Easofen for Children Strawberry 100mg/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:

100 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

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
EASOFEN FOR CHILDREN STRAWBERRY 100MG/5ML ORAL SUSPENSION
IBUPROFEN
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 an analgesic (pain killer) for
relief of teething pain,
earache, headache, muscular minor aches and sprains, sore throats and
cold and flu symptoms
DO NOT GIVE TO BABIES UNDER 3 MONTHS OR BABIES WEIGHING LESS THAN 5
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 weighs
LES

Summary of Product characteristics

Health Products Regulatory Authority
16 November 2022
CRN00D6G5
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Easofen for Children Strawberry 100mg/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml oral suspension contains 100 mg Ibuprofen
Excipients with known effect
Maltitol liquid 2.5 g/5 ml and sodium 17.92 mg/5 ml oral suspension
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Suspension
A white to off-white strawberry flavoured suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of fever and relief of mild to moderate pain, such as cold
and flu symptoms, teething pain, headache, sprains and
strains and to ease the pain of sore throats and earache.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For pain and fever: The daily dosage of Easofen 100mg/5ml Oral
Suspension is 20 to 30 mg of ibuprofen/kg bodyweight in
divided doses.
This can be achieved as follows:
3 to 6 months: 2.5ml, 3 times a day.
6 to 12 months: 2.5ml, 3 times a day.
1 to 3 years: 5ml, 3 times a day.
4 to 6 years: 7.5ml, (5ml & 2.5ml) 3 times a day.
7 to 9 years: 10ml, 3 times a day.
10 to 12 years: 15 ml 3 times a day.
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 100 mg ibuprofen.
This product should only be given to infants aged 3 – 6 months who
weigh more than 5kg.
Do not dose more frequently than at 6 hourly intervals.
Not suitable for children under 3 months of age unless advised by your
doctor.
Method of administration
For oral administration.
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms (see section 4.4)
Health Products Regulatory Authority
16 November 2022
CRN00D6G5
Page 2 of 12
For patients with sensitive stomachs the product can be taken during a
meal.
For children aged 3 – 5 months medical advice should be sought if
symptoms worsen or not later