Calpol Six Plus 250mg/5ml Oral Suspension

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Paracetamol

Verfügbar ab:

Johnson & Johnson (Ireland) Limited

ATC-Code:

N02BE; N02BE01

INN (Internationale Bezeichnung):

Paracetamol

Dosierung:

250 mg/5ml

Darreichungsform:

Oral suspension

Verschreibungstyp:

Product not subject to medical prescription

Therapiebereich:

Anilides; paracetamol

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

1995-01-25

Gebrauchsinformation

Package leaflet: Information for the user
Read all of this leaflet carefully before you start using 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 your child gets 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 your child does not feel better or
feels worse after 3 days.
What is in this leaflet
1. What CALPOL
®
is and what it is used for
2. What you need to know before you use CALPOL
®
3. How to use CALPOL
®
4. Possible side-effects
5. How to store CALPOL
®
6. Contents of the pack and other information
1
What Calpol
®
is and what it is used for
The paracetamol in CALPOL SIXPLUS
®
Suspension is used to
relieve pain such as teething pain and toothache, headache,
migraine, neuralgia, sore throat and aches and pains that come
with colds and flu. It also brings down fever (high temperature).
2
What you need to know before you
use Calpol
®
Do not give your child this medicine…
■ If s/he has ever had a bad reaction to paracetamol or any
of the other ingredients in this medicine (see section 6).
■ If s/he is taking anything else with paracetamol in it.
If any of these apply, get advice from a doctor or
pharmacist without using CALPOL
®
.
Warnings and precautions
Talk to your doctor or pharmacist…
■ If your child has serious kidney or liver problems.
■ If your child has an inherited intolerance
to fructose or been diagnosed with an
intolerance to some other sugars.
■ If your child has Gilbert’s syndrome (familial non-
haemolytic jaundice).
■ If your child has a condition called Glucose-6-phosphate
dehydrogenase deficiency.
■ If your child has haemolytic anaemia.
■ If your child has glutathione deficiency.
■ If your child is

Fachinformation

Health Products Regulatory Authority
11 April 2022
CRN00CSYF
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calpol Six Plus 250mg/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains -
Paracetamol 250 mg.
Excipients with known effect:
Sucrose 2.1g/5ml, Sorbitol 1.89g/5ml, sodium 1.3mg/5ml, propylene
glycol (E1520) 9.72mg /5ml, ethanol 0.0749mg /5ml,
methyl parahydroxybenzoate (E218) 4mg/5ml and Sunset Yellow (E110)
0.25mg/5ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Suspension
An orange coloured and flavoured viscous oral suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Calpol products are indicated for the treatment of mild to moderate
pain and as antipyretics.
Calpol is indicated for the symptomatic relief of headache, migraine,
neuralgia, toothache and teething pains, sore throat,
influenza, feverishness and feverish colds.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
CHILDREN AGED 6 YEARS – 12 YEARS:
CHILD'S AGE
HOW MUCH
HOW OFTEN (IN 24 HOURS)
6 – 8 years
One 5 ml spoonful (large end)
4 times
8 – 10 years
One 5.0 ml spoonful (large end) and one 2.5ml spoonful (small end)
4 times
10 – 12 years
Two 5 ml spoonfuls (large end)
4 times

Do not give more than 4 doses in any 24-hour period

Leave at least 4 hours between doses

Do not give this medicine to your child for more than 3 days without
speaking to your doctor or
pharmacist

Do not give to children under the age of 6 years.

It is important to SHAKE THE BOTTLE for at least 10 seconds before
use.
​
​
CHILDREN AGED 12 – 16 YEARS:
Two – three 5ml spoonfuls (large end) up to 4 times a day.
ADULTS AND CHILDREN OVER 16 YEARS:
Two – four 5ml spoonfuls (large end) up to 4 times a day.
Health Products Regulatory Authority
11 April 2022
CRN00CSYF
Page 2 of 9
CHILDREN UNDER 6 YEARS
Not recommended.
RENAL IMPAIRMENT:
It is recommended, when giving paracetamol to patients with renal
impairment, to reduce the dose and to increase t