INFORMATION FOR THE PATIENT

What the medication is used for:

VIMOVO^® treats the signs and symptoms of:

• Osteoarthritis.
• Rheumatoid arthritis.
• Ankylosing spondylitis.

VIMOVO^® helps to reduce pain, swelling, redness and heat (inflammation). It is used for people who:

• need to take an anti-inflammatory medicine.
• are at risk of getting a stomach ulcer (sore) or an ulcer in the small intestine (gut).

VIMOVO^® contains 2 drugs which work together:

• Naproxen belongs to a group of medicines called “nonsteroidal anti-inflammatory drugs” (NSAIDs). It reduces the substances in your body which cause pain and swelling.
• Esomeprazole belongs to a group of medicines called “proton pump inhibitors” (PPIs). It reduces the amount of acid produced by your stomach.
• Naproxen can damage the stomach but esomeprazole helps reduce this damage.

VIMOVO^® only treats the symptoms of pain and inflammation of the illness as long as you use it. VIMOVO^® does not cure the illness.

When it should not be used:

Do not use VIMOVO^® if:

• you have heart bypass surgery (planning to have or recently had).
• you have severe, uncontrolled heart failure.
• you have bleeding in the brain or other bleeding disorders.
• you are pregnant (after 28 weeks of pregnancy).
• you are currently breastfeeding (or planning to breastfeed).
• you are allergic to ASA (Acetylsalicylic Acid), other NSAIDs, naproxen, esomeprazole, substituted benzimidazoles or other ingredients of VIMOVO (see “What are the Ingredients in VIMOVO”).
• you have an active ulcer.
• you have active bleeding from the stomach or gut
• you have inflammatory bowel disease (Crohn’s Disease or Ulcerative Colitis).
• you have liver disease (active or severe).
• you have kidney disease (severe or worsening).
• you have high potassium in the blood.
• you are taking rilpivirine

What the medicinal ingredient is:

Naproxen (enteric-coated, delayed release core) and Esomeprazole (as esomeprazole magnesium trihydrate, immediate release coating)

What the nonmedicinal ingredients are:

Carnauba wax, croscarmellose sodium, glycerol monostearate, hypromellose, iron oxide black, iron oxide yellow, macrogols, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion, methyl parahydroxybenzoate, polydextrose, polysorbate, povidone, propylene glycol, propyl parahydroxybenzoate, silica colloidal anhydrous, titanium dioxide and triethyl citrate.

What dosage forms it comes in:

VIMOVO^® (naproxen/esomeprazole) 375/20 mg tablets are yellow, oval film coated tablets printed ‘375/20’ in black ink on one side.