Active ingredient
- naproxen
- esomeprazole magnesium trihydrate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 21727/0088.
VIMOVO 500 mg/20 mg modified-release tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIMOVOTM 500 mg/20 mg modified-release tablets
naproxen and esomeprazole
Read all of this leaflet carefully before you start taking this medicine.
In this leaflet:
1. What VIMOVO is and what it is used for
2. What you need to know before you take VIMOVO
3. How to take VIMOVO
4. Possible side effects
5. How to store VIMOVO
6. Contents of the pack and other information
1. 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.
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:
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.
2. What you need to know before you take VIMOVO
Do not take VIMOVO if:
Do not take VIMOVO if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking VIMOVO.
Warnings and Precautions
Talk to your doctor or pharmacist before taking VIMOVO.
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 other disease:
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:
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 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:
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.
Children and adolescents
VIMOVO is not recommended for use in children or adolescents aged 18 years or younger.
Other medicines and VIMOVO
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 VIMOVO can affect the way some other medicines work. Also some other medicines can affect the way VIMOVO works.
Do not take this medicine and tell your doctor or pharmacist if you are taking:
Tell your doctor or pharmacist if you are taking any of the following medicines:
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking VIMOVO.
VIMOVO with 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.
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant, might become pregnant or are breast-feeding. VIMOVO 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 VIMOVO. If this happens, do not drive or use any tools or machines.
VIMOVO contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). These ingredients may cause allergic reactions. These reactions may not happen straight away.
VIMOVO contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take VIMOVO
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
How much to take
If you take more VIMOVO than you should
If you take more VIMOVO than you should, talk to your doctor or pharmacist straight away. Symptoms of an overdose may include lethargy, dizziness, drowsiness, upper abdominal pain and or discomfort, heartburn, indigestion, nausea, liver problems (shown in a blood test), kidney problems which can be severe, higher than normal levels of acid in your blood, confusion, vomiting, bleeding of the stomach or intestines, high blood pressure, breathing difficulties, coma, sudden allergic reactions (which may include breathlessness, skin rashes, swelling of the face and/or throat, and/or collapse) and uncontrolled movements of the body.
If you forget to take VIMOVO
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. 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:
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)
Uncommon, rare or very rare (may affect up to 1 in 100 people or less)
Not known (frequency cannot be estimated from the available data)
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:
or search for MHRA Yellow Card in the Google Play or Apple App Store
By reporting side effects you can help provide more information on the safety of this medicine.
5. 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.
6. Contents of the pack and other information
What VIMOVO contains
What VIMOVO looks like and contents of the pack
These are 18x9.5 mm oval yellow tablets marked 500/20 in black ink.
Bottle:
Pack sizes - 6, 10, 20, 30, 60, 100, 180 or 500 modified-release tablets.
The bottles contain silica-gel desiccant (to keep the tablets dry). Do not eat the sachet containing the desiccant.
Aluminium blister package:
Pack sizes- 10, 20, 30, 60 or 100 modified-release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation for VIMOVO is held by
VIMOVO is manufactured by
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name Reference number
VIMOVO 500 mg/20 mg tablets 21727/0088
This is a service provided by the Royal National Institute of Blind People.
This medicinal product is authorised in the Member States of the EEA under the name Vimovo, in the following countries:
Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, Germany, Ireland, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Portugal, Romania, Spain, Sweden and United Kingdom.
This leaflet was last updated in November 2020.
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