Kopen 250mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Phenoxymethylpenicillin potassium

Available from:

Athlone Laboratories Ltd

ATC code:

J01CE; J01CE02

INN (International Name):

Phenoxymethylpenicillin potassium

Dosage:

250 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

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

Therapeutic area:

Beta-lactamase sensitive penicillins; phenoxymethylpenicillin

Authorization status:

Marketed

Authorization date:

1987-07-24

Patient Information leaflet

0007
CCF21-007
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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
(chemist).

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 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 250mg Tablets are and what they are used for
2)
What you need to know before you take Kopen 250mg Tablets
3)
How to take Kopen 250mg Tablets
4)
Possible side effects
5)
How to store Kopen 250mg Tablets
6)
Contents of the pack and other information
1.
WHAT KOPEN 250MG TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Kopen 250mg Tablets. These tablets are
dispensed by the
pharmacist.
Kopen 250mg Tablets contains Phenoxymethylpenicillin, which is a
penicillin antibiotic, used
to kill bacteria that cause infections in your body.
Kopen 250mg Tablets are 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 250MG TABLETS
DO NOT TAKE KOPEN 250MG TABLETS IF YOU:

are allergic to Phenoxymethylpenicillin, or any of the other
ingredients of this medicine
listed in section 6.

have ever had a bad reaction or allergic reaction to any
penicillin-type antibiotics
including ampicillin or cephalosporin antibiotics

have ever had a skin rash or swelling of the face or neck or shortness
of breath when
taking any antibiotic
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING KOPEN

Summary of Product characteristics

Health Products Regulatory Authority
11 June 2021
CRN00CD9D
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kopen 250mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg of phenoxymethylpenicillin (as
phenoxymethylpenicillin potassium). Each tablet also contains
94.6mg of lactose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets
Circular white tablets approximately 10.5 mm in diameter, embossed
‘Pen 250’.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use in the treatment of infections caused by penicillin-sensitive
gram positive bacteria and in particular 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 or 500mg every six hours depending on the severity of
the condition.
ELDERLY: As for adults
RENAL IMPAIRMENT: The dosage should be reduced 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
250mg twice daily is recommended for long term prophylaxis or
rheumatic fever.
CHILDREN
INFANTS (UP TO 1 YEAR): Tablets are not usually given to this age
group. A liquid medicine is available.
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.
Health Products Regulatory Authority
11 June 2021
CRN00CD9D
Page 2 of 6
For oral administration only
Ideally, each dose should be given half an hour before (or at least
three hours after) a meal.
T