Paracetamol/Ibuprofen Vale 32 mg/ml + 9.6 mg/ml oral suspension

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Vale Pharmaceuticals Limited 3 Anglesea Street, Clonmel, Co. Tipperary, E91 D6C5, Ireland

ATC code:

N02BE51

INN (International Name):

IBUPROFEN 9.6 mg PARACETAMOL 32 mg

Pharmaceutical form:

ORAL SUSPENSION

Composition:

IBUPROFEN 9.6 mg PARACETAMOL 32 mg

Prescription type:

POM

Therapeutic area:

ANALGESICS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2023-02-27

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL/IBUPROFEN VALE
32 MG/ML + 9.6 MG/ML ORAL SUSPENSION
paracetamol/ibuprofen
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor or pharmacist.
−
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
−
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.
WHAT IS IN THIS LEAFLET
1.
What Paracetamol/Ibuprofen Vale
is and what it is used for
2.
What you need to know before you take Paracetamol/Ibuprofen Vale
3.
How to take Paracetamol/Ibuprofen Vale
4.
Possible side effects
5.
How to store Paracetamol/Ibuprofen Vale
6.
Contents of the pack and other information
1.
WHAT
PARACETAMOL/IBUPROFEN VALE IS AND WHAT IT IS USED FOR
Paracetamol/Ibuprofen Vale contains paracetamol and ibuprofen.
Paracetamol is an active substance that relieves pain.
Ibuprofen belongs to a group of medicines called non-steroidal
anti-inflammatory drugs (or NSAIDs). It
relieves pain and reduces inflammation (swelling, redness or
soreness).
Paracetamol/Ibuprofen Vale is used for short-term management of mild
to moderate acute pain which is not
considered to be relieved by paracetamol or ibuprofen (alone) in
children 2-12 years of age with body weight
of 12 kg and above.
Ask your doctor or pharmacist if you have any questions about this
medicine.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL/IBUPROFEN VALE
DO NOT USE PARACETAMOL/IBUPROFEN VALE:
-
if your child is allergic to paracetamol, ibuprofen or any of the
other ingredients of this medicine (listed
in section 6);
-
if your child has a peptic ulcer (i.e. stomach or duodenal ulcer) or
bleeding, or has had two or more
episodes of an ulcer or bleeding

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Paracetamol/Ibuprofen Vale 32 mg/ml + 9.6 mg/ml oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 32 mg paracetamol and 9.6 mg ibuprofen.
Excipients with known effect
Maltitol liquid (E965) 250 mg/ml
Propylene glycol (E1520) 9.6 mg/ml
Sodium benzoate (E211) 1 mg/ml
Sodium 1.23 mg/ml
Glycerol (E422) 150 mg/ml
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension.
A viscous pink suspension, free from foreign substances and with
characteristic strawberry flavour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Paracetamol/Ibuprofen Vale is indicated for the short-term management
of mild to moderate acute pain which
is not considered to be relieved by paracetamol or ibuprofen (alone)
in children 2-12 years of age with body
weight of 12 kg and above.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For oral administration and short term use only (not more than 3
days).
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms (see section
4.4).
_Paediatric population _
Paracetamol/Ibuprofen Vale is intended for use in children aged
between 2 years and 12 years.
2
Paracetamol/Ibuprofen Vale is not intended for use in children under 2
years of age and in children with
body weight under 12 kg.
Doses should be given every 6 hours as necessary, with no more than 4
doses in 24 hours.
In children up to 10 years of age it is essential to respect the
posology on the basis of body weight and not
age, which is approximate and reported only for information.
BODY WEIGHT
AGE (APPROXIMATE)
DOSE (ML)
MAXIMUM DAILY DOSE (ML)
12 - <14kg
2 years
4.5
18
14 - <16kg
3 years
5.5
22
16 - <18kg
4 years
6
24
18 - <20kg
5 years
7
28
20 - <22kg
6 years
7.5
30
22 - <25kg
7 years
8.5
34
25 - <28kg
8 years
9.5
38
28 - <31kg
9 years
10.5
42
31 - <33kg
10 years
11.5
46
33-<40 kg*
11-12 years
12.5
50
*
In children over 10 years of age, the relationship between weight and
age is