Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Phenoxymethylpenicillin potassium may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
e Phenoxymethylpenicillin Powder for Oral Solution
3. How to take Phenoxymethylpenicillin Powder for Oral Solution 4. Possible side effects
5. How to store Phenoxymethylpenicillin Powder for Oral Solution
doctor or pharmacist. Their directions may
PHENOXYMETHYLPENICILLIN
differ from theinformation contained in this
POWDER FOR ORAL SOLUTION
eaflet.
Solution 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
Powder for Oral Solution if:
much to take and how often. If it does not, or
or get worse. If you have any further
You ever had a bad reaction or allergic
you are not sure, check with your doctor or
questions on the use of this medicine, ask
reaction to any Phenoxymethylpenicillin or
pharmacist.
your doctor or pharmacist.
Cephalosporin-type antibiotic. An example
How much of your medicine to take
of a Cephalosporin-type antibiotic is
Always take this medicine exactly as your
Cefradine.
doctor or pharmacist has told you. Check with
Like all medicines, this medicine can cause
your doctor or pharmacist if you are not sure.
side effects, although not everybody gets
The dose will depend on the patient and will
them.
when taking any antibiotic
be decided by your doctor.
STOP taking the medicine and tell your
You are allergic (hypersensitive) to
The usual doses for each age group are as
doctor IMMEDIATELY
Phenoxymethylpenicillin or any of the
follows:
any of the following:
other ingredients of this medicine (listed in
Adults including the elderly and children
Section 6)
over 12 years
include:
250mg to 500mg every six hours (one to two
shortness of breath, skin rash or itching,
5ml spoonfuls of 250mg/5ml)
hives, swelling of the skin (especially of
250mg twice daily is recommended for long
the lips, face or tongue), chills or fever,
term prevention of rheumatic fever (one 5ml
painful joints
spoonful of 250mg/5ml)
severe peeling/blistering of the skin
Children
Serum sickness-like reactions
Solution: Your medicine may interfere with other medicines that you may be taking. Please inform your doctor or pharmacist if you are
Infants (up to 1 year): 62.5mg every
(characterised by fever, chills, joint
taking, or have recently taken any other
6-12 years: 250mg every six hours (one 5m
if you experience
profuse watery diarrhoea usually with
The Bloc,
blood and mucus, stomach pain and fever
38 Springfield Way, Anlaby, Hull,
The usual dose is 250mg twice daily on a
The following are other possible side effects:
For preventing the recurrence of
Mouth
rheumatic fever or chorea: The usual dose is 250mg twice daily ona continuing basis.
either half an hour before a meal or at least
For children aged between 6 and 12 years,
HU10 6RJ, United Kingdom This leaflet was last revised in 07/2020.
sick), vomiting (being sick) and diarrhea
continuing basis.
dosage is 500mg every 12 hours.
Blood
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Flamingo Pharma (UK) Limited.
rheumatic fever or chorea:
Take your medicine on an empty stomach
Flamingo Pharma (UK) Ltd.
Manufacturer:
they worry you.
For adults and children over 12 years, the
Marketing Authorization Holder
Middlesex, HA1
For preventing the recurrence of
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polypropylene CR Cap.
11-15 Peterborough Road, Harrow,
effects. Tell your doctor or pharmacist if
cell disease:
250mg/5ml Powder for Oral Solution are
1st Floor, Kirkland House,
5ml spoonfuls of 125mg/5ml)
Phenoxymethylpenicillin Powder for Oral
Phenoxymethylpenicillin 125mg/5ml and
round bottle with White Round
The following are the more common
without a spleen or patients with sickle
Reconstituted solution: Slight opaque
reconstitution in the Translucent HDPE
spoonful of 250mg/5ml or two
Neomycin)
Powder: White to off white granular powder,
free from agglomerates or caking.
available in the size of 100ml on
spoonful of 125mg/5ml)
For the prevention of infection in patients
What Phenoxymethylpenicillin Powder
solution with orange odour.
pains and oedema)
Erythromycin, Chloramphenicol, and
Sodium (E954), Orange flavour, Refreshing
of the pack
You have ever had a skin rash or swelling
and psoriasis)
phenoxymethylpenicillin potassium.
Other ingredients: Sucrose, Saccharin
for Oral Solution looks like and contents
of the face or neck or shortness of breath
1-5 years: 125mg every six hours (one 5ml
phenoxymethylpenicillin as
flavour
6 hours
Active ingredient: Each 5ml of oral solution contains 125mg or 250mg of
Keep taking this medicine until your doctor
The pharmacist's label should tell you how
OF THE PACK AND
for Oral Solution contains:
Phenoxymethylpenicillin Powder for Oral
Do not take Phenoxymethylpenicillin
Talk to your doctor or pharmacist or nurse before taking:
6. CONTENTS
What Phenoxymethylpenicillin Powder
If you stop taking
ORAL SOLUTION
BEFORE YOU TAKE
medicines even those not prescribed.
measures will help protect the environment.
dose to make up for a forgotten dose.
Follow all directions given to you by your
Phenoxymethylpenicillin Powder for Oral
Only keep it if your doctor tells you to. Do not throw away any medicines via
you have an intolerance to some sugars,
without a spleen or patients with sickle cell
Other medicines and
return any left over to the pharmacist.
¢ You suffer from allergies and/or asthma
at 2°C-8°C in a refrigerator. If your doctor tells you to stop your treatment
easily.
prevention against:
e.g. vomiting
Reconstituted solution: Store up to 7 days
contains 2.17g of sucrose per 5ml dose.
Phenoxymethylpenicillin is indicated for
¢ You suffer from any kidney problems
date refers to the last day of that month. Dry powder: Store below 25°C, Store in the
enable the doctor to identify your medicine
movement disorder) recurring
Warnings and precautions ¢ You suffer from any stomach problems,
Do not use this medicine after the expiry date which is stated on the label. The expiry
250mg/5ml Powder for Oral Solution
or chorea (an abnormal involuntary
2. WHAT YOU NEED TO KNOW
FOR ORAL SOLUTION
original package.
Emergency Department even if there are no
Phenoxymethylpenicillin 125mg/5ml Powder
PHENOXYMETHYLPENICILLIN POWDER
s prepared by the pharmacist before
give 100ml of oral solution. The strength you
500 mm
children below 5 years, the dosage is 125mg
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Approved by
Regulatory
Marketing
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Driving and using machines
better.
ispensing by adding water to the powder to
This medicine should not affect your ability
If you take more Phenoxymethylpenicillin
to drive or to use machinery.
Powder for Oral Solution than you should
Phenoxymethylpenicillin Powder for Oral
If you accidently take too many doses, tell
Solution contains Sucrose and Sodium.
your doctor immediately or contact your
Sucrose
nearest Hospital casuality/accident and
are given will be decided by your doctor. Phenoxymethylpenicillin, the active
ngredient, is an antibiotic, which belongs to a group of medicines called penicillins, hich are used to kill bacteria that cause
signs of discomfort. Take your medicine in
for Oral Solution contains 2.31g of sucrose
nfections in your body.
its original packaging with you in order to
per 5ml dose. Phenoxymethylpenicillin
Your medicine is used to:
If you forget to take
wastewater.
Phenoxymethylpenicillin Powder for Oral
Ask your pharmacist how to throw away
Solution
contact your doctor before taking this
If you forget to take a dose, take it as soon
medicinal product.
as you remember, unless it is almost time
PHENOXYMETHYLPENICILLIN
disease).
POWDER
FOR
medicines you no longer use. These
for your next dose. Do not take a double
Peed
1e).O4
SOLUTION
three hours after a meal. Guar gum can
ek de
PENICILLIN POWDER
FOR ORAL
the eyes
dosage is 500mg every 12 hours.
If any of the side effects get serious, or if
For children aged between 6 and 12 years,
you notice any side effect not listed in this
the dosage is 250mg every 12 hours and for
leaflet, you should contact your doctor or
children below 5 years, the dosage is 125mg
pharmacist.
every 12 hours.
Reporting of side effects
For children over 12 years the dose should
If you get any side effects, talk to your
not exceed the maximum adult doses.
doctor, pharmacist or nurse. This includes
For elderly, the dosage is as for the adult.
any possible side effects not listed in this
The dosage should be lowered in poor renal
leaflet.
function.
You can also report side effects directly via
Patients with kidney and liver problems
the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for
might be changed by your doctor.
MHRA Yellow Card in the Google Play or
cause reduced absorption of phenoxymethylpenicillin. Your doctor will
IS AND WHAT IT IS
Apple App Store. By reporting side effects
advise you about this.
if you have liver problems along with
you can help provide more information on
he name of your medicine is
Pregnancy, breast-feeding and fertility
kidney problem.
the safety of this medicine.
Phenoxymethylpenicillin 125mg/5ml and
If you are pregnant or breast-feeding, think
How long to take your medicine for
250mg/5ml Powder for Oral Solution. It is
you may be pregnant or are planning to
Keep taking this medicine until your doctor
available in two strengths as a powder for
have a baby, ask your doctor or pharmacist
tells you to stop.
econstitution. The powder for reconstitution
for advice before taking this medicine.
Do not stop taking it just because you feel
Keep this medicine out of the sight and
reach of children.
USED FOR
Phenoxymethylpenicillin 125 mg/5ml Powder for Oral Solution comes as oral solution containing 125mg / 5ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Phenoxymethylpenicillin 125 mg/5ml Powder for Oral Solution is phenoxymethylpenicillin potassium.
Medicines with the same active substance, strength and form include: Phenoxymethylpenicillin Sugar Free 125mg / 5ml Powder for Oral Solution. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Phenoxymethylpenicillin 125 mg/5ml Powder for Oral Solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Phenoxymethylpenicillin and phenoxymethylpenicillin potassium are indicated in the treatment of mild to moderately severe infections associated with micro-organisms whose susceptibility to penicillin is within the range of serum levels attained with the dosage form.
Phenoxymethylpenicillin is indicated for the treatment of the following infections (see section 4.4 and 5.1)
Streptococcal infections:
Pharyngitis
Scarlet fever
Skin and soft tissue infections (e.g. erysipelas)
Pneumococcal infections:
Pneumonia
Otitis media
Vincent's gingivitis and pharyngitis
Phenoxymethylpenicillin is also indicated for (see section 5.1):
Prophylaxis of rheumatic fever and/or choreaProphylaxis of pneumococcal infection (e.g. in asplenia and inpatients with sickle cell disease
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Posology
For oral administration only.
The dosage and frequency of Phenoxymethylpenicillin depends on the severity and localisation of the infection and expected pathogens.
Phenoxymethylpenicillin Solution should be taken at least 30 minutes before or 2 hours after food, as ingestion of Phenoxymethylpenicillin with meals slightly reduces the absorption of the drug.
Phenoxymethylpenicillin 250mg is approximately equivalent to 400,000 units.
The usual dosage recommendations are as follows:
Adults (including the elderly) and children over 12 years:
250mg - 500mg every six hours
Children:
Infants (up to 1 year)
62.5mg every six hours
1-5 years
125mg every six hours
6-12 years
250mg every six hours
Prophylactic Use
Prophylaxis of rheumatic fever/chorea: 250mg twice daily on a continuing basis
Prophylaxis of pneumococcal infection (e.g. in asplenia and in sickle cell disease):
Adults and children over 12 years: 500mg every 12 hours
Children 6-12 years: 250mg every 12 hours
Children below 5 years: 125mg every 12 hours.
Elderly
The dosage is as for adults. The dosage should be reduced if renal function is markedly impaired.
Renal impairment
The dosage should be reduced if renal function is markedly impaired.
Hepatic impairment
Dosage adjustment may be necessary in patients with impaired liver function when they also have renal failure. In this situation the liver may be a major excretion route.
Method of Administration
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Phenoxymethylpenicillin is contraindicated in patients known to be hypersensitive to Penicillin or to any of the excipients listed in section 6.1 and should be used with caution in patients with known histories of allergy.
Penicillin should be used with caution in individuals with histories of significant allergies and/or asthma.
All degrees of hypersensitivity, including fatal anaphylaxis, have been observed with oral penicillin. These reactions are more likely to occur in individuals with a history of sensitivity to penicillins, cephalosporins and other allergens. Enquiries should be made for such a history before therapy is begun. If any allergic reaction occurs, the drug should be discontinued and the patient treated with the usual agents (e.g. adrenaline and other pressor amines, antihistamines and corticosteroids).
Oral therapy should not be relied upon for patients with severe illness, or with nausea, vomiting, gastric dilation, achalasia or intestinal hypermotility.
Occasionally patients do not absorb therapeutic amounts of orally administered penicillin.
Administer with caution in the presence of markedly impaired renal function, as safe dosage may be lower than the usually recommended doses.
Streptococcal infections should be treated for a minimum of 10 days, and post therapy cultures should be performed to confirm the eradication of the organisms.
Prolonged use of antibiotics may promote the over growth of non-susceptible organisms, including fungi. If super infection occurs, appropriate measures should be taken.
Sucrose:
This product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Aminoglycosides: Neomycin is reported to reduce the absorption of phenoxymethylpenicillin.
Anticoagulants: Penicillins may interfere with anticoagulant control.
Bacteriostatic antibiotics: Certain bacteriostatic antibiotics such as Chloramphenicol, Erythromycin and Tetracyclines have been reported to antagonise the bactericidal activity of penicillins and concomitant use is not recommended.
Guar gum: Reduced absorption of phenoxymethylpenicillin
Methotrexate: Use of Phenoxymethylpenicillin while taking methotrexate can cause reduced excretion of methotrexate thereby increasing the risk of toxicity.
Probenecid: Reduced excretion of phenoxymethylpenicillin by competing with it for renal tubular secretion.
Sulfinpyrazone: Excretion of penicillins reduced by sulfinpyrazone.
Typhoid vaccine (oral): Penicillins may inactivate oral typhoid vaccine if ingested concomitantly.
Pregnancy:
There are no or a limited amount of data from the use of Phenoxymethylpenicillin in pregnant women. As a precautionary measure, it is preferable to avoid the use of Phenoxymethylpenicillin during pregnancy.
Breast-feeding:
Phenoxymethylpenicillin metabolites are excreted in human milk to such an extent that effects on breastfed newborns are likely.
None known
The most common reactions to oral penicillin are gastrointestinal effects and hypersensitivity reactions. Although hypersensitivity reactions have been reported much less frequently after oral than after parenteral therapy, it should be remembered that all forms of hypersensitivity, including fatal anaphylaxis have been observed with oral penicillin.
The following convention has been utilised for the classification of undesirable effects:-
Very common (>1/10)
Common (>1/100, <1/10)
Uncommon (>1/1000, <1/100)
Rare (>1/10,000, <1/1000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data).
Infections and infestations
Not known
Pseudomembranous colitis
Blood and lymphatic disorders
Very rare
Changes in blood counts, including, thrombocytopenia, neutropenia, leucopenia, eosinophilia and haemolytic anaemia.
Not known
Coagulation disorders (including prolongation of bleeding time and defective platelet function)
Gastrointestinal disorders
Common
Nausea, vomiting, abdominal pain, diarrhoea
Not known
Sore mouth and black hairy tongue (discolouration of tongue)
Hepatobiliary diorders
Very rare
Hepatitis and cholestatic jaundice
Immune disorders
Common
Allergic reactions (typically manifest as skin reactions (See Skin and subcutaneous disorders)).
Rare
Severe allergic reactions causing angioedema, laryngeal oedema and anaphylaxis
Unknown
Serum sickness-like reactions characterised by fever, chills, arthralgia and oedema
Nervous system disorders
Unknown
Central nervous system toxicity including convulsions (especially with high doses or in severe renal impairment); paraesthesia may occur with prolonged use, Neuropathy (usually associated with high doses of parenteral penicillin)
Renal and urinary disorders
Very rare
Interstitial nephritis
Uncommon
Nephropathy (usually associated with high doses of parenteral penicillin)
Skin and subcutaneous disorders
Common
Urticarial, erythematous or mobilliform rash and pruritus
Rare
Exfoliative dermatitis
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the yellow card scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Symptoms: A large oral overdose of penicillin may cause nausea, vomiting, stomach pain, diarrhoea, and rarely, major motor seizures. If other symptoms are present, consider the possibility of an allergic reaction. Hyperkalaemia may result from overdosage, particularly for patients with renal insufficiency.
Management: No specific antidote is known. Symptomatic and supportive therapy is recommended. Activated charcoal with a cathartic, such as sorbitol may hasten drug elimination. Penicillin may be removed by haemodialysis.
Ask anything about Phenoxymethylpenicillin 125 mg/5ml Powder for Oral Solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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