Apo-Celecoxib capsules

Country: Armenía

Tungumál: enska

Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Virkt innihaldsefni:

celecoxib

Fáanlegur frá:

Apotex Inc.

ATC númer:

M01AH01

INN (Alþjóðlegt nafn):

celecoxib

Skammtar:

200mg

Lyfjaform:

capsules

Einingar í pakka:

(100) in plastic container

Gerð lyfseðils:

Prescription

Leyfisstaða:

Registered

Leyfisdagur:

2017-12-08

Upplýsingar fylgiseðill

IMPORTANT: PLEASE READ
_APO-CELECOXIB Product Monograph _
Page 46 of 49
PART III: CONSUMER INFORMATION
APO-CELECOXIB
CELECOXIB CAPSULES
READ THIS INFORMATION EACH TIME YOU REFILL YOUR
PRESCRIPTION IN CASE NEW INFORMATION HAS BEEN
ADDED.
THIS LEAFLET IS A SUMMARY DESIGNED SPECIFICALLY FOR
YOU TO READ. IT WILL NOT TELL YOU EVERYTHING ABOUT
APO-CELECOXIB. See your health care provider and
pharmacist regularly and ask them questions about
your health and any medications you take.
ABOUT THIS MEDICATION
WHAT THE MEDICATION IS USED FOR:
Your health care provider has prescribed APO-
CELECOXIB for you for one or more of the following
medical conditions:

Osteoarthritis – relieve pain

Rheumatoid Arthritis – relieve joint pain and
swelling

Ankylosing Spondylitis – relieve pain

Sprains, After orthopaedic (bone and joint)
surgery (NOT open heart surgery), dental
extraction – to relieve short-term pain
(maximum use of 7 days)
WHAT IT DOES:
APO-CELECOXIB (celecoxib), as a nonsteroidal anti-
inflammatory drug (NSAID), can reduce the type of
prostaglandins (chemicals), produced by your body
which cause joint swelling, redness and pain. At
prescribed doses, APO-CELECOXIB does not affect
the type of prostaglandins that helps maintain the
protective layer of the stomach, and reduces the
chances of bleeding from the stomach.
APO-CELECOXIB, as a nonsteroidal anti-
inflammatory drug (NSAID), does NOT cure your
illness or prevent it from getting worse. APO-
CELECOXIB can only relieve pain and reduce
swelling as long as you continue to take it.
WHEN IT SHOULD NOT BE USED:
DO NOT TAKE APO-CELECOXIB IF YOU HAVE ANY OF
THE FOLLOWING MEDICAL CONDITIONS:

HEART BYPASS SURGERY (PLANNING TO HAVE
OR RECENTLY HAD)

SEVERE, UNCONTROLLED HEART FAILURE

ALLERGY TO CELECOXIB OR ANY OF THE OTHER
INGREDIENTS IN APO-CELECOXIB

ALLERGY TO SULFONAMIDE DRUGS

ALLERGY TO ASA (ACETYLSALICYLIC ACID) OR
OTHER NSAIDS (NONSTEROIDAL ANTI-
INFLAMMATORY DRUGS)

CURRENT PREGNANCY (AFTER 28 WEEKS OF
PREGNANCY)

CURRENTLY BR

Vara einkenni

_APO-CELECOXIB Product Monograph_
Page 1 of 49
PRODUCT MONOGRAPH
APO-CELECOXIB
CELECOXIB CAPSULES
100 MG AND 200 MG
NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID)
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
MARCH 21, 2016
TORONTO ONTARIO
M9L 1T9
CONTROL NO.: 189166
_APO-CELECOXIB Product Monograph_
Page 2 of 49
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.............................................................. 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
.......................................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................................
4
ADVERSE REACTIONS
.....................................................................................................13
DRUG INTERACTIONS
......................................................................................................20
DOSAGE AND ADMINISTRATION
.....................................................................................23
OVERDOSAGE
...................................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
......................................................................25
STORAGE AND
STABILITY................................................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................27
PART II: SCIENTIFIC INFORMATION
...................................................................................28
PHARMACEUTICAL INFORMATION
..................................................................................28
CLINICAL TRIALS
........................................................................................