Co-codamol 15mg/500mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Codeine phosphate; Paracetamol

Available from:

Accord-UK Ltd

ATC code:

N02AJ06

INN (International Name):

Codeine phosphate; Paracetamol

Dosage:

15mg ; 500mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

Schedule 5 (CD Inv)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070100; GTIN: 5012617026804

Patient Information leaflet

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 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 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.
Co-codamol contains two different analgesics (painkillers) called
paracetamol and codeine (as codeine phosphate hemihydrate).
Codeine belongs to a group of medicines called opioid
analgesics which act to relieve pain.
Co-codamol can be used in children over 12 years of age for the
short-term relief of moderate or severe 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
DO NOT TAKE CO-CODAMOL:
•
if you are allergic to codeine, paracetamol or any of the other
ingredients of this medicine (listed in Section 6). Signs of an
allergic reaction include a rash and breathing problems. There
can also be swelling of the legs, arms, face, throat or tongue
•
if you are allergic to soya or peanut
•
if you have severe asthma attacks or severe breathing
problems
•
if you have recently had a head injury
•
if you have severe liver problems
•
if you have been told by your doctor that you have increased
pressure in your head. Signs of this include: headaches, being
sick (vomiting) and blurred eyesight
•
if you have recently had an operation on your liver,
gallbladder or bile

Summary of Product characteristics

OBJECT 1
CO-CODAMOL 15/500MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 27-Jan-2017 | Accord-UK Ltd
1. Name of the medicinal product
Co-codamol 15/500mg Film-coated Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 15 mg codeine phosphate hemihydrate
and 500 mg Paracetamol
Excipient with known effect: Each film-coated tablet contains 0.97 mg
lecithin soya (E322).
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Film-coated tablet
Co-codamol film-coated tablets are light yellow, oval, 8.5 x 17 mm,
biconvex tablets, marked '5 15' on
one side with a score line.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
For the relief of moderate to severe pain in adults and children above
12 years.
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
The duration of treatment should be limited to 3 days and if no
effective pain relief is achieved the
patients/carers should be advised to seek the views of a physician.
_Adults over 18 years:_
One or two tablets not more frequently than every 4 hours, up to a
maximum of 8 tablets in any 24 hour
period.
_Maximum daily dose:_
• The maximum daily dose of Paracetamol must not exceed 4000 mg.
• Maximum single dose is 1000 mg (2 tablets).
_Elderly:_ As adults, however a reduced dose may be required. See
section 4.4.
_Renal insufficiency_
In case of renal insufficiency the dose should be reduced due to
available data on the paracetamol
component:
Glomerulal filtration
Dose
10 – 50 ml/min
One Co-codamol 500 mg / 15 mg tablet every 6
hours
< 10 ml/min
One Co-codamol 500 mg / 15 mg tablet every 8
hours
_Hepatic insufficiency: _As adults, however a reduced dose may be
required. See section 4.4.
_Chronic a