Calprofen 100mg/5ml oral suspension 5ml sachets

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; GTIN: 5010123728359

Betegtájékoztató

17-0473
900270A
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■
This medicine brings down high temperature (also called fever)
and relieves pain such as headache, toothache, sore throat and
symptoms of cold and flu.
■
The medicine is OK for most babies over 3 months, children
and adults.
■
The active ingredient in this medicine is Ibuprofen which is a
non-steroidal anti-inflammatory (NSAID) painkiller.
■
Follow the dosage instructions carefully. Children of different
ages need different amounts. These are shown in the table.
_See section 3_
■
Speak to your doctor if anything in this list applies:
■
If a child suffers from any of the conditions mentioned in
section 2. _See section 2_
■
If a child is taking aspirin at doses of above 75 mg a day.
_See section 2_
■
If a child is taking any other medicines. _See section 2_
■
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_
■
If the symptoms persist or worsen. _See section 3_
■
Do not use this product and speak to your doctor if you
are trying to get pregnant, suspect you are pregnant,
are pregnant or are breast-feeding. _See section 2_
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
Ibuprofen belongs to a group of medicines called non-steroidal
anti-inflammatory painkillers (NSAIDs).
The Ibuprofen in CALPROFEN
®
is used as an analgesic for relief of
mild to moderate pain due to sore throat, teething pain, toothache,
headache, minor aches and pains, symptoms of cold and flu.
CALPROFEN
®
also brings down a high temperature including
post-immunisation fever.
This product is intended for use in children aged 3 months to 12
years.
2
Before giving the medicine to
your child
This product is suitable for most people but a few people should not
use
it. If you are in any doubt you should contact your doctor or
pharmacist.
Do not give your child this medicine…

Termékjellemzők

OBJECT 1
CALPROFEN 100MG/5ML IBUPROFEN SUSPENSION
(SACHETS)
Summary of Product Characteristics Updated 30-Apr-2018 | McNeil
Products Ltd
1. Name of the medicinal product
Calprofen 100mg/5ml Ibuprofen Suspension
2. Qualitative and quantitative composition
Ibuprofen 100 mg/5 ml
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
Oral Suspension
Sugar Free, Colour Free and Strawberry Flavour
4. Clinical particulars
4.1 Therapeutic indications
Children aged 3 months to 12 years:
Mild to moderate pain due to sore throat, teething pain, toothache,
rheumatic or muscular pain, headache,
minor aches and pains, symptoms of cold and influenza,
post-immunisation pyrexia and reduction of
fever.
4.2 Posology and method of administration
To be taken orally. For short term use only.
Massage the sachet before opening.
Children aged 3 months to 12 years:
For pain and fever – 20mg/kg/day in divided doses.
Infants 3-6 months
weighing more than 5 kg:
One 2.5ml dose may be taken 3 times in 24 hours
Infants 6-12 months:
2.5 ml three times a day
Children 1-2 years:
2.5 ml three to four times a day
Children 3-7 years:
5 ml three to four times a day
Children 8-12 years:
10 ml three to four times a day
Post-immunisation fever:
2.5 ml (50 mg) followed by one further dose of 2.5 ml (50mg) six hours
later if necessary. No more than
2 doses in 24 hours. If fever is not reduced, consult a doctor.
Do not give to children under 3 months of age.
For children aged ≥3 months to ≤5 months: if the child's symptoms
worsen or if the symptoms persist for
more than 24 hours, consult a doctor
For children aged 6 months and over: if symptoms worsen or if the
symptoms persist for more than 3
days, consult a doctor
Discard any unused portion of an opened sachet.
4.3 Contraindications
Hypersensitivity to ibuprofen or any of the excipients in the product.
Patients who have previously shown hypersensitivit