BUPLEX JUNIOR 100 MG/5ml Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

IBUPROFEN

Available from:

Actavis Group PTC ehf

ATC code:

M01AE01

INN (International Name):

IBUPROFEN

Dosage:

100 MG/5ml

Pharmaceutical form:

Oral Suspension

Administration route:

Oral use

Units in package:

Bottle containing 60 ml, 100 ml or 200 ml

Prescription type:

Product not subject to medical prescription

Therapeutic group:

Anti-inflammatory and antirheumatic products, non-steroids; propionic acid derivatives

Therapeutic area:

Propionic acid derivatives

Therapeutic indications:

It is indicated in children 3 months to 12 years (> 5 kg) for: the reduction of fever, including post immunisation pyrexia; the relief of the symptoms of colds and influenza; the relief of mild to moderate pain, such as a sore throat, teething pain, toothache, earache, headache, minor aches and sprains

Authorization status:

Authorised

Authorization date:

2015-06-26

Patient Information leaflet

Ibuprofen 100mg/5ml Oral Suspension PIL - Ireland
item no: AAAJ0542
print proof no: 3
origination date: 24.05.16
originated by: S.Anson
revision date: 13.01.17
revised by: jh
dimensions: 160 x 440
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
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5.
6.
1.
2.
3.
date sent: 24.05.16
supplier: Actavis Balkanpharma Troyan AD Bulgaria
technically app. date: 25.05.16
min pt size: 9
TECHNICAL APPROVAL
PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
• The leaflet is written in terms of giving this medicine to your
child, but if you are an adult who is intending to take this
medicine yourself the information in this leaflet will apply to
you as well.
• If your child gets 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 your child does not feel better or
feels worse
• after 24 hours if your child is aged under 6 months
• after 3 days if your child is aged over 6 months
WHAT IS IN THIS LEAFLET
1. WHAT BUPLEX JUNIOR IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE GIVING BUPLEX JUNIOR TO
YOUR CHILD
3. HOW TO USE BUPLEX JUNIOR
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE BUPLEX JUNIOR
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT BUPLEX JUNIOR IS AND WHAT IT IS USED FOR
It contains ibuprofen which belongs to a group of medicines
called non-steroidal anti-inflammatory drugs (NSAIDs) which
act to relieve pain, swelling (inflammation) and reduce fever.
Buplex Junior is for use in children from 3 months of age who
weigh more than 5 kg.
Buplex Junior can be used for the relief of mild to moderate
pain

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Buplex Junior 100mg/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is ibuprofen.
5 ml of oral suspension contains 100 mg of ibuprofen.
Excipients with known effect:
5 ml of oral suspension contains 2 g of maltitol liquid.
5 ml of oral suspension contains 7.370 mg of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension
White to almost white suspension with orange-vanilla flavour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Children 3 months to 12 years (> 5 kg):
the reduction of fever, including post immunisation pyrexia
the relief of the symptoms of colds and influenza
the relief of mild to moderate pain, such as a sore throat, teething
pain, toothache, earache, headache, minor
aches and sprains.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to
control symptoms (see section 4.4).
_Children from 3 months of age_
FOR POST IMMUNISATION PYREXIA: One 2.5 ml dose followed by one further
2.5 ml dose 6 hours later if necessary.
No more than two 2.5 ml doses in 24 hours. If the fever is not
reduced, consult your doctor.
FOR PAIN, FEVER AND SYMPTOMS OF COLD AND INFLUENZA: The daily dosage
of Buplex Junior 100mg/5ml Oral
Suspension is 20-30 mg/kg bodyweight in divided doses. Using the oral
dosing syringe provided this can be
achieved as follows:
Infants 3 – 6 months weighing more than 5 kg: One 2.5ml dose may be
taken 3 times in 24 hours.
Infants 6 - 12 months (7 – 10 kg): One 2.5 ml dose may be taken 3 to
4 times in 24 hours.
Children 1 - 3 years (10 – 15 kg): One 5 ml dose may be taken 3
times in 24 hours.
Children 4 - 6 years (15 – 20 kg): 7.5 ml may be taken 3 times in 24
hours.
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