Calpol Six Plus 250mg/5ml Sugar/Colour Free Oral Suspension

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Paracetamol

متاح من:

McNeil Healthcare (Ireland) Ltd

ATC رمز:

N02BE; N02BE01

INN (الاسم الدولي):

Paracetamol

جرعة:

250 mg/5ml

الشكل الصيدلاني:

Oral suspension

نوع الوصفة الطبية :

Medicinal product not subject to medical prescription

المجال العلاجي:

Anilides; paracetamol

الوضع إذن:

Marketed

تاريخ الترخيص:

1994-10-14

نشرة المعلومات

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
®
Sugar/Colour Free
Suspension 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 is allergic to paracetamol or any of the
other ingredients of this medicine (listed in section 6).
■
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 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.
■
IF YOUR CHILD HAS AN INHERITED INTOLERANCE
TO FRUCTOSE or been diagnosed with an
INTOLERANCE TO SOME OTHER SUGARS. 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 CHOLES

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calpol Six Plus 250mg/5ml Sugar/Colour Free Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
CALPOL SIX PLUS SUGAR/COLOUR FREE SUSPENSION contains Paracetamol 250
mg per 5 ml.
Excipients with known effect:
Maltitol 2040mg per 5ml
Sorbitol 1400mg per 5ml
Methyl parahydroxybenzoate 5.0mg per 5ml
Propyl parahydroxybenzoate 1.0mg per 5ml
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral Suspension
An off-white oral suspension with an odour of strawberries.
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
For oral administration
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CHILDREN AGED 6 YEARS – 12 YEARS:
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.
CHILDREN UNDER 6 YEARS:
Not suitable for administration to children under 6years of age. [See
Section 4.3]
HEPATIC/RENAL DYSFUNCTION:
Caution should be exer