CP.PEN.JNT.So.Sp.AT.V3P2 PATIENT INFORMATION LEAFLET Adults including the elderly and children over Blood P713/4 12 years • problems with blood clotting (unusual bleeding PHENOXYMETHYLPENICILLIN 250mg to 500mg every six hours (one to two 5ml or bruising) 125mg/5ml AND 250mg/5ml ORAL SOLUTION spoonfuls of 250mg/5ml) • infections or fever (may be caused by low Prophylactic use: 250mg twice daily is white blood cells) Read all of this leaflet carefully before you start taking this medicine because it contains recommended for long term prophylaxis of • anaemia (may cause lack of energy or information for you. (one 5ml spoonful of 250mg/5ml) tiredness) • Keep this leaflet. You may need to read it again. Kidney • If you have further questions, ask your doctor or pharmacist (chemist). Children • kidney problems, which might cause blood in • This medicine has been prescribed for you only. Do not pass it on to others. It may harm Infants (up to 1 year): 62.5mg every six hours the urine or reduced amounts of urine them, even if their signs of illness are the same as yours. 1 - 5 years: 125mg every six hours (one 5ml Liver • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side spoonful of 125mg/5ml) • jaundice - yellowing of skin or whites of the eyes effects not listed in this leaflet. See section 4. 6 - 12 years: 250mg every six hours (one 5ml spoonful of 250mg/5ml or two 5ml spoonfuls of If any of the side effects get serious, or if you WHAT IS IN THIS LEAFLET 125mg/5ml) notice any side effect not listed in this leaflet, you 1. What Phenoxymethylpenicillin Oral Solution is and what it is used for should contact your doctor or pharmacist. 2. What you need to know before you take Phenoxymethylpenicillin Oral Solution When to take your medicine 3. How to take Phenoxymethylpenicillin Oral Solution Phenoxymethylpenicillin should be given in Reporting of side effects 4. Possible side effects divided doses (4 times a day) or as directed by If you get any side effects, talk to your doctor or 5. How to store Phenoxymethylpenicillin Oral Solution your doctor. Take your medicine on an empty pharmacist or nurse. This includes any possible 6. Contents of the pack and other information stomach either half an hour before a meal or at side effects not listed in this leaflet. You can also least three hours after a meal. report side effects directly via the yellow card scheme at www.mhra.gov.uk/yellowcard or WHAT PHENOXYMETHYLPENICILLIN • Oral Typhoid vaccine ( can stop this How long to take your medicine for search for MHRA Yellow Card in the Google Play ORAL SOLUTION IS AND WHAT IT IS from working) Keep taking this medicine until your doctor tells or Apple App Store. By reporting side effects you USED FOR • Some other (Tetracycline, you to stop. Do not stop taking it just because can help provide more information on the safety 1. Erythromycin, Chloramphenicol and Neomycin) you feel better. of this medicine. The name of your medicine is Phenoxymethylpenicillin 125mg/5ml and Taking with food and drink If you take more Phenoxymethylpenicillin HOW TO STORE 250mg/5ml Oral Solution. It is available in two Take your medicine on an empty stomach either Oral Solution than you should PHENOXYMETHYLPENICILLIN ORAL strengths as a powder for reconstitution. The half an hour before a meal or at least three hours If you accidentally take too much SOLUTION powder for reconstitution is prepared by the after a meal. Guar gum can cause reduced Phenoxymethylpenicillin Oral Solution, contact 5. pharmacist before dispensing by adding water to absorption of phenoxymethylpenicillin. Your your doctor or pharmacist who will recommend KEEP OUT OF THE SIGHT AND REACH OF the powder to give 100ml of oral solution. The doctor will advise you about this. what action you should take. CHILDREN strength you are given will be decided by your doctor. and breast-feeding If you forget to take Phenoxymethylpenicillin Expiry Date Phenoxymethylpenicillin, the active ingredient, is If you are pregnant or breast-feeding, think you Oral Solution Do not use your medicine after the expiry date an , which belongs to a group of may be pregnant or are planning to have a baby, If you do forget to take a dose of stated on the label. The expiry date refers to the medicines called , which are used to ask your doctor or pharmacist for advice before Phenoxymethylpenicillin Oral Solution at the last day of the month. kill bacteria that cause infections in your body. taking this medicine. correct time, take it as soon as you remember, then carry on as before. Do not take a double Storage Conditions Your medicine is used to: Phenoxymethylpenicillin Oral Solution dose to make up for a forgotten dose. Store in the original package. Keep the bottle • treat bacterial infections of the ear, throat, contains Sucrose, , Sodium tightly closed. respiratory tract, skin and soft tissues benzoate, Sodium, E124 & E110 If you stop taking your medicine Dry powder: Store in a dry place below 25°C. • prevent infections such as rheumatic fever or Sucrose If you stop taking the medicine before your Protect from light. chorea recurring. Phenoxymethylpenicillin 125mg/5ml Oral doctor tells you to stop, your condition may Reconstituted solution: Store up to 7 days in a Phenoxymethylpenicillin is indicated for Solution contains 2.80g of sucrose per 5ml dose. re-occur or get worse. If you have any further refrigerator. prophylaxis against: Phenoxymethylpenicillin 250mg/5ml Oral questions on the use of this medicine, ask your Do not throw away any medicines via • Pneumococcal Infection (e.g. in asplenia and Solution contains 2.89g of sucrose per 5ml dose. doctor or pharmacist or nurse. wastewater or household waste. Ask your in patients with ). • This should be taken into account in patients pharmacist how to throw away medicines you no with diabetes mellitus. May be harmful to teeth. longer use. These measures will help protect the • If you have been told by your doctor that you 4. POSSIBLE SIDE EFFECTS environment. WHAT YOU NEED TO KNOW BEFORE have an intolerance to some sugars, contact If your doctor tells you to stop your treatment, YOU TAKE your doctor before taking this medicinal product. return any left over to the pharmacist. Only keep PHENOXYMETHYLPENICILLIN Potassium Like all medicines this medicine can cause side it if your doctor tells you to. ORAL SOLUTION Phenoxymethylpenicillin 125mg/5ml Oral Solution effects, although not everybody gets them. 2. contains 14.2mg of potassium per 5ml dose. Do not take Phenoxymethylpenicillin Oral Phenoxymethylpenicillin 250mg/5ml Oral Solution STOP taking the medicine and tell your CONTENTS OF THE PACK AND Solution if: contains 28.4mg of potassium per 5ml dose. doctor IMMEDIATELY if you experience any of 6. OTHER INFORMATION • You ever had a bad reaction or allergic • This should be taken into account by patients the following: • an allergic reaction - symptoms may include: reaction to any Phenoxymethylpenicillin or with reduced kidney function or patients on a What Phenoxymethylpenicillin Oral Solution shortness of breath, skin rash or itching, hives, -type antibiotic. An example of a controlled potassium diet. contains Cephalosporin-type antibiotic is . Sodium benzoate swelling of the skin (especially of the lips, face Each 5ml spoonful of oral solution contains • You are allergic to any of the ingredients • Sodium benzoate may increase jaundice or tongue), chills or fever, painful joints 125mg or 250mg of phenoxymethylpenicillin as • contained in this medicine. (yellowing of the skin and eyes) in newborn severe peeling/blistering of the skin phenoxymethylpenicillin potassium. It also • • You are taking methotrexate (a cytotoxic drug babies (up to 4 weeks old). This medicine seizures contains sodium benzoate, saccharin sodium, • used to treat cancers and psoriasis) contains 16 mg sodium benzoate in each 5ml profuse watery diarrhoea usually with blood trusil orange flavour, orange colour (containing dose which is equivalent to 320mg/100ml bottle. and mucus, stomach pain and fever sunset yellow (E110) and ponceau 4R (E124)) Take special care with your medicine if: Sodium and sucrose. • You suffer from any stomach problems, e.g. • This medicine contains less than 1 mmol The following are the more common effects. vomiting sodium (23mg) per 5 ml dose, that is to say Tell your doctor or pharmacist if they worry What Phenoxymethylpenicillin Oral Solution • You suffer from any kidney problems essentially “sodium free”. you. looks like and contents of the pack • You suffer from and/or asthma E124 & E110 • stomach pain or cramps, (feeling sick), Dry powder: an off white pale pink granular Ponceau 4R (E124) and sunset yellow (E110) vomiting (being sick) and diarrhoea powder. Taking other medicines may cause allergic type reactions. Reconstituted solution: a clear orange solution Your medicine may interfere with other The following are other possible side effects: with an orange odour and flavour. medicines that you may be taking. Please inform HOW TO TAKE Mouth Phenoxymethylpenicillin Oral Solution is your doctor or pharmacist if you are taking, or PHENOXYMETHYLPENICILLIN ORAL • sore mouth available in size 100ml on reconstitution. have recently taken any other medicines even SOLUTION • black hairy tongue those not prescribed. 3. • sore throats The product licence holder and manufacturer How much of your medicine to take • teeth may appear stained, usually returning to is: Athlone Laboratories Limited, Talk to your doctor or pharmacist or nurse before Always take this medicine exactly as your doctor normal with brushing (this has been reported in Ballymurray, Co. Roscommon, Ireland. taking: or pharmacist has told you, check with your children). PL 06453/0024 and PL 06453/0025 • Anticoagulants (e.g. warfarin - to prevent doctor or pharmacist if you are not sure. Skin • pins and needles or numbness blood clots) The dose will depend on the patient and will be This leaflet was last revised January 2021 • Sulfinpyrazone or Probenecid (medicines decided by your doctor. The usual doses for CP.PEN.JNT.So.Sp.AT.V3P2 used to treat gout) each age group are as follows: P713/4

Customer: KENT Originated by: DOB (AWG) Colours Product: Phenoxymethylpenicillin Oral Solution JNT PIL Sugared, Spoon 148mm x 280mm Dimensions: Pantone Blue Item Code: CP.PEN.JNT.So.Sp.AT.V3P2 280 Proof No and Date: 2 15/03/2021 Revision: Safety update ARTWORK FOR SUBMISSION Supersedes: CP.PEN.JNT.So.Sp.AT.V3P1