Airtal 100mg Film-coated Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Aceclofenac

Boleh didapati daripada:

EURODRUG LABORATORIES (M) SDN. BHD.

INN (Nama Antarabangsa):

Aceclofenac

Unit dalam pakej:

10 Tablets; 20 Tablets; 40 Tablets; 50 Tablets; 100 Tablets

Dikeluarkan oleh:

Industrias Farmaceuticas Almirall, S.A. (IFA)

Risalah maklumat

AIRTAL ® 100MG FILM-COATED TABLET
Aceclofenac (100mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What _Airtal_ is used for
2.
How _Airtal_ works
3.
Before you use _Airtal_
4.
How to use _Airtal_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of _Airtal_
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
12.
Serial Number
WHAT _AIRTAL_ IS USED FOR
Airtal is used to relieve pain and reduce
redness and swelling (inflammation) in
patients suffering from:

Osteoarthritis - inflammation of
the joints. This is a common
condition in patients over the age
of 50 and causes damage to the
tissues and bones in the joints.

Rheumatoid arthritis - long term
inflammation of the joints caused
by the body’s own immune
system (autoimmune response).

Ankylosing spondylitis -
inflammation of the
spine/backbone which can lead to
the joints fusing together.
HOW _AIRTAL_ WORKS
Airtal belongs to a group of medicines
called non-steroidal anti-inflammatory
drugs (NSAIDs). They have anti-
inflammatory and painkiller properties
causing a lowering of swelling, redness
(inflammation) and pain. The
medicine/active ingredient of Airtal is
aceclofenac.
Airtal works by blocking the production
of hormone-like substances called
prostaglandins. Prostaglandins have
many functions in the body including
an important role in both the way the
body responds to inflammation and also
the reabsorption of calcium in some
diseases of the bone.
BEFORE YOU USE _AIRTAL_
-
_When you must not use it _

if you are allergic to aceclofenac
or any of the other ingredients of
this medicine (listed in section 6).
if you are allergic to aspirin or
any other NSAIDs (such as
ibuprofen, naproxen or
diclofenac).

if you have taken aspirin or any
other NSAIDs and experienced
one of the following:
- asthma attack causing tightness
in the chest wheezing and
difficulty breathing.
- runny nose, itching and/or
sneezing (irritation of the nose).
- raised red circular patc

Ciri produk

AIRTAL
®
100 MG FILM-COATED TABLET
NON STEROIDAL ANTI-INFLAMMATORY DRUG
FORMULATION:
Each Aceclofenac (Airtal
®
) Film-coated tablet contains:
Aceclofenac ……………….……………………. 100mg
Excipients: microcrystalline cellulose, croscarmellose sodium,
glyceryl palmitostearate, povidone, hydroxypropyl methyl cellulose,
polyoxyl 40 stearate and titanium dioxide.
White circular biconvex film-coated tablets.
INDICATION:
Aceclofenac (Airtal
®
) is indicated for the relief of pain and inflammation in,
osteoarthritis, rheumatoid arthritis and ankylosing
spondylitis.
MECHANISM OF ACTION:
Aceclofenac (Airtal
®
) is a non-steriodal agent with anti-inflammatory and analgesic
properties. Its pharmacotherapeutic group is:
Non-steroidal anti-inflammatory and anti-rheumatic products.
Derivatives of acetic acid and related substances. (ATC Code:
M01AB16). Aceclofenac’s mechanism of action is largely based on
inhibiting prostaglandin synthesis. Aceclofenac is a potent
inhibitor of the enzyme cyclooxygenase, which is involved in producing
prostaglandins. After oral administration, Aceclofenac is
rapidly and completely absorbed as unaltered drug. Maximum plasma
concentrations are reached approximately 1.25 to 3.00 hours
after administration. Aceclofenac penetrates into the synovial fluid,
where its concentrations reach approximately 57% of the plasma
concentrations. The volume of distribution is approximately 25 L.
The plasma half-life is around 4 hours. Aceclofenac shows high protein
binding (>99%). Aceclofenac mainly circulates in the form of
unaltered drug. The principal metabolite found in the plasma is
4’-hydroxyaceclofenac. Approximately two thirds of the dose
administered is excreted through the urine, predominantly in the form
of hydroxymetabolites.
The
results
from
preclinical
studies
performed
with
aceclofenac
are
congruent
with
those
expected
in
non-steroidal
anti-
inflammatory drugs. The main target organ was the gastrointestinal
tract. No unexpected findings were recorded.
Aceclofenac was consi