Ibuprofen 100mg/5ml oral suspension sugar free

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ibuprofen

Available from:

Accord-UK Ltd

ATC code:

M01AE01

INN (International Name):

Ibuprofen

Dosage:

20mg/1ml

Pharmaceutical form:

Oral suspension

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5012617025692

Patient Information leaflet

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IBUPROFEN 100MG/5ML ORAL SUSPENSION PIL - UK
Black
BBBA0910
S.Anson
02.06.17
15.02.18
S.Anson
160 x 440
8pt
Actavis Troyan Bulgaria
02.06.17
02.06.17
7
IBUPROFEN 100MG/5ML
ORAL SUSPENSION
PACKAGE LEAFLET: INFORMATION FOR THE USER
_Continued over page_
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use this medicine exactly as described in this
leaflet or as your doctor, pharmacist or nurse has told
you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or
advice.
•
The leaflet is written in terms of giving this medicine
to your child, but if you are an adult who is intending
to take this medicine yourself the information in this
leaflet will apply to you as well.
•
If your child gets any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
•
You must talk to a doctor if your child does not feel
better or feels worse:
-
after 24 hours if your child is aged under 6 months
-
after 3 days if your child is aged over 6 months.
•
The full name of this medicine is Ibuprofen
100mg/5ml Oral Suspension but within the leaflet it
will be referred to as Ibuprofen Oral Suspension.
WHAT IS IN THIS LEAFLET
1
WHAT IBUPROFEN ORAL SUSPENSION IS AND WHAT
IT IS USED FOR
2
WHAT YOU NEED TO KNOW BEFORE GIVING
IBUPROFEN ORAL SUSPENSION TO YOUR CHILD
3
HOW TO USE IBUPROFEN ORAL SUSPENSION
4
POSSIBLE SIDE EFFECTS
5
HO

Summary of Product characteristics

OBJECT 1
IBUPROFEN 100MG/5ML ORAL SUSPENSION
Summary of Product Characteristics Updated 23-Mar-2018 | Accord-UK Ltd
1. Name of the medicinal product
Ibuprofen 100mg/5ml Oral Suspension
2. Qualitative and quantitative composition
The active ingredient is ibuprofen.
5 ml of oral suspension contains 100 mg of ibuprofen.
Excipients with known effect:
5 ml of oral suspension contains 2 g of maltitol liquid.
5 ml of oral suspension contains 7.370 mg of sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral suspension
White to almost white suspension with orange-vanilla flavour.
4. Clinical particulars
4.1 Therapeutic indications
Children 3 months to 12 years (> 5 kg):
• the reduction of fever, including post immunisation pyrexia
• the relief of the symptoms of colds and influenza
• the relief of mild to moderate pain, such as a sore throat,
teething pain, toothache, earache, headache,
minor aches and sprains.
4.2 Posology and method of administration
Posology
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
_Children, from 3 months of age_
FOR POST IMMUNISATION PYREXIA: One 2.5 ml dose followed by one further
2.5 ml dose 6 hours later if
necessary. No more than two 2.5 ml doses in 24 hours. If the fever is
not reduced, consult your doctor.
FOR PAIN, FEVER AND SYMPTOMS OF COLD AND INFLUENZA: The daily dosage
of Ibuprofen oral suspension is
20-30 mg/kg bodyweight in divided doses. Using the oral dosing syringe
provided this can be achieved as
follows:
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 (7 – 10 kg): One 2.5 ml dose may be taken 3 to
4 times in 24 hours.
Children 1 - 3 years (10 – 15 kg): One 5 ml dose may be taken 3
times in 24 hours.
Children 4 - 6 years (15 – 20 kg): 7.5 ml may be taken 3 times in 24
hours.
Children 7 - 9 years (20 – 30 kg): 10 ml may be taken 3 times in 24
hours.
Children 10 - 12