Brand Name Choices
No generic medication is available for Vimovo (Naproxen/Esomeprazole Magnesium)
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:
• 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.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may happen with this medicine. Stop taking VIMOVO and see a doctor immediately if you notice any of the following serious side effects – you may need urgent medical treatment:
• Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction).
• Reddening of your skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals.
• Yellowing of the skin or the whites of your eyes, having dark urine and tiredness which can be symptoms of liver problems.
• Medicines such as VIMOVO may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Signs include chest pain spreading to your neck and shoulders and down your left arm, confusion or muscle weakness or numbness which may only be on one side of your body.
• You pass black sticky bowel motions (stools) or have bloody diarrhoea.
• You vomit any blood or dark particles that look like coffee grounds. Talk to your doctor as soon as possible if you experience any of the following: VIMOVO may in rare cases affect the white blood cells leading to immune deficiency. If you have an infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, you must consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important for you to give information about your medication at this time. Other possible side effects include:
Common (may affect up to 1 in 10 people)
• Feeling tired.
• Feeling thirsty.
• Feeling depressed.
• Feeling breathless.
• Increased sweating.
• Itchy skin and skin rashes.
• Spinning feeling (vertigo).
• Red or purple marks, bruising or spots on your skin.
• Feeling sick (nausea) or being sick (vomiting).
• A fluttering feeling in your heart (palpitations).
• Disturbed sleep or trouble sleeping (insomnia).
• Hearing problems or ringing in your ears.
• Dizziness, feeling drowsy or feeling light-headed.
• Swelling of your hands, feet and ankles (oedema).
• An inflammation inside the mouth.
• Eyesight problems.
• Diarrhoea, stomach pain, heartburn, indigestion, constipation, burping or wind (flatulence).
• Stomach ulcer or ulcer in the first part (duodenum) of the small intestine.
• Inflammation of the lining of the stomach (gastritis).
• Benign polyps in the stomach.
Uncommon, rare or very rare (may affect up to 1 in 100 people or less)
• A sore mouth or mouth ulcers.
• Eyesight problems such as blurred vision, conjunctivitis or eye pain.
• Strange dreams.
• Feeling sleepy.
• An increased in the amount of sugar (glucose) in your blood. The symptoms may include feeling thirsty and increased amount of urine.
• Low levels of sugar (glucose) in your blood. The symptoms may include feeling hungry or weak, sweating and a fast heart beat.
• Inflammation of the blood vessels.
• Perforation (hole) of the stomach or intestine.
• Systemic lupus erythematosus (SLE), a disease where the body’s immune system attacks the body, which causes joint pain, skin rashes and fever.
• Enlarged lymph glands.
• Fracture of the hip, wrist or spine (if VIMOVO is used in high doses and over long duration).
• Dry mouth.
• Hearing loss.
• Asthma attack.
• Fits or seizures.
• Period problems.
• Weight changes.
• Hair loss (alopecia).
• Lumpy rash (hives).
• Joint pain (arthralgia).
• Enlarged breasts in men.
• Sore or swollen tongue.
• Twitching or muscle tremor.
• Appetite problems or taste changes.
• Muscle weakness or pain (myalgia).
• Your blood may take longer to clot.
• Problems for women in getting pregnant.
• Fever, redness or other signs of infection.
• An irregular, slow or very fast heart beat.
• Tingling feelings such as “pins and needles”.
• Difficulty with your memory or concentration.
• Feeling agitated, confused, anxious or nervous.
• Generally feeling unwell, weak and lacking energy.
• Swollen or painful parts of your body because you have gained water.
• High or low blood pressure. You may feel faint or dizzy.
• Skin rash or blistering, or your skin becoming more sensitive on exposure to sunlight.
• Seeing, feeling or hearing things that are not there (hallucinations).
• Changes in your blood test results, such as to see how your liver is working. Your doctor can explain more.
• An infection called “thrush” which can affect the gut and is caused by a fungus.
• Blood in your urine (water) or other kidney problems. You may have back pain.
• Difficulty breathing, which may get slowly worse. This may be signs of pneumonia or swelling of your lungs developing.
• Low levels of salt (sodium) in your blood. This may cause weakness, being sick (vomiting) and cramps.
• Symptoms of meninigitis such as fever, feeling or being sick, a stiff neck, headache, sensitivity to bright light and confusion.
• Problems with your pancreas. Signs include severe stomach pain which spreads to your back.
• Pale coloured stools which are a sign of serious liver problems (hepatitis). Serious liver problems may lead to liver failure and disorder of the brain.
• Colitis or worsening of inflammatory bowel disease such as Crohn’s disease or ulcerative colitis. Signs include stomach pain, diarrhoea, vomiting and weight loss.
• Blood problems such as a reduced number of red cells (anaemia), white cells or platelets. This can cause weakness, bruising, fever, severe chills, sore throat or make infections more likely.
• Increased number of a certain type of white blood cells (eosinophilia).
• A shortage of all types of blood cells (pancytopenia).
• Problems with the way your heart pumps blood around the body or damage to your blood vessels. Signs may include tiredness, shortness of breath, feeling faint, chest pain or general pain.
Not known (frequency cannot be estimated from the available data)
• If you are on VIMOVO for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
• Rash, possibly with pain in the joints. Do not be concerned by this list of possible side effects. You may not get any of them.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via: United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard Ireland HPRA Pharmacovigilance Earlsfort Terrace IRL
•Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected] By reporting side effects you can help provide more information on the safety of this medicine.
How to Store Vimovo
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton, bottle or blister after EXP. The expiry date refers to the last day of that month. Do not store above 30°C. Bottle: Store in the original package and keep the bottle tightly closed in order to protect from moisture. Blister: Store in the original package in order to protect from moisture. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
2 to 3 weeks on average
The average shipping time is 2 weeks in North America and 4 weeks internationally. We offer free shipping on all orders shipped to North America. Shipping is a flat rate of $20.00 for all other countries.
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