Calpol Infant Sugar Free Colour Free 120mg/5ml oral suspension

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Paracetamol

Dostupné s:

McNeil Products Ltd

ATC kód:

N02BE01

INN (Mezinárodní Name):

Paracetamol

Dávkování:

24mg/1ml

Léková forma:

Oral suspension

Podání:

Oral

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 04070100; GTIN: 3574660418439

Informace pro uživatele

■
This medicine brings down high temperatures (also called
fever) and relieves pain.
■
The medicine is OK for most babies over 2 months and
children up to 6 years.
■
Do not give it to children on this list:
■
Not to babies or children taking some other medicines.
_See section 2_
■
Not to anyone who is allergic to the ingredients.
_See section 6_
■
Follow the dosage instructions carefully. Children of
different ages need different amounts. These are shown in
the tables. _See section 3_
■
Speak to your doctor if anything in this list applies:
■
If a child is not getting better, or needs more medicine
than shown in the table. _See section 3_
■
If a child gets a rash, breathing problems, diarrhoea or
gets very tired. _See section 3_
Now read this whole leaflet carefully before you use this
medicine. Keep the leaflet: you might need it again.
1 What the medicine is for
The paracetamol in CALPOL
®
Infant Sugar Free Colour Free
120 mg/5 ml Oral Suspension is used to relieve pain and /
or bring down fever (high temperature) in many conditions
including post-immunisation fever, teething, headache, cold and
flu, toothache, earache, sore throat and other aches and pains.
2 Before giving the
medicine to your child
This medicine is suitable for most people but a few people
should not use it. If you are in any doubt, talk to your doctor
or pharmacist.
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 is between 2-3 months old and is taking this
medicine for other causes of pain and fever and:
■
Weighs less than 4 kg or
■
Was born before 37 weeks
If any of these applies, get advice from a pharmacist
or doctor without using CALPOL
®
.
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 is taking any othe

Charakteristika produktu

OBJECT 1
CALPOL INFANT SUGAR FREE COLOUR FREE 120 MG/5
ML ORAL SUSPENSION
Summary of Product Characteristics Updated 20-Jan-2016 | McNeil
Products Ltd
1. Name of the medicinal product
CALPOL Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension
2. Qualitative and quantitative composition
CALPOL Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension
contains 120 mg Paracetamol in
each 5 ml.
Excipients: maltitol liquid (E965), sorbitol liquid (E420), methyl
parahydroxybenzoate (E218), ethyl
parahydroxybenzoate (E214) and propyl parahydroxybenzoate (E216). See
section 4.4 for further
information.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral Suspension.
An off-white strawberry flavoured suspension.
4. Clinical particulars
4.1 Therapeutic indications
CALPOL Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension is
indicated for the treatment of
mild to moderate pain and as an antipyretic. It can be used in many
conditions including headache,
toothache, earache, teething, sore throat, colds and influenza, aches
and pains and post-immunisation
fever.
4.2 Posology and method of administration
FOR THE RELIEF OF FEVER AFTER VACCINATIONS AT 2, 3 AND 4 MONTHS
2.5ml. This dose may be given up to 4 times a day starting at the time
of vaccination. Do not give more
than 4 doses in any 24 hour period. Leave at least 4 hours between
doses. If your baby still needs this
medicine two days after receiving the vaccine talk to your doctor or
pharmacist.
AGE : 2 – 3 MONTHS
DOSE
PAIN AND OTHER CAUSES OF FEVER - if your baby
weighs over 4 kg and was born after 37 weeks
2.5 ml
If necessary, after 4-6 hours, give a second 2.5 ml
dose
• Do not give to babies less than 2 months of age.
• Leave at least 4 hours between doses.
• Do not give more than 2 doses. This is to ensure
that fever that may be due to a serious infection is
quickly diagnosed. If your child is still feverish after
two doses, talk to your doctor or pharmacist.
CHILDREN AGED 3 MONTHS – 6 YEARS:
CHILD'S AGE
HOW MUCH
HOW OFTEN