Vimovo

PACKAGE LEAFLET: INFORMATION FOR THE USER

VIMOVO 500 mg/20 mg modified-release tablets

naproxen and esomeprazole
Read this leaflet carefully before taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful. If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What VIMOVO is and what it is used for
2. What you need to know before taking 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.

• Naproxen belongs to a group of medicines known as "Non-Steroidal Anti-Inflammatory Drugs" (NSAIDs). It reduces pain and inflammation.
• Esomeprazole belongs to a group of medicines known as "proton pump inhibitors". It reduces the amount of acid in the stomach. Esomeprazole helps reduce the risk of developing stomach ulcers and stomach problems in patients who need to take NSAIDs.

What VIMOVO is used for
VIMOVO is used in adults to relieve symptoms of:

• Osteoarthritis.
• Rheumatoid arthritis.
• Ankylosing spondylitis.

VIMOVO helps relieve pain, swelling, redness, and warmth (inflammation).
This medicine will be prescribed to you if it is considered likely that a lower dose of NSAID
would not be effective in relieving your pain, and if you are at risk of developing a stomach ulcer or duodenal ulcer (in the first part of the small intestine) when taking NSAIDs.

2. What you need to know before taking VIMOVO

Do not take VIMOVO if:

• You are allergic (hypersensitive) to naproxen.
• You are allergic to esomeprazole or to 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 in the treatment of HIV).
• Acetylsalicylic acid (e.g. aspirin), naproxen, or other NSAIDs such as ibuprofen, diclofenac, or COX-2 inhibitors (e.g. celecoxib, etoricoxib) have previously caused you asthma (difficulty breathing) or an allergic reaction such as itching or skin rash (urticaria).
• You are in the last 3 months of pregnancy.
• You have severe liver, kidney, or heart problems.
• You have a stomach or intestinal ulcer.
• You have a bleeding disorder or severe sudden bleeding.

Do not take VIMOVO if you have any of the conditions listed above. If in doubt,
consult your doctor or pharmacist before taking VIMOVO.
Warnings and precautions
Talk to your doctor before taking VIMOVO.
Do not take VIMOVO and consult your doctor immediately if any of the following events occur before or
during treatment with VIMOVO, as this medicine may mask symptoms of other diseases:

• You lose weight significantly without reason and have difficulty swallowing.
• You start vomiting food or blood.
• Presence of black stools (indicating digested blood in the stool).

If any of the above events occur (or if you have any doubts), consult your doctor or pharmacist before
taking this medicine.
Consult your doctor or pharmacist before taking this medicine if:

• You have intestinal inflammation (Crohn’s disease or ulcerative colitis).
• You have any other liver or kidney problems, or if you are elderly.
• You are taking medicines such as oral corticosteroids, warfarin, clopidogrel, selective serotonin reuptake 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 (a component of VIMOVO) that reduces stomach acidity.
• You need to undergo a specific blood test (chromogranin A).

If any of the above events occur (or if you have any doubts), consult your doctor or pharmacist before
taking this medicine.
If you have previously had a stomach ulcer or gastrointestinal bleeding, inform your doctor. You will be asked to report any unusual stomach symptoms (e.g. pain) to your doctor.
Medicines such as VIMOVO may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk is higher with high doses and long-term treatment. Do not exceed the recommended dose or duration of treatment.
VIMOVO contains the NSAID naproxen. As with all NSAIDs, naproxen should be used at the lowest effective dose for the shortest possible time to minimize the risk of adverse effects. Your doctor will therefore regularly assess whether VIMOVO remains appropriate for you.
VIMOVO is not suitable for rapid relief of acute pain, as it takes several hours for the pain-relieving component, naproxen, to reach effective levels in the blood.
Additionally, consult your doctor before taking this medicine if you have heart problems, have had a stroke, or think you may be at risk of such conditions. You may be at risk if:

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

If you are taking a proton pump inhibitor (a component of VIMOVO), especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
If you notice the appearance of 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 report any other adverse effects such as joint pain.
Serious skin rashes have occurred in patients taking esomeprazole (see also section 4). The rash may involve ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red, swollen eyes). These serious skin reactions often occur after flu-like symptoms such as fever, headache, and muscle pain. The rash may cover large areas of the body, with blistering and peeling of the skin.
If at any time during treatment (even after several weeks) you develop a skin rash or any of these skin symptoms, stop taking this medicine and contact your doctor immediately.
Children and adolescents
The use of VIMOVO is not recommended in children or adolescents under 18 years of age.
Other medicines and VIMOVO
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines and herbal products. This is because VIMOVO may affect how other medicines work. Also, other medicines may affect how VIMOVO works.
Do not take this medicine and inform your doctor or pharmacist if you are taking:

• A medicine called “atazanavir” or “nelfinavir” (used in the treatment of HIV). Inform 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 continue taking VIMOVO.
• Other NSAID medicines (including COX-2 inhibitors).
• Certain medicines such as ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections).
• Erlotinib (or other similar anticancer drugs).
• Cholestyramine (used to lower cholesterol).
• Clarithromycin (used to treat infections).
• Quinolone antibiotics (for infections) such as ciprofloxacin or moxifloxacin.
• Diazepam (used to treat anxiety, to relax muscles, or in the treatment of epilepsy).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Lithium (used to treat certain types of depression).
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and some cancers).
• Probenecid (for gout).
• Selective serotonin reuptake inhibitors (SSRIs) (used to treat severe depression and anxiety disorders).
• Cyclosporine or tacrolimus (medicines used to reduce the body's immune response).
• Digoxin (used to treat heart conditions).
• Sulfonylureas such as glimepiride (oral medicines used in diabetic patients to control blood sugar levels).
• 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).
• Medicines used to prevent blood clotting, such as 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 events occur (or if you have any doubts), consult 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 meals.
Pregnancy, breastfeeding, and fertility

• Do not take VIMOVO if you are in the last 3 months of pregnancy.
• Consult 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 VIMOVO.
• Do not breastfeed while taking VIMOVO. This is because small amounts of the medicine may pass into breast milk. If you intend to breastfeed, you should not take VIMOVO. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant, could become pregnant, or are breastfeeding. VIMOVO may make it more difficult to conceive. Inform your doctor if you are planning a pregnancy or if you have fertility problems.

Driving and using machines
You may experience dizziness or blurred vision while taking VIMOVO. If this occurs, do not drive or operate tools or machinery.
VIMOVO contains methyl 4-hydroxybenzoate (E218) and propyl 4-hydroxybenzoate (E216).
These components may cause allergic reactions. These reactions may not occur immediately.
VIMOVO contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

3. How to take VIMOVO

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Taking this medicine

• Swallow the tablets whole with water. Do not chew, divide, or crush the tablets. It is important to take the tablets whole so that the medicine works properly.
• Take the tablets at least 30 minutes before meals. Food may reduce the protective effect of VIMOVO on your stomach and intestines. Food may also cause a significant delay in pain and inflammation relief.
• If you take this medicine for a long period, your doctor will want to monitor you (especially if you take it for more than one year).

Dosage

• Take one tablet twice daily for the duration prescribed by your doctor.
• VIMOVO is available only in the 500 mg/20 mg strength. If your doctor feels this dose is not suitable for you, they may prescribe an alternative therapy.

If you take more VIMOVO than you should
If you take more VIMOVO than you should, inform your doctor or pharmacist immediately. Symptoms of overdose may include lethargy, dizziness, drowsiness, upper abdominal pain and/or discomfort, heartburn, indigestion, nausea, liver problems (evident from blood tests), kidney problems which may be severe, increased levels of acid in the blood, confusion, vomiting, gastrointestinal bleeding, high blood pressure, breathing difficulties, coma, sudden allergic reactions (which may include shortness of breath, skin rashes, swelling of the face and/or throat, and/or collapse), and involuntary body movements.

If you forget to take VIMOVO

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

If you have any questions about the use of this medicine, consult 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 occur with this medicine.
Stop taking VIMOVO and contact a doctor immediately if you experience any of the following serious side effects,
as you may require urgent medical treatment:

• Sudden wheezing, swelling of the lips, tongue and throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction).

• Sudden onset of a severe skin rash or redness of the skin with blisters or peeling, which may also occur several weeks after starting treatment. Severe blisters and bleeding may also occur in the lips, eyes, mouth, nose and genitals. Skin rashes may progress to severe widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to life-threatening consequences. These may be "erythema multiforme", "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms (DRESS)". These effects are very rare and may affect up to 1 in 10,000 people.

• Yellowing of the skin or whites of the eyes, dark urine and fatigue, which may be symptoms of liver problems.

• Medicines such as VIMOVO may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. Signs include chest pain spreading to the neck and shoulders and radiating to the left arm, confusion or muscle weakness or numbness, which may affect one side of the body only.

• Black, tarry stools or diarrhoea with blood.

• Vomiting blood or dark particles resembling coffee grounds.

Tell your doctor as soon as possible if you experience any of the following symptoms:
VIMOVO may rarely interfere with the number or function of white blood cells, resulting in immune deficiency.
If you have an infection with symptoms such as fever with a severe worsening of general condition or fever with signs of local infection such as neck, throat or mouth pain, or difficulty urinating, you must contact your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out with a blood test. It is important for you at this time to provide information about your medicine.
Other possible side effects include:
Common (may affect up to 1 in 10 people)

• Headache.
• Fatigue.
• Thirst.
• Depression.
• Shortness of breath.
• Increased sweating.
• Itching of the skin and skin rashes.
• Dizziness (vertigo).
• Red or purple spots, bruises or marks on the skin.
• Nausea or vomiting.
• Rapid, light heartbeats (palpitations).
• Disturbed sleep or difficulty sleeping (insomnia).
• Hearing problems or ringing in the ears.
• Dizziness, drowsiness or lightheadedness.
• Swelling of the hands, feet and ankles (oedema).
• Inflammation inside the mouth.
• Vision problems.
• Diarrhoea, stomach pain, heartburn, indigestion, constipation, belching or flatulence.
• Gastric ulcer or duodenal ulcer (in the first part of the small intestine).
• Inflammation of the stomach lining (gastritis).
• Benign polyps in the stomach.

Uncommon, rare or very rare (may affect up to 1 in 100 people or fewer)

• Mouth pain or mouth ulcers.
• Vision problems such as blurred vision, conjunctivitis or eye pain.
• Strange dreams.
• Feeling sleepy.
• Increased levels of sugar (glucose) in the blood. Symptoms may include feeling thirsty and increased urination.
• Low levels of sugar (glucose) in the blood. Symptoms may include feeling hungry or weak, sweating and rapid heartbeat.
• Coma.
• Inflammation of blood vessels.
• Perforation (hole) of the stomach or intestine.
• Systemic lupus erythematosus (SLE), a disease in which the immune system attacks the body, causing joint pain, skin rashes and fever.
• Enlarged lymph nodes.
• Fracture of the hip, wrist or spine (if Vimovo is used at high doses and for long durations).
• Fever.
• Fainting.
• Dry mouth.
• Aggressiveness.
• Hearing loss.
• Asthma attack.
• Seizures or epileptic fits.
• Menstrual disorders.
• Weight changes.
• Hair loss (alopecia).
• Raised skin rash (urticaria).
• Joint pain (arthralgia).
• Breast enlargement in men.
• Sore or swollen tongue.
• Involuntary movements or muscle tremors.
• Loss of appetite or altered taste.
• Muscle weakness or muscle pain (myalgia).
• Blood may take longer than normal to clot.
• Fertility problems in women.
• Fever, redness or other signs of infection.
• Irregular, slow or very fast heartbeat.
• Tingling sensations.
• Memory or concentration problems.
• Restlessness, confusion, anxiety or agitation.
• General feeling of being unwell, weakness and lack of energy.
• Swollen or painful parts of the body due to increased fluid retention.
• High or low blood pressure. You may feel faint or dizzy.
• Skin rashes or blisters, or skin becoming more sensitive to sunlight.
• Seeing, feeling or hearing things that are not there (hallucinations).
• Changes in blood test results, such as those used to check liver function. Your doctor can explain these to you in detail.
• Infection called "candidiasis" that may affect the digestive tract and is caused by a fungus.
• Blood in the urine or other kidney problems. You may feel back pain.
• Breathing difficulties, which may slowly worsen. This may be a symptom of pneumonia or lung swelling.
• Low levels of salt (sodium) in the blood. This may cause weakness, vomiting and cramps.
• Symptoms of meningitis such as fever, nausea or vomiting, stiff neck, headache, sensitivity to bright light and confusion.
• Pancreatic problems. Symptoms include severe stomach pain spreading to the back.
• Pale-coloured stools, which are a symptom of serious liver problems (hepatitis). Serious liver problems may lead to liver failure and brain disorders.
• Colitis or worsening of intestinal inflammation such as Crohn's disease or ulcerative colitis. Symptoms include stomach pain, diarrhoea, vomiting and weight loss.
• Blood disorders, such as a lower number of red blood cells (anaemia), white blood cells or platelets. This may cause weakness, bruising, fever, severe shivering, sore throat or increased susceptibility to infections.
• Increased number of a certain type of white blood cells (eosinophilia).
• Deficiency of all types of blood cells (pancytopenia).
• Problems with the way the heart pumps blood around the body or damage to blood vessels. Symptoms may include fatigue, shortness of breath, feeling faint, chest pain or general pain.

Frequency not known (frequency cannot be estimated from the available data)

• If you take VIMOVO for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness or increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor should decide whether to periodically monitor your blood magnesium levels.
• Erythema, possible joint pain.

Do not be alarmed by this list of possible side effects. It is possible that none of them will occur.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
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 pack after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Bottle: Store in the original packaging and keep the bottle tightly closed to protect the medicine from moisture.
Blister: Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What VIMOVO contains

• The active substances are naproxen 500 mg and esomeprazole 20 mg.
• The other components (excipients) in the tablet core are croscarmellose sodium, magnesium stearate, povidone K90, colloidal silicon dioxide; in the film coating are 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.

Description of the appearance of VIMOVO and package contents
The tablets are 18x9.5 mm oval, yellow, printed with the code "500/20" in black ink.
Bottle:
Package sizes - 6, 10, 20, 30, 60, 100, 180 or 500 modified-release tablets.
The bottles contain silica gel desiccants (to keep the tablets dry). Do not ingest the
sachet containing the desiccant.
The bottles have silica gel desiccants in the screw cap (to keep the tablets dry).
Aluminum blister pack:
Package sizes - 10, 20, 30, 60 or 100 modified-release tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
GRÜNENTHAL ITALIA S.r.l.
Via Carlo Bo, 11
20143 Milan, Italy
Manufacturer
AstraZeneca AB, Gärtunavägen, SE-151 85 Södertälje (Sweden)
Grünenthal GmbH, Zieglerstraße 6, 52078 Aachen (Germany)
This medicinal product is authorized in the European Economic Area countries under the
following names:

This patient information leaflet was last approved on: