PATIENT INFORMATION LEAFLET(FLAT PIL) - Athlone Laboratories
PATIENT INFORMATION LEAFLET(FLAT PIL) - Athlone Laboratories
PATIENT INFORMATION LEAFLET(FLAT PIL) - Athlone Laboratories
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<strong>PATIENT</strong> <strong>INFORMATION</strong> <strong>LEAFLET</strong>(<strong>FLAT</strong> <strong>PIL</strong>)<br />
Kopen Sugar Free<br />
125mg/5ml and 250mg/5ml Powder for Oral Solution<br />
Phenoxymethylpenicillin<br />
Please read this leaflet carefully before you start to take your medicine. If you do not understand it or<br />
you want to know more, ask your doctor or pharmacist. Keep the leaflet, you may want to read it again.<br />
WHAT IS YOUR MEDICINE?<br />
The name of your medicine is KOPEN Sugar Free Powder for Oral Solution. It is available as an off<br />
white powder for reconstitution. The powder for reconstitution is prepared by the pharmacist before<br />
dispensing by adding water to the powder to give 100ml of oral solution.<br />
The reconstituted oral solution appears as a clear orange solution with an orange odour and flavour.<br />
Each 5ml spoonful of oral solution contains 125mg or 250mg of phenoxymethylpenicillin as<br />
phenoxymethylpenicillin potassium. It also contains sodium benzoate (E211), saccharin sodium, trusil<br />
orange flavour, orange colour (containing Sunset yellow E110 and Ponceau 4R E124), sorbitol and<br />
ammonium glycyrrhizate.<br />
Phenoxymethylpenicillin, the active ingredient, is an antibiotic used to kill bacteria, which cause<br />
infections in your body.<br />
WHO HAS MADE YOUR MEDICINE?<br />
KOPEN Sugar Free Powder for Oral Solution is manufactured by <strong>Athlone</strong> <strong>Laboratories</strong> Limited,<br />
Ballymurray, Co. Roscommon, Ireland. The product authorisations are also held by <strong>Athlone</strong><br />
<strong>Laboratories</strong> Limited, Ballymurray, Co. Roscommon, Ireland.<br />
WHAT IS YOUR MEDICINE USED FOR?<br />
Your medicine is used to treat bacterial infections.<br />
Before taking your medicine....<br />
Before you take KOPEN Sugar Free Powder for Oral Solution, please read the following questions:<br />
Have you ever had a bad reaction or allergic reaction to any phenoxymethylpenicillin-type antibiotic or<br />
any of the ingredients contained in this medicine listed above?<br />
Are you pregnant or trying to become pregnant?<br />
Are you breast feeding?<br />
Do you suffer from any kidney problems?<br />
If the answer is yes to any of these questions, you must tell your doctor before taking this medicine.<br />
The 125mg/5ml product and the 250mg/5ml product both contain 16g of sorbitol. When taken<br />
according to the dosage recommendations each dose supplies up to 0.8g of sorbitol. If you have been<br />
told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this<br />
medicinal product. Unsuitable in hereditary fructose intolerance. Can cause stomach upset and<br />
diarrhoea.<br />
Colours E110 and E124 may cause allergic reactions.<br />
ARE YOU TAKING ANY OTHER MEDICINES?
Your medicine may interfere with other medicines that you may be taking such as probenecid which is<br />
used to treat gout. Your doctor will advise you about this.<br />
You should also mention to your doctor or pharmacist any other medicines that you are taking,<br />
including any that you can buy without prescription.<br />
HOW SHOULD YOU TAKE YOUR MEDICINE?<br />
KOPEN Sugar Free Powder for Oral Solution should be given in divided doses (3 to 4 times a day) and<br />
preferably half an hour before meals.<br />
The following dosage schedule applies to KOPEN Sugar Free Powder for Oral Solution:<br />
ADULTS AND CHILDREN OVER 5 YEARS: 250mg to 500mg every six hours.<br />
CHILDREN: 1 - 5 years; 125mg every six hours. The usual total daily dosage is 500mg in divided<br />
doses.<br />
INFANTS (UP TO 1 YEAR): 62.5 mg every 6 hours.<br />
ELDERLY: As for adults.<br />
NOTE;<br />
Your doctor may advise you to take your medicine in a different way, so you should always follow<br />
your doctor's advice about when and how to take your medicine and always read the label. Your<br />
pharmacist may be able to help if you are not sure.<br />
If you do forget to take a dose of your medicine at the correct time, take it as soon as you remember,<br />
then carry on as before.<br />
If you accidentally take too much medicine, contact your doctor or pharmacist who will recommend<br />
what action you should take.<br />
REMEMBER:<br />
Keep taking this medicine until your doctor tells you to stop. Do not stop taking it just because you feel<br />
better. If you stop taking the medicine, your condition may re-occur or get worse.<br />
WHAT ABOUT SIDE EFFECTS?<br />
Like all medicines, KOPEN Sugar Free Powder for Oral Solution may cause you some problems. Some<br />
patients find that they suffer from an upset stomach, diarrhoea or rarely severe bloody diarrhoea<br />
(pseudomembraneous colitis) or colouration of the tongue. If you suffer badly from any of these you<br />
should contact your doctor.<br />
If you suffer from any of the following conditions discontinue your medicine immediately and contact<br />
your doctor as they may be signs of an allergy which may be fatal: skin rashes, itching or any other<br />
skin trouble, swelling, joint pain or fever, breathing difficulties and swelling of the airways which may<br />
lead to heart failure (anaphylaxis).<br />
Some people may get thrush (a yeast infection of the vagina, mouth or skin folds) during or<br />
after treatment with antibiotics. You can get treatment for thrush from your doctor or<br />
pharmacist.<br />
This medicine very rarely may affect your liver, kidneys or blood particularly in patients who<br />
suffer with renal impairment or who are taking large doses. Your doctor or pharmacist will<br />
be able to help you if you have any questions.<br />
Prolonged use of antibiotics may lead to a tolerance and growth of infection
If you have any other problems and think that your medicine may be causing them, tell your doctor or<br />
pharmacist.<br />
HOW SHOULD YOU STORE YOUR MEDICINE?<br />
Do not use your medicine after the expiry date shown on the label.<br />
KOPEN Sugar Free Powder for Oral Solution should be stored as follows:<br />
Dry powder: Store below 25 o C. Store bottle in the original carton. Keep the bottle tightly closed in<br />
order to protect from moisture.<br />
Reconstituted solution: Store for 7 days at 2 o C-8 o C in a refrigerator. Store in the original container.<br />
Keep the bottle tightly closed. Discard after 7 days.<br />
Keep all medicines out of the reach and sight of children. Your medicines could harm them.<br />
If your doctor tells you to stop your treatment, return any left over to the pharmacist. Only keep it if<br />
your doctor tells you to.<br />
FURTHER <strong>INFORMATION</strong><br />
A REMINDER: Remember, this medicine is for you. Only a doctor can prescribe it for you.<br />
Never give it to others. It may harm them even if their symptoms are the same as yours.<br />
This leaflet is a summary. It does not contain all the information about your medicine. If you have any<br />
further questions or are not sure about anything, ask your doctor or pharmacist, who have access to<br />
additional information.<br />
Date of revision: July 2011
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