Celecoxib 200mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Celecoxib

Available from:

Zentiva Pharma UK Ltd

ATC code:

M01AH01

INN (International Name):

Celecoxib

Dosage:

200mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5000283657170

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CELECOXIB 100 MG CAPSULES
CELECOXIB 200 MG CAPSULES
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 capsules are and what it is used for
2. What you need to know before you take
celecoxib capsules
3. How to take celecoxib capsules
4. Possible side effects
5. How to store celecoxib capsules
6. Contents of the pack and other information
1. WHAT CELECOXIB CAPSULES ARE AND WHAT IT IS USED FOR
The name of your medicine is Celecoxib 100mg and
200mg Capsules (called celecoxib capsules throughout
this leaflet). Celecoxib capsules are used for the relief
of signs and symptoms of RHEUMATOID ARTHRITIS,
OSTEOARTHRITIS AND ANKYLOSING SPONDYLITIS in adults.
Celecoxib capsules belong 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. Celecoxib capsules acts by
reducing the production of prostaglandins, thereby
reducing the pain and inflammation.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CELECOXIB CAPSULES
You have been prescribed celecoxib capsules by
your doctor. The following information will help you
get the best results with celecoxib capsules. If you
have any further questions please ask your doctor or
pharmacist.
DO NOT TAKE CELECOXIB CAPSULES
• if you are ALLERGIC to CELECOXIB or any of the OTHER
INGR

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Celecoxib 200 mg hard capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Celecoxib 200 mg: Each capsule contains 200 mg celecoxib.
Excipient(s) with known effect: lactose (each capsule contains 48.35
mg lactose
monohydrate; see section 4.4).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard.
Celecoxib 200 mg: Celecoxib 200 mg capsule is opaque, white with two
yellow
bands, one of which is marked ‘200’.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Celecoxib is indicated in adults for the symptomatic relief in the
treatment of
osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
The decision to prescribe a selective 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
revaluated 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
200mg twice daily may increase efficacy. In the absence of an increase
in therapeutic
benefit after two weeks, other therapeutic options should be
considered.
Rheumatoid arthritis
The initial recommended daily dose is 200 mg taken in two divided
doses. The dose
may, if needed, later be increased to 200 mg twice daily. In the
absence of an increase
in therapeutic benefit after two weeks, other therapeutic options
should be considered.
Ankylosing spondylitis
The recommended daily dose is 200 mg taken once daily or in two
divided doses. In a
few patients, with insufficient relief from symptom