Phenoxymethylpenicillin 125 mg/5mL Oral Solution – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Phenoxymethylpenicillin 125 mg/5mL Oral Solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

5 ml of reconstituted syrup contain:

Phenoxymethylpenicillin potassium equivalent to phenoxymethylpenicillin 125 mg

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Powder for oral solution

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Phenoxymethylpenicillin potassium is an orally active penicillin indicated for 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 should not be used for serious infections because absorption can be unpredictable and plasma concentrations variable.

Lower respiratory tract: pneumonia, bronchitis

Upper respiratory tract: bacterial pharyngitis, otitis media

Others: skin and soft tissues infections, scarlatina, erysipelas, Vincent’s gingivitis, prophylaxis of rheumatic fever/or choreaand pneumococcal infection prophylaxis in asplenia or patients with sickle cell disease.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology and method of administration

Posology

The dose will depend upon the severity, type and site of infection. In general the treatment must be continued 2-3 days after improvement of the symptoms.

To avoid late complications (rheumatic fever), infections with β

-haemolytic streptococci should be treated for 10 days.

The treatment of acute otitis media with penicillin V should be limited to 5 days. However, 5-10 days treatment may be recommended in patients with potential for complications.

For children

Up to 1 year of age: 62.5 mg every 6 hours

1-5 years of age: 125 mg every 6 hours

6-12 years of age: 250 mg every 6 hours

For adults (including elderly)

250-500 mg every 6 hours

Prevention of recurrence of rheumatic fever/ chorea: 250mg twice daily on a continuing basis

Prevention of pneumococcal infection in asplenia or sickle cell disease:

Adult: 500mg every 12 hours

Child under 5 years: 125mg every 12 hours

Child 6-12 years: 250mg every 12 hours

Elderly

The dosage should be reduced if renal function is markedly impaired.

Special dosage:

Administer with caution in the presence of markedly impaired renal function due to the increased risk of encephalopathy. As a safe dosage may be lower than usually recommended.

The elimination of phenoxymethylpenicillin potassium is reduced in case of renal insufficiency. The dose interval should be adjusted to every 8 hours to 12 hours according to the severity of renal 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.

The recommended dose is to be taken about half an hour before meals or 2 hours after food, as ingestion of Phenoxymethylpenicillin with meals slightly reduces the absorption of the drug.

Method of Administration

For instructions on dilution of the product before administration, see section 6.6.

4.3 Contraindications

Phenoxymethylpenicillin potassium should not be given to patients with a history of penicillin hypersensitivity. Penicillin or any of the excipients contained in the product and should be used with caution in patients with known histories of allergy.

Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics e.g. cephalosporms. Severe acute infections should not be treated with phenoxymethylpenicillin.

4.4 Special warnings and precautions for use

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. Cross sensitivity may occur with cephalosporins and other beta lactam antibiotics. These reactions are more likely to occur in individuals with a history of sensitivity to penicillins, cephalosporins and other allergens.

Enquiry should be made for such a history before therapy with a penicillin begins. 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 in patients with severe illness, or with nausea, vomiting, gastric dilation, cardiospasm, achalasia or intestinal hypermotility.

Occasionally, patients do not absorb therapeutic amounts of orally administered penicillin.

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.

Caution should be used when treating patients with a history of antibiotic-associated colitis.

Severe empyema, bacteraemia, pericarditis, meningitis and arthritis should not be treated with phenoxymethylpenicillin during the acute phase.

Patients with a past history of rheumatic fever receiving continuous prophylaxis may harbour penicillin-resistant organisms. In these patients, the use of another prophylactic agent should be considered.

Oral penicillin should not be used as adjunctive prophylaxis for genito - urinary instrumentation or surgery, lower intestinal tract surgery, sigmoidoscopy and child birth.

4.5 Interaction with other medicinal products and other forms of interaction

Probenecid delays the elimination of penicillin through the kidneys and thus prolongs its action.

Phenoxymethylpenicillin reduces the excretion of the cytotoxic drug, methotrexate thereby increasing the risk of toxicity.

Avoid concomitant administration with bacteriostatic antibiotics such as tetracycline, erythromycin, chloramphenicol and sulphonamides because it can diminish the effect of phenoxymethylpenicillin 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 contraceptive precautions while taking phenoxymethylpenicillin.

The simultaneous administration of guar gum diminishes the absorption of penicillins.

Aminoglycosides: Neomycin is reported to reduce the absorption of phenoxymethylpenicillin.

Anticoagulants: Penicillins may interfere with anticoagulant control.

Sulfinpyrazone: Excretion of penicillins reduced by sulfinpyrazone.

Typhoid vaccine (oral): Penicillins may inactivate oral typhoid vaccine if ingested concomitantly.

4.6 Fertility, pregnancy and lactation

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 studies.

However, as with other drugs, caution should be exercised when prescribing to pregnant patients.

Breast-feeding

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/sensitization

Caution should therefore be exercised when prescribing for the nursing mother.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Hypersensitivity

Although reactions have been reported much less frequently after oral than after parenteral therapy, it should be remembered that all degrees of hypersensitivity, including fatal anaphylaxis, have been observed with oral penicillin.

Pseudomembranous colitis requires immediate attention and treatment with an appropriate antibiotherapy (i.e. vancomycin).

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.

4.9 Overdose

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.

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 over dosage, 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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Beta lactamase sensitive penicillins

ATC Code: J01CE02

Mechanism of action:

Phenoxymethylpenicillin potassium is a beta lactam antibiotic with bactericidal action against Gram-positive bacteria and Gram-negative cocci. Its antimicrobial action is similar to that of benzylpenicillin. Phenoxymethylpenicillin potassium is usually active against the following organisms:

Gram-positive aerobes and anaerobes including

Bacillus anthracis

Clostridium perfringens

Clostridium tetani

Corynebacterium diphtheriae

Erysipelothrix rhusiopathiae

Listeria mono cyto genes

Peptostreptococcus spp.

Streptococcus agalactiae (Group B)

Streptococcus pneumoniae

Streptococcus pyogenes (Group A}

Gram-negative including

Neisseria meningitides

Neisseria gonorrhoeae

Phenoxymethylpenicillin potassium is inactivated by penicillinase and other beta lactamases.

Phenoxymethylpenicillin binds to penicillin-binding proteins located on the inner membrane of the bacterial cell wall. Phenoxymethylpenicillin binds to and inactivates these proteins resulting in weakening of the bacterial cell wall and lysis.

5.2 Pharmacokinetic properties

Absorption:

Phenoxymethylpenicillin is stable under acidic conditions so it can be administered by oral route. Phenoxymethylpenicillin is rapidly, but incompletely absorbed after oral administration and the absorption level is around 60%. The simultaneous administration of food slightly decreases the peak plasma concentration of phenoxymethylpenicillin, but does not appear to affect the extent of absorption. Peak plasma concentrations are reached in

about 45 minutes. The peak plasma concentration increases approximately in proportion with increased doses.

Distribution:

Phenoxymethylpenicillin passes into the tissues (volume of distribution about 0.2 l.kg-1 of body weight. The plasma protein binding is about 80%.

Biotransformation:

Phenoxymethylpenicillin is partially metabolised to inactive penicilloic acid by hydrolysis of the lactam ring. This metabolism occurs in the liver.

Elimination:

About 40% of the dose is eliminated in the urine either as under unchanged or as penicilloic acid in the first 10 hours after oral administration. The plasma half-life of phenoxymethylpenicillin is about 45 minutes. It is however extended in case of renal insufficiency.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of this SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

The excipients in the syrup: sodium saccharin, citric acid, sodium citrate, sucrose, banana flavour, preservative:

E 211: sodium benzoate

colouring agent:

El 27 Erythrosine

6.2 Incompatibilities

None known.

6.3 Shelf life

The shelf life of the product is 36 months.

6.4 Special precautions for storage

Do not store above 25^oC.Keep the container tightly closed.

Store the reconstituted solution preferably in a refrigerator (2-8°C).

Phenoxymethylpenicillm Potassium solution should be kept out of reach and sight of children.

6.5 Nature and contents of container

The product comes in amber coloured glass bottles of 60 ml and 100 ml fitted with ROPP caps.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

The reconstituted syrup should be used within 7 days.

7 MARKETING AUTHORISATION HOLDER

Flamingo Pharma UK Ltd.

1^st floor, Kirkland House,

11-15 Peterborough Road,

Harrow, Middlesex,

HA12AX, United Kingdom.

8 MARKETING AUTHORISATION NUMBER(S)

PL 43461/0072

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

16/07/2025

10 DATE OF REVISION OF THE TEXT

16/07/2025