Maxilief Effervescent Tablets Paracetamol 500mg Codeine Phosphate Hemihydrate 8mg Caffeine 30mg

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Paracetamol; Codeine phosphate hemihydrate; Caffeine

Disponibil de la:

Clonmel Healthcare Ltd

Codul ATC:

N02BE; N02BE51

INN (nume internaţional):

Paracetamol; Codeine phosphate hemihydrate; Caffeine

Dozare:

500/8/30 milligram(s)

Forma farmaceutică:

Effervescent tablet

Tip de prescriptie medicala:

Product not subject to medical prescription

Zonă Terapeutică:

Anilides; paracetamol, combinations excl. psycholeptics

Statutul autorizaţiei:

Marketed

Data de autorizare:

2002-10-11

Prospect

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
MAXILIEF EFFERVESCENT TABLETS
Paracetamol
500mg
Codeine Phosphate Hemihydrate
8mg
Caffeine
30mg
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
WHAT IS IN THIS LEAFLET
1. What Maxilief Effervescent Tablets are and what they are used for
2. What you need to know before you take Maxilief Effervescent Tablets
3. How to take Maxilief Effervescent Tablets
4. Possible side effects
5. How to store Maxilief Effervescent Tablets
6. Contents of the pack and other information.
1. WHAT MAXILIEF EFFERVESCENT TABLETS ARE AND WHAT THEY ARE USED
FOR
Maxilief Effervescent Tablets contain paracetamol 500 mg, codeine
phosphate hemihydrate 8 mg and
caffeine 30 mg.
Paracetamol is an analgesic (a painkiller) and an antipyretic (reduces
fever). This product contains
codeine. Codeine belongs to a group of medicines called opioid
analgesics which act to relieve pain. It
can be used on its own or in combination with other pain killers such
as paracetamol. Codeine
phosphate hemihydrate also has some weak cough suppressant action.
Caffeine is a stimulant which
acts to enhance the analgesic effects of paracetamol.
Maxilief Effervescent Tablets are used for the relief of headache,
including migraine, musculoskeletal
pain, toothache, backache, common cold, influenza and menstrual pain.
Codeine can be used in children over 12 years of age for the
short-term relief of acute moderate pain
that is not relieved by other painkillers such as paracetamol or
ibuprofen alo

Caracteristicilor produsului

Health Products Regulatory Authority
19 May 2022
CRN00CWMM
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Maxilief Effervescent Tablets Paracetamol 500mg Codeine Phosphate
Hemihydrate 8mg Caffeine 30mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500mg, Codeine Phosphate 8mg and
Caffeine 30mg.
Excipients with known effect:
Sorbitol (E420) 50mg and Sodium 388mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent Tablets
Flat, white, bevelled-edge tablets, scored on one side and plain on
reverse.
The scoreline is only to facilitate breaking and not to divide into
equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of symptoms of headache, including migraine,
musculoskeletal pain, toothache, backache, common cold,
influenza and menstrual 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
For oral administration only.
Adults (including the elderly)
Two tablets dissolved in a glass of water three to four times in a 24
hour period as required. The dose should not be repeated
more frequently than every 6 hours.
A maximum of 8 tablets in 24 hours should not be exceeded.
Paediatric population:
Maxilief is contraindicated in children below the age of 12 years for
the symptomatic treatment of cold (see section 4.3).
_Children aged 16 to 18 years:_
One to two tablets dissolved in a glass of water every 6 hours when
necessary up to a maximum of 8 tablets in 24 hours.
_Children aged 12 to 15 years:_
One tablet dissolved in a glass of water every 6 hours when necessary
up to a maximum of four tablets in 24 hours.
_Children aged less than 12 years:_
Codeine 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 codei