Vimovo 375/20mg Tabs

DIN

02361701

Size

60 Tablets

SKU

0620641014435

Directions

375/20 mg (naproxen/esomeprazole) twice a day

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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).
What it does:

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.

ABOUT THE DISEASE

Osteoarthritis (OA):

Osteoarthritis is the most common form of arthritis, and it occurs when the protective cartilage that cushions the ends of the bones wears down over time. Osteoarthritis most commonly affects joints in your hands, knees, hips and spine, although the disorder it can affect any joint. Although damage caused by Osteoarthritis to the joints can’t be reversed, symptoms can usually be managed. Maintaining a healthy weight, active lifestyle, and receiving certain treatments may slow the progression of the disease and help to improve pain and joint function

Rheumatoid arthritis (RA) :

An autoimmune disorder, Rheumatoid Arthritis occurs in patient’s when their immune system mistakenly attacks it’s own body’s tissues, causing a painful swelling that can eventually result in bone erosion and joint deformity. Rheumatoid arthritis is a chronic inflammatory disorder that can affect more than just joints. In some patient’s the condition can damage a wide variety of body systems, including the skin, eyes, lungs, heart and blood vessels.

Ankylosing spondylitis (AS):

Ankylosing spondylitis, also known as axial spondyloarthritis, is an inflammatory disease that, over time, can cause some of the bones in the spine, called vertebrae, to fuse together. This fusing can compromise the patient’s spine flexibility and can result in a hunched posture. If the patient’s ribs are affected, it can be difficult for the patient to breathe deeply. There are two different types of Axial spondyloarthritis. When the condition cannot be seen on X-ray of the patient but is found based on symptoms, blood tests and other imaging tests, it is called nonradiographic axial spondyloarthritis. When the condition is found on the patient’s X-ray, it is called ankylosing spondylitis, also known as axial spondyloarthritis

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