Cebrex 200mg Capsule

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CELECOXIB

Boleh didapati daripada:

MYLAN HEALTHCARE SDN. BHD.

INN (Nama Antarabangsa):

CELECOXIB

Unit dalam pakej:

1 X 10s Capsules; 3 X 10s Capsules; 10 x 10s Capsules

Dikeluarkan oleh:

PFIZER PHARMACEUTICALS LLC

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
CEBREX
®
Celecoxib (200 mg Capsule)
PLD TITLE
:
CEBREX
PLD DATE
:
20 June 2023
COUNTRY
:
Malaysia
REFERENCE DOCUMENT
:
Malaysia LPD dated 14 December 2021
REASON FOR CHANGE
:
TW 3000086 Update PRH details from Pfizer Parke Davis to Mylan
Healthcare
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
CEBREX
®
Celecoxib (200 mg Capsule)
1
WHAT IS IN THIS LEAFLET
1.
What Cebrex is used for
2.
How Cebrex works
3.
Before you use Cebrex
4.
How to use Cebrex
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Cebrex
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT CEBREX
IS USED FOR
Cebrex 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 CEBREX WORKS
Cebrex 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.
Cebrex acts by reducing the production
of prostaglandins, thereby reducing the
pain and inflammation.
BEFORE YOU TAKE CEBREX
-
_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
Cebrex.
_ _
•
If you are allergic (hypersensitive) to
celecoxib or any of the other
ingredients of Cebrex
•
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

Ciri produk

1
CEBREX
®
200 MG CAPSULE
1. NAME OF THE MEDICINAL PRODUCT
CEBREX 200 mg Capsule
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 200 mg capsule contains 200 mg celecoxib.
3. PHARMACEUTICAL FORM
Hard capsules for oral use.
200 mg Capsules: Opaque white to off-white, hard gelatin capsule
(containing white to off white
granulation) with identifying markings, 200 mg marked with gold ink.
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.
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 dose is
200 mg twice daily, as needed.
_TREATMENT OF PRIMARY DYSMENORRHEA_:
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 dose is 200 mg twice daily, as needed.
_LOW BACK PAIN (LBP)_:
Usual dosage for adults is 100 mg of celecoxib orally twice daily,
morning and
even