VIMOVO 500MG20MG MODIFIED-RELEASE TABLETS

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

NAPROXEN; ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

Boleh didapati daripada:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

NAPROXEN; ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

Unit dalam pakej:

60Tablet Tablets; 60 Tablets

Dikeluarkan oleh:

PATHEON PHARMACEUTICALS INC

Risalah maklumat

_Consumer Medication Information_
_Leaflet (RiMUP)_
VIMOVO MODIFIED-RELEASE TABLETS
_ _
Naproxen /esomeprazole (500mg/20mg)
1
WHAT IS IN THIS LEAFLET
1.
What Vimovo is used for
2.
How Vimovo works
3.
Before you use Vimovo
4.
How to use Vimovo
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Vimovo
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
11.
Serial Number
WHAT VIMOVO IS USED FOR
Vimovo is used to treat the following
inflammatory problems:
•
Osteoarthritis (degenerative joint
disease).
•
Rheumatoid Arthritis (systemic
inflammatory disorder that affects
joints).
•
Ankylosing Spondylitis (chronic
inflammatory disease of the skeleton).
Vimovo helps to reduce pain, swelling,
redness and heat (inflammation).
You will be given this medicine if you
need to be treated with an anti-
inflammatory medicine and you are at risk
of getting a stomach ulcer or an ulcer in
your small intestine (gut). This medicine
has been shown to reduce the risk of
ulcers occurring when compared to taking
naproxen on its own.
HOW VIMOVO WORKS
Vimovo contains two different medicines
called naproxen and esomeprazole. Each
of these medicines works in a different
way.
Naproxen belongs to a group of medicines
called “Non-Steroidal Anti-Inflammatory
Drugs” (NSAIDs). It works by reducing
inflammation.
Esomeprazole belongs to a group of
medicines called “proton pump
inhibitors”. It works by reducing the
amount of acid your stomach produces.
Esomeprazole helps to reduce the risk of
ulcers and stomach problems developing
in patients who need to take naproxen to
reduce inflammation.
BEFORE YOU USE VIMOVO
-
_When you must not use it _
Do not take Vimovo if
•
You are allergic (hypersensitive) to
naproxen, esomeprazole, or any of the
other ingredients of Vimovo (listed
under ‘Ingredients’ section).
•
You are allergic to other proton pump
inhibitor medicines.
•
You are taking a medicine called
“atazanavir” or “nelfinavir” (used to
treat HIV).
•
If aspirin,

Ciri produk

1
VIMOVO
 500 MG/20 MG MODIFIED-RELEASE TABLETS
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains 500 mg naproxen and 20 mg
esomeprazole (as 22.3mg
magnesium trihydrate).
VIMOVO contains very low, non-preserving levels of 0.02 mg methyl
parahydroxybenzoate
and 0.01 mg propyl parahydroxybenzoate (see sections “Special
warnings and precautions for
use” and “List of excipients”).
For a full list of excipients, see section “List of excipients”.
PHARMACEUTICAL FORM
Modified-release tablet containing enteric-coated (gastro-resistant)
naproxen and film-coated
esomeprazole.
Oval, biconvex, yellow tablet marked ‘500/20’ in black ink.
THERAPEUTIC INDICATIONS
Symptomatic treatment of osteoarthritis, rheumatoid arthritis and
ankylosing spondylitis, in
patients who are at risk for developing non-steroidal
anti-inflammatory drug (NSAID)-
associated gastric and/or duodenal ulcers and where treatment with
lower doses of naproxen
or of other NSAIDs is not considered sufficient.
POSOLOGY & METHOD OF ADMINISTRATION
Posology in adults
The dose is 1 tablet (500 mg/20 mg) twice daily.
Undesirable effects of naproxen may be minimised by using the lowest
effective dose for the
shortest duration possible (see section “Special warnings and
precautions for use”). In
patients not treated with a NSAID previously, a lower daily dose of
naproxen or of another
NSAID should be considered. When total daily dose of 1000 mg of
naproxen is not
considered appropriate, alternative therapeutic regimens should be
utilized.
Treatment should be continued to achieve individual treatment goals,
reviewed at regular
intervals and discontinued if no benefit seen.
Due to the delayed release of naproxen from the enteric-coated
formulation, VIMOVO is not
intended for the treatment of acute pain conditions (such as dental
pain or gout). However,
flares of osteoarthritis, rheumatoid arthritis and ankylosing
spondylitis may be treated with
VIMOVO.
Method of administration
VIMOVO must be swallowed whole with water,