Package Insert: Information for the User

VIMOVO 500mg/20mg Modified-Release Tablets

naproxeno and esomeprazol

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1.What is VIMOVO and for what it is used

2.What you need to know before starting to take VIMOVO

3.How to take VIMOVO

4.Possible adverse effects

5.Storage of VIMOVO

6.Contents of the package and additional information

What is VIMOVO

VIMOVO contains two different medicines called naproxen and esomeprazole. Each of these medicines works in a different way.

• Naproxen belongs to a group of medicines called “nonsteroidal anti-inflammatory drugs” (NSAIDs). It reduces pain and inflammation.
• Esomeprazole belongs to a group of medicines called “proton pump inhibitors”. It reduces the amount of acid in your stomach.

Esomeprazole helps to reduce the risk of ulcers and stomach problems that can occur in patients who need to take NSAIDs.

What is VIMOVO used for

VIMOVO is used in adults to relieve symptoms of:

• Arthritis.
• Rheumatoid arthritis.
• Ankylosing spondylitis.

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

You will receive this medicine if it is considered unlikely that a lower dose of NSAID will relieve your pain and you are at risk of developing a stomach ulcer or a duodenal ulcer while taking an NSAID.

Do not take VIMOVO:

Do not take VIMOVO if you are in any of the above situations.If you are unsure, consult your doctor or pharmacist before taking VIMOVO.

Warnings and precautions

Consult your doctor or pharmacist before starting to take VIMOVO.

Do not take VIMOVO and consult your doctor immediately if you experience any of the following episodes before or during treatment with VIMOVO, as this medication may mask symptoms of another disease:

• If you lose weight significantly without apparent reason and have trouble swallowing.
• If you experience vomiting of food or blood.
• If your stools are black (tinged with blood).

If you are in any of these situations (or are unsure), consult your doctor or pharmacist before taking this medication.

Consult your doctor or pharmacist before taking this medication if:

• You have inflammation in your intestines (Crohn's disease or ulcerative colitis).
• You have other liver or kidney problems or are elderly.
• You are taking medications such as oral corticosteroids, warfarin, clopidogrel, Selective Serotonin Reuptake Inhibitors (SSRIs), acetylsalicylic acid (aspirin), or NSAIDs including COX-2 inhibitors (see Section Taking VIMOVO with other medications).
• You have ever had a skin reaction after treatment with a similar medication to VIMOVO for reducing stomach acid.
• You are scheduled to have a specific blood test (Cromogranin A).

If you are in any of these situations (or are unsure), consult your doctor or pharmacist before taking this medication.

If you have had a stomach ulcer or bleeding in the past, inform your doctor. You will be asked to inform your doctor of any unusual stomach symptoms (e.g. pain).

Some medications, such as VIMOVO, may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.The risk is always higher with high doses and prolonged treatment.Do not exceed the recommended dose or duration of treatment.

VIMOVO contains the NSAID naproxen. Like all NSAIDs, naproxen should be used at the lowest effective dose for the shortest possible duration to reduce the risk of unwanted effects.Your doctor will evaluate you at regular intervals to determine if VIMOVO is still appropriate for you.

VIMOVO is not suitable for rapid relief of acute pain, as several hours are needed for the analgesic naproxen to reach the bloodstream.

Consult your doctor before taking this medication if you have any heart problems, a history of stroke, or think you are at risk of these problems.You may be at risk if:

• You have high blood pressure;
• You have circulation or coagulation problems;
• You are diabetic;
• You have high cholesterol levels;
• You are a smoker.

Taking a proton pump inhibitor (one of the components of VIMOVO), especially for more than a year, may slightly increase the risk of fractures of the hip, wrist, or spine.Inform your doctor if you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).

If you experience a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with VIMOVO.Remember to mention any other symptoms you may notice, such as joint pain.

Severe skin reactions have been reported in patients taking esomeprazole (see also Section 4). The rash may include mouth, throat, nose, genital, and conjunctivitis (red, swollen eyes). These severe skin reactions usually occur after symptoms similar to the flu, such as fever, headache, and body aches. The rash may cover large areas of the body with blisters and skin peeling.

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

During treatment with VIMOVO, kidney inflammation may occur. Signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. Inform your doctor of these signs.

Children and adolescents

VIMOVO is not recommended for use in children or adolescents under 18 years of age.

Taking VIMOVO with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications and herbal remedies.This is because VIMOVO may affect the mechanism of action of other medications.Also, some medications may affect the mechanism of action of VIMOVO.

Do not take this medication and inform your doctor or pharmacist if you are taking:

Inform your doctor or pharmacist if you are taking any of the following medications:

• Acetylsalicylic acid (aspirin) (used as an analgesic or to prevent blood clots). If you are taking low doses of acetylsalicylic acid (aspirin), it may still be possible to take VIMOVO.
• Other NSAIDs (including COX-2 inhibitors).
• Certain medications such as ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections).
• Erlotinib (or another anticancer medication of the same class).
• Colestiramine (used to reduce cholesterol).
• Claritromycin (used to treat infections).
• “Quinolone antibiotics” (for infections), such as ciprofloxacin or moxifloxacin.
• Diazepam (used to treat anxiety, relax muscles, or epilepsy).
• Hidantoins such as phenytoin (used to treat epilepsy).
• Lithium (used to treat certain types of depression).
• Metotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer).
• Probenecid (used to treat gout).
• “Selective Serotonin Reuptake Inhibitors” (SSRIs) (used to treat severe depression and anxiety disorders).
• Ciclosporin or tacrolimus (medications used to reduce the body's immune response).
• Digoxin (used to treat heart rhythm disorders).
• Sulfonilureas such as glimepiride (oral medications used to control blood sugar levels in diabetes).
• Medications 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).
• Corticosteroids such as hydrocortisone or prednisolone (used as anti-inflammatory medications).
• Medications to prevent blood clotting, such as warfarin, dicumarol, heparin, or clopidogrel.
• Rifampicin (used to treat tuberculosis).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).
• Cilostazol (used to treat leg pain due to poor blood flow).

If you are in any of these situations (or are unsure), consult your doctor or pharmacist before taking VIMOVO.

Taking VIMOVO with food and drinks

Do not take VIMOVO with food, as it may reduce and/or delay the effect of VIMOVO.Take the tablets at least 30 minutes before meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

Pregnancy

Do not take VIMOVO if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery.VIMOVO may cause kidney and heart problems in the fetus.VIMOVO may affect bleeding tendency, both yours and the baby's, and may delay or prolong delivery more than expected.Do not use VIMOVO during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor.If you need treatment during this period or while trying to become pregnant, you should use the lowest dose for the shortest possible time.If you take it for more than a few days from week 20 of pregnancy, VIMOVO may cause kidney problems in the fetus that may lead to low amniotic fluid levels or narrowing of a blood vessel (ductus arteriosus) in the baby's heart.If you need to prolong treatment for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding

Do not breastfeed if you are taking VIMOVO, as small amounts may pass into breast milk.If you are planning to breastfeed your baby, do not take VIMOVO.

Fertility

VIMOVO may make it difficult to become pregnant. Inform your doctor if you are planning to become pregnant or have difficulty becoming pregnant.

Driving and operating machinery

You may feel dizzy or experience blurred vision during treatment with VIMOVO.If this happens, do not drive or use tools or machinery.

VIMOVO containsparahydroxybenzoate (E218) methyl ester and parahydroxybenzoate propyl ester (E216)

These components may cause allergic reactions. These reactions may be delayed.

VIMOVO contains less than 1 mmol of sodium (23mg) per tablet, which is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor.In case of doubt,consult your doctor or pharmacist again.

How to Take This Medication

• Swallow the whole tablets with water.Do not break, chew, or crush the tablets.It is essential to swallow the tablets whole for the medication to work correctly.
• Take the tablets at least 30minutes before meals. Food may reduce the protective effect of Vimovo on your stomach and intestines. Food may also cause a significant delay in the relief of pain and inflammation.
• If you have been taking this medication for a long time, your doctor will want to perform checks (especially if you have been taking it for more than a year).

How Much to Take

• Take one tablet twice a day for the time your doctor tells you.
• VIMOVO is only available as 500mg/20mg. If your doctor thinks this dose is not suitable for you, they may prescribe another treatment.

If You Take More VIMOVO Than You Should

If you take more VIMOVO than you should, consult your doctor or pharmacist immediately.The symptoms of an overdose may include drowsiness, dizziness, somnolence, upper abdominal pain and/or discomfort,heartburn, indigestion, nausea, liver problems (which are observed in a blood test), severe kidney problems, high levels of acid in your blood, disorientation, vomiting, stomach or intestinal bleeding, high blood pressure, breathing difficulties, coma, sudden allergic reactions (which may include shortness of breath, skin rash, facial and/or throat swelling, and/or collapse) and uncontrolled body movements.

In case of an overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take VIMOVO

• If you forget to take a dose, take it as soon as you remember.However, if there is little time left for the next dose, skip the missed dose.
• Do not take a double dose (two doses at once) to make up for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.This medicine may cause the following side effects.

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 ringing in the ears, swelling of the lips, tongue, and throat or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction).

• Sudden appearance of a severe rash or skin redness with blistering or peeling, even after several weeks of treatment.Severe blisters and bleeding in the lips, eyes, mouth, nose, and genitals may also occur.Skin rashes can turn into severe skin damage and generalized (peeling of the epidermis and superficial mucous membranes) with potentially fatal consequences.This may be a "multiforme erythema", "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms". These effects are very rare and can affect up to 1 in 10,000 people.

• Yellowing of the skin or white of the eyes, dark urine, and fatigue that may be symptoms of liver problems.
• Medicines like VIMOVO may be related to a small increase in the risk of having a heart attack (myocardial infarction) or stroke.The signs are chest pain that radiates to the neck and shoulders and descends to the left arm, confusion, or numbness or weakness that can affect only one side of the body.
• Dark, pasty stools or bloody diarrhea.
• Vomiting with blood or dark particles that look like coffee grounds.

Tell your doctor as soon as possible if you experience any of the following symptoms:

In rare cases, VIMOVO may affect white blood cells in the blood, which can lead to immunosuppression.

If you present an infection with symptoms such as fever with a severe worsening of the general state of health or fever with symptoms of local infection such as neck pain, throat pain, or mouth pain or difficulty urinating, you should consult your doctor as soon as possible to rule out the lack of white blood cells (agranulocytosis) through a blood test.It is essential that at that moment you inform your doctor of your medication.

Other side effects are:

Frequent (may affect up to 1 in 10 people)

• Headache.
• Feeling tired.
• Feeling thirsty.
• Feeling depressed.
• Feeling short of breath.
• Increased sweating.
• Itching of the skin and skin rash.
• Feeling like everything is spinning (dizziness).
• Red or purple marks, bruises, or spots on the skin.
• Nausea or vomiting.
• Feeling like your heart is pounding.
• Difficulty sleeping or insomnia.
• Problems with hearing or ringing in the ears.
• Dizziness, feeling sleepy, or feeling like you're spinning.
• Swelling of the hands, feet, and ankles (edema).
• Inflammation inside the mouth.
• Eye problems.
• Diarrhea, stomach pain, heartburn, indigestion, constipation, belching, or gas (flatulence).
• Stomach ulcers or ulcers in the first part (duodenum) of the small intestine.
• Inflammation of the stomach lining (gastritis).
• Benign polyps in the stomach.

Rare, rare, or very rare (may affect up to 1 in 100 people or less)

• Sores or ulcers in the mouth.
• Eye problems such as blurred vision, conjunctivitis, or eye pain.
• Strange dreams.
• Feeling sleepy.
• Increased blood sugar (glucose) in the blood. Symptoms may include feeling thirsty and urinating more frequently.
• Low blood sugar (glucose) in the blood. Symptoms may include feeling hungry or weak, sweating, and an increased heart rate.
• Coma.
• Inflammation of the blood vessels.
• Puncture (hole) in the stomach or intestine.
• Lupus erythematosus systemic (LES), a disease in which the immune system attacks the body itself, causing joint pain, skin rashes, and fever.
• Enlargement of the lymph nodes.
• Fracture of the hip, wrist, or spine (if VIMOVO is used in high doses and for long periods).
• Fever.
• Fainting.
• Dry mouth.
• Aggression.
• Loss of hearing.
• Asthma attack.
• Tremors or convulsions.
• Problems with menstruation.
• Weight changes.
• Hair loss (alopecia).
• Skin rash with blisters.
• Joint pain (arthralgia).
• Enlargement of the breasts in men.
• Pain or swelling of the tongue.
• Muscle spasms or tremors.
• Problems with appetite or altered taste.
• Weakness or muscle pain (myalgia).
• Blood may take longer to clot.
• Difficulty getting pregnant if female.
• Fever, redness, or other signs of infection.
• Irregular, slow, or very fast heartbeats.
• Feeling prickly.
• Difficulty with memory or concentration.
• Feeling agitated, confused, anxious, or nervous.
• Feeling unwell, weak, and lacking energy.
• Swelling or pain in some parts of the body due to fluid retention.
• High or low blood pressure. You may experience dizziness or fainting.

• Skin rash or blistering, or increased sensitivity to the sun.
• To see, feel, or hear things that do not exist (hallucinations).

• Changes in blood test results, such as those done to check liver function. Your doctor will explain it better.
• Infection called "candidiasis" that can affect the intestine and is caused by a fungus.
• Blood in the urine or other kidney problems.You may have back pain.
• Difficulty breathing, which may worsen slowly. It may indicate the development of pneumonia or inflammation in the lungs.
• Low sodium levels in the blood,which can cause weakness, vomiting, and cramps.
• Symptoms of meningitis such as fever, feeling unwell, neck stiffness, headache, sensitivity to bright light, and confusion.
• Problems with the pancreas. The signs are intense stomach pain that extends to the back.
• Light-colored stools that are a sign of severe liver problems (hepatitis). Severe liver problems that cause liver failure and brain damage.
• Colitis or worsening of an inflammatory bowel disease, such as Crohn's disease or ulcerative colitis. The signs are stomach pain, diarrhea, vomiting, and weight loss.
• Blood problems, such as a decrease in red blood cells (anemia), white blood cells, or platelets,which can cause weakness, bruises, fever, intense chills, sore throat, or more likely infections.
• Increased number of a certain type of white blood cell (eosinophilia).
• Decrease in all types of blood cells (pancytopenia).
• Problems with the way the heart pumps blood throughout the body or damage to blood vessels. Symptoms are fatigue, difficulty breathing, weakness, chest pain, or generalized pain.

Unknown frequency (cannot be estimated from available data)

• If you are taking VIMOVO for more than three months, it is possible that your magnesium levels in the blood will decrease.Magnesium deficiency can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or increased heart rate.If you have any of these symptoms, inform your doctor immediately.Magnesium deficiency can also lead to a decrease in potassium or calcium levels in the blood.Your doctor may decide to perform periodic tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

Do not worry about this list of possible side effects.You may not experience any of them.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through the Spanish System of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging, bottle, or blister after CAD.The expiration date is the last day of the month indicated.

Do not store at a temperature above 86°F.

Bottle: Store this medication in the original packaging and keep the bottle perfectly closed to protect it from moisture.

Blister:Store this medication in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of VIMOVO

• The active principles are naproxen 500 mg and esomeprazole 20 mg.
• The other components (excipients) of the tablet core are sodium croscarmellose, magnesium stearate, povidone K90, colloidal silicon dioxide; and in the film coating, carnauba wax, 40-55 monoester of glycerol, hypromellose type 2910 (3 mPas, 6 mPas, and 50 mPas), iron oxide (E172 yellow, black), macrogol 8000, copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion 30%, methylparahydroxybenzoate of methyl (E218), dextrin, polisorbate 80, propylene glycol, propylparahydroxybenzoate of propyl (E216), sodium lauryl sulfate, titanium dioxide (E171), and triethyl citrate.

Appearance of the product and contents of the package

Oval-shaped tablets of 18x9.5 mm in yellow color marked with 500/20 in black ink.

Bottle:

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

The bottles contain a silica gel desiccant (to keep the tablets dry). Do not ingest the overwrap that contains the desiccant.

or

The bottles contain silica gel desiccant in the cap (to keep the tablets dry).

Aluminum blister pack:

Package sizes: 10, 20, 30, 60, or 100 modified-release tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36

28027 Madrid

Spain

Responsible manufacturer:

Grünenthal GmbH

Zieglerstraße 6

52078 Aachen

Germany

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last reviewed date of the package insert: July 2023

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/