Co-Codamol 30mg/500mg Effervescent Tablets

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Paracetamol; Codeine phosphate hemihydrate

Предлага се от:

Amdipharm Limited

АТС код:

N02AJ; N02AJ06

INN (Международно Name):

Paracetamol; Codeine phosphate hemihydrate

дозиране:

30 mg/500 milligram(s)

Лекарствена форма:

Effervescent tablet

Терапевтична област:

Opioids in combination with non-opioid analgesics; codeine and paracetamol

Статус Оторизация:

Not marketed

Дата Оторизация:

2010-10-08

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER
CO-CODAMOL 30MG/500MG
EFFERVESCENT TABLETS
CODEINE PHOSPHATE HEMIHYDRATE/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 further questions, ask your doctor, pharmacist or
nurse.
-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, pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
The name of your medicine is Co-codamol 30mg/500mg Effervescent
Tablets. It will be referred
to as Co-codamol Effervescent Tablets for ease hereafter.
WHAT IS IN THIS LEAFLET
1. What Co-codamol Effervescent Tablets are and what they are used for
2. What you need to know before you take Co-codamol Effervescent
Tablets
3. How to take Co-codamol Effervescent Tablets
4. Possible side effects
5. How to store Co-codamol Effervescent Tablets
6. Content of the pack and other information
1. WHAT CO-CODAMOL EFFERVESCENT TABLETS ARE AND WHAT THEY ARE USED FOR
Co-codamol Effervescent Tablets contain paracetamol and codeine.
Paracetamol is an analgesic
(relieves pain) and an antipyretic (lowers raised temperatures). This
product contains codeine.
Codeine belongs to a group of medicines called opioid analgesics which
act to relieve pain.
Co-codamol Effervescent Tablets are used for the relief of mild to
severe short term 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 EFFERVESCENT
TABLETS
Do not take with any other paracetamol-containing products. Do not
take for longer than directed
by your prescriber. Do not use Co-codamol for pain relief in children
and adolescents (0-

Данни за продукта

Health Products Regulatory Authority
23 December 2019
CRN0095ZC
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Co-Codamol 30mg/500mg Effervescent Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Codeine Phosphate hemihydrate 30mg and
Paracetamol 500mg.
Excipient(s) with known effect:
Each tablet also contains 487mg of sorbitol and 413 mg of sodium.
For the full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Effervescent Tablet
Bevelled, flat, round, white tablet with a scoreline on one face
Although Co-codamol tablets have a score line the tablets are not to
be halved as they do not divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of mild to severe acute 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
Adults: The usual dose is one or two tablets every six hours as
required. The total daily dose should not exceed 4 g paracetamol
(8 tablets in a day).
Codeine 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. The total daily dose should
not exceed 120mg codeine (8 tablets in a day).
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.
Older People: As for adults, however a reduced dose may be required
(see section 4.4)
Paediatric population:
Children aged 16 and over:
Two tablets to be taken every six hours as required, up to a maximum
of eight tablets in any 24-hour period.
Children aged 12 to 15 years:
One tablet to be taken every six hours as required, up to a maximum of
four tablets in any 24-hour period.
Children aged less than 12 years:
Codeine should not be used in children below