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PHENOXYMETHYLPENICILLIN 125MG/5ML SUGAR FREE ORAL SOLUTION

Active substance(s): PHENOXYMETHYLPENICILLIN POTASSIUM

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PACKAGE LEAFLET INFORMATION FOR THE PATIENT

PHENOXYMETHYLPENICILLIN 125mg/5ml
SUGAR FREE ORAL SOLUTION
PHENOXYMETHYLPENICILLIN 250mg/5ml
SUGAR FREE ORAL SOLUTION
(phenoxymethylpenicillin potassium)
This medicine is available as any of the above names but will be
referred to as Phenoxymethylpenicillin Sugar Free Oral Solution
throughout the following leaflet.
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 further questions, please ask your doctor or
pharmacist (chemist).
• 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 of the side effects, talk to your doctor or
pharmacist, this includes possible side effects not listed
in this leaflet. See section 4.
IN THIS LEAFLET
1. What Phenoxymethylpenicillin Sugar Free Oral Solution is
and what it is used for
2. What you need to know before you take
Phenoxymethylpenicillin Sugar Free Oral Solution
3. How to take Phenoxymethylpenicillin Sugar Free Oral
Solution
4. Possible side effects
5. How to store Phenoxymethylpenicillin Sugar Free Oral
Solution
6. Contents of the pack and other information
1. WHAT PHENOXYMETHYLPENICILLIN SUGAR FREE
ORAL SOLUTION IS AND WHAT IT IS USED FOR
Phenoxymethylpenicillin Sugar Free Oral Solution is available in
two strengths as a powder for reconstitution. The powder for
reconstitution is prepared by the pharmacist before dispensing
by adding water to the powder to give 100ml of oral solution. The
strength you are given will be decided by your doctor.
Phenoxymethylpenicillin, the active ingredient, is an antibiotic,
which belongs to a group of medicines called penicillins, which
are used to kill bacteria that cause infections in your body.
Your medicine is used to:
• treat bacterial infections of the ear, throat, respiratory tract,
skin and soft tissues
• prevent infections such as rheumatic fever or chorea recurring
• prevent pneumococcal infection (e.g. in asplenia and in
patients with sickle cell disease).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PHENOXYMETHYLPENICILLIN SUGAR FREE ORAL
SOLUTION
Do not take Phenoxymethylpenicillin Sugar Free Oral
Solution if:
• You have ever had a bad reaction or allergic reaction to any
penicillin-type antibiotic including cephalosporin drugs
• You have ever had a skin rash or swelling of the face or neck
or shortness of breath when taking any antibiotic
• You are allergic to any of the ingredients contained in this
medicine
Warnings and precautions:
• You suffer from any stomach problems, e.g. vomiting
• You suffer from any kidney problems
• You suffer from allergies and/or asthma
Other medicines and Phenoxymethylpenicillin Sugar Free
Oral Solution:
Your medicine may interfere with other medicines that you may
be taking. Please inform your doctor or pharmacist if you are
taking, or have recently taken, any other medicines even those
not prescribed, including herbal and homeopathic remedies.

Talk to your doctor or pharmacist if you are taking:
• Methotrexate (a drug used to treat cancers and psoriasis)
• Some other antibiotics (tetracyclines, erythromycin, neomycin
and chloramphenicol have been reported to reduce the effect
of penicillin)
• Sulfinpyrazone or probenecid (medicines used to treat gout)
• Anti-coagulants (e.g. warfarin - to prevent blood clots)
• Oral typhoid vaccine (penicillin can stop this from working)
Phenoxymethylpenicillin Sugar Free Oral Solution with food
and drink
Guar gum (used as a thickening agent and normally found in
puddings and ice-cream and benefiber) can reduce the
absorption of phenoxymethylpenicillin.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine.
Driving and using machines
This medicine should not affect your ability to drive or to use
machinery.
Important information about some of the ingredients in your
medicine
Ponceau 4R (E124) and sunset yellow (E110)
Can cause allergic type reactions including asthma. Such
allergies are common in those people who are allergic to aspirin.
Sorbitol (E420)
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 PHENOXYMETHYLPENICILLIN SUGAR
FREE ORAL SOLUTION
Follow all directions given to you by your doctor or pharmacist.
Their directions may differ from the information contained in this
leaflet. The pharmacist’s label should tell you how much to take
and how often. If it does not, or you are not sure, check with your
doctor or pharmacist.
How much of your medicine to take
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 dose will depend on the patient and will be decided by your
doctor.
The usual doses for each age group are as follows:
Adults including the elderly and children over 12 years
250mg to 500mg every six hours (one to two 5ml spoonfuls of
250mg/5ml)
Children
Infants (up to 1 year): 62.5mg every 6 hours
1- 5 years: 125mg every six hours (one 5ml spoonful of
125mg/5ml)
6 – 12 years: 250mg every six hours (one 5ml spoonful of
250mg/5ml or two 5ml spoonfuls of 125 mg/5ml)
For preventing the recurrence of rheumatic fever or chorea:
The usual dose is 250mg twice daily on a continuing basis.
For the prevention of infection in patients without a spleen
or patients with sickle cell disease:
For adults and children over 12 years, the dosage is 500mg
every 12 hours.
For children aged between 6 and 12 years, the dosage is 250mg
every 12 hours and for children below 5 years, the dosage is
125mg every 12 hours.
For children over 12 years the dose should not exceed the
maximum adult doses.
For elderly, the dosage is as for the adult. The dosage should be
lowered in poor renal function.

Patients with kidney and liver problems
• If you have kidney problems the dose might be changed by
your doctor.
• Dosage might be changed by your doctor if you have liver
problems along with kidney problem.
When to take your medicine
Phenoxymethylpenicillin Sugar Free Oral Solution is usually
prescribed to be taken four times a day. It is best to take it as
evenly spaced as possible.
Take this medicine when your stomach is empty. This means at
least 30mins before food and preferably not less than two hours
after food.
If you take more Phenoxymethylpenicillin Sugar Free Oral
Solution than you should
If you accidentally take too much medicine, contact your doctor
or pharmacist who will recommend what action you should take.
If you forget to take Phenoxymethylpenicillin Sugar Free
Oral Solution
If you forget to take a dose, take it as soon as you remember,
unless it is almost time for your next dose. 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 your doctor tells you to stop. Do
not stop taking it just because you feel better. If you stop taking
the medicine, your condition may re-occur or get worse.
4. POSSIBLE SIDE EFFECTS
Like all medicines phenoxymethylpenicillin can cause side
effects although not everybody gets them.
STOP taking the medicine and tell your doctor
IMMEDIATELY if you experience any of the following:
• an allergic reaction - symptoms may include: shortness of
breath, skin rash or itching, hives, swelling of the skin
(especially of the lips, face or tongue), chills or fever, painful
joints
• severe peeling/blistering of the skin
• Serum sickness-like reactions (characterised by fever, chills,
joint pains and oedema)
• seizures
• profuse watery diarrhoea usually with blood and mucus,
stomach pain and fever
Tell your doctor or pharmacist if you notice any of the
following and they worry you.
• stomach pain or cramps, nausea (feeling sick), vomiting (being
sick) and diarrhoea
• sore mouth
• hepatitis
• convulsions
• black hairy tongue
• pins and needles or numbness
• sore throats, infections, or fever (may be caused by low white
blood cells)
• problems with blood clotting (unusual bleeding or bruising)
• anaemia (may cause lack of energy or tiredness)
• kidney problems, which might cause blood in the urine or
reduced amounts of urine
• jaundice – yellowing of skin or whites of the eyes
If any of the side effects get serious, or if you notice any side
effect not listed in this leaflet, you should contact your doctor or
pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via
www.mhra.gov.uk/yellowcard. By reporting side effects you can
help provide more information on the safety of this medicine.

5. HOW TO STORE PHENOXYMETHYLPENICILLIN SUGAR
FREE ORAL SOLUTION
• Keep out of the sight and reach of children.
• Do not use your medicine after the expiry date shown on the
label. The expiry date refers to the last day of that month.
• Dry powder: Do not store above 25°C. Store in the original
container. Keep the container tightly closed. Protect from
moisture. Protect from light. Store in a dry place.
• Reconstituted solution: Store for 7 days at 2°C-8°C in a
refrigerator. Store in the original container. Keep the container
tightly closed.
• 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.
• 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.
• If your medicine appears to be discoloured or shows any other
signs of deterioration, please return it to your pharmacist who
will advise you further.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Phenoxymethylpenicillin Sugar Free Oral Solution
contains:
Powder for reconstitution:
• Phenoxymethylpenicillin 125mg/5ml Sugar Free Oral
Solution: Each 5ml of oral solution contains 125mg of
phenoxymethylpenicillin (as phenoxymethylpenicillin
potassium).
• Phenoxymethylpenicillin 250mg/5ml Sugar Free Oral
Solution: Each 5ml of oral solution contains 250mg of
phenoxymethylpenicillin (as phenoxymethylpenicillin
potassium).
Other ingredients: sodium benzoate, saccharin sodium, trusil
orange flavour, orange colour (containing sunset yellow (E110),
ponceau 4R (E124)), sorbitol (E420) and ammonium
glycyrrhizate.
What Phenoxymethylpenicillin Sugar Free Oral Solution
looks like and contents of the pack:
Phenoxymethylpenicillin Sugar Free Oral Solution is an off white,
granular powder for reconstitution. The reconstituted oral
solution is a clear orange solution with an orange odour and
flavour.
It is available in a plastic container with a child proof screw cap
and a 5ml plastic measuring spoon.
Phenoxymethylpenicillin Sugar Free Oral Solution is available as
a powder for reconstitution as 100ml of solution.
Manufactured by Athlone Laboratories Limited, Ballymurray, Co.
Roscommon, Ireland.
Procured from within the EU and repackaged by the Product
Licence holder: O.P.D. Laboratories Ltd., Unit 6 Colonial Way,
Watford, Herts WD24 4PR.
POM
PL 15814/1213
Phenoxymethylpenicillin 125mg/5ml Sugar Free Oral
Solution
PL 15814/1214
Phenoxymethylpenicillin 250mg/5ml Sugar Free Oral
Solution
Leaflet revision and issue date (Ref.): 01.06.2016.
To request a copy of this leaflet in Braille, large print or audio
please call 01923 332 796.

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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