Kopen Sugar Free 125mg/5ml Powder for Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Phenoxymethylpenicillin potassium

Available from:

Athlone Pharmaceuticals Limited

ATC code:

J01CE; J01CE02

INN (International Name):

Phenoxymethylpenicillin potassium

Pharmaceutical form:

Powder for oral solution

Therapeutic area:

Beta-lactamase sensitive penicillins; phenoxymethylpenicillin

Authorization status:

Marketed

Authorization date:

1988-04-11

Patient Information leaflet

1
CCRF21179-2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KOPEN SUGAR FREE
125MG/5ML AND 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 further questions, please 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 illness are the same as yours.
•
If you get any of the 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 Kopen Sugar Free Powder for Oral Solution
is and what it is used for
2. What you need to know before you take Kopen Sugar Free Powder for
Oral
Solution
3. How to take Kopen Sugar Free Powder for Oral Solution
4. Possible side effects
5. How to store Kopen Sugar Free Powder for Oral Solution
6. Contents of the pack and other information
1.
WHAT KOPEN SUGAR FREE POWDER FOR ORAL SOLUTION IS AND WHAT IT IS USED
FOR
The name of your medicine is Kopen Sugar Free Powder for Oral
Solution. It is available as a
pale yellow 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 reconstituted oral solution appears as a yellow solution with an
orange odour and flavour.
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:
▪
infection occurring in patients without a spleen or in patients with
sickle cell
disease (a blood disorder)
▪
rheumatic fever.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KOPEN S

Summary of Product characteristics

Health Products Regulatory Authority
24 November 2023
CRN00DQXX
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kopen Sugar Free 125mg/5ml Powder for Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of Oral Solution contains 125mg of Phenoxymethylpenicillin as
Phenoxymethylpenicillin Potassium.
Excipients with known effect
Sorbitol
The 125mg/5ml solution contains 792.93 mg of sorbitol in each 5 ml
dose.
Sodium Benzoate (E211)
Each 5ml of Oral Solution contains 16mg of Sodium benzoate (E 211).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for Oral Solution.
A pale yellow granular powder
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use in treatment of infections caused by susceptible
staphylococci, pneumococci, gonococci, and haemolytic streptococci.
Phenoxymethylpenicillin is also indicated for
• Prophylaxis of pneumococcal infection (e.g. in asplenia and in
patients with sickle cell disease).
• Prophylaxis of rheumatic fever.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults: 250mg to 500mg every six hours depending on the severity of
the condition.
The elderly: as for adults
Renal Impairment: Reduced dosage if renal function is markedly
impaired.
Prophylactic use:
• Pneumococcal infection (e.g. asplenia)
Adults: 500mg every 12 hours
Children 6 - 12 years: 250mg every 12 hours
Children <5 years: 125mg every 12 hours
• Rheumatic fever
250 mg twice daily is recommended for long-term prophylaxis of
rheumatic fever.
Health Products Regulatory Authority
24 November 2023
CRN00DQXX
Page 2 of 7
Children
INFANTS (UP TO 1 YEAR): 62.5 mg every six hours. The total daily dose
is 250mg in divided doses.
Children 1 - 5 years: 125mg 6 hourly
Children 6 - 12 years: 250mg 6 hourly
Method of Administration
For instructions on reconstitution on the medicinal product before
administration, see section 6.6.
For oral administration on