Celecoxib - 1 A Pharma Capsules Hard 100mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CELECOXIB

Available from:

1 A Pharma GmbH

ATC code:

M01AH01

INN (International Name):

CELECOXIB

Pharmaceutical form:

HARD CAPSULE

Composition:

CELECOXIB 100 milligram(s)

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2017-08-25

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CELECOXIB - 1 A PHARMA 100 MG CAPSULES, HARD
CELECOXIB - 1 A PHARMA 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 - 1 A Pharma
is and what it is used for
2.
What you need to know before you take Celecoxib - 1 A Pharma
3.
How to take Celecoxib - 1 A Pharma
4.
Possible side effects
5.
How to store Celecoxib - 1 A Pharma
6.
Contents of the pack and other information
1.
WHAT CELECOXIB - 1 A PHARMA
IS AND WHAT IT IS USED FOR
Celecoxib - 1 A Pharma
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 - 1 A Pharma
reduces the
production of prostaglandins that cause pain and inflammation and not
the ones that protect the
stomach.
Celecoxib - 1 A Pharma
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

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Celecoxib - 1A Pharma 100 mg capsules, hard
Celecoxib - 1A Pharma 200 mg capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Celecoxib – 1 A Pharma 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).
[Nationally completed name] 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 - 1A Pharma 100 mg capsules, hard:
Capsule (length 17.7 – 18.3 mm): white body and blue cap, containing
white to slightly yellowish
pellets.
Celecoxib - 1A Pharma 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
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).
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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