AMOXICILLIN 125MG/5ML ORAL SUSPENSION (SUGAR FREE)
Active substance: AMOXICILLIN TRIHYDRATE
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Patient Information Leaflet
AMOXICILLIN 125mg/5ml & 250mg/5ml ORAL SUSPENSION SUGAR FREE
code area
Please read this leaflet carefully before you start to take your medicine. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET 1. What your medicine is and what it is used for 2. Before you take your medicine 3. How to take your medicine 4. Possible side effects 5. How to store your medicine 6. Further information 1. WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR Amoxicillin is one of a group of antibiotic medicines called penicillins. Amoxicillin works by interfering with the bacteria that cause the infection. Amoxicillin can treat a wide range of infections including those of the following: chest (bronchitis or pneumonia) tonsils (tonsillitis) skin ears (otitis media) sinuses (sinusitis) gums (abscesses) kidneys teeth heart (endocarditis) blood (septicaemia) bone the bladder or the urethra (the tube which carries urine from the bladder) he female reproductive system including infections caused by difficulties during childbirth (puerperal sepsis and septic t abortion) abdomen (intra-abdominal sepsis and peritonitis) gonorrhoea (a sexually transmitted infection) infections associated with pregnancy typhoid and paratyphoid (fevers caused by a group of bacteria called Salmonella) 2. BEFORE YOU TAKE YOUR MEDICINE Do not take this medicine and consult your doctor if any of the following applies to you or your child: ou have ever had a bad reaction or allergy to any penicillin-type antibiotic Y ou have ever had a skin rash or swelling of the face or neck or shortness of breath when taking any antibiotic Y ou are allergic to any of the ingredients contained in this medicine (See section 6, Further information) Y Take special care with your medicine Check with your doctor or pharmacist before taking this medicine if: ou suffer from kidney disease or kidney problems, as you may require a lower dose than normal Y ou have glandular fever Y ou are not passing water regularly Y ou have an intolerance to some sugars as this medicine contains sorbitol Y Taking other medicines Check with your doctor or pharmacist if you are taking, or have recently taken any other medicines even those not prescribed by a doctor. In particular tell your doctor if you are taking any of the following: he contraceptive pill (in which case you will have to take extra contraceptive measures such as using a condom) T nticoagulants e.g. warfarin, phenindione A hemotherapy drugs e.g. methotrexate C rugs used to treat gout e.g. probenecid, allopurinol, sulfinpyrazone D ome other antibiotics (e.g. neomycin and tetracyclines can reduce the effect of amoxicillin) S ral typhoid vaccine (may not work if taken with amoxicillin) O Some penicillins may increase the effects of muscle relaxing drugs given as part of an anaesthetic for surgery. Tell the doctor you are taking amoxicillin if you need to have an anaesthetic. Having urine or blood tests If you or your child are having urine tests for diabetes (sugar in the urine) or blood tests for liver function, let the doctor know. Amoxicillin can affect the results of these tests. Pregnancy and breast-feeding Check with your doctor before you take this medicine if you are pregnant or breast-feeding. Important information about some of the ingredients in your medicine This medicinal product contains sorbitol. Sorbitol may cause stomach upset and diarrhoea. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 3. HOW TO TAKE YOUR MEDICINE Follow all directions given to you by your doctor or pharmacist. Their directions may differ from the information contained in this leaflet. Your doctor may advise you to take your medicine in a different way, so you should always follow your doctors advice about when and how to take your medicine and always read the label. Your pharmacist may be able to help if you are not sure. Try to give/take this medicine as part of the daily routine, for example at mealtimes. You may give/take amoxicillin before, with or after food, unless the label advises a specific time. You should make sure you/your child have several more drinks of water each day unless told otherwise by your doctor. Dosage: Adults (including the elderly): The total daily dose should not exceed 6g in total, given in divided doses. he usual dose for most infections is 5ml of 250mg/5ml to be taken 3 times a day. T For more serious infections the dose may be doubled to 10ml of 250mg/5ml 3 times a day he following doses may be given in the following conditions: T - Severe or recurrent chest infections: 3 g twice daily - Simple urinary tract infections: two 3g doses 10 to 12 hours between doses (short course) - Dental abscesses: two 3g doses given orally with 8 hours between doses - Gonorrhoea: a single 3g dose he following are the usual doses for preventing infection during dental procedures or other surgery: T - If a general anaesthetic is not used, 3g given orally one hour before surgery and another dose six hours later if necessary - If a general anaesthetic is used, 3g given orally four hours before anaesthesia and 3g six hours after the initial dose
AAAD1053 P541/2
Amoxicillin 125mg/5ml & 250mg/5ml 100ml PIL - UK
item no: print proof no:
AAAD1053 3
colours/plates: 1. Black 2. 3. 4. 5. 6. Non Printing Colours 1. 2. 3.
dimensions: 148x335 pharmacode: min pt size: 7pt
origination date: 05-01-12 originated by: approved for print/date revision date: revised by:
BW 11-04-12 BW
Technical Approval date sent: Marketing to send technically app. date:
supplier: Athlone Laboratories
Children: hildren weighing more than 40kg should be given the usual adult dosage C hildren under 40kg: C - he total daily dose should not exceed 3g in total, given in divided doses. T All doses are worked out depending on the childs body weight in kilograms. Your doctor will advise you how much medicine you should give to your baby or child. The usual dose is 40mg to 90mg for each kilogram of body weight a day, given in two or three divided doses. Patients with kidney problems If you have kidney problems, the dose prescribed by your doctor may be lower than the usual dose. If you take more of your medicine than you should If you (or somebody else) accidentally take too much of your medicine, speak to your doctor or go to your nearest hospital immediately. You should take this leaflet and any medicine you still have to show the doctor. Severe cases of nausea, vomiting and diarrhoea can be treated with rehydration therapy, by drinking fluids containing sodium, water and sugar to prevent dehydration. If you forget to take your medicine If you forget to take a dose, take it as soon as you remember, unless it is within an hour of your next dose, then carry on as before. Do not take a double dose to make up for the dose you have missed. If you stop taking your medicine Keep taking this medicine until it is finished or your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking the medicine, some bacteria may survive and cause the infection to come back, or your condition may re-occur or get worse. If you/your child, are still unwell after taking all the medicine, go and see your doctor. Never give/take more than the recommended dose each day. 4. POSSIBLE SIDE EFFECTS As with all medicines, some people may experience side effects with amoxicillin. If you or your child experience any of the following events STOP taking your medicine and tell your doctor or go to your nearest hospital immediately: ypersensitivity symptoms may include swollen face, mouth, lips, throat or tongue, reddening of the skin, breathing H problems, joint pain and fever. If these symptoms occur, STOP taking amoxicillin right away and tell your doctor. evere diarrhoea possibly with bleeding S llergic skin reactions with itching e.g. hives, nettle rash, blistering or peeling of the skin. If you start to itch or get a rash, A STOP taking amoxicillin and tell your doctor immediately. ellowing of the skin or the whites of your eyes (jaundice) Y ifficulty or discomfort in passing urine or having blood in the urine D The following events are less serious but you may wish to discuss them with your doctor or pharmacist if they become troublesome or last a long time. Common side effects (have been reported in more than 1 in 100 people) include: ausea (feeling sick) or diarrhoea N Uncommon side effects (have been reported in between 1 in 100 and 1 in 1000 people taking amoxicillin) include: omiting V Very rare side effects (have been reported in less than 1 in 10,000 people) include: hrush (a yeast infection of the vagina, mouth or skin folds). You can get treatment for thrush from your doctor or T pharmacist. ooth discolouration. The colour usually returns to normal with brushing. T lackening of the tongue B nflammation of the kidney I onvulsions may occur in patients on high doses or with kidney problems C xcessive body movements (hyperkinesia) or dizziness E eduction (reversible) in blood cell counts which may cause anaemia (may be characterised by feeling weak or lightR headed) or a longer time taken for blood to clot. Tell your doctor that you are taking amoxicillin if you are having blood tests. rystalluria, forming of crystals in the urine C arker coloured urine, faeces becoming paler D If you notice any side effects not mentioned in this leaflet please inform your doctor or pharmacist. 5. HOW TO STORE YOUR MEDICINE Do not use your medicine after the expiry date shown on the label. The expiry date to be followed is that included by the pharmacist after the medicine is made up for you. Store in original package. Keep the bottle tightly closed. Dry powder: Store in a dry place below 25oC. Reconstituted suspension: Store up to 14 days at 2oC-8oC in a refrigerator. Keep out of THE reach and sight of children. If your doctor tells you to stop your treatment, return any left over to the pharmacist. Only keep it if your doctor tells you to. 6. FURTHER INFORMATION What your medicine contains Amoxicillin Oral Suspension Sugar Free is available in two strengths containing either 125mg/5ml or 250mg/5ml of the active ingredient amoxicillin as amoxicillin trihydrate. The suspensions also contain sodium benzoate (E211), disodium edetate, sodium citrate dihydrate, orange bramble flavour, quinoline yellow (E104), citric acid monohydrate, colloidal anhydrous silica, xanthan gum, sorbitol (E420) and saccharin sodium. What your medicine looks like and contents of the pack The suspensions are pale yellow with a characteristic odour. Amoxicillin Oral Suspensions Sugar Free are available in bottles of 100ml. The product is made by: Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Ireland. The product licences are also held by Athlone Laboratories Limited. The Product is distributed by: Actavis, Barnstaple, EX32 8NS, UK PL 06453/0049 PL 06453/0050 Date of last revision: March 2012 Amoxicillin 125mg/5ml Oral Suspension Sugar Free Amoxicillin 250mg/5ml Oral Suspension Sugar Free
AAAD1053 P541/2
Actavis, Barnstaple, EX32 8NS, UK
Amoxicillin 125mg/5ml & 250mg/5ml 100ml PIL - UK
item no: print proof no:
AAAD1053 3
colours/plates: 1. Black 2. 3. 4. 5. 6. Non Printing Colours 1. 2. 3.
dimensions: 148x335 pharmacode: min pt size: 7pt
origination date: 05-01-12 originated by: approved for print/date revision date: revised by:
BW 11-04-12 BW
Technical Approval date sent: Marketing to send technically app. date:
supplier: Athlone Laboratories
AMOXICILLIN 125mg/5ml & 250mg/5ml ORAL SUSPENSION SUGAR FREE
code area
Please read this leaflet carefully before you start to take your medicine. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET 1. What your medicine is and what it is used for 2. Before you take your medicine 3. How to take your medicine 4. Possible side effects 5. How to store your medicine 6. Further information 1. WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR Amoxicillin is one of a group of antibiotic medicines called penicillins. Amoxicillin works by interfering with the bacteria that cause the infection. Amoxicillin can treat a wide range of infections including those of the following: chest (bronchitis or pneumonia) tonsils (tonsillitis) skin ears (otitis media) sinuses (sinusitis) gums (abscesses) kidneys teeth heart (endocarditis) blood (septicaemia) bone the bladder or the urethra (the tube which carries urine from the bladder) he female reproductive system including infections caused by difficulties during childbirth (puerperal sepsis and septic t abortion) abdomen (intra-abdominal sepsis and peritonitis) gonorrhoea (a sexually transmitted infection) infections associated with pregnancy typhoid and paratyphoid (fevers caused by a group of bacteria called Salmonella) 2. BEFORE YOU TAKE YOUR MEDICINE Do not take this medicine and consult your doctor if any of the following applies to you or your child: ou have ever had a bad reaction or allergy to any penicillin-type antibiotic Y ou have ever had a skin rash or swelling of the face or neck or shortness of breath when taking any antibiotic Y ou are allergic to any of the ingredients contained in this medicine (See section 6, Further information) Y Take special care with your medicine Check with your doctor or pharmacist before taking this medicine if: ou suffer from kidney disease or kidney problems, as you may require a lower dose than normal Y ou have glandular fever Y ou are not passing water regularly Y ou have an intolerance to some sugars as this medicine contains sorbitol Y Taking other medicines Check with your doctor or pharmacist if you are taking, or have recently taken any other medicines even those not prescribed by a doctor. In particular tell your doctor if you are taking any of the following: he contraceptive pill (in which case you will have to take extra contraceptive measures such as using a condom) T nticoagulants e.g. warfarin, phenindione A hemotherapy drugs e.g. methotrexate C rugs used to treat gout e.g. probenecid, allopurinol, sulfinpyrazone D ome other antibiotics (e.g. neomycin and tetracyclines can reduce the effect of amoxicillin) S ral typhoid vaccine (may not work if taken with amoxicillin) O Some penicillins may increase the effects of muscle relaxing drugs given as part of an anaesthetic for surgery. Tell the doctor you are taking amoxicillin if you need to have an anaesthetic. Having urine or blood tests If you or your child are having urine tests for diabetes (sugar in the urine) or blood tests for liver function, let the doctor know. Amoxicillin can affect the results of these tests. Pregnancy and breast-feeding Check with your doctor before you take this medicine if you are pregnant or breast-feeding. Important information about some of the ingredients in your medicine This medicinal product contains sorbitol. Sorbitol may cause stomach upset and diarrhoea. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 3. HOW TO TAKE YOUR MEDICINE Follow all directions given to you by your doctor or pharmacist. Their directions may differ from the information contained in this leaflet. Your doctor may advise you to take your medicine in a different way, so you should always follow your doctors advice about when and how to take your medicine and always read the label. Your pharmacist may be able to help if you are not sure. Try to give/take this medicine as part of the daily routine, for example at mealtimes. You may give/take amoxicillin before, with or after food, unless the label advises a specific time. You should make sure you/your child have several more drinks of water each day unless told otherwise by your doctor. Dosage: Adults (including the elderly): The total daily dose should not exceed 6g in total, given in divided doses. he usual dose for most infections is 5ml of 250mg/5ml to be taken 3 times a day. T For more serious infections the dose may be doubled to 10ml of 250mg/5ml 3 times a day he following doses may be given in the following conditions: T - Severe or recurrent chest infections: 3 g twice daily - Simple urinary tract infections: two 3g doses 10 to 12 hours between doses (short course) - Dental abscesses: two 3g doses given orally with 8 hours between doses - Gonorrhoea: a single 3g dose he following are the usual doses for preventing infection during dental procedures or other surgery: T - If a general anaesthetic is not used, 3g given orally one hour before surgery and another dose six hours later if necessary - If a general anaesthetic is used, 3g given orally four hours before anaesthesia and 3g six hours after the initial dose
AAAD1053 P541/2
Amoxicillin 125mg/5ml & 250mg/5ml 100ml PIL - UK
item no: print proof no:
AAAD1053 3
colours/plates: 1. Black 2. 3. 4. 5. 6. Non Printing Colours 1. 2. 3.
dimensions: 148x335 pharmacode: min pt size: 7pt
origination date: 05-01-12 originated by: approved for print/date revision date: revised by:
BW 11-04-12 BW
Technical Approval date sent: Marketing to send technically app. date:
supplier: Athlone Laboratories
Children: hildren weighing more than 40kg should be given the usual adult dosage C hildren under 40kg: C - he total daily dose should not exceed 3g in total, given in divided doses. T All doses are worked out depending on the childs body weight in kilograms. Your doctor will advise you how much medicine you should give to your baby or child. The usual dose is 40mg to 90mg for each kilogram of body weight a day, given in two or three divided doses. Patients with kidney problems If you have kidney problems, the dose prescribed by your doctor may be lower than the usual dose. If you take more of your medicine than you should If you (or somebody else) accidentally take too much of your medicine, speak to your doctor or go to your nearest hospital immediately. You should take this leaflet and any medicine you still have to show the doctor. Severe cases of nausea, vomiting and diarrhoea can be treated with rehydration therapy, by drinking fluids containing sodium, water and sugar to prevent dehydration. If you forget to take your medicine If you forget to take a dose, take it as soon as you remember, unless it is within an hour of your next dose, then carry on as before. Do not take a double dose to make up for the dose you have missed. If you stop taking your medicine Keep taking this medicine until it is finished or your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking the medicine, some bacteria may survive and cause the infection to come back, or your condition may re-occur or get worse. If you/your child, are still unwell after taking all the medicine, go and see your doctor. Never give/take more than the recommended dose each day. 4. POSSIBLE SIDE EFFECTS As with all medicines, some people may experience side effects with amoxicillin. If you or your child experience any of the following events STOP taking your medicine and tell your doctor or go to your nearest hospital immediately: ypersensitivity symptoms may include swollen face, mouth, lips, throat or tongue, reddening of the skin, breathing H problems, joint pain and fever. If these symptoms occur, STOP taking amoxicillin right away and tell your doctor. evere diarrhoea possibly with bleeding S llergic skin reactions with itching e.g. hives, nettle rash, blistering or peeling of the skin. If you start to itch or get a rash, A STOP taking amoxicillin and tell your doctor immediately. ellowing of the skin or the whites of your eyes (jaundice) Y ifficulty or discomfort in passing urine or having blood in the urine D The following events are less serious but you may wish to discuss them with your doctor or pharmacist if they become troublesome or last a long time. Common side effects (have been reported in more than 1 in 100 people) include: ausea (feeling sick) or diarrhoea N Uncommon side effects (have been reported in between 1 in 100 and 1 in 1000 people taking amoxicillin) include: omiting V Very rare side effects (have been reported in less than 1 in 10,000 people) include: hrush (a yeast infection of the vagina, mouth or skin folds). You can get treatment for thrush from your doctor or T pharmacist. ooth discolouration. The colour usually returns to normal with brushing. T lackening of the tongue B nflammation of the kidney I onvulsions may occur in patients on high doses or with kidney problems C xcessive body movements (hyperkinesia) or dizziness E eduction (reversible) in blood cell counts which may cause anaemia (may be characterised by feeling weak or lightR headed) or a longer time taken for blood to clot. Tell your doctor that you are taking amoxicillin if you are having blood tests. rystalluria, forming of crystals in the urine C arker coloured urine, faeces becoming paler D If you notice any side effects not mentioned in this leaflet please inform your doctor or pharmacist. 5. HOW TO STORE YOUR MEDICINE Do not use your medicine after the expiry date shown on the label. The expiry date to be followed is that included by the pharmacist after the medicine is made up for you. Store in original package. Keep the bottle tightly closed. Dry powder: Store in a dry place below 25oC. Reconstituted suspension: Store up to 14 days at 2oC-8oC in a refrigerator. Keep out of THE reach and sight of children. If your doctor tells you to stop your treatment, return any left over to the pharmacist. Only keep it if your doctor tells you to. 6. FURTHER INFORMATION What your medicine contains Amoxicillin Oral Suspension Sugar Free is available in two strengths containing either 125mg/5ml or 250mg/5ml of the active ingredient amoxicillin as amoxicillin trihydrate. The suspensions also contain sodium benzoate (E211), disodium edetate, sodium citrate dihydrate, orange bramble flavour, quinoline yellow (E104), citric acid monohydrate, colloidal anhydrous silica, xanthan gum, sorbitol (E420) and saccharin sodium. What your medicine looks like and contents of the pack The suspensions are pale yellow with a characteristic odour. Amoxicillin Oral Suspensions Sugar Free are available in bottles of 100ml. The product is made by: Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Ireland. The product licences are also held by Athlone Laboratories Limited. The Product is distributed by: Actavis, Barnstaple, EX32 8NS, UK PL 06453/0049 PL 06453/0050 Date of last revision: March 2012 Amoxicillin 125mg/5ml Oral Suspension Sugar Free Amoxicillin 250mg/5ml Oral Suspension Sugar Free
AAAD1053 P541/2
Actavis, Barnstaple, EX32 8NS, UK
Amoxicillin 125mg/5ml & 250mg/5ml 100ml PIL - UK
item no: print proof no:
AAAD1053 3
colours/plates: 1. Black 2. 3. 4. 5. 6. Non Printing Colours 1. 2. 3.
dimensions: 148x335 pharmacode: min pt size: 7pt
origination date: 05-01-12 originated by: approved for print/date revision date: revised by:
BW 11-04-12 BW
Technical Approval date sent: Marketing to send technically app. date:
supplier: Athlone Laboratories
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
