal discharge doctor or pharmacist as soon as Starch Glycolate, Colloidal (vaginal thrush) possible if any of these, or any anhydrous Silica, magnesium - aseptic meningitis, headache, other unusual events or problems Stearate, Insta Moistshield [PI dizziness, tiredness, hot flushes occur during or after treatment 108592], Isopropyl Alcohol and with CLAVAM Tablets. - tooth discolouration Dichloromethane. - unusually active This is not a complete list of all CLAVAM tablets are available only (hyperactivity) possible side-effects. Others may with a doctor's prescription. occur in some people and there may MORE SERIOUS EFFECTS CLAVAM tablets come in Blister be some side-effects not yet known. • Tell your doctor immediately packs of 10 and HDPE pack of 20`s if you notice any of the Tell your doctor or pharmacist if following during or after you notice any side-effects from taking CLAVAM tablets: your medicine which are not - itching, rash mentioned here. Supplier - dark urine or pale stools Do not be alarmed by this list of - yellowing of the skin or eyes possible side-effects. You may not Your CLAVAM tablets are (jaundice) experience any of them. supplied by:

CLAVAM Published by MIMS March 2021 3 PHARMACOR PTY. LTD SUITE 803, LEVEL 8, TOWER A, THE ZENITH, 821 PACIFIC HIGHWAY.CHATSWOOD, NSW, 2067, Australia Australian Registration Numbers for CLAVAM 875mg/125mg tablets is - Blister Packs AUST R 202571 Bottle Packs AUST R 202577

Where to go for further Information 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. The information provided applies only to: CLAVAM tablets. Date of First Inclusion In Australian Register of Therapeutic Goods (The ARTG) 14/11/2013 This document was last updated in Sept 2020

CLAVAM Published by MIMS March 2021 4