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.
for The name of your medicine is Phenoxymethylpenicillin film-coated tablets. Phenoxymethylpenicillin film-coated tablets belong to a family of medicines called antibiotics, in a group called 'penicillins'. Antibiotics are used to kill the bacteria or "germs" which cause infections. Your doctor, or dentist, will have prescribed Phenoxymethylpenicillin film-coated tablets for treating an infection which is caused by bacteria which are sensitive to penicillin antibiotics.
e Phenoxymethylpenicillin film-coated tablets Do not take Phenoxymethylpenicillin film-coated tablets if:
Talk to your doctor, pharmacist or nurse before taking Phenoxymethylpenicillin filmcoated tablets if:
This medicine is not expected to affect your ability to drive or use machinery. Phenoxymethylpenicillin film-coated tablets contain potassium This medicine contains 28 mg potassium per tablet. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
Phenoxymethylpenicillin film-coated tablets Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Each dose should be swallowed with a drink of water, at least 30 minutes before food. Try to space the doses as evenly as possible throughout the day. The recommended dose is: Adults: The recommended dose for adults is 250 mg or 500 mg (i.e. one or two tablets) every 6 hours. This may vary depending on the type of infection you have. If you have poor kidney function the dose may be lowered. Use in children and adolescents: For children aged 6 – 12 years of age the recommended dose is 250 mg (i.e. one tablet) every 6 hours. For children aged 1 – 5 years of age the recommended dose is 125 mg (i.e. half a tablet) every 6 hours. How long to take your medicine for: Your doctor will tell you how long to take your medicine for based on the type of infection you have. 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 this medicine, your condition may reoccur or get worse. If you take more Phenoxymethylpenicillin film-coated tablets than you should Always take your medicine as recommended by your doctor. A large overdose may cause nausea (feeling sick), vomiting (being sick) and diarrhoea. Rarely seizures (fits) may occur. If you (or someone else) take too much medicine, or if you think a child has swallowed any of the tablets, tell your doctor immediately or go to your local hospital emergency department. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were swallowed. If you forget to take Phenoxymethylpenicillin film-coated tablets If you miss a dose, take another as soon as you remember and then carry on as before. Do not take a double dose to make up for a forgotten dose.
If you stop taking Phenoxymethylpenicillin film-coated tablets Keep taking your medicine until the course is finished. Do not stop taking your tablets just because you feel better – if you stop too soon the infection may start up again. When you have finished Phenoxymethylpenicillin film-coated tablets If your symptoms persist, tell your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects Like all medicines Phenoxymethylpenicillin film-coated tablets can cause side effects, although not everybody gets them. Tell your doctor if you think your medicine is making you feel unwell or if you get any of the following side effects: The following side effects are rare, however if you think you are having an allergic reaction stop taking your tablets and tell your doctor immediately or go to your local hospital emergency department as severe allergic reactions may require emergency treatment.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Phenoxymethylpenicillin film-coated tablets Keep this medicine out of the sight and reach of children. Do not use Phenoxymethylpenicillin film-coated tablets after the expiry date which is stated on the carton or blister strip. The expiry date refers to the last day of that month. Do not store above 25°C. Store in the original packaging. Do not use Phenoxymethylpenicillin film-coated tablets if you notice any visible signs of deterioration. 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.
What Phenoxymethylpenicillin contains The active substance is phenoxymethylpenicillin. Each film coated tablet contains 500 mg of phenoxymethylpenicillin (as phenoxymethylpenicillin potassium). The other ingredients are: calcium hydrogen phosphate dihydrate, maize starch, microcrystalline cellulose, magnesium stearate. Film-coating ingredients are: macrogol polyvinyl alcohol graft copolymer (E1209), talc (E553b), titanium dioxide (E171), GMCC Type 1(E471), polyvinyl alcohol-part. hydrolyzed (E1203). What Phenoxymethylpenicillin film-coated tablets contain: White to off white, circular, biconvex film coated tablet, with break line on one side and E41 on other side. White opaque PVC-Al blister pack. Packs containing 10,14,20,28,30,50,56,60,84,98 & 100's tablets are available. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Brown & Burk UK Ltd, Micro House, 5 Marryat Close, Hounslow, TW4 5DQ, United Kingdom. This leaflet was revised in 03/2024.
Phenoxymethylpenicillin 500 mg Film-coated tablets comes as tablet containing 500mg. 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 500 mg Film-coated tablets is phenoxymethylpenicillin potassium.
This leaflet reproduces the patient information leaflet approved for Phenoxymethylpenicillin 500 mg Film-coated tablets, 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.
For use in the treatment of mild to moderately severe infections caused by penicillin sensitive organisms.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Posology
Adults: The dosage is 250-500 mg every six hours.
Elderly: The dosage is as for adults. The dosage should be reduced if renal function is markedly impaired.
Prophylactic Use: The dosage is 250 mg daily for long term prophylaxis of rheumatic fever.
Paediatric population
Children 1-5 years: 125 mg every six hours
6-12 years: 250 mg every six hours
To avoid late complications (rheumatic fever), infections with β-haemolytic streptococci should be treated for 10 days.
The treatment of acute otitis media with Phenoxymethylpenicillin should be limited to 5 days. However, 5-10 days treatment may be recommended in patients with potential for complications.
Method of administration
Phenoxymethylpenicillin 500mg film-coated tablets are for oral use.
Each tablet should be swallowed whole with water, at least 30 minutes before food, as ingestion of phenoxymethylpenicillin with meals slightly reduces the absorption of the drug.
Phenoxymethylpenicillin is contraindicated in patients with known penicillin hypersensitivity.
Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics e.g. cephalosporins. Severe acute infections should not be treated with phenoxymethylpenicillin.
All degree of hypersensitivity, including fatal anaphylaxis, have been observed with oral penicillin. These reactions are more likely occur in individuals with a history of sensitivity to penicillin, cephalosporin, and other allergens.
Enquiry should be made for such a history before therapy with a penicillin begins. If an 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 other corticosteroids).
Oral therapy should not be relied upon in patients with severe illness, or with nausea, vomiting, gastric dilation, cardiospasm 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 the safe dosage may be lower than the usually recommended.
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 overgrowth of non-susceptible organisms including fungi. If super-infection occurs, appropriate measures should be taken.
Each tablet of Phenoxymethylpenicillin 500 mg film-coated tablets contains 28 mg of potassium, which may be harmful to people on low potassium diets and may cause stomach upset, diarrhoea and hyperkalaemia. High doses should be used with caution in patients receiving potassium-containing drugs or potassium sparing-diuretics.
During treatment with phenoxymethylpenicillin non-enzymatic glucose tests may be false-positive.
Probenecid delays the elimination of the peniciilin through the kidneys and thus prolong its action.
Phenoxymethylpenicillin reduces the excretion of cytotoxic drug, methotrexate.
Avoid concomitant administration with bacteriostatics antibiotics such as tetracycline, erythromycin, chloramphenicol and sulphonamides because it can diminish the effect of Phenoxymethylpeniccillin potassium.
In case of simultaneous administration of Phenoxymethylpenicillin and oral contraceptives, the hormonal contraception can lose its efficacy. Patients should be advised to use additional forms of contraceptives precautions while taking Phenoxymethylpenicillin.
The simultaneous administration of guar gum diminishes the absorption of penicillin.
Phenoxymethylpenicillin has the following interaction information:
Neomycin - absorption of phenoxymethylpenicillin reduced by neomycin.
Coumarin – common experience in anticoagulant clinics is that INR can be altered by a course of broad-spectrum penicillins such as ampicillin, although studies have failed to demonstrate an interaction with coumarins.
Phenindione – common experience in anticoagulant clinics is that INR can be altered by a course of broad-spectrum penicillins such as ampicillin, although studies have failed to demonstrate an interaction with phenindione.
Sulfinpyrazone- excretion of penicillin reduced by sulfinpyrazone.
Typhoid Vaccines – antibacterials inactive oral typhoid vaccine.
Pregnancy
Animal studies with phenoxymethylpenicillin potassium have shown no teratogenic effects.
Phenoxymethylpenicillin potassium has been in extensive clinical use and suitability in human pregnancy has been well documented in clinical trials. However, as with other drugs, caution should be exercised when prescribing to pregnant patients.
Lactation
Breast feeding is not contraindicated with phenoxymethylpenicillin potassium.
Trace quantities of phenoxymethylpenicillin potassium can be detected in breast milk. While adverse effects are apparently rare, two potential problems exist for nursing infant:
- modification of bowel flora
- direct effects on the infant such as allergy/sensitisation
Caution should therefore be exercised when prescribing for the nursing mother.
None Known.
Hypersensitivity
Potential allergic reactions include urticaria, angioneurotic oedema, erythema multiforme, exfoliative dermatitis, fever, joint pain, serum sickness-like reactions, haemolytic anaemia, interstitial nephritis or anaphylactic shock (which could be fatal) with collapse and anaphylactoid reactions (asthma, purpura, gastrointestinal symptoms). Although these are less common, and take a milder course, in oral treatment than during parenteral penicillin treatment, it should be remembered that all degrees of hypersensitivity, including fatal anaphylaxis, have been observed with oral penicillin.
Gastro-intestinal tract
Phenoxymethylpenicillin potassium is generally well tolerated. Occasionally soft stools occur and they do not require the interruption of the treatment. Nausea, diarrhoea, vomiting, stomatitis and glossitis are sometimes seen.
Sustained severe diarrhoea should prompt suspicion of pseudomembranous colitis. As this condition may be life-threatening phenoxymethylpenicillin should be withdrawn immediately and treatment guided by bacteriologic studies with appropriate antibiotherapy (i.e. vancomycin).
Blood
Eosinophilia, haemolytic anaemia, leukopenia, thrombocytopenia and agranulocytosis are extremely rare. Other possible effects on the blood composition include: neutropenia, haemolytic anaemia and coagulation disorders.
Central nervous system
Central nervous system toxicity, including convulsions, has been reported, especially following high doses or in severe renal impairment. Paraesthesia has been reported with prolonged use.
As with other broad-spectrum antibiotics prolonged use may result in the overgrowth of non-susceptible organisms, e.g. candida. This may present a vulvo-vaginitis.
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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Cases of intended or accidental overdosage should be brought under medical supervision for symptomatic treatment. It is advisable to monitor blood levels in patients with renal malfunction.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Phenoxymethylpenicillin 500 mg Film-coated tablets. 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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