Vimovo (Naproxen/Esomeprazole)

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Vimovo 500mg/20mg

Product of United Kingdom
Manufactured by: Grunenthal Ltd
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Vimovo 500mg/20mg
Product of United Kingdom
Manufactured by Grunenthal Ltd
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Vimovo 375mg/20mg

Product of Canada
Manufactured by: AstraZeneca
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Vimovo 375mg/20mg
Product of Canada
Manufactured by AstraZeneca
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Vimovo 500mg/20mg

Product of Canada
Manufactured by: AstraZeneca
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Vimovo 500mg/20mg
Product of Canada
Manufactured by AstraZeneca
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Naproxen/Esomeprazole 375mg/20mg

Product of Canada
Manufactured by: Mylan
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Naproxen/Esomeprazole 375mg/20mg
Product of Canada
Manufactured by Mylan
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Naproxen/Esomeprazole 500mg/20mg

Product of Canada
Manufactured by: Mylan
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Naproxen/Esomeprazole 500mg/20mg
Product of Canada
Manufactured by Mylan
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Vimovo (Naproxen/Esomeprazole) Dosage and Side Effects

VIMOVO treats the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.

Warnings and Precautions

This medicine should be used at the lowest dose and for the shortest time suitable for your condition. Talk to your doctor if you have any concerns about your treatment.

Tell any doctor, dentist, pharmacist or health care professional that you see, that you are taking this medicine. This is especially important if you are planning to have heart surgery.

Do NOT drink alcohol while taking this medication. You would be more likely to get stomach problems.

Fertility may be decreased. The use of VIMOVO is not recommended in women trying to get pregnant.

Tell your doctor or pharmacist about symptoms that may be a sign of a more serious problem in your stomach or intestine such as:

  • trouble swallowing.
  • unplanned weight loss.
  • vomiting blood or food.
  • black (blood-stained) stools.
  • 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
  • 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.

Patients who took a drug in the same class as VIMOVO after a type of heart surgery (coronary artery bypass grafting (CABG)) were more likely to have heart attacks, strokes, blood clots in the leg(s) or lung(s), and infections or other complications than those who did NOT take that drug. VIMOVO must not be used after recent CABG.

VIMOVO should NOT be used in patients under 18 years of age.

If you take antibiotics while taking VIMOVO: If you experience symptoms such as severe (bloody or repeated watery) diarrhea, with or without fever, abdominal pain or tenderness, you may have bowel inflammation caused by a bacterial infection (Clostridium difficile). If this happens, stop taking the drug combination and call your healthcare professional immediately.

Long-term use of PPIs, like esomeprazole, may interfere with the absorption of Vitamin B12 from the diet. This may cause a shortage of Vitamin B12 in your body. Talk to your doctor about this risk.

Long-term use of PPIs may lead to low blood magnesium in some people. When blood magnesium is lower than normal, it may also lead to low blood calcium and low blood potassium.

Using PPIs for a long time (every day for a year or longer) may increase risks of broken bones of the hip, wrist or spine. Talk to your doctor about this risk.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Side Effects

VIMOVO may cause some side effects, especially if you use it for a long time or take large doses. When these side effects occur, you may need to see a health care provider. These are not all the possible side effects you may feel when taking VIMOVO. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

VIMOVO may cause you to become drowsy or tired. Be careful about driving or doing activities that require you to be alert. If you become drowsy, dizzy or light-headed after taking VIMOVO, do NOT drive or use machines.

VIMOVO may cause you to become more sensitive to sunlight. Sunlight or sunlamps may cause sunburn, skin blisters, skin rash, redness, itching or discolouration, or vision changes. If you have a reaction from the sun, check with your health care provider.

Stomach upset is a common problem with NSAIDs, such as naproxen. The esomeprazole in VIMOVO helps to reduce this side effect. However, side effects, usually mild, have been reported with esomeprazole use. These side effects may not be caused by esomeprazole in your case, but only a doctor can assess this. If these become bothersome (or last more than 1-2 days), discuss with your doctor.

Common:

  • Nausea.
  • Stomach upset.
  • Diarrhea.
  • Headache.

Uncommon:

  • Dry mouth.
  • Dizziness.
  • Insomnia.
  • Feeling of burning/prickliness/numbing.
  • Swelling of extremities.
  • Feeling sleepy.
  • Feeling like you or your surroundings are moving (vertigo).

Rare:

  • Taste disorders.
  • Nervousness.
  • Hair loss.
  • Increased sweating.

Stopping VIMOVO after taking it for a long time may cause your stomach to increase acid production. This may cause stomach symptoms. Carefully follow your doctor’s instructions when stopping VIMOVO.

Interactions with this medication

NOT a complete list

  • Acetylsalicylic Acid (ASA) or other NSAIDs (e.g. celecoxib, diclofenac, ibuprofen, indomethacin, ketorolac, meloxicam, naproxen).
  • Antacids.
  • Antidepressants (Selective Serotonin Reuptake Inhibitors (SSRIs), e.g. citalopram, fluoxetine, paroxetine, sertraline).
  • Blood pressure medications (ACE (angiotensin converting enzyme) inhibitors, e.g. enalapril, lisinopril, perindopril, ramipril) or ARBs (angiotensin II receptor blockers, e.g. candesartan, irbesartan, losartan, valsartan).
  • Blood thinners (e.g. warfarin, ASA, clopidogrel).
  • Corticosteroids (including glucocorticoids e.g. prednisone).
  • Cyclosporin.
  • Digoxin.
  • Diuretics (e.g. furosemide, hydrochlorothiazide).
  • Erlotinib (or any other anticancer drug from the same class).
  • Lithium.
  • Methotrexate.
  • Oral contraceptives.
  • Oral hypoglycemics (diabetes medications).
  • Tacrolimus.

Your health care provider may prescribe low-dose ASA (acetylsalicylic acid) as a blood thinner to reduce your risk of having a heart attack or stroke while you are taking VIMOVO. Take only the amount of ASA prescribed by your health care provider. The beneficial effects of VIMOVO apply whether you take ASA or not.

Studies with esomeprazole have shown that blood levels of some drugs may be influenced if taken at the same time as drugs used to prevent fungal infections (itraconazole, ketoconazole, voriconazole), anxiety (diazepam), epilepsy (phenytoin), drugs to speed up stomach emptying (cisapride), poor circulation in the legs (cilostazol), heart problems (digoxin), treatment for tuberculosis (rifampin), St John’s Wort (Hypericum perforatum) or a certain type of anticancer drug (erlotinib or any other anticancer drug from the same class). However, none of these interactions have been shown to change the effectiveness of esomeprazole or the other drug.

Drugs used to prevent blood clotting (warfarin or coumarin derivatives, clopidogrel) have been reported to interact with esomeprazole. Speak to your doctor or pharmacist if you are taking any of these drugs as monitoring may be required when you start or stop taking VIMOVO. Use of VIMOVO with clopidogrel should be avoided.

Esomeprazole may decrease the effectiveness of some drugs used for HIV treatment. Atazanavir and nelfinavir should not be used with VIMOVO.

Proper Use of this medication

Carefully follow your health care provider’s directions on how to take VIMOVO.

Do NOT take more of it.

Do NOT take it more often.

Do NOT take it for a longer period of time than your health care provider recommends.

If possible, you should take the lowest dose of this medication for the shortest time period. Taking too much VIMOVO may increase your chances of unwanted and sometimes dangerous side effects, especially if you are elderly, have other diseases or take other medications.

This medication has been prescribed specifically for you. Do NOT give it to anyone else. It may harm them, even if their symptoms seem to be similar to yours.

  • VIMOVO should be taken at least 30 minutes before a meal.
  • The tablets should be swallowed whole with water.
  • Do not chew, split or crush them.

Overdose

If you think you have taken too much VIMOVO, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose of VIMOVO, take the dose as soon as possible. Then go back to your regular schedule. If you remember your missed dose close to the time of your next dose, do not take the missed dose. Do not double dose. Just take the next dose on time.

Other related products

The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

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