Calprofen 100mg/5ml oral suspension

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Ibuprofen

Tersedia dari:

McNeil Products Ltd

Kode ATC:

M01AE01

INN (Nama Internasional):

Ibuprofen

Dosis:

20mg/1ml

Bentuk farmasi:

Oral suspension

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 10010100; GTIN: 5010123728328 5010123728311

Selebaran informasi

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

Karakteristik produk

OBJECT 1
CALPROFEN 100MG/5ML ORAL SUSPENSION IBUPROFEN
Summary of Product Characteristics Updated 04-May-2018 | McNeil
Products Ltd
1. Name of the medicinal product
Calprofen 100mg/5ml Oral Suspension Ibuprofen
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, post-immunisation pyrexia, rheumatic or
muscular pain, headache, reduction of
fever, sore throat, teething pain, toothache, minor aches and pains,
symptoms of cold and influenza.
4.2 Posology and method of administration
To be taken orally. For short term use only.
Children aged 3 months to 12 years:
Not recommended for children weighing less than 5 kg.
For pain and fever – 20mg/kg/day in divided doses.
Infants 3-6 months:
2.5 ml three times a day. Do not use for more than 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
Doses should be taken every 6 – 8 hours when required, and at least
4 hours should be left between doses.
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
4.3 Contraindications
Hypersensitivity to Ibuprofen or any of the excipients in t