Paracetamol/Codeine 500 mg/30 mg, effervescent tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Codeine phosphate hemihydrate; PARACETAMOL

Available from:

Bristol Laboratories Limited

ATC code:

N02AJ; N02AJ06

INN (International Name):

Codeine phosphate hemihydrate; PARACETAMOL

Dosage:

500/30 milligram(s)

Pharmaceutical form:

Effervescent tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

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

Authorization status:

Not marketed

Authorization date:

2014-12-05

Patient Information leaflet

Package Leaflet: Information for the User
Paracetamol/Codeine 500 mg / 30 mg Effervescent Tablets
Paracetamol/Codeine Phosphate Hemihydrate
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 Paracetamol/Codeine 500 mg / 30 mg Effervescent Tablets are
and what they
are used for
2. What you need to know before you take Paracetamol/Codeine 500 mg /
30 mg Effervescent Tablets
3. How to take Paracetamol/Codeine 500 mg / 30 mg Effervescent Tablets
4. Possible side effects
5. How to store Paracetamol/Codeine 500 mg / 30 mg Effervescent
Tablets
6. Contents of the pack and other information
1. What Paracetamol/Codeine 500 mg / 30 mg Effervescent Tablets are
and what they are used for
This medicine contain Paracetamol/Codeine. Paracetamol is an analgesic
(relieves pain) and an antipyretic
(lowers raised temperatures). Codeine belongs to a group of medicines
called opioid analgesics which act
to relieve pain.
This medicine can be used in patients over 16 years 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
Paracetamol/Codeine 500 mg / 30 mg Effervescent Tablets
Do not take this medicine if:
•
you are allergic to paracetamol or codeine, or any of the other
ingredients of this medicine (listed in
section 6)
•
you suffer from breathing problems, for example chronic bronchitis or
emphysema or are suffering an
asthma attack
•
you are taking monoamine oxidase inhibitors (MAOIs) or ha

Summary of Product characteristics

Health Products Regulatory Authority
16 November 2018
CRN008L7G
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol/Codeine 500 mg/30 mg, effervescent tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500mg and Codeine Phosphate
hemihydrate 30mg.
Excipients with known effect: Each tablet also contains 487 mg of
sorbitol and 413
mg of sodium.
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Effervescent tablet
Bevelled, flat, round, white tablet with a scoreline on one face.
Although the tablets have a score line, they are not to be halved as
they do not
divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PARACETAMOL CODEINE 500 mg / 30 mg, effervescent tablets is indicated
in the
relief of severe pain in adults. 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 four hours as
required. The total
daily dose should not exceed 4 g paracetamol and 240 mg of codeine (8
tablets in a
day).
Elderly: As for adults, however a reduced dose may be required (see
section 4.4)
Health Products Regulatory Authority
16 November 2018
CRN008L7G
Page 2 of 16
Paediatric population:
_Adolescents 16-18 years old (body weight >35 kg)_
The dose should primarily be calculated based on the codeine component
and body
weight. The recommended dose for codeine is 0.5-1 mg / kg body weight
/ dose
with a maximum dose of codeine of 60mg, every 6 hours when necessary
up to
maximum dose of 240 mg daily. The maximum doses of 15 mg / kg body
weight /
dose (60 mg / kg body weight / day) of paracetamol and 1 mg / kg body
weight /
dose (4 mg / kg body weight / day) of codeine must not be exceeded. Do
not take
more that 8 tablets in a 24 hour period.
_Children aged 12- 15 years:_
This com