Duomax 32 mg/ml + 9.6 mg/ml oral suspension

Země: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Dostupné s:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATC kód:

N02BE51

INN (Mezinárodní Name):

PARACETAMOL 32 mg IBUPROFEN 9.6 mg

Léková forma:

ORAL SUSPENSION

Složení:

PARACETAMOL 32 mg IBUPROFEN 9.6 mg

Druh předpisu:

POM

Terapeutické oblasti:

ANALGESICS

Přehled produktů:

Licence number in the source country: NOT APPLICAPABLE

Stav Autorizace:

Authorised

Datum autorizace:

2023-02-27

Informace pro uživatele

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
DUOMAX 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 Duomax
is and what it is used for
2.
What you need to know before you take Duomax
3.
How to take Duomax
4.
Possible side effects
5.
How to store Duomax
6.
Contents of the pack and other information
1.
WHAT DUOMAX IS AND WHAT IT IS USED FOR
Duomax 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).
Duomax 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 DUOMAX
DO NOT USE DUOMAX:
-
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 in the stomach or small intestine in
the past;
-
if your child has ever had bleeding or perforation in the stomach or
intestine associated with previous
treatment with NSAIDs
-
with any other medicines c

Charakteristika produktu

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Duomax 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
Duomax 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 _
Duomax is intended for use in children aged between 2 years and 12
years.
2
Duomax 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 no longer homogeneous due to pubertal development
which has a different impact o