VIMOVO 500 mg/20 mg modified-release tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
01-06-2018
Summary of Product characteristics
(SPC)
01-06-2018
Active ingredient:
ESOMEPRAZOLE; Naproxen
Available from:
Imbat Limited
ATC code:
M01AE; M01AE52
INN (International Name):
ESOMEPRAZOLE; Naproxen
Dosage:
500/20 milligram(s)
Pharmaceutical form:
Modified-release tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Propionic acid derivatives; naproxen and esomeprazole
Authorization status:
Authorised
Authorization date:
2018-02-09
Patient Information leaflet
Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIMOVO
® 500 MG/20 MG
MODIFIED-RELEASE TABLETS
naproxen/esomeprazole
Your medicine is available using the above name but will be
referred to as VIMOVO throughout the leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE.
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
symptoms 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.
IN THIS LEAFLET:
1.
What VIMOVO is and what it is used for
2.
What you need to know before you take VIMOVO
3.
How to take VIMOVO
4.
Possible side effects
5.
How to store VIMOVO
6.
Contents of the pack and other information
1.
WHAT VIMOVO IS AND WHAT IT IS USED FOR
WHAT VIMOVO IS
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 reduces
pain and inflammation.
Esomeprazole belongs to a group of medicines called
“proton pump inhibitors”. It reduces the amount of acid
in your stomach.
Esomeprazole helps to reduce the risk of ulcers and stomach
problems developing in patients who need to take NSAIDs.
WHAT VIMOVO IS USED FOR
VIMOVO is used in adults for the relief of symptoms of:
Osteoarthritis.
Rheumatoid arthritis.
Ankylosing spondylitis.
VIMOVO helps to reduce pain, swelling, redness and heat
(inflammation).
You will be given this medicine if a lower dose of NSAID is
considered unlikely to relieve your pain and you are at risk of
getting a stomach ulcer or an ulcer in the first part
(duodenum) of your small intestine (gut) when taking
NSAIDs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
VIMOVO
DO NOT TAKE VIMO
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
VIMOVO 500 mg/20 mg modified-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains 500 mg naproxen and 20 mg
esomeprazole (as magnesium trihydrate).
Excipient(s) with known effect
VIMOVO contains methyl parahydroxybenzoate and propyl
parahydroxybenzoate
(see sections 4.4 and 6.1).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release tablet containing enteric-coated (gastro-resistant)
naproxen and film-coated esomeprazole.
_Product imported from Romania_
Oval, biconvex, yellow tablet marked ‘500/20’ in black ink.
4 CLINICAL PARTICULARS
As per PA0970/060/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0970/060/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
TABLET CORE
Croscarmellose sodium
Magnesium stearate
Povidone K90
Silica, colloidal anhydrous
COATING
Carnauba wax
Glycerol monostearate 40-55
Hypromellose type 2910 (3 mPas, 6 mPas and 50 mPas)
Iron oxide (E172) (yellow)
Macrogol 8000
Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%
Methyl parahydroxybenzoate (E218)
Polydextrose
Polysorbate 80
Propyl parahydroxybenzoate (E216)*
Sodium laurilsulfate
Titanium dioxide (E171)
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PRINTING INK
Hypromellose
Iron oxide (E172)
Read the complete document
