Naproxen + Esomeprazole - Oral

Naproxen and Esomeprazole are combined in this medicine.

Naproxen + Esomeprazole helps relieve pain and inflammation in individuals who are at risk of developing ulcers of the stomach or intestine.

This medicine is used to provide relief in pain associated with joint disorders such as ankylosing spondylitis (inflammation in the joints of your spine), osteoarthritis (a joint disorder where the protective tissue that covers the ends of bones wears down causing joint pain, swelling and stiffness), and rheumatoid arthritis (inflammation in the joints of fingers, wrist, feet, and ankles).

Naproxen + Esomeprazole may be used to treat other conditions as decided by your doctor.

Take Naproxen + Esomeprazole exactly as directed by your doctor or according to the instructions on the label. Do not take more or less than instructed by your doctor.

Take this medicine at least 30 minutes before meals.

To take the modified-release tablet, swallow it whole with a glass of water. Do not divide, chew, or crush the tablet.

You may stop taking this medicine when you have no more pain and inflammation.

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and return to your normal dosing schedule.

DO NOT double a dose under any circumstances.

Do not take Naproxen + Esomeprazole if you ever had an allergic reaction (e.g. rashes, breathlessness, swollen eyes) to Naproxen, Esomeprazole, or similar medicines such as ibuprofen, diclofenac, celecoxib and omeprazole.

Alert your doctor if you have the following conditions:

• history of asthma, hives or other allergic reactions after taking aspirin or similar medicines for pain and inflammation
• active peptic ulcer (open sores in the lining of the stomach, small intestine, or lower food pipe)
• bleeding problems e.g. bleeding in the stomach or intestine
• severe heart failure (weakness and inability of the heart to pump blood)
• severe kidney disease
• severe liver disease

as Naproxen + Esomeprazole may not be suitable for you.

Do not take this medicine if you are in your 3rd trimester of pregnancy. If you become pregnant while being treated with Naproxen + Esomeprazole, alert your doctor immediately. This medicine may cause harm to your unborn child.

This medicine should not be used to treat pain in the setting of coronary artery bypass graft surgery (a procedure to improve and restore the blood flow in the heart).

Do not take Naproxen + Esomeprazole with certain medicines for HIV infection, such as atazanavir, nelfinavir and rilpivirine.

Inform your doctor if you have the following conditions:

• uncontrolled high blood pressure
• heart problems e.g. mild to moderate heart failure
• disease of the blood vessels supplying the brain
• problems in the blood vessels or blood circulation
• diabetes
• high lipid (fats) level in the blood
• current or history of asthma
• history of ulcer or bleeding in the stomach or intestine
• history of stomach or bowel disease e.g. ulcerative colitis (a disease that causes inflammation and sores in the linings of the large intestine and rectum), Crohn's disease (a long-term inflammatory disease of the digestive tract that usually affects the small intestine and colon)
• systemic lupus erythematosus (autoimmune disease that causes inflammation of certain organs in the body)
• low volume of circulating fluids in the body
• swelling of the ankles, feet or hand
• blood clotting problems
• mild to moderate kidney disease
• mild to moderate liver disease

Let your doctor know if you are in your 1st or 2nd trimester of pregnancy or if you are breastfeeding.

Be sure to check with your doctor or pharmacist before giving Naproxen + Esomeprazole to a child, elderly, or debilitated individual (physically or mentally weak, usually due to illness or old age). They may be more sensitive to the side effects.

If you are going to have certain laboratory tests (e.g. diagnostic tests for certain tumour), inform your doctor that you are taking Naproxen + Esomeprazole.

Avoid long-term use of any painkillers.

Why is it important to keep my appointments with the doctor?

Keep your appointments with your doctor. Your doctor needs to monitor your condition and check your response to the medication regularly.

• Routine tests (e.g. liver and kidney function, complete blood count, blood electrolyte levels) may be done while you are being treated with this medicine. Your doctor will advise you about how often you need to have these tests.
• Your blood pressure may rise to unsafe levels without you noticing it. Monitor your blood pressure regularly during treatment.

Naproxen + Esomeprazole may cause dizziness, drowsiness, or blurred vision. If affected, do not drive or take part in any activity in which you need to be alert or need to see clearly.

Other side effects include any of the following: headache, indigestion, diarrhoea, stomach wind, constipation, nausea, vomiting, excessive sweating, ringing in the ears, and difficulty sleeping.

Some side effects may need immediate medical help. Alert your doctor quickly if you experience any of the following:

• signs and symptoms of allergic reactions e.g. rashes, breathlessness, swelling of the face, eyes or mouth
• pass out bloody or black as tar stools and vomiting blood or ground coffee-like material
• signs and symptoms of heart attack e.g. chest pain, tightness or pressure, pain that may spread to the arms, jaw, neck, shoulder or back, shortness of breath, lightheadedness
• weakness or numbness on one side of the body, trouble speaking, vision problems, changes in balance or coordination
• yellowing of the skin or eyes, abdominal pain, dark coloured urine, tiredness, swelling in the legs and ankles
• rashes with peeling of the skin or blistering of the lips, mouth or eyes accompanied by fever
• severe diarrhoea, severe stomach pain or cramps, watery or bloody stools
• pain or difficulty in passing urine, change in how much urine is passed, blood in the urine

Inform your doctor if any of these side effects do not go away or are severe, or if you experience other side effects.

Do not take Naproxen + Esomeprazole with certain medicines for HIV infection such as atazanavir, nelfinavir and rilpivirine.

Inform your doctor and pharmacist if you are taking any of these medicines:

• other NSAIDs (medicines for pain and inflammation) e.g. ibuprofen, diclofenac, aspirin
• blood-thinning medicines e.g. warfarin, clopidogrel, cilostazol
• medicines used in organ transplants or certain immune disorders e.g. ciclosporin, tacrolimus
• medicines for cancer e.g. erlotinib, methotrexate
• water pills or medicines for water retention e.g. furosemide, hydrochlorothiazide
• medicines for high blood pressure e.g. propranolol, losartan, enalapril
• anti-inflammatory medicines e.g. prednisolone, hydrocortisone
• certain medicines to treat fungal infection e.g. ketoconazole, itraconazole, voriconazole
• certain medicines to treat depression
• lithium (medicine for mood disorders)
• colestyramine (cholesterol-lowering medicine)
• phenytoin (medicine for epilepsy [fits or seizures])
• rifampicin (medicine to treat TB, a lung infection known as tuberculosis)
• digoxin (medicine for heart failure)
• probenecid (medicine for gout or high uric acid level in the blood)
• St. John's wort (herbal medicine)

This list does not include all medicines that may interact with Naproxen + Esomeprazole.

Always notify your doctor and pharmacist if you are taking any other medicines, including herbal tonics such as traditional Chinese medicines, supplements, and medicines that you buy without a prescription.

Avoid alcohol.

Store in a cool, dry place away from the reach of children.

Protect from moisture.

Medicines must not be used past the expiry date.