Nurofen for Children Six Plus Strawberry 200 mg/5 ml oral suspension

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Ibuprofen

Disponibil de la:

Reckitt Benckiser Ireland Ltd

Codul ATC:

M01AE; M01AE01

INN (nume internaţional):

Ibuprofen

Dozare:

200 mg/5ml

Forma farmaceutică:

Oral suspension

Tip de prescriptie medicala:

Product not subject to medical prescription

Zonă Terapeutică:

Propionic acid derivatives; ibuprofen

Statutul autorizaţiei:

Marketed

Data de autorizare:

2010-12-21

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
Nurofen for Children Six Plus
Strawberry 200mg/5ml Oral Suspension
ibuprofen
For use in children from 20kg body weight (6 years) to 40kg body
weight (12 years).
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 or pharmacist has told
you
•
Keep this leaflet. You may need to read it again
•
Ask your pharmacist if you need more information or advice.
•
If your child gets any side effects, talk to your doctor or
pharmacist. 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 if
your child feels worse after 3
days.
IN THIS LEAFLET:
1.
What Nurofen for Children is and what it is used for
2.
What you need to know before you use Nurofen for Children
3.
How to use Nurofen for Children
4.
Possible side-effects
5.
How to store Nurofen for Children
6.
Contents of the pack and other information
1.
WHAT NUROFEN FOR CHILDREN IS AND WHAT IT IS USED FOR?
Ibuprofen belongs to a group of medicines called Non-Steroidal
Anti-Inflammatory Drugs
(NSAIDs). These medicines work by changing how the body responds to
pain, and high body
temperature. This product has been specifically formulated for
children as it is given by mouth to:
•
Reduce fever
•
Relieve symptoms of mild to moderate pain
You must talk to a doctor if your child does not feel better or if
your child feels worse after 3 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NUROFEN FOR CHILDREN
DO NOT GIVE NUROFEN FOR CHILDREN TO CHILDREN WHO:
•
Are allergic to ibuprofen or other similar painkillers (NSAIDs) or to
any of the other
ingredients of this medicine (listed in Section 6)
•
Have ever suffered from shortness of breath, asthma, a runny nose,
swelling on their face
and/or hands or hives after using acetylsalicylic acid or other
similar pain killers (NSAIDs)
•
Have ever h

Caracteristicilor produsului

Health Products Regulatory Authority
17 August 2023
CRN00D7K7
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nurofen for Children Six Plus Strawberry 200 mg/5 ml oral suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of oral suspension contains 40mg ibuprofen
Excipients with known effects:
Maltitol liquid 2226 mg per 5 ml
Sodium 9.18 mg (0.40 mmol) per 5 ml
Propylene glycol (E 1520): 16.45 mg per 5 ml
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension.
An off-white, viscous suspension with a strawberry flavour.
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 Nurofen For Children is 20-30
mg/kg bodyweight in divided doses. Using the
measuring device provided this can be achieved as follows:
CHILD'S WEIGHT (AGE)
QUANTITY AND METHOD OF ADMINISTRATION
FREQUENCY
IN 24 HOURS
20-29kg (6-9 years)
1 x 200mg/5ml
(using the correct end of the spoon once)
3 times
30-40kg (10-12 years)
1 x 300mg/7.5ml
(using the spoon twice (5ml and 2.5ml)
3 times
Doses should be given approximately every 6 to 8 hours.
Notintended for children under 6 years of age or under 20kg.
For short-term use only
If symptoms worsen medical advice should be sought.
If this medicinal product is required for more than 3 days, or if
symptoms worsen a doctor should be consulted.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4).
SPECIAL PATIENT GROUPS
Renal insufficiency: (see section 5.2)
Health Products Regulatory Authority
17 August 2023
CRN00D7K7
Page 2 of 11
No dose reduction is required in patients with mild to moderate
impairment to renal function (patients with severe renal
insufficiency, see section 4.3).
Hepatic insufficiency (see section 5.2):
No dose reduction is