Celecoxib 100mg capsules

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Celecoxib

Tilgjengelig fra:

Macleods Pharma UK Ltd

ATC-kode:

M01AH01

INN (International Name):

Celecoxib

Dosering :

100mg

Legemiddelform:

Oral capsule

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 10010100; GTIN: 8901463119365

Informasjon til brukeren

Ÿ
Dextromethorphan (used to treat coughs)
The dose is usually:
Celecoxib capsules contain
LACTOSE
(a type of sugar).
If you have been told by your doctor that you
have an intolerance to some sugars, contact your
doctor before taking this medicinal product.
IF YOU TAKE MORE CELECOXIB CAPSULES THAN YOU
SHOULD
FOR
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.
n
one 100 mg capsule twice a day.
CELECOXIB CAPSULES CONTAIN LACTOSE
You should not take more capsules than your doctor
tells you to. If you take too many capsules contact
your doctor, pharmacist or hospital and take your
medicine with you.
n
one 100 mg capsule twice a day.
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines:
_ _
OTHER MEDICINES AND CELECOXIB CAPSULES
You should be aware of how you react to Celecoxib
capsules before you drive or operate machinery. If
you feel dizzy or drowsy after taking Celecoxib
capsules, do not drive or operate machinery until
these effects wear off.
IF YOU FORGET TO TAKE CELECOXIB CAPSULES_ _
The dose is usually:
You should not take more than 400 mg per day.
pregnant. You should inform your doctor if you are
planning to become pregnant or if you have problems
to become pregnant (see section on Pregnancy and
breast-feeding).
DRIVING AND USING MACHINES
n
one 200 mg capsule once a day; or
FOR
ANKYLOSING SPONDYLITIS:
the usual dose is 200
mg each day, increased by your doctor to a maximum
of 400 mg, if needed.
If you forget to take a capsule, take it as soon as you
remember. Do not take a double dose to make up for
a forgotten dose.
FOR OSTEOARTHRITIS:
the usual dose is 200 mg each
day, increased by your doctor to a maximum of 400
mg, if needed.
KIDNEY OR LIVER PROBLEMS:
make sure your doctor
knows if you have liver or kidney problems as you
may need a lower dose.
NSAIDs, including Celecoxib capsules, may make it
more difficult to become pregnant. You should tel

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Celecoxib 100 mg capsules, hard.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg celecoxib.
Excipient(s) with known effect: lactose (each capsule, contains 16.90
mg lactose,
anhydrous; see section 4.4).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Size ‘4’capsules, containing white to off white powder, having
white opaque
cap, white opaque body with ‘C5’ imprinted on a blue band on the
cap and
‘100mg’ imprinted on a blue band on the body.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Celecoxib Capsules 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 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 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 o