Calprofen 100mg/5ml oral suspension paediatric

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Ibuprofen

Beszerezhető a:

McNeil Products Ltd

ATC-kód:

M01AE01

INN (nemzetközi neve):

Ibuprofen

Adagolás:

20mg/1ml

Gyógyszerészeti forma:

Oral suspension

Az alkalmazás módja:

Oral

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 10010100

Betegtájékoztató

Babies under 3 months
Do not give to babies under 3 months.
Consult your doctor.
Children from 3 months to 12 years
For Pain and Fever Relief:
Age
Dose
3 months - 6 months
2.5 ml 3 times a day.
■
weighing over 5 kg
Do not use for more than 24 hours
6 months - 1 year
2.5 ml 3 times a day
1 year - 2 years
2.5 ml 3 or 4 times a day
3 years - 7 years
5 ml 3 or 4 times a day
8 years - 12 years
10 ml (5 ml + 5 ml) 3 or 4 times a day
■
Doses should usually be given every 6 - 8 hours. Leave at least 4
hours
between doses.
■
Short term use only:
-
Do not give to babies aged from 3 months to under 6 months for more
than 24 hours.
-
Do not give to children aged 6 months or over for more than 3 days.
■
If symptoms persist or worsen consult your doctor.
For Post-Immunisation Fever:
Age
Dose
Babies and children
2.5 ml up to twice a day
3 months and over
■
weighing over 5 kg
If necessary, the second dose should be given 6 hours after the first
one.
■
Do not give more than 2 doses in 24 hours.
■
Do not give to a child under 3 months unless recommended by
your doctor.
■
If the fever is not reduced you should consult your doctor.
Speak to your doctor
■
If your baby needs more than the dose shown in the table, or if the
fever doesn't go away, speak to your doctor as soon as possible.
■
If you are not sure of your child's illness or it is accompanied by a
rash, breathing difficulties, diarrhoea or excessive tiredness or
lethargy, speak to your doctor straight away. Do not give
CALPROFEN
®
until you get medical advice.
If anyone has taken too much
If anyone has taken too much of this product, contact a doctor or your
nearest Accident and Emergency Department (Casualty), taking this
leaflet and pack with you.
The symptoms can include nausea, stomach pain, vomiting (may be
blood streaked), headache, ringing in the ears, confusion and shaky
eye movement. At high doses, drowsiness, chest pain, palpitations,
loss of consciousness, convulsions (mainly in children), weakness and
dizziness, blood in urine, cold body feel

Termékjellemzők

OBJECT 1
CALPROFEN IBUPROFEN SUSPENSION
Summary of Product Characteristics Updated 04-May-2018 | McNeil
Products Ltd
1. Name of the medicinal product
Calprofen Ibuprofen Suspension
2. Qualitative and quantitative composition
Ibuprofen 100 mg / 5ml
Also contains maltitol syrup (E965), sodium methylhydroxybenzoate
(E219), sodium
propylhydroxybenzoate (E217), propylene glycol (E1520) and ethanol.
For excipients - see section 6.1
3. Pharmaceutical form
100 mg / 5ml Oral Suspension
Sugar free, colour free, strawberry flavoured white uniform
suspension.
4. Clinical particulars
4.1 Therapeutic indications
Prescription and OTC: Calprofen Ibuprofen Suspension is used as an
analgesic for relief of mild to
moderate muscular pain, rheumatic pain, post-immunisation pyrexia,
symptomatic relief of headache,
earache, dental pain, dysmenorrhoea, neuralgia, migraine and backache.
It can also be used in minor
injuries such as sprains and strains. Ibuprofen 100 mg / 5 ml
Ibuprofen Suspension is effective in the
relief of feverishness and symptoms of colds and influenza.
In the treatment of non-articular rheumatic conditions, Calprofen
Ibuprofen Suspension is indicated for
periarticular conditions such as frozen shoulder (capsulitis),
bursitis, tendonitis, tenosynovitis and low
back pain. Calprofen Ibuprofen Suspension can also be used in soft
tissue injuries such as sprains and
strains.
4.2 Posology and method of administration
For oral administration and short-term use only.
CHILDREN:
For pain and fever - 20mg/kg/day in divided doses (including OTC use).
Infants 3-6 months
weighing more than 5 kg:
One 2.5 ml dose may be taken 3 times in 24 hours
Infants 6-12 months:
2.5ml three times a day.
Children 1-2 years:
2.5ml three to four times a day
Children 3-7 years:
5ml three to four times a day
Children 8-12 years:
10ml three to four times a day.
Post-immunisation fever: 2.5ml (50mg) followed by one further dose of
2.5ml (50mg) six hours later if
necessary. No more than 2 doses in 24 hours. If fever is not reduced,
consult a doctor.
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