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

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Paracetamol

Disponível em:

McNeil Products Ltd

Código ATC:

N02BE01

DCI (Denominação Comum Internacional):

Paracetamol

Dosagem:

24mg/1ml

Forma farmacêutica:

Oral suspension

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 04070100; GTIN: 5010123718855 5010123719982

Folheto informativo - Bula

■
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
®
Sugar Free 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
includin

Características técnicas

OBJECT 1
CALPOL SUGAR FREE INFANT SUSPENSION SACHETS
Summary of Product Characteristics Updated 26-Jan-2016 | McNeil
Products Ltd
1. Name of the medicinal product
CALPOL Sugar Free Infant Suspension Sachets
2. Qualitative and quantitative composition
Calpol Sugar Free Infant Suspension Sachets contains 120 mg
Paracetamol in each 5 ml.
Excipients: maltitol liquid ((E965), contains 2.72 g of maltitol 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 Sugar Free 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
On