Celecoxib 200mg 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 :

200mg

Legemiddelform:

Oral capsule

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 10010100; GTIN: 8901463119372

Informasjon til brukeren

160 mm
100 mm
20 mm
16 mm
16 mm
4 mm
GRAIN DIRECTION
GRAIN DIRECTION
700 mm
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).
OTHER MEDICINES AND CELECOXIB CAPSULES
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines:
_ _
Ÿ
Dextromethorphan (used to treat coughs)
Ÿ
ACE inhibitors or angiotensin II antagonists
(used for high blood pressure and heart failure)
Ÿ
Diuretics (used to treat excess fluid in the body)
Ÿ
Fluconazole and rifampicin (used to treat fungal
and bacterial infections)
Ÿ
Warfarin or other oral anticoagulants (blood-
thinning” agents that reduce blood clotting)
Ÿ
Lithium (used to treat some types of depression)
Ÿ
Other medicines to treat depression, sleep
disorders, high blood pressure or an irregular
heartbeat
Ÿ
Neuroleptics (used to treat some mental
disorders)
Ÿ
Methotrexate (used to treat rheumatoid arthritis,
psoriasis and leukaemia)
Ÿ
Carbamazepine (used to treat epilepsy/seizures
and some forms of pain or depression)
Ÿ
Barbiturates (used to treat epilepsy/seizures and
some sleep disorders)
Ÿ
Ciclosporin and tacrolimus (used for immune
system suppression e.g. after transplants)
Celecoxib capsules can be taken with low dose
acetylsalicylic acid (75 mg or less daily). Ask your
doctor for advice before taking both medicines
together.
PREGNANCY, BREAST-FEEDING AND FERTILITY
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
PREGNANCY
Celecoxib capsules must not be used by women who
are pregnant or can become pregnant
_ _
(i.e. women of
child bearing potential who are not using adequate
contraception) during ongoing treatment. If you
become pregnant during treatment with Celecoxib
capsules you should discontinue the treatment and
contact your doctor for alternative treatment.
BREAST-FEEDING
Celecoxib c

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Celecoxib 200 mg capsules, hard.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 200 mg celecoxib.
Excipient(s) with known effect: lactose (each capsule, contains 33.80
mg lactose,
anhydrous; see section 4.4).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Size ‘2’ capsules, containing white to off white powder, having
white opaque
cap, white opaque body with ‘C6’ imprinted on a yellow band on the
cap and
‘200mg’ imprinted on a yellow 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 da