Vimovo

The recommended daily dose of esomeprazole - naproxen is one 375/20 mg tablet twice daily or one 500/20 mg tablet twice daily. The lowest dose possible for the shortest time period to control the pain should be used.

Esomeprazole - naproxen should be taken at least 30 minutes before meals. You should swallow the esomeprazole - naproxen tablet whole with water. It should not be split, chewed, or crushed.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Vimovo exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Vimovo at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause diarrhea or constipation, depending on the person; it may cause stomach ache; it may cause dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may increase your blood pressure; it may cause nausea or, rarely, vomiting; it may make your skin more sensitive to UV rays (e.g., sunlight, tanning lamps) - avoid exposure to UV rays as much as possible and protect yourself when out in the sun. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

375/20 mg
Each yellow, oval, film-coated tablet printed "375/20" in black ink on one side contains 20 mg of esomeprazole and 375 mg of naproxen. Nonmedicinal ingredients: 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.

500/20 mg
Each yellow, oval, film-coated tablet printed "500/20" in black ink on one side contains 20 mg of esomeprazole and 500 mg of naproxen. Nonmedicinal ingredients: 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.

Do not take Vimovo if you:

• are allergic to naproxen, esomeprazole, or any ingredients of Vimovo
• are 18 years of age or younger
• are breast-feeding
• are in the third trimester (last 3 months) of pregnancy
• are taking the medication rilpivirine
• have a bleeding disorder including bleeding in the brain
• have an active ulcer or bleeding in the stomach or intestines
• have a history of Asthma or allergic-type reactions after taking Asa or other NSAIDs (i.e., complete or partial syndrome of ASA-intolerance-rhinosinusitis, Hives, swelling of the skin, or sac-like growths of the inflamed nose tissue)
• have high blood potassium
• have inflammatory bowel disease (e.g., Crohn's Disease, Ulcerative Colitis)
• have scheduled heart bypass surgery or have recently had this surgery
• have severe Kidney Disease
• have severe untreated heart failure
• have severely impaired liver function or active liver disease

There may be an interaction between esomeprazole - naproxen and any of the following:

• 5-ASA medications (e.g., Mesalamine, olsalzine, Sulfasalazine)
• acetylsalicylic acid (ASA)
• alcohol
• Aliskiren
• alpha agonists (e.g., Clonidine, methyldopa)
• amphetamines (e.g., Dextroamphetamine, lisdexamphetamine)
• angiotensin converting enzyme inhibitors (ACEIs; Captopril, enalapril, ramipril)
• angiotensin receptor blockers (ARBs; e.g., candasartan, Irbesartan, Losartan)
• Apixaban
• "azole" antifungal medications (e.g., itraconazole, ketoconazole, Voriconazole)
• antacids
• birth control pills
• beta-adrenergic blockers (e.g., atenolol, Propranolol, Sotalol)
• Bimatoprost
• bisphosphonates (e.g., Alendronate, etidronate, Risedronate)
• Bosutinib
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Capecitabine
• Carbamazepine
• Celecoxib
• Cholestyramine
• Clobazam
• clarithromycin
• Clopidogrel
• corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• Cyclosporine
• dabigatran
• Deferasirox
• delavirdine
• Desmopressin
• dexmethylphenidate
• Diazepam
• Digoxin
• Dipyridamole
• diuretics (water pills e.g., Hydrochlorothiazide, Furosemide, triamterene)
• Edoxaban
• Enzalutamide
• Eplerenone
• glucosamine
• Haloperidol
• Heparin
• herbal medications that affect blood clotting (e.g., ginkgo biloba, garlic, ginger, ginseng, glucosamine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, nelfinavir, ritonavir, saquinavir)
• Hydralazine
• Ifosfamide
• Imipramine
• iron salts (e.g., ferrous fumarate, ferrous gluconate, ferrous sulfate)
• Latanoprost
• ledipasvir
• lithium
• low molecular weight heparins (e.g., Dalteparin, Enoxaparin, Tinzaparin)
• Methotrexate
• Methylphenidate
• Moclobemide
• multivitamins/minerals with vitamin A and vitamin E
• mycophenolate
• other nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., Ibuprofen, Diclofenac, Ketorolac, naproxen)
• omega-3 fatty acids
• Obinutuzumab
• pentamidine
• Pentoxifylline
• Phenobarbital
• Phenytoin
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• raltegravir
• Riociguat
• rifampin
• rilpivirine
• Rivaroxaban
• St. John's wort
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., Desvenlafaxine, Duloxetine, Venlafaxine)
• sodium phosphates
• "statin" anti-cholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• sulfonamides (e.g., sulfamethoxazole) or sulfonylureas (e.g., Glyburide)
• Tacrolimus
• tenofovir
• Ticagrelor
• Ticlopidine
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• trimipramine
• certain tyrosine kinase inhibitors (e.g., Dabrafenib, Dasatinib)
• velpatasvir
• vitamin E
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Vimovo. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take Vimovo.

HEALTH CANADA ADVISORY

June 8, 2021

Health Canada has issued new information concerning the use of non-steroidal anti-inflammatory drugs (NSAIDs). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Allergy: Some people who are allergic to other anti-inflammatory medications also experience allergic reactions to naproxen. Before you take naproxen, inform your doctor about any previous adverse reactions you have had to medications. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing, or swelling of the face and throat.

Breathing Problems: People who have asthma, long-term breathing problems, or allergic conditions such as hay fever or nasal polyps are more likely to experience difficulty breathing and allergic reactions caused by NSAIDs. If you have a history of allergic reactions to other substances, or respiratory illness, discuss with your doctor how Vimovo may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Vimovo, and whether any special monitoring is needed.

Blood tests: If you are taking esomeprazole - naproxen for a long time, you should get a blood test done to make sure that different blood components and enzymes are in the normal range (e.g., hemoglobin, hematocrit, red blood cells, white blood cells, magnesium, sodium, potassium, etc.).

Diarrhea: When gastric acid is decreased, the number of bacteria normally in the digestive system increases. Occasionally, this can cause serious infection in the digestive tract. If you experience severe watery or bloody diarrhea, fever, or abdominal pain while taking esomeprazole, contact your doctor as soon as possible.

Dizziness: While taking esomeprazole - naproxen, use caution while driving and carrying out activities that require you to be alert. If you are feeling dizzy, drowsy, or lightheaded, you should not drive or operate machinery.

Eye problems: If you experience blurred and/or diminished vision while taking esomeprazole - naproxen, you should stop taking Vimovo and get an eye exam. Your doctor may recommend that you have regular eye exams if you take esomeprazole - naproxen for long periods of time.

Fertility: As with other NSAIDs, Vimovo may make it more difficult for a couple to conceive if the woman is taking naproxen. Stopping the medication allows the body's chemistry to return to normal which often resolves this issue. Women who are trying to conceive, having difficulty conceiving, or are being tested to see if they are infertile should avoid using esomeprazole - naproxen.

Fluid retention: Use of naproxen can cause fluid retention and swelling. This can lead to high blood pressure and worsening of heart failure. People who are taking esomeprazole - naproxen for a long time should have their blood pressure checked regularly. In addition, if you have heart failure, decreased heart function, blood pressure, increased age, or another condition that puts you at risk of fluid retention, discuss with your doctor how Vimovo may affect your medical condition, how your medical condition may affect dosing and effectiveness of Vimovo, and whether any special monitoring is needed.

Gastrointestinal: As with other NSAIDs, naproxen can increase the risk of ulcers, bleeding, perforation, and obstruction in the digestive system. Esomeprazole helps to prevent these complications, but they can still occur. If you have a history of stomach or intestinal ulcer or gastrointestinal bleeding, discuss with your doctor how Vimovo may affect your medical condition, how your medical condition may affect dosing and effectiveness of Vimovo, and whether any special monitoring is needed. If you notice symptoms of stomach or intestinal ulcers or bleeding (such as black tarry stools, vomiting blood or material that looks like coffee grounds, or coughing up blood), stop taking the medication and seek medical attention immediately.

Heart attack and stroke: Vimovo is associated with an increased risk of heart attack or stroke. The risk is increased with higher total daily doses and taking the medication over a long period of time. If you have a history of heart disease (e.g., heart attack, stroke, heart failure, blood vessel disorders) or have risk factors for heart disease (e.g., high blood pressure, High Cholesterol, Diabetes, smoking, kidney disease), discuss with your doctor how Vimovo may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Vimovo, and whether any special monitoring is needed. Vimovo should not be taken by people who have recently had or are planning to have open heart (bypass) surgery.

High blood potassium: There is a risk of high blood potassium when taking naproxen. The people who are most at risk are seniors; people who have diabetes or kidney failure; and people taking beta-adrenergic blockers (e.g., Metoprolol, Atenolol), angiotensin converting enzyme (ACE) inhibitors (e.g., Ramipril, Enalapril), or some diuretics (e.g., triamterene, Amiloride). People with high blood potassium levels should not take Vimovo.

Kidney function: If you have mild-to-moderate kidney impairment, discuss with your doctor how Vimovo may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Vimovo, and whether any special monitoring is needed.

Long term use of NSAIDs can cause decreased kidney function. If you notice any changes in kidney function, such as decreased urine production or increased fluid retention contact your doctor.

Liver function: If you have mild-to-moderate liver impairment, discuss with your doctor how Vimovo may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Vimovo, and whether any special monitoring is needed.

Osteoporosis fractures: Long-term use of esomeprazole may be related to an increased risk of bone fractures in the hip, wrist, or spine, as a result of weakened bones. This risk is further increased if you are already at risk of developing osteoporosis. If you have osteoporosis or have risk factors for developing osteoporosis, discuss with your doctor how Vimovo may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Vimovo, and whether any special monitoring is needed.

Other anti-inflammatory medications: Esomeprazole - naproxen should not be used with other anti-inflammatory medications including naproxen. However, low doses of ASA may be used to prevent heart disease or blood vessel problems.

Sun sensitivity: Esomeprazole - naproxen may make you more sensitive to sunlight. Any exposure to sunlight may cause Sunburn, skin blisters, skin rash, redness, itching, or discoloration. You should limit your exposure to sunlight, tanning booths, and sun lamps. You should also use a sunscreen with at least SPF 30. In addition, if you are taking esomeprazole - naproxen and are in the sun, make sure to cover up (wear sunscreen, long sleeves, and a hat).

Urinary problems: Esomeprazole - naproxen may cause problems such as bladder pain, painful urination, frequent urination, blood in the urine, and irritation of the bladder. If you experience any urinary symptoms, stop taking Vimovo and consult with your health care provider.

Vitamin B12: Long-term use of esomeprazole may lead to Vitamin B12 deficiency. If you are a vegetarian or have low Vitamin B12 levels, discuss with your doctor if any special monitoring is required.

Pregnancy: When naproxen is taken during the last 3 months of pregnancy, there is an increased risk of the child developing heart problems and of the mother having a longer labour. If you become pregnant while taking Vimovo, contact your doctor immediately.

Breast-feeding: It is not known if naproxen or esomeprazole pass into breast milk. Due to the potential for harm to a baby if they are exposed to Vimovo, breast-feeding must be stopped before starting Vimovo.

Children: The safety and effectiveness of using Vimovo have not been established for children.

Seniors: Seniors appear to have a higher risk of side effects with Vimovo. The lowest effective dosage should be used under close medical supervision.

This medication is typically used twice a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Depending on the treated condition, it may be used regularly or only as needed. Follow the instructions provided by your health care professional. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. This medication should be swallowed whole. It should not be split, crushed or chewed. This medication should be taken 30 minutes before a meal. This medication may irritate the stomach. It is best to avoid coffee, spicy food or alcohol.