Brupro for Children Six Plus 200 mg/5 ml oral suspension

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Ibuprofen

Доступна з:

Rowa Pharmaceuticals Limited

Код атс:

M01AE01

ІПН (Міжнародна Ім'я):

Ibuprofen

Фармацевтична форма:

Oral suspension

Терапевтична области:

ibuprofen

Статус Авторизація:

Marketed

Дата Авторизація:

2022-03-11

інформаційний буклет

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BRUPRO FOR CHILDREN SIX PLUS 200 MG/ 5ML 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, 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.
•
If you or 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 YOU OR YOUR CHILD DO NOT FEEL BETTER OR
IF YOU OR YOUR CHILD FEEL
WORSE AFTER 3 DAYS.
WHAT IS IN THIS LEAFLET
1.
What Brupro for Children Six Plus is and what it is used for
2.
What you need to know before you use Brupro for Children Six Plus
3.
How to use Brupro for Children Six Plus
4.
Possible side effects
5.
How to store Brupro for Children Six Plus
6.
Contents of the pack and other information.
1.
WHAT BRUPRO FOR CHILDREN SIX PLUS 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
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BRUPRO FOR CHILDREN SIX PLUS
Do not give Brupro for Children Six Plus to children who:
•
ARE UNDER 6 YEARS OF AGE OR UNDER 20 KG IN WEIGHT.
•
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 (ASPIRIN)
or OTHER SIMILAR PAINKILLERS
(NSAIDS)
•
have ever had
GASTROINTESTINAL BLEEDING OR PERFORA

Характеристики продукта

Health Products Regulatory Authority
26 February 2024
CRN00DZC8
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brupro for Children Six Plus 200 mg/5 ml oral suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of oral suspension contains 200 mg ibuprofen.
Excipients with known effect
Each 5 ml of oral suspension contains 140 mg sorbitol, 50 mg propylene
glycol, 10 mg sodium benzoate and 5.25 mg ethanol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension
White or almost 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
For pain and fever: The daily dosage of Brupro for Children Six Plus
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
3 times
30-40kg (10-12 years)
1 x 300mg/7.5ml
3 times
Do not dose more frequently than at 6 hourly intervals. The
recommended dose should not be exceeded.
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)
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):
Health Products Regulatory Authority
26 February 2024
CRN00DZC8
Page 2 of 12
No dose reduction is required in patients with mild to moderate
impairment to hepatic function (patients with severe hepatic
dysfunction, see s