Care Ibuprofen for Children 100mg5ml oral suspension

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Ibuprofen

Διαθέσιμο από:

Thornton & Ross Ltd

Φαρμακολογική κατηγορία (ATC):

M01AE01

INN (Διεθνής Όνομα):

Ibuprofen

Δοσολογία:

20mg/1ml

Φαρμακοτεχνική μορφή:

Oral suspension

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 10010100; GTIN: 5011309400816

Φύλλο οδηγιών χρήσης

FRONT FACE TOP
MHRA HEADER BOX
PCP HEADER BOX
PRODUCT TITLE
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
COLOURS USED
FONTS USED
OPERATOR
ARTWORK NO.
CRN
REASON FOR
CHANGE
SUFFIX
MHRA/IMB
SUBMISSION
REQUIRED
APPROVED BY
DATE
ISSUED BY
DATE
Leaflet
100ml
92767231802
338 x 148mm Flat (29 x 148mm folded)
1
19.02.2018
Care Ibuprofen for Children Oral
Suspension
Yes
A
GKE
930145
14746
Update in line with
PSUSA/10345/201702
Helvetica
9pt
16pt
Process Black
Keyline (Non-Printing)
2767231802
Datamatrix:
VERIFIED
POINT SIZES USED
MIN MAX
MHRA HEADER BOX
PCP HEADER BOX
PRODUCT TITLE
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
COLOURS USED
FONTS USED
OPERATOR
ARTWORK NO.
CRN
REASON FOR
CHANGE
SUFFIX
MHRA/IMB
SUBMISSION
REQUIRED
APPROVED BY
DATE
ISSUED BY
DATE
Leaflet
100ml
92767231802
338 x 148mm Flat (29 x 148mm folded)
1
19.02.2018
Care Ibuprofen for Children Oral
Suspension
Yes
A
GKE
930145
14746
Update in line with
PSUSA/10345/201702
Helvetica
9pt
16pt
Process Black
Keyline (Non-Printing)
2767231802
Datamatrix:
VERIFIED
POINT SIZES USED
MIN MAX
CARE IBUPROFEN FOR
CHILDREN ORAL SUSPENSION
(Ibuprofen 100mg/5ml)
IMPORTANT INFORMATION ABOUT IBUPROFEN FOR
CHILDREN
•
This medicine reduces fever and relieves mild
to moderate pain in infants and children
between 6 months and 12 years old.
•
Follow the dosage instructions carefully.
Children of different ages need different
amounts. See section 3.
DO NOT GIVE….
•
For longer than 3 days.
•
To infants under 6 months old.
•
To anyone who is allergic to the ingredients.
See section 6.
•
To anyone who is allergic to aspirin.
TALK TO YOUR DOCTOR….
•
If your child is taking or is allergic to any
other painkiller.
•
If your child has asthma.
NOW READ THE REST OF THE LEAFLET BEFORE YOU
USE THIS MEDICINE. IT INCLUDES OTHER
INFORMATION WHICH MIGHT BE ESPECIALLY
IMPORTANT FOR YOU.
•
Keep this leaflet. You may need to read it
again.
•
Ask your pharmacist if you need any more
information or advice.
•
If any of the side effects gets serious, or if
y

Αρχείο Π.Χ.Π.

OBJECT 1
CARE IBUPROFEN FOR CHILDREN ORAL SUSPENSION
Summary of Product Characteristics Updated 08-Mar-2018 | Thornton &
Ross Ltd
1. Name of the medicinal product
Care Ibuprofen for Children Oral Suspension
2. Qualitative and quantitative composition
Ibuprofen 100 mg / 5ml
3. Pharmaceutical form
Oral Suspension
A white, opaque smooth suspension.
4. Clinical particulars
4.1 Therapeutic indications
For reduction of fever (including post immunisation fever) and relief
of mild to moderate pain such as
headache, sore throat, teething pain and toothache, cold and flu
symptoms, minor aches and sprains.
4.2 Posology and method of administration
To be taken with or after food.
For oral administration and short term use only.
Children 8 to 12 years: 10ml three to four times daily.
Children 3 to 7 years: 5ml three to four times daily.
Children 1 to 2 years: 2.5ml three to four times daily.
Infants 6 to 12 months: 2.5ml three times daily.
If this medicinal product is required for more than 3 days, or if
symptoms worsen a doctor should be
consulted.
Not to be given to children under six months of age except on the
advice of a doctor.
For post immunisation fever: 2.5ml followed by one further 2.5ml 6
hours later, if necessary. No more
than 2 doses in 24 hours. If fever is not reduced, consult your
doctor.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
4.3 Contraindications
Patients with a known hypersensitivity to Ibuprofen, Aspirin or any of
the product's constituents.
Patients with a history of bronchospasm, rhinitis or urticaria
particularly associated with therapy with
aspirin or other anti-inflammatory drugs.
Active or history of recurrent peptic ulcer/haemorrhage (two or more
distinct episodes of proven
ulceration or bleeding).
History of gastrointestinal bleeding or perforation, related to
previous NSAIDs therapy.
Severe heart failure (NYHA Class IV), renal failure or hepatic failure
(see section 4.4).
Last trimester of p