Vimovo - Naproxen and esomeprazole uses, dose and side effects

Naproxen belongs to a group of medicines called non-steroidal anti-inflammatory drugs ( NSAIDs ). It relieves pain and inflammation.
Esomeprazole belongs to a group of medicines called proton pump inhibitors. It reduces the amount of stomach acid in the stomach.

Patients who need to take NSAIDs can get ulcers and stomach problems, but esomeprazole helps reduce that risk.

What Vimovo is used for

Vimovo is used by adults to relieve the symptoms of:

arthritis
rheumatoid arthritis
Bechterew’s disease.

Vimovo helps reduce pain, swelling, redness, and heat ( inflammation ).

You are given this medicine because your doctor thinks that a lower dose of NSAID is unlikely to relieve your pain and you are at risk of developing stomach ulcers or ulcers in the first part of the small intestine ( duodenum ) when you take NSAIDs.

The naproxen and esomeprazole found in Vimovo may also be approved to treat other conditions not listed in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Vimovo

Do not take Vimovo

if you are allergic to naproxen
if you are allergic to esomeprazole or other proton pump inhibitor medicines
if you are allergic to any of the other ingredients of this medicine (listed in section 6)
if you are taking a medicine called atazanavir or nelfinavir (used against HIV )
if aspirin, naproxen, or other NSAID medicines, such as ibuprofen, diclofenac, or COX-2 inhibitors (e.g. celecoxib, etoricoxib) have caused you to have asthma (wheezing) or an allergic reaction, such as itching or rash ( urticaria, hives )
if you are 7-9 months pregnant
if you have severe liver, kidney, or heart problems
if you have a stomach or intestinal ulcer
if you have a bleeding disorder or have severe and unexpected bleeding

Do not use 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.

Vimovo can mask symptoms of other diseases. Therefore, you must not take Vimovo if any of the following happen to you before or while you are taking Vimovo, and you must contact your doctor immediately:

you lose a lot of weight for no reason at all and have difficulty swallowing.
you start vomiting food or blood.
the stool is black (with blood in it).

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

Before taking this medicine, consult a doctor or pharmacist:

if you have any inflammation of the intestine ( Crohn’s disease or ulcerative colitis )
if you have any other liver or kidney problems, or if you are elderly.
if you are taking certain medicines such as oral corticosteroids, warfarin, clopidogrel, SSRIs (selective serotonin reuptake inhibitors), aspirin, or NSAIDs, including COX-2 inhibitors (see section Other medicines and Vimovo)
if you have ever had a skin reaction after treatment with a medicine similar to esomeprazole (one of the components of Vimovo) which reduces stomach acid
if you are going to undergo a specific blood test (chromogranin A)

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

If you have had stomach ulcers or bleeding in the stomach in the past, tell your doctor. Your doctor will ask you to report any unusual stomach symptoms (eg pain).

Medicines such as Vimovo may be associated with a small increase in the risk of heart attack (myocardial infarction) or stroke. The possible risk is higher if you take a high dose and are treated for a long time. Do not exceed the recommended dose or duration of treatment.

Vimovo contains naproxen which is an NSAID medicine. Like all NSAIDs, naproxen should be used in the lowest effective dose for the shortest possible time to reduce the risk of side effects. Your doctor will therefore periodically assess whether Vimovo is still suitable for you.

Vimovo is not suitable for quick relief of acute pain, as it takes several hours for the pain-relieving substance naproxen to be absorbed into the blood.

If you have any heart problems, have had a stroke in the past or if you think you are at risk of such diseases, you should also consult your doctor before taking the medicine. You may be at risk of getting such a disease:

if you have high blood pressure
if you have problems with blood circulation or blood clotting
if you have diabetes
if you have high cholesterol
if you smoke

Using proton pump inhibitors such as esomeprazole (which is an active substance in Vimovo) and especially if you use Vimovo for more than a year, may slightly increase the risk of having a hip, wrist, or vertebral fracture (broken bone). Tell your doctor if you have osteoporosis or if you use medicines called corticosteroids because they can increase the risk of osteoporosis.

If you develop a rash, especially in areas exposed to the sun, tell your doctor as soon as possible as you may need to stop treatment with Vimovo. Also remember to mention any other side effects, such as joint pain.

Serious skin rashes have occurred in patients taking esomeprazole (see also section 4). The rash can consist of sores in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). These severe skin rashes often come after flu-like symptoms such as fever, headache, and body aches. The rash can cover large parts of the body with blisters and peeling skin.

If at any time during treatment (even after several weeks) you develop a rash or any of these skin symptoms, stop taking this medicine and contact your doctor immediately.

Children and young people

Vimovo is not recommended for use in children and adolescents who are 18 years of age or younger.

Other medicines and Vimovo

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also includes over-the-counter medicines, including (traditional) herbal medicines and herbal medicines. The reason for this is that Vimovo can affect the function of certain other medicines. Some other medicines can also affect how Vimovo works.

You should not take this medicine but instead tell your doctor or pharmacist if you are taking:

a medicine called atazanavir or nelfinavir (used for HIV ).

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

acetylsalicylic acid (used as a pain reliever or as a blood clot prevention medicine). If you are taking low-dose aspirin, you may still be able to take Vimovo
other NSAIDs (including COX-2 inhibitors)
certain medicines such as ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat infections caused by a fungus)
erlotinib (or another cancer drug in the same class)
cholestyramine (used to lower cholesterol)
clarithromycin (used to treat infection )
quinolone antibiotics (against infection ), such as ciprofloxacin or moxifloxacin.
diazepam (used to treat anxiety, relax muscles, or in epilepsy )
hydantoins, e.g. phenytoin (used to treat epilepsy )
lithium (used to treat certain types of depression)
methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer)
probenecid (for gout )
SSRIs (selective serotonin reuptake inhibitors) (used to treat endogenous depression and anxiety disorders)
ciclosporin or tacrolimus (medicines used to suppress the body’s immune system).
digoxin (used to treat heart disease)
sulfonamides, e.g. glimepiride (medicine taken by mouth to regulate blood sugar in diabetes )
medicines used to treat high blood pressure: diuretics (eg furosemide or hydrochlorothiazide, ACE inhibitors (eg enalapril ), angiotensin II receptor antagonists (eg losartan ), and beta-blockers (eg propranolol)
corticosteroid drugs, e.g. hydrocortisone or prednisolone (used as anti-inflammatory drugs)
medicines that prevent the blood from clotting (coagulating), e.g. warfarin, dicoumarol, heparin, or clopidogrel
rifampicin (used to treat tuberculosis )
St. John’s wort (Hypericum perforatum) (used to treat mild depression)
cilostazol (used for leg pain due to poor blood flow)

If any of the above apply to you (or if 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 the tablets at least 30 minutes before eating.

Pregnancy, breastfeeding, and fertility

Do not take Vimovo during the last three months of pregnancy.
Consult your doctor before taking the medicine if you are 1-6 months pregnant. Your doctor will decide if you can take Vimovo.
You must not breastfeed if you are taking Vimovo because small amounts of the medicine can pass into breast milk. If you plan to breastfeed, you should not take Vimovo.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Vimovo can make it harder to get pregnant. You should tell your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Driving ability and use of machinery

You may feel dizzy or have blurred vision while taking Vimovo. In this case, you should not drive a car or use tools or machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.

Vimovo contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216)

These ingredients can cause allergic reactions. Reactions may not occur immediately.

Vimovo contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost “sodium-free”.

How to take Vimovo

Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.

Take the medicine like this

Swallow the tablets whole with water. The tablets must not be chewed, split, or crushed. For the medicine to work as intended, you must take the tablets whole.
Take the tablets at least 30 minutes before eating. Food can reduce Vimovo’s protective effect on the stomach and intestines. Food can also significantly delay the relief of pain and inflammation.
If you take the medicine for a long time, your doctor will want to check you regularly (especially if you take it for more than a year).

This is how much you should take

Take one tablet twice a day for as long as your doctor says you need.
Vimovo is only available in the 500 mg/20 mg strength. If your doctor thinks that dose one is not suitable for you, he/she may prescribe another medicine.

If you have taken too much Vimovo

If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.

The symptoms of overdose can include lethargy, lack of energy, difficulty concentrating ( lethargy ), dizziness, drowsiness, pain and/or discomfort in the upper abdomen, heartburn, indigestion, nausea, liver problems (shown with a blood test), kidney problems that can be serious, higher acidity of the blood than common, confusion, vomiting, bleeding in the stomach or intestines, high blood pressure, difficulty breathing, coma, sudden allergic reactions (which may include shortness of breath, rash, swelling of the face and/or throat, and/or collapse) and uncontrolled body movements.

If you forget to take Vimovo

If you have forgotten to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the forgotten dose.
Do not take a double dose (two doses at the same time) to compensate for a missed dose.

If you have any further questions about this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur 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 onset of wheezing, swelling of the lips, tongue, and throat or body, rash, fainting, or difficulty swallowing (severe allergic reaction ).
Sudden, severe skin rashes or skin redness with blisters and peeling skin may occur even after several weeks of treatment. There may also be severe blistering and bleeding in the lips, eyes, mouth, nose, and genitals. The skin rash can develop into serious widespread skin damage (skin peeling of the epidermis and superficial mucous membranes) with life-threatening consequences. This could be “erythema multiforme”, “Stevens-Johnson syndrome”, “toxic epidermal necrolysis” or “drug reaction with eosinophilia and systemic symptoms”. These side effects are very rare and may occur in up to 1 in 10,000 users.
Yellowing of the skin or the whites of the eyes, dark urine, and tiredness, can be symptoms of liver disease.
Medicines such as Vimovo may be associated with a small increase in the risk of heart attack (myocardial infarction) or stroke. Signs include chest pain radiating up the neck and shoulders and out into the left arm; confusion or muscle weakness or numbness, which may only be felt on one side of the body.
Sticky, black stools or bloody diarrhea.
Vomiting with blood or dark particles that look like coffee grounds.

Talk to your doctor as soon as possible if you notice any of the following:

In rare cases, Vimovo can affect the white blood cells, leading to immunodeficiency.

If you get an infection with symptoms such as fever and greatly worsened general condition. or fever with symptoms of local infection, such as pain in the neck, throat, or mouth, or difficulty urinating, you must see a doctor as soon as possible, so that a blood test can be taken to rule out a lack of white blood cells ( agranulocytosis ). You must inform us about which medicines you are currently taking.

Other possible side effects include:

Common (may affect up to 1 in 10 users)

headache
fatigue
thirst
Depression
shortness of breath
increased sweating
itching and rash
vertigo (a feeling that everything is spinning)
red or purple marks, spots, or dots on the skin
nausea or vomiting
palpitation _ _
sleep disorders or insomnia (insomnia)
hearing problems or tinnitus (ringing in the ears)
dizziness, drowsiness, or lightheadedness when standing up
swelling of the hands, feet, and ankles ( edema )
inflammation of the mouth
vision problems
diarrhea, stomach ache, heartburn, indigestion, constipation, belching, or flatulence
peptic ulcer or ulcer in the first part of the small intestine ( duodenum )
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 users or less)

sore mouth or mouth sores
vision problems, such as blurred vision, eye inflammation ( conjunctivitis ), or eye pain
strange dreams
somnolence
the increased amount of sugar ( glucose ) in the blood. Symptoms may include thirst and increased urine output
low levels of sugar ( glucose ) in the blood. Symptoms may include feeling hungry or weak, sweating, and a fast heartbeat
coma
inflammation of the blood vessels
hole in the stomach or intestine
systemic lupus erythematosus ( SLE ), is a disease in which the body’s immune system attacks the body, causing joint pain, rash, and fever
enlarged lymph nodes
fracture of the hip, wrist, or vertebrae (if Vimovo is used in high doses and for a long time)
fever
fainting
dry mouth
aggressiveness
hearing loss
asthma attacks
convulsions or convulsions
menstrual disorders
weight changes
hair loss ( alopecia )
raised, bumpy rash ( hives )
joint pain ( arthralgia )
breast augmentation in men
tongue burning or a swollen tongue
muscle twitching or tremors
appetite disturbances or taste changes
muscle weakness or muscle pain ( myalgia )
longer coagulation time for the blood
problems for women to get pregnant
fever, redness, or other signs of infection
irregular, slow, or very fast heartbeat
tingling in the skin, as if a body part is “sleeping”
memory or concentration difficulties
worry, confusion, anxiety, or nervousness
general malaise, weakness, and lack of energy
swollen or sore body parts because you have accumulated fluid
high or low blood pressure. Fainting, dizziness
skin rash or blisters, or the skin becoming more sensitive to exposure to sunlight
that you see, feel, or hear things that are not there (hallucinations)
changed values of certain blood tests, for example, to check liver function. Your doctor can explain more
an infection of the intestine with the fungus Candida
blood in the urine or other kidney disease. Possibly also back pain
breathing difficulties, which may slowly get worse. This could be a sign of pneumonia or that your lungs are swelling
low levels of salt ( sodium ) in the blood. This can cause weakness, vomiting, and convulsions
symptoms of meningitis, e.g. fever, nausea or vomiting, neck stiffness, headache, sensitivity to bright light, and confusion
problems with the pancreas. Signs include severe abdominal pain that spreads to the back
pale stools which are a sign of serious liver problems ( hepatitis ). Severe liver problems can lead to liver failure and brain disorders
colitis or worsening of inflammatory bowel diseases, such as Crohn’s disease or ulcerative colitis. Signs include abdominal pain, diarrhea, vomiting, and weight loss
problems with the blood, e.g. reduced a number of red blood cells (anemia; anemia ), white blood cells, or platelets. This can cause weakness, bruising, fever, severe frostbite, sore throat, or increase the risk of infection
increased number of a certain type of white blood cell ( eosinophilia ).
lack of all types of blood cells (pancytopenia).
problems with how the heart pumps blood around the body or damage to blood vessels. Signs may include fatigue, shortness of breath, feeling weak, chest pain, or general aches.

Has been reported (occurring in an unknown number of users)

If you use Vimovo for more than three months, magnesium levels in your blood may drop. Low levels of magnesium can manifest as fatigue, involuntary muscle movements, confusion, seizures, dizziness, and a fast heart rate. If you experience any of these symptoms, see a doctor immediately. Low levels of magnesium can also lead to reduced levels of potassium or calcium in the blood. The doctor may measure the magnesium level in the blood using regular blood tests.
skin rash, possibly with pain in the joints

Don’t be alarmed by this list of possible side effects. You don’t have to get any of them.

How to store Vimovo

Keep this medicine out of the sight and reach of children.

Use before the expiry date which is stated on the carton, can or blister after EXP. The expiration date is the last day of the specified month.

Store at a maximum of 30 °C.

Bottle: Store in the original packaging in a tightly closed jar. Moisture sensitive.

Blister: Store in the original packaging. Moisture sensitive.

Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.

Contents of the packaging and other information

Contents declaration

The active substances are naproxen 500 mg and esomeprazole 20 mg.
Other ingredients (excipients) in the tablet core 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 parahydroxybenzoate (E218), polydextrose, polysorbate 80, propylene glycol, propyl parahydroxybenzoate (E216), sodium lauryl sulfate, titanium dioxide (E171), triethyl citrate.

Appearance and package sizes of the medicine

18 x 9.5 mm oval yellow tablets marked 500/20 with black print

Can:

Pack sizes – 6, 10, 20, 30, 60, 100, 180, or 500 modified-release tablets.

The cans contain desiccant in the form of silica gel (to keep the tablets dry). Do not eat the desiccant sachet.

The jars contain a desiccant in the form of silica gel in the screw cap (to keep the tablets dry).

Aluminum blister pack:

Pack sizes – 10, 20, 30, 60, or 100 modified-release tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing Authorisation Holder

Grünenthal GmbH, Zieglerstraße 6, 52078 Aachen, Germany

Manufacturer

AstraZeneca AB, 151 85 Södertälje, Sweden