Etoricoxib 60mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Etoricoxib

Dostopno od:

Zentiva Pharma UK Ltd

Koda artikla:

M01AH05

INN (mednarodno ime):

Etoricoxib

Odmerek:

60mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 10010100; GTIN: 5000283658733

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Etoricoxib 30 mg film-coated tablets
Etoricoxib 60 mg film-coated tablets
Etoricoxib 90 mg film-coated tablets
Etoricoxib 120 mg film-coated tablets
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
The name of your medicine is Etoricoxib film-coated tablets
(referred to as etoricoxib throughout this leaflet). The active
substance etoricoxib belongs to a group of medicines called
selective COX-2 inhibitors. These belong to a family of
medicines called non-steroidal anti-inflammatory drugs
(NSAIDs).
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 incr

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Etoricoxib
60 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH film-COATED TABLET CONTAINS 60 MG OF ETORICOXIB.
Excipient with known effect: Also contains 1.68 mg of lactose
monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
60 mg: Green, round, biconvex, film-coated tablets debossed with
‘444’ on
one side and ‘L’ on other side. The tablet diameter is 8.00 mm.
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 patient is clinically stabilised, down-