Co-codamol 8mg/500mg effervescent tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Codeine phosphate; Paracetamol

Available from:

Zentiva Pharma UK Ltd

ATC code:

N02AJ06

INN (International Name):

Codeine phosphate; Paracetamol

Dosage:

8mg ; 500mg

Pharmaceutical form:

Effervescent tablet

Administration route:

Oral

Class:

Schedule 5 (CD Inv)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070100; GTIN: 5000283588481 5000283652038

Patient Information leaflet

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PACKAGE LEAFLET – INFORMATION FOR THE USER
CO-CODAMOL 8/500 EFFERVESCENT 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 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.
WHAT IS IN THIS LEAFLET:
1. What co-codamol is and what it is used for
2. What you need to know before you take co-codamol
3. How to take co-codamol
4. Possible side effects
5. How to store co-codamol
6. Contents of the pack and other information
1. WHAT CO-CODAMOL IS AND WHAT IT IS USED FOR
The name of your medicine is Co-codamol 8/500 Effervescent Tablets
(called
co-codamol throughout this leaflet). Co-codamol contains two different
medicines
called codeine phosphate and paracetamol. Codeine belongs to a group
of
medicines called opioid analgesics which act to relieve pain. It can
be used on
its own or in combination with other painkillers such as paracetamol.
Co-codamol
is used to treat pain and relieve the symptoms of colds, flu and sore
throats.
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
IMPORTANT THINGS YOU SHOULD KNOW ABOUT CO-CODAMOL
•
DO NOT TAKE FOR LONGER THAN YOUR DOCTOR TELLS YOU.
•
TAKING CODEINE REGULARLY FOR A LONG TIME CAN LEAD TO ADDICTION, WHICH
MIGHT CAUSE
YOU TO FEEL RESTLESS AND IRRITABLE WHEN YOU STOP

Summary of Product characteristics

OBJECT 1
CO-CODAMOL 8/500 EFFERVESCENT TABLETS (POM)
Summary of Product Characteristics Updated 09-Feb-2018 | Zentiva
1. Name of the medicinal product
Co-codamol 8/500 Effervescent Tablets
2. Qualitative and quantitative composition
Each effervescent tablet contains 500mg paracetamol and 8mg codeine
phosphate.
Excipients with known effect:
Each tablet contains 50mg of sorbitol and 10mg of saccharin sodium
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Effervescent Tablet
Flat white tablets with bevelled edges
4. Clinical particulars
4.1 Therapeutic indications
For the relief of most painful and febrile conditions such as headache
including migraine, neuralgia,
toothache, sore throat, colds, influenza, dysmenorrhoea and rheumatic
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
Do not take continuously for more than 3 days without consulting your
doctor.
Adults:
Two tablets, to be dissolved in a glass of water, every 4 hours when
necessary up to a maximum of 8
tablets in 24 hours.
Children aged 16 to 18 years:
One to two tablets every 6 hours when necessary up to a maximum of
four doses in 24 hours.
Children aged 12 to 15 years:
One tablet every 6 hours when necessary to a maximum of four doses in
24 hours.
Paediatric population
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 section 4.3 and 4.4).
Co-codamol is contraindicated in children below the age of 12 years
for the symptomatic treatment of
cold (see sections 4.3).
Children aged 12 years to 18 years: Co-codamol is not recommended for
use in children aged 12 years to
18 years with compromised respiratory function for the symptomatic
treatment of colds (see section