Easofen for Children Six Plus Strawberry 200mg/5ml Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibuprofen

Available from:

Clonmel Healthcare Ltd

ATC code:

M01AE; M01AE01

INN (International Name):

Ibuprofen

Dosage:

200 mg/5ml

Pharmaceutical form:

Oral suspension

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Propionic acid derivatives; ibuprofen

Authorization status:

Marketed

Authorization date:

2014-07-11

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
EASOFEN FOR CHILDREN SIX PLUS STRAWBERRY 200MG/5ML ORAL SUSPENSION
IBUPROFEN
FOR CHILDREN 6 TO 12 YEARS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get 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 you do not feel better or if you feel
worse after 3 days.
WHAT IS IN THIS LEAFLET
1
What Easofen oral suspension is and what it is used for
2
What you need to know before you use Easofen oral suspension
3
How to use Easofen oral suspension
4
Possible side effects
5
How to store Easofen oral suspension
6
Contents of the pack and other information
1.
WHAT EASOFEN ORAL SUSPENSION IS AND WHAT IT IS USED FOR
Easofen oral suspension is a medicine that reduces pain and fever
(non-steroidal anti-inflammatory
drug, NSAID).
Easofen oral suspension is used as short-term symptomatic treatment
of:
•
mild to moderate pain.
•
fever.
Easofen 200 mg/5 ml oral suspension is not for use in children under 6
years of age or under 20 kg.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE EASOFEN ORAL SUSPENSION
This medicine is suitable for the majority of people but certain
people should not use it. Talk to your
doctor or pharmacist if you are unsure.
DO NOT USE THIS MEDICINE
•
if your child is allergic to ibuprofen or any of the other ingredients
of this medicine (listed in
section 6)
•
if your child previously suffered an allergic reaction (e.g. skin
rash, runny nose or
wheezing/breathlessness, swelling of the lips, face, tongue or throat)
AFTER TAKING ASPIRIN
or
OTHER NON-STEROIDAL ANTI-INFLAMMATORY (NSAID) MEDICINES
•
if your child is taking any other
ANTI-INFLAM

Summary of Product characteristics

Health Products Regulatory Authority
16 November 2022
CRN00D6G5
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Easofen for Children Six Plus Strawberry 200mg/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of oral suspension contains 200 mg Ibuprofen.
Excipients with known effect
Maltitol liquid 2.5 g/5 ml and sodium 28.97 mg/5 ml oral suspension
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Suspension
White to off-white suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the short-term symptomatic treatment of mild to moderate pain.
For the short-term symptomatic treatment of fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For pain and fever: The daily dosage of Easofen 200mg/5ml oral
suspension for children is 20-30mg/kg bodyweight in divided
doses. Using the measuring device provided this can be achieved as
follows:
Child's age (weight)
Quantity and method of administration
Frequency (in 24 hour period)
6-9 years (20-30kg)
1 x 200ml/5ml (One 5 ml dose)
3 times
9-12 years (30-40kg)
1 x 300mg/7.5ml (5 ml + 2.5 ml)
3 times
Doses should be given approximately every 6 to 8 hours.
The package includes an oral syringe for oral administration of
Easofen. The oral syringe is graduated in 0.25 ml steps up to 5
ml. 5 ml of oral suspension corresponds to 200 mg ibuprofen.
For patients with sensitive stomachs it is recommended that Easofen
200mg/5ml oral suspension is taken during a meal.
_Not intended for children under 6 years of age or under 20kg._
Method of administration
For oral use.
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms (see section 4.4)
If in children aged from 6 years this medicinal product is required
for more than 3 days, or if symptoms worsen a doctor should
be consulted.
Health Products Regulatory Authority
16 November 2022
CRN00D6G5
Page 2 of 13
Special patient groups
Renal insufficiency: (see section 5.2)
No dose reduction is required in