Co-codamol 8mg/500mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Paracetamol; Codeine phosphate

Dostępny od:

The Boots Company Plc

Kod ATC:

N02AJ06

INN (International Nazwa):

Paracetamol; Codeine phosphate

Dawkowanie:

500mg ; 8mg

Forma farmaceutyczna:

Oral tablet

Droga podania:

Oral

Klasa:

Schedule 5 (CD Inv)

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 04070100; GTIN: 5014363003214

Ulotka dla pacjenta

PACK MOCK UP
ARTWORK TEXT SIZE
MAIN HEADINGS:
13pt
SUB HEADINGS:
11pt
BODY HEADINGS:
9pt
VERSION
NO.
DATE
ISSUED
REASON FOR CHANGE
1
16/11/2022
Safety changes requested
by the MAH
17907/0162
MHRA approved v1 dated
26/05/2022 WBA-2430 R2
Internally approved
32 Tablets
Boots Paracetamol and
Codeine Tablets
PRODUCT NAME:
PRODUCT LICENCE NO.:
WORDING REF:
STATUS:
PACK DETAILS:
PACK SIZE:
Blister strips in a carton
ARTWORK
PARACETAMOL & CODEINE TABLETS
(Codeine phosphate and Paracetamol)
IMPORTANT THINGS YOU SHOULD KNOW ABOUT BOOTS
PARACETAMOL & CODEINE TABLETS
• THIS MEDICINE CAN ONLY BE USED FOR THE SHORT
TERM TREATMENT OF ACUTE MODERATE PAIN WHEN
OTHER PAINKILLERS HAVE NOT WORKED. DO NOT TAKE
LESS THAN FOUR HOURS AFTER TAKING OTHER PAINKILLERS.
• YOU SHOULD ONLY TAKE THIS PRODUCT FOR A MAXIMUM
OF 3 DAYS AT A TIME. IF YOU NEED TO TAKE IT FOR
LONGER THAN 3 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 3 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 3 DAYS IT CAN MAKE THEM WORSE.
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 queries, 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 Boots Paracetamol & Codeine Tablets are and
what they are used for
2. What you need to know before you take Boots
Paracetamol & Codeine Tablets
3. How to take Boots Paracetamol & Codeine Tablets
4. Possible side effects
5. How to store Boots Paracetamol & Codeine T

Charakterystyka produktu

PL 17907/0162
Bristol Laboratories Ltd
Version 14
Page
1
of
19
JANUARY 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Co-Codamol 8mg/500mg Tablets
Boots Paracetamol and Codeine Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500mg Paracetamol and 8mg Codeine phosphate.
Excipient(s) with known effect:
Methyl para hydroxy benzoate (E218): 70.0 to 75.0 %
Propyl para hydroxy benzoate (E216): 9.0 to 13.0%
Ethyl para hydroxy benzoate (E214): 14.0 to 18.0%
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
Clean, white tablets, bevelled edged, debossed with ‘8’ and broken
breakline on one
side and ‘BL’ on the other side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Codeine is indicated in patients older than 12 years of age for the
short term
treatment of acute moderate pain which is not considered to be
relieved by
other analgesics such as paracetamol or ibuprofen (alone).
For the symptomatic relief of pain including, headache, migraine,
toothache,
period pains, rheumatic pains, including muscle pains and backache.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
ADULTS OVER 18 YEARS
:
Co-codamol should be used at the lowest effective dose for the
shortest period
of time. One or two tablets to be swallowed with water. The dose
should not
be repeated more frequently than every four to six hours and not more
than
PL 17907/0162
Bristol Laboratories Ltd
Version 14
Page
2
of
19
JANUARY 2023
four times in any 24 hour period. Maximum dose is 8 tablets (4.0gm of
paracetamol and 64mg of codeine in divided doses) per 24 hours.
Do not take continuously for more than 3 days without consulting your
doctor.
_ _
PAEDIATRIC POPULATION:
CHILDREN AGED 16 YEARS TO 18 YEARS:
The recommended dose for children 16 years and older is 1 to 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 dose for children 12 years to 15 years is 1 tablet
which may
be repeated every 6