Calpol 6 Plus Suspension Oral Suspension 250mg/5ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PARACETAMOL

Available from:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ATC code:

N02BE01

INN (International Name):

PARACETAMOL 250 mg/5ml

Pharmaceutical form:

ORAL SUSPENSION

Composition:

PARACETAMOL 250 mg/5ml

Prescription type:

OTC

Therapeutic area:

ANALGESICS

Authorization status:

Authorised

Authorization date:

2006-10-30

Patient Information leaflet

Page 1 of 5
1
WHAT CALPOL 6 PLUS SUSPENSION IS AND WHAT IT IS USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU USE CALPOL 6 PLUS SUSPENSION
PACKAGE LEAFLET: INFORMATION FOR THE USER
CALPOL* 6 PLUS SUSPENSION
Paracetamol 250 mg/5 ml Oral Suspension
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 recommended for your child only. Do not pass it
on to others. It may harm
them, even if their signs of illness are the same.
•
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.
WHAT IS IN THIS LEAFLET:
1
What Calpol 6 Plus Suspension is and what it is used for
2
What you need to know before you use Calpol 6 Plus Suspension
3
How to use Calpol 6 Plus Suspension
4
Possible side effects
5
How to store Calpol 6 Plus Suspension
6
Contents of the pack and other information
Calpol 6 Plus Suspension contains 250mg paracetamol (the active
ingredient) in each 5ml dose. There
are also some inactive ingredients in Calpol 6 Plus Suspension.
Calpol 6 Plus Suspension is used for the relief of mild to moderate
pain including toothache and headache.
It is also used to lower a high temperature (fever). For severe pain,
a very high temperature, or if the
medicine does not appear to be easing the symptoms, consult your
doctor.
DO NOT GIVE CALPOL 6 PLUS SUSPENSION:
•
If your child is allergic (hypersensitive) to paracetamol or any of
the other ingredients of Calpol 6
Plus Suspension (listed in Section 6).
WARNINGS AND PRECAUTIONS
•
Talk to your doctor or pharmacist before using Calpol 6 Plus
Suspension:
o
If your child suffers from severe kidney or liver disease.
Page 2 of 5
3
HOW TO USE CALPOL 6 PLUS SUSPENSION
o
If your child has inherited intolerance to fructose.
o
If your child is taking warfarin or similar medici

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
PRODUCT SUMMARY
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Calpol 6 Plus Suspension.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol Ph. Eur 250mg in each 5ml.
Excipients with known effect:
Sorbitol 70% solution
Propylene glycol
Sunset yellow
Methyl parahydroxybenzoate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the treatment of mild to moderate pain (including teething pain)
and as an
antipyretic.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
6 TO 12 YEARS:
CHILD'S AGE
HOW MUCH
HOW OFTEN (IN 24
HOURS)*
Under 6 years
Not recommended
N/A
6 – 8 years
5 ml
4 times
8 – 10 years
7.5 ml (5 ml + 2.5 ml)
4 times
10 – 12 years
10 ml (5 ml + 5 ml)
4 times
•
Do not give more than 4 doses in any 24 hour period
•
Leave at least 4 hours between doses
day
Children aged 12-16 years: 10 – 15ml (Two to three 5 ml doses) up to
4 times a
Adults and children over 16 years: 10 – 20 ml (Two to four 5 ml
doses) up to 4
times a day.
It is important to
SHAKE THE BOTTLE
for at least 10 seconds before use
.
Use in the Elderly: In the elderly the dosage of paracetamol is as for
adults (500
mg to 1 g every 4 to 6 hours up to a maximum of 4 g daily) as the rate
and extent
of paracetamol absorption is normal. The dosage may need to be
adjusted in the
elderly as the plasma half-life is longer and paracetamol clearance is
lower than in
young adults.
The dosage should not be continued for more than 3 days without
consulting a
doctor.
For oral administration
Hepatic Dysfunction
Caution should be exercised when administering Calpol 6 Plus
Suspension to
patients with severe hepatic impairment. Dose-related toxicity has
been reported;
avoid large doses.
Renal Dysfunction
Caution should be exercised when administering Calpol 6 Plus
Suspension to
patients with moderate to severe renal impairment.
4.3.
CONTRA-INDICATIONS
Calpol 6 Plus Suspension is contra-indicated in patients with known
hypersensitivity to