Ibuprofen Nutra Essential 40 mg / ml oral suspension

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Nutra Essential OTC, S.L. C/La Granja 1-28108 Alcobendas Madrid , Spain

ATC code:

M01AE01

INN (International Name):

IBUPROFEN 40 mg/ml

Pharmaceutical form:

ORAL SUSPENSION

Composition:

IBUPROFEN 40 mg/ml

Prescription type:

OTC

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-04-07

Patient Information leaflet

PATIENT INFORMATION LEAFLET
IBUPROFEN NUTRA ESSENTIAL 40 MG / ML ORAL SUSPENSION
Ibuprofen
READ ALL OF THIS PATIENT INFORMATION LEAFLET CAREFULLY BEFORE STARTING
TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist or nurse have
told you
- Keep this leaflet. You may need to read it again.
- Ask our 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 or your child do not feel better or
if you or your child feel worse after
24 hours (infants aged 3-5 months, weighing more than 5kg) or after 3
days (children aged from 6
months, adolescents and adults).
WHAT IS IN THIS LEAFLET:
1. What Ibuprofen Nutra Essential is and what it is used for
2. What you need to know before you take Ibuprofen Nutra Essential
3. How to take Ibuprofen Nutra Essential
4. Possible side effects
5. How to store Ibuprofen Nutra Essential
6. Contents of the pack and other information
1. WHAT IBUPROFEN NUTRA ESSENTIAL IS AND WHAT IT IS USED FOR
Ibuprofen belongs to the group of medicines called nonsteroidal
anti-inflammatory drugs (NSAID).
This medicinal product is indicated for the treatment of fever and
mild to moderate pain in adults and children
aged over 3 months.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN NUTRA ESSENTIAL
DO NOT TAKE IBUPROFEN NUTRA ESSENTIAL:
-
If you are allergic to ibuprofen or any other components of this
medicine (included in section 6).
-
If you have had a stomach or duodenal haemorrhage or have suffered
from a perforation in the
digestive system whilst taking a non-steroidal anti-inflammatory
drugs.
-
If you suffer from or have suffered from, a stomach or duodenal ulcer
or haemorrhage on more
than one occasion.
-
If you have had allergic reactions such as asthma, rhinitis or hives
when taking aspirin or other
non-steroid

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ibuprofen Nutra Essential 40 mg / ml oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral suspension contains 40 mg of ibuprofen. Excipient(s)
with known effect:
Each millilitre of oral suspension contains 500 mg of liquid maltitol
and 5.79 mg of sodium.
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
White or off-white, viscous, oral suspension with strawberry flavour.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Symptomatic treatment of fever Treatment of mild or moderate pain.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology.
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms
(see section 4.4).
_Paediatric population _
_ _
The dose of ibuprofen to administer depends on the age and weight of
the child. For children aged between 3
months and 12 years, the recommended daily dose is 20 to 30 mg/kg of
weight, in three or four doses (see the
table below).
The interval between doses shall depend on the evolution of the
symptoms, but it shall never be less
than 4 hours.
The following dosage guideline in recommended.
AGE
BODY WEIGHT
POSOLOGY
Children aged from 3 to 6
months
Approx. from 5 to 7.6 kg
1.25
ml
3
times
daily
(corresponds to 150 mg of
ibuprofen/day)
Children aged from 6 to 12
months
Approx. from 7.7 to 9 kg
1.25 ml of 3 to 4 times daily
(corresponds to 150-200 mg of
ibuprofen/day)
Children aged from 1 to 3 years
Approx. from 10 to 15 kg
2.5
ml
3
times
daily
(corresponds to 300 mg of
ibuprofen/day)
Children aged from 4 to 6 years
Approx. from 16 to 20 kg
3.75
ml
3
times
daily
(corresponds to 450 mg of
ibuprofen/day)
Children aged from 7 to 9 years
Approx. from 21 to 29 kg
5 ml 3 times daily (equivalent to
600 mg of ibuprofen/day)
Children aged from 10 to 12
years
Approx. from 30 to 40 kg
7.5 ml 3 times daily (equivalent
to 900 mg of ibuprofen/day)
Use of this medicinal product is not recommended in children aged
under 3 months or under 5 kg.
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