Co-codamol 30mg/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:

30mg ; 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: 5000283609094

Patient Information leaflet

419363 (alt 418555) GMID 657774 PB Cocodamol 500-30mg 10x10 GB
Operator A.Schmitz 148 x 210 DC
Code 170
black min. 8pt helvetica - Version 2
Seite 3
Seite 1
PACKAGE LEAFLET – INFORMATION FOR THE USER
CO-CODAMOL 30/500 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 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 30/500 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 severe 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
•
TAKING CODEINE REGULARLY FOR A LONG TIME CAN LEAD TO ADDICTION, WHICH
MIGHT
CAUSE YOU TO FEEL RESTLESS AND IRRITABLE WHEN YOU STOP TAKING THE
TABLETS
•
TAKING PAINKILLER FOR HEADACHES TOO OFT

Summary of Product characteristics

OBJECT 1
CO-CODAMOL 30/500 EFFERVESCENT TABLETS
Summary of Product Characteristics Updated 09-Feb-2018 | Zentiva
1. Name of the medicinal product
Co-codamol 30/500 Effervescent Tablets
2. Qualitative and quantitative composition
Each tablet contains 500mg paracetamol and 30mg codeine phosphate
hemihydrate.
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 Tablets.
White bevelled-edge tablets, scored on one face.
4. Clinical particulars
4.1 Therapeutic indications
For the relief of severe 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.
Elderly
As for adults, however a reduced dose may be required. See warnings.
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).
METHOD OF ADMINISTRATION
For oral administration.
4.3 Contraindications
• Hypersensitivity to paracetamol, codeine 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 and
following biliary tract surgery;
monoamine ox