Etoricoxib 30mg tablets

Country: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Etoricoxib

থেকে পাওয়া:

Milpharm Ltd

এটিসি কোড:

M01AH05

INN (International Name):

Etoricoxib

ডোজ:

30mg

ফার্মাসিউটিকাল ফর্ম:

Oral tablet

প্রশাসন রুট:

Oral

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 10010100; GTIN: 8901175029747

তথ্য লিফলেট

Package leaflet: Information for the user
ETORICOXIB 30 MG FILM-COATED TABLETS
ETORICOXIB 60 MG FILM-COATED TABLETS
ETORICOXIB 90 MG FILM-COATED TABLETS
ETORICOXIB 120 MG FILM-COATED TABLETS
Etoricoxib
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 Etoricoxib is and what it is used for
2.
What you need to know before you take
Etoricoxib
3.
How to take Etoricoxib
4.
Possible side effects
5.
How to store Etoricoxib
6.
Contents of the pack and other information 1. WHAT ETORICOXIB IS AND WHAT IT IS USED FOR
WHAT IS ETORICOXIB?
•
Etoricoxib contains the active substance
etoricoxib. Etoricoxib is one of a group of
medicines called selective COX-2 inhibitors.
These belong to a family of medicines called
non-steroidal anti-inflammatory drugs
(NSAIDs).
WHAT IS ETORICOXIB USED FOR?
•
Etoricoxib helps to reduce the pain and
swelling (inflammation) in the joints and
muscles of people 16 years of age and older
with osteoarthritis, rheumatoid arthritis,
ankylosing spondylitis and gout.
•
Etoricoxib is also used for the short-term
treatment of moderate pain after dental
surgery in people 16 years of age and older.
WHAT IS OSTEOARTHRITIS?
Osteoarthritis is a disease of the joints. It results
from the gradual breakdown of cartilage that
cushions the ends of the bones. This causes
swelling (inflammation), pain, tenderness,
stiffness and disability.
WHAT IS RHEUMATOID ARTHRITIS?
Rheumatoid arthritis is a long term inflammatory
disease of the joints. It causes pain, stiffness,
swelling, and increasin

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Etoricoxib 30mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30mg of etoricoxib.
Excipient with known effect:
Each film-coated tablet contains 0.84mg lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets.
Bluish green, round (approx. 6.0mm diameter), biconvex, film-coated
tablets
debossed with “443” on one side and “L” on the other side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Etoricoxib is indicated in adults and adolescents 16 years of age and
older for the
symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA),
ankylosing
spondylitis, and the pain and signs of inflammation associated with
acute gouty
arthritis. Etoricoxib is indicated in adults and adolescents 16 years
of age and older
for the short-term treatment of moderate pain associated with dental
surgery.
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, 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
As the cardiovascular risks of etoricoxib 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 recommended dose is 30mg once daily. In some patients with
insufficient
relief from symptoms, an increased dose of 60mg once daily may
increase
efficacy. In the absence of an increase in therapeutic benefit, other
therapeutic
options should be considered.
_Rheumatoid arthritis_
The recommended dose is 60mg once daily. In some patients with
insufficient
relief from symptoms, an increased dose of 90mg once daily may
increase
efficacy. Once the patient is clinically stabil