Do not take Eproxen if:

• You are allergic (hypersensitive) to naproxen.
• You are allergic to esomeprazole or other proton pump inhibitor medicines.
• You are allergic to any of the other ingredients of this medicine (listed in Section 6).
• You are taking a medicine called “atazanavir” or “nelfinavir” (used to treat HIV).
• If acetylsalicylic acid (e.g. aspirin), naproxen or other NSAIDS such as ibuprofen, diclofenac or COX-2 inhibitors (e.g. celecoxib, etoricoxib) have caused you to have asthma (wheeziness) or an allergic reaction such as itchiness or skin rash (urticaria).
• You are in the last 3 months of pregnancy.
• You have severe problems with your liver, kidney or heart.
• You have an ulcer in your stomach or gut.
• You have any bleeding disorder or serious and unexpected bleeding.

Do not take Eproxen if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Eproxen

Warnings and Precautions

Talk to your doctor or pharmacist before taking Eproxen.

You must not take Eproxen and talk to your doctor straight away if any of the following happen to you before or while you are taking Eproxen, as this medicine may hide the symptoms of other disease:

• You lose a lot of weight for no reason and have problems swallowing.
• You start to vomit food or blood.
• You pass black stools (blood-stained faeces).

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking this medicine.

Check with your doctor or pharmacist before taking this medicine if:

• You have inflammation of your intestines (Crohn’s disease or ulcerative colitis).
• You have any other problems with your liver or kidneys or if you are elderly.
• You are taking medicines such as corticosteroids taken by mouth, warfarin, clopidogrel, Selective Serotonin Reuptake Inhibitors (SSRIs), acetylsalicylic acid (aspirin) or NSAIDs including COX-2 inhibitors (see section Other medicines and Eproxen).
• You have ever had a skin reaction after treatment with a medicine similar to esomeprazole (which is a component of Eproxen) that reduces stomach acid.
• You are due to have a specific blood test (Chromogranin A).

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking this medicine.

If you have previously experienced stomach ulcer or bleeding you should let your doctor know. You will be asked to report any unusual symptoms from your stomach (e.g. pain) to your doctor.

Medicines such as Eproxen may be associated with a small increase in the risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and long lasting treatment. Do not exceed the recommended dose or length of treatment.

VIMOVO contains the NSAID naproxen. As for all NSAIDs, naproxen should be used at the lowest effective dose for the shortest duration possible to reduce the risk of undesirable effects. Your doctor will therefore assess at a regular interval whether Eproxen is still appropriate for you.

Eproxen is not suitable to achieve rapid relief of acute pain, as it takes several hours before the painkilling substance naproxen is taken up in your blood.

Also, check with your doctor before taking this medicine if you have any heart problems, previous stroke or think you might be at risk of these problems. You may be at risk of getting these problems if:

• You have high blood pressure.
• You have problems with your blood circulation or with your blood clotting.
• You have diabetes.
• You have high cholesterol.
• You are a smoker.

Taking a proton pump inhibitor (which is a component of Eproxen), especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Eproxen. Remember to also mention any other ill-effects like pain in your joints.

Children and adolescents

Eproxen is not recommended for use in children or adolescents aged 18 years or younger.

Other medicines and Eproxen

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription, including herbal medicines. This is because Eproxen can affect the way some other medicines work. Also some other medicines can affect the way Eproxen works.

Do not take this medicine and tell your doctor or pharmacist if you are taking:

• A medicine called “atazanavir” or “nelfinavir” (used to treat HIV).

Tell your doctor or pharmacist if you are taking any of the following medicines:

• Acetylsalicylic acid (aspirin) (used as a painkiller or to prevent blood clots). If you take low dose acetylsalicylic acid (aspirin) you may still be able to take Eproxen.
• Other NSAID medicines (including COX-2 inhibitors).
• Certain drugs such as ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat infections caused by a fungus).
• Erlotinib (or another anticancer drug from the same class).
• Cholestyramine (used to reduce cholesterol).
• Clarithromycin (used to treat infection).
• “Quinolone antibiotic” (for infections), such as ciprofloxacin or moxifloxacin.
• Diazepam (used to treat anxiety, to relax your muscles or used in epilepsy).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Lithium (used to treat some types of depression).
• Methotrexate (used to treat rheumatoid arthritis, psoriasis and cancer).
• Probenecid (for gout).
• “Selective Serotonin Reuptake Inhibitors” (SSRIs) (used to treat major depression or anxiety disorder).
• Ciclosporin or tacrolimus (medicines used to dampen down the body’s immune reactions).
• Digoxin (used to treat heart disorders).
• Sulphonylureas such as glimepiride (oral medicines used to control your blood sugar in diabetes).
• Medicines used to treat high blood pressure called diuretics (such as furosemide or hydrochlorothiazide), ACE inhibitors (such as enalapril), angiotensin II receptor antagonists (such as losartan) and beta-blockers (such as propranolol).
• Corticosteroid medicines such as hydrocortisone or prednisolone (used as anti-inflammatory medicines).
• Medicine to stop your blood clotting, like warfarin, dicoumarol, heparin or clopidogrel.
• Rifampicin (used for treatment of tuberculosis).
• St. John’s Wort (Hypericum perforatum) (used to treat mild depression).
• Cilostazole (used for pain in the legs due to poor blood flow).

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Eproxen.

Eproxen with food and drink

Do not take Eproxen with food as this may reduce and/or delay the effect of Eproxen. Take your tablets at least 30 minutes before you have a meal.

Pregnancy, breast-feeding and fertility

• Do not take Eproxen if you are in the last 3 months of pregnancy.
• Talk to your doctor before taking this medicine if you are in the first or second trimester of pregnancy. Your doctor will decide whether you can take Eproxen.
• Do not breast-feed if you are taking Eproxen. This is because small amounts may pass into the mothers’ milk. If you are planning to breast-feed you should not take Eproxen.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant, might become pregnant or are breast-feeding. Eproxen may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems to become pregnant.

Driving and using machines

You may feel dizzy or experience blurred vision while taking Eproxen. If this happens, do not drive or use any tools or machines.

Eproxen contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). These ingredients may cause allergic reactions. These reactions may not happen straight away.

Eproxen contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.