Vimovo MR Tablets

What is Vimovo?

Vimovo is a prescription-only, long-acting treatment manufactured by AstraZeneca. It contains two active ingredients:

• Naproxen 500mg: a non-steroidal anti-inflammatory (NSAID) used to relieve pain and reduce inflammation in a number of medical conditions, including arthritis.
• Esomeprazole 20mg: a proton-pump inhibitor (PPI) that reduces the production of stomach acid and helps to protect the lining of the stomach against irritation and stomach ulcers associated with long-term use of naproxen.

When is Vimovo prescribed?

Vimovo is indicated for use where 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, such as aspirin, ibuprofen, or naproxen.

In clinical trials, patients taking Vimovo were shown to have at least a 70% lower risk of developing stomach ulcers than patients on naproxen alone over a 6-month period.

Vimovo is a modified-release tablet, meaning the dose is slowly released over time to keep your pain under control throughout the entire day. For this reason, it is not suitable for the rapid relief of acute pain as it can take a few hours to be absorbed and reach its full effect.

How do you take Vimovo?

Regular naproxen should be taken with food to help protect the stomach, however, this is not the case with Vimovo. It should be taken at least 30 minutes before food on an empty stomach. Taking Vimovo with food can cause it to take longer to have an effect and also reduce the protective effect on your stomach.

The tablets should be taken twice daily, roughly 12 hours apart, for as long as indicated by your doctor. If you are taking the treatment for over a year, your regular doctor should be aware of your treatment so that the appropriate monitoring can take place during your annual check-up.

Vimovo tablets are modified-release - this means that they are specially designed to release the ingredients over time. For this reason, they should not be cut, chewed, crushed, or split as they will not have the same effect. Swallow the tablet whole with a glass of water.

Vimovo and other painkillers

Vimovo contains naproxen, which is an NSAID. This means that it should not be taken with any other drugs in the NSAID family, including aspirin, ibuprofen, naproxen, diclofenac, ketoprofen, or piroxicam.

Vimovo can be taken alongside paracetamol for extra pain relief.

Sources

1. https://www.medicines.org.uk/emc/files/pil.5743.pdf

How to take Vimovo

Vimovo should be taken twice daily in the morning and evening if required for pain. The tablets should be swallowed whole with water and not split, crushed, or chewed.

Vimovo tablets should be taken at least 30 minutes before food as this will help the protective effect on your stomach and gut and allow the medicine to work more quickly.

Vimovo contains naproxen so it should not be taken with other medicines containing NSAIDs (e.g. aspirin, ibuprofen, naproxen & diclofenac).

Do not take more than two tablets in 24 hours.

Vimovo ingredients

Vimovo is a dual-action modified-release tablet that contains two active ingredients:

• Naproxen 500mg (an anti-inflammatory painkiller)
• Esomeprazole 20mg (a proton pump inhibitor - to protect your stomach)

Vimovo are 18x9.5 mm oval yellow tablets marked 500/20 in black ink.

The other inactive ingredients in VIMOVO tablets are:

croscarmellose sodium, magnesium stearate, povidone K90, colloidal silicon dioxide, and in the film coating carnauba wax, glycerol monostearate 40-55, hypromellose type 2910 (3 mPas, 6 mPas and 50 mPas), iron oxide (E172, yellow, black), macrogol 8000, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, methyl (E218), polydextrose, polysorbate 80, propylene glycol, propyl parahydroxybenzoate (E216), sodium laurilsulfate, titanium dioxide (E171), triethyl citrate.

Vimovo side effects

Side effects can occur with all medicines, including Vimovo, although most people will not experience them. Whilst taking Vimovo you may experience the following side effects:

Common (may affect up to 1 in 10 people)

• Headache.
• 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).
• 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.

For further information on less common side effects, please see the Patient Information Leaflet.

If you experience any side effects, or if the product affects you in any other way, stop using it and talk to your doctor or pharmacist.

Vimovo warnings

You should not take Vimovo modified-release tablets 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 or you are breastfeeding.
• 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.

You should discuss taking Vimovo with your regular doctor if:

• You are in the first or second trimester of pregnancy.
• 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 Re-uptake Inhibitors (SSRIs), acetylsalicylic acid (aspirin) or NSAIDs including COX-2 inhibitors (see section Other medicines and VIMOVO).
• You have ever had a skin reaction after treatment with a medicine similar to esomeprazole (which is a component of VIMOVO) that reduces stomach acid.
• You are due to have a specific blood test (Chromogranin A).

You must not take Vimovo and talk to your doctor straight away if any of the following happen to you before or while you are taking Vimovo, as this medicine may hide the symptoms of another 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).

Other medicines

Vimovo can affect the way some other medicines work and some other medicines can affect the way Vimovo works. For this reason, you should not take this medicine and speak to your regular doctor if you are taking:

• A medicine called “atazanavir” or “nelfinavir” (used to treat HIV).
• Acetylsalicylic acid (aspirin). If you take low dose acetylsalicylic acid (aspirin) you may still be able to take VIMOVO.
• 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 the 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).

Other warnings

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 Vimovo 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 Vimovo is still appropriate for you.

Vimovo 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 Vimovo), 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 Vimovo. Remember to also mention any other ill effects like pain in your joints.

Food and drink

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

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

For full information on the warnings and contraindications for Vimovo, please see the Patient Information Leaflet