Co-dydramol 10mg/500mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Paracetamol; Dihydrocodeine tartrate

Disponível em:

Accord-UK Ltd

Código ATC:

N02AJ01

DCI (Denominação Comum Internacional):

Paracetamol; Dihydrocodeine tartrate

Dosagem:

500mg ; 10mg

Forma farmacêutica:

Oral tablet

Via de administração:

Oral

Classe:

Schedule 5 (CD Inv)

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 04070100; GTIN: 5012617011213 5012617010575 05012617004727

Folheto informativo - Bula

175x275 Leaflet Reel Fed Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Co-Dydramol (actives: dihydrocodeine tartrate,
paracetamol), Tablets, 10/500mg, 30s/100s,
- UK
175x275 (Reel Fed)
50986808
Leaflet for Blisters
6916
RH
13-01-20
* Please note that ONLY Artwork Studio is permitted to make changes to
the above artwork.
No changes are permitted by any 3rd party other than added notes and
mark ups for required changes.
approved for print/date
PROOF ROUND
Technical
Approval
NON PRINTING COLOURS
COLOURS
DATE SENT:
DATE RECEIVED:
Item number:
ORIGINATOR:
ORIGINATION DATE:
REVISION DATE:
REVISED BY:
DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
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6.
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GTIN 13
(Belgium & Slovenia):
[e-mail]
DIHYDROCODEINE-PARACETAMOL ALL STRENGTHS TABLET PIL (REEL FED) - UK
Black
Profile
BBBA7360
C Fox
15/01/2020
24/07/2020
G. Worth
175x275 (Reel Fed)
7 pt
Accord Barnstaple
N/A
N/A
3
Version 6
12.12.2019
German GTIN 14
(incorporating PZN):
Cartons and label leaflets only
(labels only when specified)
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. See section 4.
WHAT IS IN THIS LEAFLET
1 WHAT CO-DYDRAMOL TABLETS ARE AND WHAT THEY
ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
CO-DYDRAMOL TABLETS
3 HOW TO TAKE CO-DYDRAMOL TABLETS
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE CO-DYDRAMOL TABLETS
6 CONTENTS OF THE PACK AND OTHER INFORMATION
1 WHAT CO-DYDRAMOL TABLETS ARE AND WHAT THEY ARE
USED FOR
This medicine has been prescribed for you for the relief of

Características técnicas

CO-DYDRAMOL TABLETS 10/500MG
Summary of Product Characteristics Updated 11-Jan-2021 | Accord-UK Ltd
1. NAME OF THE MEDICINAL PRODUCT
CO-DYDRAMOL TABLETS BP 10/500mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg Dihydrocodeine Tartrate and 500mg
Paracetamol.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
White uncoated tablets.
White, circular, flat bevelled-edge uncoated tablets impressed with
“C” and “CT” on either side of a central division line
on one face. Nominal diameter 12.5mm.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Analgesic for the relief of mild to moderate pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Prior to starting treatment with opioids, a discussion should be held
with patients to put in place a strategy for ending
treatment with Co-Dydramol Tablets in order to minimise the risk of
addiction and drug withdrawal syndrome (see section
4.4).
It is recommended that this product should be taken during or after
meals.
_Adults and children over 16 years:_
One to two tablets every four to six hours when necessary up to a
maximum of eight tablets in 24 hours.
_Elderly:_
As for adults, however a reduced dose maybe required if renal or
hepatic function is impaired.
_Paediatric Population:_
_Children 12-15 years:_
One tablet every 4-6 hours when necessary to a maximum of 4 tablets in
24 hours.
_Children under 12 years:_
Not recommended.
METHOD OF ADMINISTRATION
For oral administration.
4.3 CONTRAINDICATIONS
• Hypersensitivity to the active substances or any of the excipients
listed in section 6.1.
• Diarrhoea caused by poisoning until the toxic material has been
eliminated, or diarrhoea associated with
pseudomembraneous colitis
• Respiratory depression
• Obstructive airways disease
• Liver disease
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Drug dependence, tolerance and potential for abuse
For all patients, prolonged use of this product may lead to drug
dependence (addiction), even at therapeutic doses. The
risks ar