Vimovo 500 mg/20 mg modified-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

VIMOVO 500mg/20mg modified-release tablets

naproxen and esomeprazole

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• 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 others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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 called "non-steroidal 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 reduce the risk of ulcers and stomach problems that can occur in patients who need to take NSAIDs.

What VIMOVO is used for

VIMOVO is used in adults for the relief of symptoms of:

• Osteoarthritis.
• Rheumatoid arthritis.
• Ankylosing spondylitis.

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

You will be prescribed this medicine if it is considered unlikely that a lower dose of an NSAID would relieve your pain, and you are at risk of developing a stomach ulcer or an ulcer in the first part of the small intestine (duodenum) while taking an NSAID.

2. What you need to know before taking VIMOVO

Do not take VIMOVO:

• If you are allergic (hypersensitive) 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 to treat HIV infection).
• If acetylsalicylic acid (e.g. aspirin), naproxen, or other NSAIDs such as ibuprofen, diclofenac, or COX-2 inhibitors (e.g. celecoxib, etoricoxib) have ever caused you asthma (wheezing) or an allergic reaction such as itching or skin rash (urticaria).
• If you are in the last 3 months of pregnancy.
• If you have severe liver, kidney, or heart problems.
• If you have a stomach or intestinal ulcer.
• If you have any bleeding disorder or serious or unexpected bleeding.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take VIMOVO.

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

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

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

Talk to your doctor or pharmacist before taking this medicine if:

• You have inflammation in your intestines (Crohn’s disease or ulcerative colitis).
• You have other liver or kidney problems or are of advanced age.
• 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 "Taking VIMOVO with other medicines").
• You have ever had a skin reaction after treatment with a medicine similar to VIMOVO used to reduce stomach acid.
• You are scheduled to have a specific blood test (Chromogranin A).

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

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

Some medicines like 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 treatment duration.

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 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 analgesic naproxen to reach the bloodstream.

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

• You have high blood pressure;
• You have circulation or blood clotting problems;
• You are diabetic;
• You have high cholesterol levels;
• You smoke.

Taking a proton pump inhibitor (which is one of the components of VIMOVO), especially for more than one 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 may increase the risk of osteoporosis).

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

Severe skin rashes have occurred in patients taking esomeprazole (see also section 4). The rash may include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red, swollen eyes). These severe skin rashes usually appear after flu-like symptoms such as fever, headache, and body aches. The rash may cover large areas of the body with blisters and skin peeling.

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.

Kidney inflammation may occur during treatment with VIMOVO. Signs and symptoms may include reduced urine volume or blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. You should report these signs to your doctor.

Children and adolescents

The use of VIMOVO is not recommended in children or adolescents aged 18 years or younger.

Taking VIMOVO with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines and herbal remedies. This is because VIMOVO may affect how other medicines work. Also, some 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 to treat HIV infection).

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 are taking low-dose acetylsalicylic acid (aspirin), you may still be able to take VIMOVO.
• Other NSAID medicines (including COX-2 inhibitors).
• Certain medicines such as ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections).
• Erlotinib (or another anticancer medicine of the same class).
• 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 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 cancer).
• Probenecid (used 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 reactions).
• Digoxin (used to treat heart disorders).
• Sulfonylureas such as glimepiride (oral medicines used to control blood glucose 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).
• Medicines 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 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 medicine.

Pregnancy

Do not take VIMOVO during the last 3 months of pregnancy, as it may harm the unborn baby or cause problems during delivery. It may cause kidney and heart problems in the unborn baby. It may affect bleeding tendency, both yours and your baby’s, and may delay or prolong labour. You should not use VIMOVO during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to become pregnant, the lowest possible dose should be used for the shortest possible time. If taken for more than a few days starting from week 20 of pregnancy, VIMOVO may cause kidney problems in the unborn baby, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If prolonged treatment is needed, your doctor may recommend additional monitoring.

Breastfeeding

Do not breastfeed while taking VIMOVO, as small amounts may pass into breast milk. If you are considering breastfeeding, you should not take VIMOVO.

Fertility

VIMOVO may make it more difficult to become pregnant. You should inform your doctor if you are planning a pregnancy or having difficulty becoming pregnant.

Driving and using machines

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

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

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

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

3. How to take VIMOVO

Follow exactly the instructions for taking this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

How to take this medicine

• Swallow the tablets whole with water. Do not split, chew or crush the tablets. It is important to swallow 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 considerable delay in pain and inflammation relief.
• If you have been taking this medicine for a long time, your doctor will want to carry out regular check-ups (especially if you have been taking it for more than one year).

How much to take

• Take one tablet twice daily for as long as your doctor has instructed.
• VIMOVO is only available as 500 mg/20 mg. If your doctor considers this dose unsuitable for you, they may prescribe a different treatment.

If you take more VIMOVO than you should

If you take more VIMOVO than you should, contact your doctor or pharmacist immediately. Symptoms of an overdose may include lethargy, dizziness, somnolence, pain and/or discomfort in the upper abdomen, heartburn, indigestion, nausea, liver problems (seen in blood tests), kidney problems which may be serious, elevated levels of acid in your blood, confusion, vomiting, bleeding from the stomach or intestines, 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 uncontrolled body movements.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine 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 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 forgotten doses.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The following adverse effects may occur with this medicine.

Stop taking VIMOVO and seek medical attention immediately if you notice any of the following serious adverse effects—you may require urgent medical treatment:

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

• Sudden appearance of a severe skin rash or redness with blistering or peeling, even after several weeks of treatment. Severe blisters and bleeding may also occur in the lips, eyes, mouth, nose, and genitals. Skin rashes may progress to severe and widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to life-threatening complications. This could 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 signs of liver problems.

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

• Dark, tarry stools or bloody diarrhea.

• Vomiting blood or dark particles resembling coffee grounds.

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

In rare cases, VIMOVO may affect white blood cells, potentially leading to immunosuppression.

If you develop an infection with symptoms such as fever accompanied by a severe worsening of general health, or fever with signs of a localized infection such as neck, throat, or mouth pain, or difficulty urinating, you should consult your doctor immediately so that a lack of white blood cells (agranulocytosis) can be ruled out via a blood test. It is important that you inform your doctor about your current medication at that time.

Other adverse effects are:

Frequent (may affect up to 1 in 10 people)

• Headache.
• Feeling of fatigue.
• Feeling of thirst.
• Feeling of depression.
• Feeling of breathlessness.
• Increased sweating.
• Itching of the skin and skin rash.
• Sensation of spinning (dizziness).
• Red or purple marks, bruising, or spots on the skin.
• Nausea or vomiting.
• Sensation of heart palpitations.
• Sleep disturbance or difficulty sleeping (insomnia).
• Hearing problems or ringing in the ears (tinnitus).
• Dizziness, drowsiness, or lightheadedness.
• Swelling of the hands, feet, and ankles (edema).
• Inflammation inside the mouth.
• Vision problems.
• Diarrhea, stomach pain, heartburn, indigestion, constipation, burping, 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.

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

• Sores or ulcers in the mouth.

• Vision problems such as blurred vision, conjunctivitis, or eye pain.

• Strange dreams.

• Drowsy feeling.

• Increased blood sugar (glucose) levels. Symptoms may include feeling thirsty and increased urination.

• Low blood sugar (glucose) levels. Symptoms may include feeling hungry or weak, sweating, and increased heart rate.

• Coma.

• Inflammation of blood vessels.

• Perforation (hole) in the stomach or intestine.

• Systemic lupus erythematosus (SLE), a disease in which the immune system attacks the body itself, causing joint pain, skin rashes, and fever.

• Enlargement of lymph nodes.

• Fracture of the hip, wrist, or spine (if VIMOVO is used at high doses and for long periods).

• Fever.

• Fainting.

• Dry mouth.

• Aggressiveness.

• Loss of hearing.

• Asthma attacks.

• Tremors or seizures.

• Menstrual problems.

• Weight changes.

• Hair loss (alopecia).

• Rash with hives.

• Joint pain (arthralgia).

• Enlargement of the breasts in males.

• Pain or swelling of the tongue.

• Muscle spasm or tremor.

• Appetite problems or altered taste.

• Muscle weakness or pain (myalgia).

• Blood may take longer to clot.

• Difficulty becoming pregnant if you are a woman.

• Fever, redness, or other signs of infection.

• Irregular, slow, or very rapid heartbeat.

• Tingling sensation.

• Memory or concentration difficulties.

• Feeling restless, confused, anxious, or nervous.

• General malaise, weakness, and lack of energy.

• Edema or pain in certain body parts due to fluid retention.

• High or low blood pressure. You may experience dizziness or fainting.

• Skin rash or blistering, or increased skin sensitivity to sunlight.

• Seeing, feeling, or hearing things that are not real (hallucinations).

• Changes in blood test results, such as those used to monitor liver function. Your doctor can explain these better.

• Infection called “candidiasis” affecting the intestine, caused by a fungus.

• Blood in the urine or other kidney problems. You may have back pain.

• Difficulty breathing, which may worsen gradually. This may indicate the development of pneumonia or lung inflammation.

• Low blood sodium (sodium) levels, which may cause weakness, vomiting, and cramps.

• Symptoms of meningitis such as fever, feeling unwell, neck stiffness, headache, sensitivity to bright light, and confusion.

• Pancreatic problems. Signs include severe stomach pain spreading to the back.

• Pale-colored stools, a sign of serious liver problems (hepatitis). Severe liver problems leading to liver failure and brain impairment.

• Colitis or worsening of inflammatory bowel disease, such as Crohn’s disease or ulcerative colitis. Signs include stomach pain, diarrhea, vomiting, and weight loss.

• Blood disorders, such as a decrease in red blood cells (anemia), white blood cells, or platelets, which may cause weakness, bruising, fever, severe chills, sore throat, or increased susceptibility to infections.

• Increase in a certain type of white blood cells (eosinophilia).

• Deficiency of all types of blood cells (pancytopenia).

• Problems with how the heart pumps blood throughout the body or damage to blood vessels. Symptoms include fatigue, shortness of breath, weakness, chest pain, or generalized pain.

Frequency not known (cannot be estimated from available data)

• If you are being treated with VIMOVO for more than three months, your blood magnesium levels may decrease. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced 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 be alarmed by this list of possible adverse effects. You may not experience any of them.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of VIMOVO

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

Do not use this medicine after the expiry date stated on the container, bottle, or blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the container and additional information

Composition of VIMOVO

• The active substances are naproxen 500 mg and esomeprazole 20 mg.
• The other components (excipients) of 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 and ethyl acrylate copolymer dispersion 30%, methylparahydroxybenzoate (E218), polydextrose, polysorbate 80, propylene glycol, propylparahydroxybenzoate (E216), sodium lauryl sulfate, titanium dioxide (E171), triethyl citrate.

Appearance of the product and contents of the container

Yellow, oval-shaped modified-release tablets measuring 18x9.5 mm, marked with "500/20" in black ink.

Bottle:

Pack 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 sachet containing the desiccant.

or

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

Aluminum blister packs in cartons:

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

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Grünenthal Pharma, S.A.
Doctor Zamenhof, 36
28027 Madrid
Spain

Manufacturer:

Grünenthal GmbH
Zieglerstraße 6
52078 Aachen
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of the package leaflet: July 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/