Calpol Infant 120mg/5ml oral suspension 5ml sachets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Paracetamol

Διαθέσιμο από:

McNeil Products Ltd

Φαρμακολογική κατηγορία (ATC):

N02BE01

INN (Διεθνής Όνομα):

Paracetamol

Δοσολογία:

24mg/1ml

Φαρμακοτεχνική μορφή:

Oral suspension

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 04070100; GTIN: 5010123720261

Φύλλο οδηγιών χρήσης

■
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 Suspension Sachets
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 doctor or
pharmacist 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 other medicines
including:
■
_meto

Αρχείο Π.Χ.Π.

OBJECT 1
CALPOL INFANT SUSPENSION SACHETS
Summary of Product Characteristics Updated 26-Jan-2016 | McNeil
Products Ltd
1. Name of the medicinal product
Calpol Infant Suspension Sachets
2. Qualitative and quantitative composition
Calpol Infant Suspension Sachets contains 120mg Paracetamol in each
5ml.
Excipients: sucrose (contains 2.2 g of sucrose in each 5 ml), sorbitol
liquid (E420), methyl
parahydroxybenzoate (E218), ethyl parahydroxybenzoate (E214), propyl
parahydroxybenzoate (E216)
and carmoisine (E122). See section 4.4 for further information.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral Suspension
A pink strawberry flavoured suspension
4. Clinical particulars
4.1 Therapeutic indications
Calpol Infant Suspension Sachets 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 & 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 (IN 24 HOURS)
3 – 6 months
One 2.5 ml spoonful (small end)
4 times
6 – 24 months
One 5 ml spo