Co-codamol 8mg/500mg tablets

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Paracetamol; Codeine phosphate

Tillgänglig från:

Bristol Laboratories Ltd

ATC-kod:

N02AJ06

INN (International namn):

Paracetamol; Codeine phosphate

Dos:

500mg ; 8mg

Läkemedelsform:

Oral tablet

Administreringssätt:

Oral

Klass:

Schedule 5 (CD Inv)

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 04070100; GTIN: 5060013941863 5060013941610 5060013941627

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
CO-CODAMOL 8MG/500MG TABLETS
(Codeine phosphate and Paracetamol)
THIS MEDICINE CONTAINS CODEINE WHICH IS AN OPIOID, WHICH CAN CAUSE
ADDICTION. YOU CAN GET WITHDRAWAL SYMPTOMS IF YOU STOP
TAKING IT SUDDENLY.
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 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 Co-codamol Tablets are and what they are used for
2 .
What you need to know before you take Co-codamol Tablets
3 .
How to take Co-codamol Tablets
4 .
Possible side effects
5 .
How to store Co-codamol Tablets
6 .
Contents of the pack and other information
1. WHAT CO-CODAMOL TABLETS ARE AND WHAT THEY ARE USED FOR
This medicine has been prescribed for you to relieve from pain. It
contains the codeine which belongs to a class of medicines called
opioids,
which are ‘pain relievers’. It also contains paracetamol, another
analgesic to relieve pain. This medicine has been prescribed to you
and
should not be given to anyone else. Opioids can cause addiction and
you may get withdrawal symptoms if you stop taking it suddenly. Your
prescriber should have explained how long you will be taking it for
and when it is appropriate to stop, how to do this safely. Co-codamol
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 CO-CODAMOL TABLETS
IMPORTANT INFORMATION:
•
Do not take for longer than directed by your prescriber.
•
Taking codeine regular

Produktens egenskaper

PL 17907/0163
Bristol Laboratories Ltd
Version 14
Page
1
of
16
JANUARY 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Co-Codamol 8mg/500mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of Paracetamol and 8 mg of Codeine
phosphate
Excipient(s) with known effect:
Methyl para hydroxy benzoate (E218) : 70.0 to 75.0 %
Propyl para hydroxy benzoate (E216) : 9.0 to 13.0%
Ethyl para hydroxy benzoate (E214): 14.0 to 18.0%
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
Clean, white tablets, bevelled edged, debossed with ‘8’ and broken
breakline
on one side and ‘BL’ on the other side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Codeine is indicated in patients older than 12 years of age for the
short term
treatment of acute moderate pain which is not considered to be
relieved by
other analgesics such as paracetamol or ibuprofen (alone).
For the symptomatic relief of pain including headache, migraine,
toothache,
period pains, rheumatic pains, including muscle pains and backache.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Prior to starting treatment with opioids, a discussion should be held
with
patients to put in place a strategy for ending treatment with codeine
in order to
minimise the risk of addiction and drug withdrawal syndrome (see
section
4.4).
PL 17907/0163
Bristol Laboratories Ltd
Version 14
Page
2
of
16
JANUARY 2023
_Posology _
ADULTS OVER 18 YEARS
:
One or two tablets to be swallowed with water. The dose should not be
repeated more frequently than every four to six hours and not more
than four
times in any 24 hour period. Maximum dose is 8 tablets (4.0gm of
paracetamol
and
64mg
of
codeine
in
divided
doses)
per
24
hours.
CHILDREN AGED 16 YEARS TO 18 YEARS:
The recommended dose for children 16 years and older is 1 to 2 tablets
every 6
hours when necessary up to a maximum of 8 tablets in 24 hours.
CHILDREN AGED 12 YEARS TO 15 YEARS:
The recommended dose for children 12 years to 15 years is 1 tablet
every 6
hours wh