Co-codamol 8mg/500mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Codeine phosphate; Paracetamol

Available from:

Actavis UK Ltd

ATC code:

N02AJ06

INN (International Name):

Codeine phosphate; Paracetamol

Dosage:

8mg ; 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: 5012617002273 5012617007834 5012617007841 5012617015334

Patient Information leaflet

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JDE No.:
Co-Dydramol Tablets
8/500mg x 30’s (UK)
296x210 (Reel Fed)
50912681
Leaflet for Blisters
7178
R.Wrey
18/10/16
296x210 Leaflet Reel Fed Bi Fold Profile (BST)
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PARACETAMOL CODEINE 500MG/8MG 30 & 32 TABLETS PIL - UK
Black
Profile
BBBA0153
C.Grant
20/10/16
19.12.16
S.Anson
296 x 210
8pts
Actavis UK
N/A
N/A
05
page 4
page 1
CO-CODAMOL TABLETS 8/500MG
(codeine phosphate and paracetamol)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
THIS MEDICINE CAN ONLY BE USED FOR
THE SHORT TERM TREATMENT OF ACUTE
MODERATE PAIN which is NOT RELIEVED by
paracetamol, ibuprofen or aspirin alone.
Do not take less than four hours after
taking other painkillers.
•
YOU SHOULD ONLY TAKE THIS PRODUCT FOR
A MAXIMUM OF THREE DAYS at a time. If
you need to take it for longer than three
days you should see your doctor or
pharmacist for advice.
•
THIS MEDICINE CONTAINS CODEINE WHICH
CAN CAUSE ADDICTION if you take it
continuously for more than three days.
This can give you withdrawal symptoms
from the medicine when you stop taking
it.
•
IF YOU TAKE THIS MEDICINE FOR
HEADACHES FOR MORE THAN THREE DAYS IT
CAN MAKE THEM WORSE.
•
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 i

Summary of Product characteristics

OBJECT 1
CO-CODAMOL 8/500MG TABLETS (POM)
Summary of Product Characteristics Updated 19-Apr-2018 | Accord-UK Ltd
1. Name of the medicinal product
CO-CODAMOL 8/500mg TABLETS
2. Qualitative and quantitative composition
Each tablet contains 8mg Codeine Phosphate BP and 500mg Paracetamol
PhEur.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
White uncoated tablets.
4. Clinical particulars
4.1 Therapeutic indications
1) Co-codamol is indicated in children 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).
2) As an antipyretic.
4.2 Posology and method of administration
Posology
Co-codamol should be used at the lowest effective dose for the
shortest period of time. This dose may be
taken, up to 4 times a day at intervals of not less than 6 hours.
_Adults:_ 1-2 tablets which may be repeated every 6 hours. Do not take
more than 8 tablets in any 24 hour
period.
Paediatric population:
_Children aged 16-18 years: _1-2 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 co-codamol dose for children 12-15 years should be 1
tablet which may be repeated
every 6 hours when necessary up to a maximum dose of 4 tablets in any
24 hour period.
_Children aged less than 12 years:_
Co-codamol 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 sections 4.3 and
4.4).
_Elderly: _Dosage should be reduced in the elderly where there is
impairment of hepatic function.
For oral administration.
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.
4.3 Contraindications
• Hypersensitivity to the active substances, other opioids or to any
of the excipients listed in section 6.1.
• Diarrhoea