Co-codamol Tablets 15mg/500mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PARACETAMOL, CODEINE PHOSPHATE, HEMIHYDRATE

Available from:

Zentiva k.s. U kabelovny 130, Dolní Mecholupy, 102 37 Praha 10, Czech Republic

ATC code:

N02BE51

INN (International Name):

PARACETAMOL 500 mg CODEINE PHOSPHATE HEMIHYDRATE 15 mg

Pharmaceutical form:

TABLET

Composition:

PARACETAMOL 500 mg CODEINE PHOSPHATE HEMIHYDRATE 15 mg

Prescription type:

POM

Therapeutic area:

ANALGESICS

Authorization status:

Withdrawn

Authorization date:

2011-07-21

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET – INFORMATION FOR THE USER
CO-CODAMOL 15/500 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 IS CO-CODAMOL AND WHAT IS IT USED FOR
The name of your medicine is Co-codamol 15/500 Tablets (called
co-codamol throughout
this leaflet). Cocodamol 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 moderate pain. 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 TO

TAKING CODEINE REGULARLY FOR A LONG TIME CAN LEAD TO ADDICTION, WHICH
MIGHT
CAUSE YOU TO FEEL RESTLESS AND IRRITABLE WHEN YOU STOP THE TABLETS

TAKING A PAINKILLER FOR HEADACHES TOO OFTEN OR FOR TOO LONG CAN MAKE
THEM WORSE
WARNINGS AND PRECAUTIONS
DO NOT TAKE CO-CODAMOL AND TELL YOUR DOCTOR IF:

You are allergic to the active substances or

Summary of Product characteristics

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Co-codamol 15/500 Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500mg paracetamol and 15mg codeine phosphate
hemihydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Co-codamol 15/500 Tablets are white to off-white capsule-shaped
tablets, marked PRO 15
and scored on one side with a plain reverse.
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 every four hours when necessary, up to a maximum of eight
tablets in 24 hours.
ELDERLY:
The adult dose is appropriate (please refer to section 4.4 for
additional information on
elderly patients).
PAEDIATRIC POPULATION
CHILDREN AGED 16 TO 18 YEARS:
One to two tablets every 6 hours when necessary, up to a maximum of
eight tablets in 24
hours.
CHILDREN AGED 12 TO 15 YEARS:
One tablet every four hours when necessary, up to a maximum of four
tablets in 24 hours.
Page 2 of 8
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).
Do not take for more than 3 days without consulting your doctor.
METHOD OF ADMINISTRATION
For oral administration. The tablets are to be taken whole.
4.3
CONTRAINDICATIONS

Hypersensitivity to the active substances or any of the other
excipients listed in section
6.1.

Conditions
where
morphine
and
opioids
are
contraindicated
e.g.,
acute
asthma,
respiratory depression, acute alcoholism, head injuries, raised
intra-cranial pressure,
hepatocellular insufficiency and following biliary tract surgery;
monoamine oxidase
inhibitor thera