Patient leaflet - PHENOXYMETHYLPENICILLIN 125 MG / 5ML GRANULES FOR ORAL SOLUTION
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you develop any of the 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
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Polhampton Lane, Overton, Hampshire RG25 3ED
breath, swelling of the face, lips or tongue and in severe cases collapse)
- skin eruptions including nettle rash/hives (urticaria), itching or severe peeling of the skin
- serum sickness (symptoms are feeling of coldness, fever, swelling of the body, joint pains, extreme exhaustion)
- convulsions (fits)
- severe diarrhoea usually with blood or mucus, stomach pain and fever.
Tell your doctor or pharmacist if you notice any of the side effects in the following sections:
Common: may affect up to 1 in 10 people
- nausea, vomiting, stomach pain, diarrhoea.
Rare: may affect up to 1 in 1,000 people
- black hairy tongue, sore mouth.
Very rare: may affect up to 1 in 10,000 people
- a change in the number of white or red blood cells and platelets (symptoms can be bleeding under the skin and easier bruising, pale yellow skin, weakness or breathlessness, or make infections more likely)
- yellowing of the skin or whites of the eyes, pale stools and dark urine, loss of appetite, stomach discomfort caused by liver or blood problems
- inflammation of the kidney which can cause swollen ankles or high blood pressure.
Not known: frequency cannot be estimated from the available data
- problems with blood clotting
- tingling or numbness
- kidney disease.
You may develop a yeast/fungal infection if you have been taking this medicine for a long period.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Phenoxymethylpenicillin Oral Solution
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Dry granules: Do not store above 25°C. Keep the bottle tightly closed. Oral Solution: Store in a refrigerator (2 – 8°C). Keep the bottle tightly
closed. Use within 7 days of preparation.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Phenoxymethylpenicillin Oral Solution contains
Each 5ml of oral solution contains 125mg of phenoxymethylpenicillin (as potassium salt) as the active ingredient.
The other ingredients are sucrose, saccharin sodium, ponceau 4R (E124) and strawberry flavour.
What Phenoxymethylpenicillin Oral Solution looks like and contents of the pack
Phenoxymethylpenicillin Oral Solution is a clear pink solution with an odour of strawberry.
This medicine is available in a pack size of 100ml.
Marketing Authorisation Holder and Manufacturer
Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED, UK.
This leaflet was last revised in July 2017
If you would like this leaflet in a different format please contact the licence holder at the above address.
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| PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PHENOXYMETHYLPENICILLIN 125mg/5ml Granules for Oral Solution Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. – Keep this leaflet. You may need to read it again. – If you have any further questions, ask your doctor, pharmacist or nurse. – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. – If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4 | What is in this leaflet: 1. What Phenoxymethylpenicillin Oral Solution is and what it is used for 2. What you need to know before you take Phenoxymethylpenicillin Oral Solution
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1. What Phenoxymethylpenicillin Oral Solution 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. What you need to know before you take Phenoxymethylpenicillin Oral Solution
Do not take Phenoxymethylpenicillin Oral Solution if:
- you have a history of allergic reactions to any penicillins, cephalosporins or other allergy causing agents
- you are allergic to phenoxymethylpenicillin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before taking Phenoxymethylpenicillin Oral Solution if:
- you are suffering from severe illness, nausea, vomiting, stomach
bloating/cramping or difficulty swallowing
- you suffer from allergies and/or asthma
- you have impaired kidney function.
Other medicines and Phenoxymethylpenicillin Oral Solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially:
- antibacterial medicines e.g. tetracycline, erythromycin, neomycin, chloramphenicol
- probenecid or sulfinpyrazone – used for treatment of gout
- guar gum – used in diabetes
- anticoagulants e.g. warfarin (to prevent blood clots)
- methotrexate (to treat cancer or psoriasis)
- oral typhoid vaccine.
are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
This medicine may be present in breast milk and can cause an allergic reaction in the infant.
Phenoxymethylpenicillin Oral Solution contains sucrose and E124
Each 5ml of this medicine contains 2.61g of sucrose, this should be taken into account in patients with diabetes mellitus. May be harmful to the teeth. 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 Phenoxymethylpenicillin Oral Solution
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.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
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.
If you take more Phenoxymethyipenicillin Oral Solution than you should
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 forget to take Phenoxymethylpenicillin Oral Solution
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 take a double dose to make up for a forgotten dose.
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Booklet Placement
To the Patient: Shake well before each use. Store ri a refrigerator. Keep the bottle tightly closed. Use within 7 days of dispensrg. Complete the prescribed course of treatment Dispose of any unused medicine. To the Pharmacist Do not store above 25°C. Keep the bottle tightly closed. To dispense, add 65ml of water and shake welirtil allthe powder is cissolved.
For oral administration, as directed by the doctor.
For further information, see enclosed Patient Information Leaflet. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN | PQM| PL 20416/0203
Width 89 MM
Qrescent Pharma^. PHENOXYMETHYL PENICILLIN 125me/5ml
Granules for
Oral Solution
When prepared as directed, each 5ml contains phenoxymethyipenicillin 125mg (as potassium salt). Also contains sucrose and colour E124 (see leaflet for further information).
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