Etoricoxib 60mg tablets

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Etoricoxib

Доступна з:

Milpharm Ltd

Код атс:

M01AH05

ІПН (Міжнародна Ім'я):

Etoricoxib

Дозування:

60mg

Фармацевтична форма:

Oral tablet

Адміністрація маршрут:

Oral

Клас:

No Controlled Drug Status

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 10010100; GTIN: 8901175029754

інформаційний буклет

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

Характеристики продукта

OBJECT 1
ETORICOXIB 60MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 19-Jul-2017 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Etoricoxib 60 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 60 mg etoricoxib
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Dark green, apple-shaped, biconvex film coated tablet, debossed with
“60” on one side and plain on the
other, with dimensions of 7.1 x 7.3 mm ± 7.5%.
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 30 mg once daily. In some patients with
insufficient relief from symptoms, an
increased dose of 60 mg 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 60 mg once daily. In some patients with
insufficient relief from symptoms, an
increased dose of 90 mg once daily may increase efficacy. Once the
patie