Phenoxymethylpenicillin Sugar Free 250mg/5ml Powder for Oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Phenoxymethylpenicillin

Available from:

Brown & Burk UK LTD

ATC code:

J01CE; J01CE02

INN (International Name):

Phenoxymethylpenicillin

Dosage:

250 mg/5ml

Pharmaceutical form:

Powder for oral solution

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Beta-lactamase sensitive penicillins; phenoxymethylpenicillin

Authorization status:

Marketed

Authorization date:

2012-03-16

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
PHENOXYMETHYLPENICILLIN SUGAR FREE 125MG / 5ML POWDER FOR ORAL
SOLUTION
PHENOXYMETHYLPENICILLIN SUGAR FREE 250MG / 5ML POWDER FOR ORAL
SOLUTION
(Phenoxymethylpenicillin)
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 or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illnessare the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS 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 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 PHENOXYMETHYLPENICILLINSUGAR FREE ORAL SOL

Summary of Product characteristics

Health Products Regulatory Authority
16 July 2020
CRN008L8Q
Page 1 of 7
SUMMARY≦OF≦PRODUCT≦CHARACTERISTICS
1≦NAME≦OF≦THE≦MEDICINAL≦PRODUCT
Phenoxymethylpenicillin Sugar Free 250mg/5ml Powder for Oral solution
2≦QUALITATIVE≦AND≦QUANTITATIVE≦COMPOSITION
Each 5ml contains 277.2mg of Phenoxymethylpenicillin potassium
equivalent to phenoxymethylpenicillin 250mg.
Also contains 814.15mg/5ml of Sorbitol (E420).
For a full list of excipients see section 6.1.
3≦PHARMACEUTICAL≦FORM
Powder for oral solution
Phenoxymethylpenicillin 250mg is a white to off-white fine powder,
which when reconstituted as directed, yields a colourless to
pale yellow solution.
4≦CLINICAL≦PARTICULARS
4.1≦THERAPEUTIC≦INDICATIONS
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 chorea
Prophylaxis of pneumococcal infection (e.g. in asplenia and in
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
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.
Health Products Regu