Phenoxymethylpenicillin 125mg/5ml Granules For Oral Solution
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PATIENT INFORMATION LEAFLET
PHENOXYMETHYLPENICILLIN
I25mg/5ml Granules for Oral Solution
Please read all of this leaflet carefully before you start taking this medicine.
Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What this medicine is and what it is used for
2. Before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Further information
1. What this medicine is and what it is used for
This medicine belongs to the penicillin group of antibiotics. Phenoxymethylpenicillin is an antibacterial drug used in the treatment of mild to moderately severe infections such as chest and throat infections, skin and soft tissue infections, infections of the mouth, gums and teeth, scarlet fever (characterised by high fever, sore throat and skin rashes), and mild erysipelas (disease marked by red skin eruptions, chills and fever). Also used in the prevention of rheumatic fever and chorea (a group of disorders characterised by brief rapid involuntary movements of limbs, face, trunk and head).
2. Before you take this medicine
Do not take this medicine if:
• you are allergic to any penicillin or any of the other ingredients listed (see section 6).
Check with your doctor before taking this medicine if:
• you have a history of allergic reactions to penicillins, cephalosporins or other allergy causing agents
• you are suffering from severe illness, nausea, vomiting, stomach bloating/cramping or heart problems
• you have impaired kidney function.
Taking other medicines:
Check with your doctor or pharmacist before taking this medicine if you are taking other medicines, including any that you can buy without a prescription. This is important if you
are taking other medicines, especially:
• probenecid - used for treatment of gout
• guar gum - used in diabetes
• birth control pills containing oestrogen. This medicine may stop the pill from working properly, therefore, you should use additional means of birth control whilst taking this medicine and for a full cycle afterwards.
Pregnancy and breastfeeding
Check with your doctor before taking this medicine if you are pregnant or breastfeeding. This medicine may be present in breast milk and can cause an allergic reaction in the infant.
Important information about some of the ingredients of this medicine
Each 5ml of this medicine contains 2.61g of sucrose, this should be taken into account in patients with diabetes mellitus. Also if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains E124 which may cause allergic reactions.
3. How to take this medicine
For oral use. Shake the bottle well before use. Take the medicine half an hour before or at least 3 hours after a meal. The dose will be different for different medical conditions and patients. Take the medicine as directed by your doctor or pharmacist. The usual doses are as follows: Adults (including the elderly): 125 - 500mg (one to four 5ml spoonfuls), every 4 to 6 hours. For long-term preventative treatment of rheumatic fever, the dose is 125mg (one 5ml spoonful), twice a day. The dose will be reduced if you have kidney problems.
Children, up to 1 year of age: 62.5mg (2.5ml/half a 5ml spoonful) every 6 hours.
Children 1 to 5 years of age: 125mg (one 5ml spoonful), every 6 hours.
Children 6 to 12 years of age: 250mg (two 5ml spoonfuls), every 6 hours.
In patients with bacterial infection (such as streptococcal infection), treatment is continued at the full dosage for 10 days to minimise complications.
The pharmacist’s label will tell you how much to take and how often. If you are not sure about anything ask your doctor or pharmacist. You should always follow your doctor’s advice about when and how to take your medicine and always read the label.
It is important to finish your prescribed course of this medicine. If you stop taking your medicine too soon, your infection may come back.
If you have taken too much medicine:
Contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining oral solution and the container so that the medicine can be identified.
If you miss a dose of this medicine:
Take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule. DO NOT DOUBLE THE DOSES.
4. Possible side effects
Some people may have side effects when taking this medicine. If you have any unwanted side effects you should seek advice from your doctor, pharmacist or healthcare professional. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.
If you develop any of the allergic reactions listed below - IMMEDIATELY STOP taking your medicine and contact your doctor or go to the nearest hospital.
• swelling of the throat and severe allergic reaction (symptoms are itchy, red or swollen skin, wheeziness, shortness of breath, swelling of the face, lips or tongue and in severe cases collapse). Sometimes fever and eosinophilia (condition in which there are increased number of white blood cells) are the only side-effects seen
• skin eruptions including nettle rash/hives (urticaria) and itching
• serum sickness (symptoms are feeling of coldness, fever, swelling of the body, joint pains, extreme exhaustion).
Tell your doctor or pharmacist if you notice any of the side effects in the following sections:
The side effects commonly seen are:
• nausea, vomiting, stomach pain, heartburn, diarrhoea and black hairy tongue.
Side effects rarely seen
• a reduction in the number of blood cells and platelets (symptoms can be bleeding under the skin and easier bruising)
• neuropathy (a disease affecting the nerves).
These usually occur with high doses of injected penicillin.
You may develop a yeast/fungal infection if you have been taking this medicine for a long period.
5. How to store this medicine
Store this medicine in a refrigerator (2-8°C). Keep the bottle tightly closed. Use within 7 days of preparation.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
Do not take the medicine if the expiry date on the label has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal.
6. Further information Ingredients:
Each 5ml of oral solution contains 125mg of phenoxymethylpenicillin (as potassium salt) as the active ingredient.
It also contains sucrose, saccharin sodium, ponceau 4R (E124) and strawberry flavour.
What the medicine looks like:
Phenoxymethylpenicillin Oral Solution is a clear pink solution with an odour of strawberry.
This medicine is available in a pack size of 100ml.
Who makes this medicine and holds the product licence:
Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3eD Date leaflet prepared: July 2012 If you would like this leaflet in a different format please contact the licence holder at the above address.