Celebrex 400mg capsules

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CELECOXIB

Boleh didapati daripada:

VIATRIS SDN. BHD.

INN (Nama Antarabangsa):

CELECOXIB

Unit dalam pakej:

0010Capsule Capsules; 30Capsule Capsules; 100Capsule Capsules; 5Capsule Capsules

Dikeluarkan oleh:

PFIZER PHARMACEUTICALS LLC

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
CELEBREX
®
CAPSULES
Celecoxib (100 mg, 200 mg, 400 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Celebrex is used for
2.
How Celebrex works
3.
Before you use Celebrex
4.
How to use Celebrex
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Celebrex
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT CELEBREX IS USED FOR
Celebrex is used for:

Menstrual cramps or period pains.

Relief symptoms of joint pain,
tenderness, swelling and stiffness in
rheumatoid arthritis and osteoarthritis.

Relief of signs and symptoms of
ankylosing spondylitis (a chronic
inflammatory rheumatic disorder that
primarily affects, but is not limited to,
the spine).

The management of low back pain
(100 mg and 200 mg only).
HOW CELEBREX WORKS
Celebrex belongs to a group of medicinal
products called nonsteroidal anti-
inflammatory drugs (NSAID), and
specifically a sub-group known as
(COX-2) inhibitors. Your body makes
prostaglandins that may cause pain and
inflammation. In conditions such as
rheumatoid arthritis and osteoarthritis
your body makes more of these.
Celebrex acts by reducing the production
of prostaglandins, thereby reducing the
pain and inflammation.
BEFORE YOU USE CELEBREX
-
_When you must not use it_
Tell your doctor if any of the
following are true for you as patients
with these conditions should not take
Celebrex.

If you are allergic (hypersensitive) to
celecoxib or any of the other
ingredients of Celebrex

If you have had an allergic reaction
to a group of medicines called
“sulfonamides” (e.g. Some
antibiotics used to treat infections)

If as a result of taking acetylsalicylic
acid or any other anti-inflammatory
and pain-relieving medicine
(NSAID) you have had asthma, ,
severe nose congestion, or an allergic
reaction such as an itchy skin rash,
swelling of the face, lips, tongue or
throat, breathing difficulties or
wheezing

If you have been diagnosed with a
heart attack,

Ciri produk

1
1. NAME OF THE MEDICINAL PRODUCT
CELEBREX
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 mg capsule contains 100 mg celecoxib.
Each 200 mg capsule contains 200 mg celecoxib.
Each 400 mg capsule contains 400 mg celecoxib.
3. PHARMACEUTICAL FORM
Hard capsules for oral use.
100 mg Capsules: Opaque white to off-white, hard gelatin capsule with
identifying markings, 100 mg
marked with blue ink.
200 mg Capsules: Opaque white to off-white, hard gelatin capsule with
identifying markings, 200 mg
marked with gold ink.
400 mg Capsules: Hard gelatin capsule (containing white to off white
granulation), White opaque body
with green ink band containing in white “400”. White opaque cap
with green band containing in white
“7767”.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
For the management of acute pain in adults and for the treatment of
primary dysmenorrhoea.
Relief of the acute and chronic pain and inflammation of rheumatoid
arthritis and osteoarthritis.
Relief of signs and symptoms of ankylosing spondylitis.
For the management of low back pain (100 mg and 200 mg only).
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Celecoxib capsules can be taken with or without food.
Given the association between cardiovascular (CV) risk and exposure to
COX-2 inhibitors, doctors are
advised to use the lowest effective dose for the shortest possible
duration of treatment.
ADULTS
_SYMPTOMATIC TREATMENT OF OSTEOARTHRITIS (OA)_:
The recommended dose of celecoxib is 200 mg
administered as a single dose or as 100 mg twice per day.
_SYMPTOMATIC TREATMENT OF RHEUMATOID ARTHRITIS (RA)_:
The recommended dose of celecoxib is 100 mg
or 200 mg twice per day.
_ANKYLOSING SPONDYLITIS (AS)_:
The recommended dose of celecoxib is 200 mg administered as a single
dose or 100 mg twice per day. Some patients may benefit from a total
daily dose of 400 mg.
_MANAGEMENT OF ACUTE PAIN_:
The recommended dose of celecoxib is 400 mg, initially, followed by an
additional 200 mg dose, if needed on the first day. On subsequent
days, the recommended dos