PRESMEDIC IBUPROFEN TABLET 400 MG

Land: Maleisië

Taal: Engels

Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Koop het nu

Bijsluiter Bijsluiter (PIL)
28-12-2021
Productkenmerken Productkenmerken (SPC)
23-09-2022

Werkstoffen:

IBUPROFEN

Beschikbaar vanaf:

Hovid Nutriworld Sdn Bhd

INN (Algemene Internationale Benaming):

IBUPROFEN

Eenheden in pakket:

100 Tablets

Geproduceerd door:

HOVID BERHAD

Bijsluiter

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
PRESMEDIC IBUPROFEN TABLET 400 MG
IBUPROFEN (400 MG)
1
WHAT IS IN THIS LEAFLET
1.
What Presmedic Ibuprofen Tablet
is used for
2.
How Presmedic Ibuprofen Tablet
works
3.
Before you use Presmedic
Ibuprofen Tablet
4.
How to use Presmedic Ibuprofen
Tablet
5.
While you are using Presmedic
Ibuprofen Tablet
6.
Side effects
7.
Storage and Disposal of
Presmedic Ibuprofen Tablet
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT PRESMEDIC IBUPROFEN TABLET IS
USED FOR
To relief pain such as:
•
Headache
•
Dental pain
•
Period pain
•
Rheumatic pain (inflammation)
•
Muscular pain
•
backache
Also to relief fever such as fever
associated with cold and flu.
It also relieves inflammation of
muscles and joins in rheumatic disease
including juvenile arthritis and other
muscular skeletal disorder.
HOW PRESMEDIC IBUPROFEN TABLET
WORKS
This medicine belongs to a group of
medicines called non-steroidal anti-
inflammatory drugs (NSAIDs).
NSAIDs stop the production of
chemicals called prostaglandins. These
chemicals are released in your body in
response to illness and injury. In
humans, ibuprofen reduces
inflammatory pain, swellings and
fever. Furthermore, ibuprofen
reversibly inhibits platelet
aggregation.
BEFORE YOU USE PRESMEDIC IBUPROFEN
TABLET
_ _
_- When you must not use it _
Do not take this medicine if:
•
you are allergic to Ibuprofen or
any of the other ingredients of this
product.
•
you are allergic to aspirin or any
other NSAIDs medicine
•
you are pregnant, or intend to
become pregnant.
•
you have a peptic ulcer (stomach
or duodenal ulcer), a recent
history of one, or have had peptic
ulcers before.
•
you have severe heart failure
•
you have severe liver failure
•
you have severe kidney disease
_- Before you start to use it _
Tell your doctor if:
•
you are allergic to any other
medicines, foods, dyes or
preservatives.
•
you are pregnant or plan to
become pregnant
•
you are breastfeedi
                                
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Productkenmerken

                                VIIBUxx-0
DESCRIPTION
Round, 13.0mm in diameter, pink coated tablet with shallow convex
faces, bevel-edged and “HD”embossed on one face.
COMPOSITION
Ibuprofen 400 mg/tablet
This product contains Ponceau 4R as colouring agent.
PHARMACODYNAMICS
Ibuprofen
is
a
propionic
acid
derivative
NSAID
that
has
demonstrated its efficacy by inhibition of prostaglandin synthesis. In
humans, ibuprofen reduces inflammatory pain, swellings and fever.
Furthermore, ibuprofen reversibly inhibits platelet aggregation.
PHARMACOKINETICS
Ibuprofen is rapidly absorbed following administration and is rapidly
distributed throughout the whole body. The excretion is rapid and
complete via the kidneys.
Maximum plasma concentrations are reached 45 minutes after
ingestion if taken on an empty stomach. When taken with food, peak
levels are observed after 1 to 2 hours. These times may vary with
different dosage forms.
Elimination half-life is approximately 2 hours.
INDICATION
Presmedic Ibuprofen Tablet 400mg relieves pain such as headache,
dental
pain,
period
pain,
rheumatic
pain,
muscular
pain
and
backache.
Presmedic Ibuprofen Tablet 400mg relieves fever such as fever
associated with cold and flu.
Presmedic Ibuprofen Tablet 400mg relieves inflammation of muscles
and joints in rheumatic disease including juvenile arthritis and other
muscular skeletal disorder.
CONTRAINDICATIONS
It should not be use in the following conditions:
•
Hypersensitivity to ibuprofen or any of the excipients in the
product.
•
Patients who have previously shown hypersensitivity reactions
(e.g. asthma, rhinitis, angioedema, or urticarial) in response to
aspirin or other NSAID drugs.
•
Active or history of recurrent peptic ulcer/haemorrhage (two or
more distinct episodes of proven ulceration or bleeding).
•
History of gastrointestinal bleeding or perforation, related to
previous NSAIDs therapy.
•
Severe heart failure (NYHA Class IV), renal failure or hepatic
failure.
•
Last trimester of pregnancy.
WARNING AND PRECAUTIONS
WARNING
RISK OF GI ULCERATION, BLEEDING 
                                
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