Vimovo Side Effects

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Answer the side-effect intent for vimovo without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Vimovo?

Vimovo contains the active ingredient Naproxen, esomeprazole.

• Active ingredient — Naproxen, esomeprazole
• Registration number — 45/3.1/0179
• Registration holder — AstraZeneca Pharmaceuticals (Pty) Limited

It is approved for:

• Naproxen belongs to a group of medicines called “Non-Steroidal Anti- Inflammatory Drugs” (NSAIDs). It works by reducing inflammation
• Esomeprazole belongs to a group of medicines called “proton pump inhibitors”. It works by reducing the amount of acid your stomach produces. VIMOVO is used to treat inflammatory problems such as osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who need a “proton pump inhibitor” to reduce the risk of getting a stomach ulcer or an ulcer in the small intestine (gut) when treated with a Non-Steroidal Anti- Inflammatory Drug (NSAID)

Common side effects of Vimovo

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequent side effects

• Headache
• Feeling tired
• Feeling thirsty
• Feeling depressed
• Feeling breathless
• Increased sweating
• Itchy skin and skin rashes
• Spinning feeling (vertigo)
• Red or purple marks, bruising or spots on your skin
• Feeling sick (nausea) or being sick (vomiting)
• A fluttering feeling in your heart (palpitations)
• Disturbed sleep or trouble sleeping (insomnia)
• Hearing problems such as ringing in your ears
• Dizziness, feeling drowsy or feeling light-headed
• Swelling of your hands, feet and ankles (oedema)
• An inflammation inside the mouth, a sore mouth or mouth ulcers
• Eyesight problems such as blurred vision, conjunctivitis or eye pain
• Effects on your stomach or gut: diarrhoea, stomach pain, heartburn, indigestion, constipation, burping or wind (flatulence)

Less frequent side effects

• Fever
• Fainting
• Dry mouth
• Aggression
• Hearing loss
• Asthma attack
• Fits or seizures
• Period problems
• Weight changes
• Hair loss (alopecia)
• Lumpy rash (hives)
• Joint pain (arthralgia)
• Enlarged breasts in men
• Sore or swollen tongue
• Twitching or muscle tremor
• Appetite problems,or taste changes
• Muscle weakness or pain (myalgia)
• Your blood may take longer to clot
• Problems for women in getting pregnant
• Fever, redness or other signs of infection
• An irregular, slow or very fast heart beat
• Tingling feelings such as “pins and needles”
• Difficulty with your memory or concentration
• Feeling agitated, confused, anxious or nervous
• Generally feeling unwell, weak and lacking energy
• Swollen or painful parts of your body because you have gained water
• High or low blood pressure. You may feel faint or dizzy
• Skin rash or blistering, or your skin becoming more sensitive on exposure to sunlight
• Seeing, feeling or hearing things that are not there (hallucinations)
• Changes in your blood test results, such as to see how your liver is working. Your doctor can explain more
• An infection called “thrush” which can affect the gut and is caused by a fungus
• Blood in your (water) urine or other kidney problems. You may have back pain
• Difficulty breathing, which may slowly get worse (respiratory depression)
• Pneumonia (infection in the lungs)
• Fluid accumulation in your lungs (pulmonary oedema)
• Low levels of salt (sodium) in your blood. This may cause weakness, being sick (vomiting) and cramps
• Symptoms of meninigitis such as fever, feeling or being sick, a stiff neck, headache, sensitivity to bright light and confusion
• Problems with your pancreas. Signs include severe stomach pain which spreads to your back
• Pale coloured stools which are a sign of serious liver problems (hepatitis). Serious liver problems may lead to liver failure and inflammation of the brain
• Worsening of inflammatory bowel disease such as Crohn’s disease or ulcerative colitis. Signs include pain, diarrhoea, vomiting and weight loss
• Blood problems such as a reduced number of red cells (anaemia), white cells or platelets. This can cause weakness, bruising, fever, severe chills, sore throat or make infections more likely
• Problems with the way your heart pumps blood around the body or damage to your blood vessels. Signs may include tiredness, shortness of breath, feeling faint, chest pain or general pain
• Low blood magnesium (which may result in low blood calcium and/ or low potassium). Esomeprazole may 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. VIMOVO may be associated with an increased risk of heart attack (myocardial infarction) or stroke. Do not be concerned by this list of possible side effects. You may not get any of them. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• If you are hypersensitive (allergic) to naproxen, esomeprazole or any of the other ingredients of VIMOVO (listed in section 6)
• If you are allergic to other proton pump inhibitor medicines
• If you are taking a medicine called “atazanavir” or “nelfinavir” (used to treat HIV)
• If aspirin, naproxen or other NSAIDS such as ibuprofen, diclofenac or COX-2 inhibitors have caused you to have asthma (wheeziness) or an allergic reaction such as itchiness or skin rash (urticaria)
• If you are in the last 3 months of pregnancy
• If you have severe problems with your liver, kidney or heart. Do not take VIMOVO if any of the above apply to you. If you are not sure, talk to your healthcare professional before taking VIMOVO. You must not take VIMOVO and must talk to your healthcare professional 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:
• You lose a lot of weight for no reason and have problems swallowing
• You start to vomit food or blood
• You pass black stools (blood-stained faeces)

Use with care, and tell your doctor, if

• You have inflammation of your intestines (Crohn’s disease or ulcerative colitis)
• You have any other problems with your liver or kidneys or if you are elderly
• You are taking other medicines such as corticosteroids taken by mouth, warfarin, Serotonin Selective Reuptake Inhibitors (SSRIs), aspirin or NSAIDs including COX-2 inhibitors. If any of the above apply to you (or you are not sure), talk to your healthcare professional before taking this medicine. VIMOVO may be associated with an increase in the risk of you having a heart attack (myocardial infarction) or stroke. The risk may happen early in treatment. Any risk is more likely with high doses and long lasting treatment. Do not exceed the recommended dose or length of treatment. Also, check with your doctor before taking VIMOVO 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:
• You have high blood pressure
• You have problems with your blood circulation or with your blood
• clotting
• You have diabetes
• You have high cholesterol
• You are a smoker. Some population studies have indicated that the use of a proton pump inhibitor (which is a component of VIMOVO) may be associated with a small increased risk for osteoporotic bone fractures (osteoporosis is a condition where certain bones become brittle). However, other similar population-based studies found no such increased risk. It has not been established that VIMOVO causes fractures. Please inform your doctor if you have been diagnosed with osteoporosis (brittle bone disease)

Pregnancy and breastfeeding

• • The safety of VIMOVO in pregnancy has not been established
• • Talk to you doctor before taking this medicine if you are planning to get pregnant
• • Do not breastfeed if you are taking VIMOVO
• This is because small amounts may pass into the mothers’ milk
• If you are planning to breast-feed you should not take VIMOVO
• If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking VIMOVO

Interactions and medicines to check

The approved leaflet names these interactions.

• A medicine called “atazanavir” or “nelfinavir” (used to treat HIV). Tell your doctor or pharmacist if you are taking any of the following medicines:
• Aspirin, other NSAID medicines (including COX-2 inhibitors)
• Ketoconazole, itraconazole or voriconazole (used to treat infections caused by a fungus)
• Cholestryamine (used to reduce cholesterol)
• Clarithromycin (used to treat infection)
• Diazepam (used to treat anxiety, to relax your muscles or used in epilepsy)
• Hydantoins such as phenytoin (used to treat epilepsy)
• Lithium (used to treat some types of depression)
• Methotrexate (used to treat rheumatoid arthritis, psoriasis and cancer)
• Probenecid (for gout)
• “Serotonin Selective Reuptake Inhibitors” (SSRIs) such as fluoxetine (used to treat anxiety and depression)
• Sulphonylureas such as glimepiride (oral medicines used to control your blood sugar in diabetes)
• Medicines used to treat high blood pressure called diuretics (such as furosemide or hydrchlorothiazide), 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)
• Warfarin or clopidogrel (used to thin your blood). Your doctor may need to monitor you when you start or stop taking VIMOVO
• Cilostazol (used for pain in legs due to poor blood flow)
• Cyclosporin/Tacrolimus (used to prevent the immune system from attacking transplant organs). 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 and alcohol Do not take VIMOVO with food. This may reduce the effect of VIMOVO. Take your tablets at least 30 minutes before you have a meal

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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