Kapake 15mg/500mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PARACETAMOL; Codeine phosphate hemihydrate

Available from:

Galen Limited

ATC code:

N02AJ; N02AJ06

INN (International Name):

PARACETAMOL; Codeine phosphate hemihydrate

Dosage:

15/500 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

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

Therapeutic area:

Opioids in combination with non-opioid analgesics; codeine and paracetamol

Authorization status:

Marketed

Authorization date:

2010-12-21

Patient Information leaflet

1.3.1 Package Leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
KAPAKE 15MG/500MG TABLETS
(Codeine Phosphate Hemihydrate and Paracetamol)
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, pharmacist or
nurse.

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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Kapake 15mg/500mg Tablets are and what they are used for
2.
What you need to know before you take Kapake 15mg/500mg Tablets
3.
How to take Kapake 15mg/500mg Tablets
4.
Possible side effects
5.
How to store Kapake 15mg/500mg Tablets
6.
Contents of the pack and other information
1.
WHAT KAPAKE 15MG/500MG TABLETS ARE AND WHAT THEY ARE USED FOR
Kapake 15mg/500mg Tablets contain codeine, an opioid analgesic, in
combination with
paracetamol. Kapake 15mg/500mg Tablets are one of a group of medicines
called analgesics or
painkillers. They are used to relieve moderate pain.
Codeine can be used in children over 12 years of age for the
short-term relief of moderate pain
that is not relieved by other painkillers such as paracetamol or
ibuprofen alone.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KAPAKE 15MG/500MG TABLETS
DO NOT TAKE KAPAKE 15MG/500MG TABLETS:

if you are allergic to codeine phosphate hemihydrate, paracetamol or
any of the other
ingredients of this medicine (listed in section 6).

if you are suffering from increased pressure on the brain or a head
injury.

if you have been told by your doctor that you have a severe breathing
difficulty called
respiratory depression.

if you are having (or have recently had) a severe but short-lasting
asthma attack (acute
asthma).

if you con

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kapake 15mg/500mg Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Per tablet
Paracetamol
500mg
Codeine Phosphate Hemihydrate
15mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Oblong, white uncoated tablets marked ‘K1’ both sides of a
scoreline on one side, the other side is plain and
unmarked.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of moderate pain.
Codeine is indicated in patients older than 12 years of age for the
treatment of acute moderate pain which is not
considered to be relieved by other analgesics such as paracetamol or
ibuprofen (alone).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults:_
Two tablets to be taken every four hours as required, up to a maximum
of eight tablets in any 24-hour period.
_Paediatric population:_
CHILDREN AGED 16 AND OVER:
Two tablets to be taken every six hours as required, up to a maximum
of eight tablets in any 24-hour period.
CHILDREN AGED 12 TO 15 YEARS:
One tablet to be taken every six hours as required, up to a maximum of
four tablets in any 24-hour period.
CHILDREN AGED LESS THAN 12 YEARS:
Codeine should not be used in children below the age of 12 years
because of the risk of opioid toxicity due to the
variable and unpredictable metabolism of codeine to morphine (see
sections 4.3 and 4.4).
_Elderly:_
The adult dose is appropriate (please refer to section 4.4 for
additional information on elderly patients).
The duration of treatment should be limited to three days and if no
effective pain relief is achieved the patients/carers
should be advised to seek the views of a physician.
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