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

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Ibuprofen

可用日期:

Pinewood Laboratories Ltd

ATC代码:

M01AE01

INN（国际名称）:

Ibuprofen

剂量:

200 mg/5ml

药物剂型:

Oral suspension

治疗领域:

ibuprofen

授权状态:

Not marketed

授权日期:

2020-12-18

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
FENOPINE FOR CHILDREN SIX PLUS STRAWBERRY 200 MG/5 ML ORAL SUSPENSION
ibuprofen
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 you get 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 you do not feel better or if you feel
worse after 3 days.
WHAT IS IN THIS LEAFLET
1.
What Fenopine for Children is and what it is used for
2.
What you need to know before you give/take Fenopine for Children
3.
How to give/take Fenopine for Children
4.
Possible side effects
5.
How to store Fenopine for Children
6.
Contents of the pack and other information
1. WHAT FENOPINE FOR CHILDREN IS AND WHAT IT IS USED FOR
Fenopine for Children contains ibuprofen. 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
For use in children from 20 kg body weight (6 years) to 40 kg body
weight (12 years).
2.
WHAT YOU NEED TO KNOW BEFORE YOU GIVE/TAKE FENOPINE FOR CHILDREN
DO NOT GIVE/TAKE FENOPINE FOR CHILDREN IF YOU OR YOUR CHILD:
•
has an allergy or hypersensitivity to Ibuprofen or any of the other
ingredients in this medicine
(see
_Section 6_
_and Section 2: Important information about ingredients_
)
•
has had an allergic reaction or wheezing e.g. an asthma attack, runny
nose, skin reaction or
swelling after taking aspirin or other non-steroidal anti-inflammatory
painkillers
•
has ever had a stomach ulcer

产品特点

Health Products Regulatory Authority
20 December 2023
CRN00DXXS
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fenopine for Children Six Plus Strawberry 200mg/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of suspension contains 200 mg of ibuprofen.
Excipients with known effect
Liquid Maltitol 4.25 g/5 ml
Sodium Benzoate (E 211) 10 mg/5 ml
Propylene Glycol (E1520) 5.2 mg/5 ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Suspension
White/cream suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fenopine for Children is indicated in children aged 6 to 12 years.
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 for children is 20-30mg/kg
bodyweight in divided doses. Using the dosing 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 (20-29 kg)
1 x 200 mg/5 ml (One 5 ml dose)
3 times
10-12 years (30-40 kg)
1 x 300 mg/7.5 ml (5 ml + 2.5 ml)
3 times
Doses should be given approximately every 6 to 8 hours.
For patients with sensitive stomachs it is recommended that Fenopine
for Children is taken during a meal.
_Not intended for children under 6 years of age or under 20kg._
Method of administration
For oral use.
For short-term use only
If this medicinal product is required for more than 3 days, or if
symptoms worsen a doctor should be consulted.
Health Products Regulatory Authority
20 December 2023
CRN00DXXS
Page 2 of 10
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)
No dose reduction is required in patients with mild to moderate
impairment to renal function (patients with severe renal
insufficiency, see section 4.