Kapake 30mg/500mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; Codeine phosphate

Available from:

Galen Limited

ATC code:

N02AJ; N02AJ06

INN (International Name):

Paracetamol; Codeine phosphate

Dosage:

30/500 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:

1993-10-26

Patient Information leaflet

1.3.1 Package Leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
KAPAKE 30MG/500MG TABLETS
(Codeine Phosphate 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 30mg/500mg Tablets are and what they are used for
2.
What you need to know before you take Kapake 30mg/500mg Tablets
3.
How to take Kapake 30mg/500mg Tablets
4.
Possible side effects
5.
How to store Kapake 30mg/500mg Tablets
6.
Contents of the pack and other information
1.
WHAT KAPAKE 30MG/500MG TABLETS ARE AND WHAT THEY ARE USED FOR
Kapake 30mg/500mg Tablets contain codeine, an opioid analgesic, in
combination with
paracetamol. Kapake 30mg/500mg Tablets are one of a group of medicines
called analgesics or
painkillers. They are used to relieve severe pain in adults.
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 30MG/500MG TABLETS
DO NOT TAKE KAPAKE 30MG/500MG TABLETS:
-
if you are allergic to codeine phosphate, paracetamol or any of the
other ingredients of this
medicine (listed in section 6).
-
if you have suffered a head injury or have raised pressure in the
skull (may cause painful
eyes, changes in vision or headache behind the eyes).
-
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

Summary of Product characteristics

Health Products Regulatory Authority
05 November 2018
CRN008Q51
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kapake 30mg/500mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient
Per tablet
Paracetamol
500 mg
Codeine Phosphate
30 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Oblong white uncoated tablets marked ‘Kapake’ and bearing a
scoreline on one side,
the other side is plain and unmarked. The scoreline is only to
facilitate breaking for
ease of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of severe pain in adults.
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:
One or 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 12 AND OVER:
One tablet to be taken every six hours as required, up to a maximum of
four tablets
in any 24-hour period.
Health Products Regulatory Authority
05 November 2018
CRN008Q51
Page 2 of 9
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 dosage may need to be reduced and should be titrated to the
individual’s need
and overall medical condition.
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.
Method of administration
For oral use.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section
6.1.
This product is contraindicated in patients with raised i