MEDIFEN TABLET 400 MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

IBUPROFEN

Boleh didapati daripada:

ALLPAC SOLUTIONS SDN. BHD.

INN (Nama Antarabangsa):

IBUPROFEN

Unit dalam pakej:

100 Tablets

Dikeluarkan oleh:

HOVID BERHAD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
MEDIFEN TABLET 400 MG
IBUPROFEN (400 MG)
1
WHAT IS IN THIS LEAFLET
1.
What Medifen Tablet is used for
2.
How Medifen Tablet works
3.
Before you use Medifen Tablet
4.
How to use Medifen Tablet
5.
While you are using Medifen
Tablet
6.
Side effects
7.
Storage and Disposal of Medifen
Tablet
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT MEDIFEN 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 MEDIFEN 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 MEDIFEN 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 breastfeeding or wish to
breastfeed
•
you plan to have surgery
•
you have the following medical
condition:
•
heart disease or

Ciri produk

VIxxxxx-08
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
INDICATIONS
Medifen Tablet 400mg relieves pain such as headache, dental
pain,
period
pain,
rheumatic
pain,
muscular
pain
and
backache.
Medifen Tablet 400mg relieves fever such as fever associated
with cold and flu.
Medifen 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 AND PERFORATION
WITH NSAID
Seriou