Celecoxib Sandoz 200 mg capsules, hard

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CELECOXIB

Available from:

Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia

ATC code:

M01AH01

INN (International Name):

CELECOXIB 200 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

CELECOXIB 200 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2017-08-25

Patient Information leaflet

Page
1
of
12
PACKAGE LEAFLET: INFORMATION FOR THE USER
CELECOXIB SANDOZ 100 MG CAPSULES, HARD
CELECOXIB SANDOZ 200 MG CAPSULES, HARD
celecoxib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Celecoxib Sandoz is and what it is used for
2.
What you need to know before you take Celecoxib Sandoz
3.
How to take Celecoxib Sandoz
4.
Possible side effects
5.
How to store Celecoxib Sandoz
6.
Contents of the pack and other information
1.
WHAT CELECOXIB SANDOZ IS AND WHAT IT IS USED FOR
Celecoxib Sandoz contains the active substance celecoxib which belongs
to a group of medicines
called nonsteroidal anti-inflammatory drugs (NSAID), and specifically
a sub-group known as
cyclooxygenase-2 (COX-2) inhibitors. These work by lowering the amount
of prostaglandins.
Prostaglandins are substances made by your body. Some prostaglandins
cause pain and
inflammation, but others help protect the stomach lining. Celecoxib
Sandoz reduces the production
of prostaglandins that cause pain and inflammation and not the ones
that protect the stomach.
Celecoxib Sandoz is used in adults for pain relief and to alleviate
swelling of tissue in the
degenerative joint disease (osteoarthritis), inflammatory rheumatic
joint disease (rheumatoid
arthritis) and in certain types of inflammation of intervertebral
joints (ankylosing spondylitis).
You should expect your medicine to start working within hours of
taking the first dose, but you may
not experience a full effect for several days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CELECOXIB SA

Summary of Product characteristics

Page
1
of
24
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Celecoxib Sandoz 100 mg capsules, hard
Celecoxib Sandoz 200 mg capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Celecoxib Sandoz 100 mg capsule, hard:
Each hard capsule contains 100 mg celecoxib.
Excipient(s)
with
known
effect:
Each
hard
capsule
contains
6.65
mg
lactose
(as
lactose
monohydrate).
Celecoxib Sandoz 200 mg capsule, hard
Each hard capsule contains 200 mg celecoxib.
Excipient(s)
with
known
effect:
Each
hard
capsule
contains
13.3
mg
lactose
(as
lactose
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
Celecoxib Sandoz 100 mg capsules, hard:
Capsule (length 17.7 – 18.3 mm): white body and blue cap, containing
white to slightly yellowish
pellets.
Celecoxib Sandoz 200 mg capsules, hard:
Capsule (length 19.1 – 19.7 mm): white body and orange cap,
containing white to slightly yellowish
pellets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In adults for the symptomatic relief in the treatment of:
-
osteoarthritis
-
rheumatoid arthritis
-
ankylosing spondylitis
Page
2
of
24
The decision to prescribe a selective cyclooxygenase-2 (COX-2)
inhibitor should be based on an
assessment of the individual patient’s overall risks (see sections
4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
As the cardiovascular risks of celecoxib may increase with dose and
duration of exposure, the
shortest duration possible and the lowest effective daily dose should
be used. The patient’s need for
symptomatic relief and response to therapy should be re-evaluated
periodically, especially in
patients with osteoarthritis (see sections 4.3, 4.4, 4.8 and 5.1).
_Osteoarthritis _
The usual recommended daily dose is 200 mg taken once daily or in two
divided doses. In some
patients, with insufficient relief from symptoms, an increased dose of
200 mg twice daily may
increase efficacy. In the absence of an increase in therapeutic
benefit after two weeks, other
therapeutic op