Calpol Six Plus Fastmelts 250 mg Paracetamol Orodispersible Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; Paracetamol

Available from:

McNeil Healthcare (Ireland) Ltd

ATC code:

N02BE; N02BE01

INN (International Name):

Paracetamol; Paracetamol

Dosage:

250 milligram(s)

Pharmaceutical form:

Orodispersible tablet

Prescription type:

Medicinal product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol

Authorization status:

Marketed

Authorization date:

2001-02-23

Patient Information leaflet

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 FASTMELTS
™
is used to relieve
pain such as tooth pain, headache, 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 any of the ingredients.
■
If s/he is taking anything else with paracetamol in it.
■
If s/he has phenylketonuria (a hereditary disease discovered
at birth.)
If any of these applies, 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.
Other medicines and Calpol
®
Tell your doctor or pharmacist if your child is taking any
other medicines including:
■
_metoclopramide _or _domperidone _(used to treat nausea and
vomiting)
■
_colestyramine _(used to treat high cholesterol)
■
_anticoagulants _(drugs that thin the blood, such as warfarin)
■
_anticonvulsants _(drugs to treat epilepsy)
If you are not sure about the medicine your child is taking,
show the bottle or pack to

Summary of Product characteristics

Health Products Regulatory Authority
25 September 2018
CRN008JY4
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calpol Six Plus Fastmelts 250 mg Paracetamol Orodispersible Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains –
Paracetamol 250 mg
Excipients with known effect:
Aspartame (E951) 8 mg
_For the full list of excipients, see section 6.1_
3 PHARMACEUTICAL FORM
Orodispersible tablet
White, round, bi-convex tablets with central concave depression and a
characteristic
strawberry odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Calpol Six Plus Fastmelts are indicated for the treatment of mild to
moderate pain
such as headache, teething pain and sore throat, and as an antipyretic
(e.g. fever
associated with colds and flu).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral:
Tablets should be placed in the mouth where they melt on the tongue.
The tablet will
rapidly disperse to a pleasant tasting paste that can be easily
ingested. Alternatively
the tablet can be dispersed in a teaspoonful of water or milk.
Adults and Children
Child’s Age
How Much
How often (in 24 hours)
UNDER 6 YEARS
NOT RECOMMENDED
N/A
6 - 9 years
1 tablet
4 times
9 - 12 years
2 tablets
4 times
Health Products Regulatory Authority
25 September 2018
CRN008JY4
Page 2 of 9
12 - 16 years
2 to 3 tablets
4 times
Adults and children over 16 years
2 to 4 tablets
4 times
oDo not give more than 4 doses in any 24 hour period
oLeave at least 4 hours between doses
oDo not give this medicine to your child for more than 3 days without
speaking
to your doctor or pharmacist
USE IN THE ELDERLY
Normal adult dosage is appropriate. However, a reduction in dosing may
be
necessary in frail, elderly subjects (see Section 5.2).
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
Calpol Six Plus Fastmelts are contra-indicated in patients with
phenylketonuria.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Calpol Six Plus Fastmelts should be used with