Vimovo 500/20 Side Effects

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Answer the side-effect intent for vimovo 500/20 without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Vimovo 500/20?

Vimovo-500-20 contains the active ingredient Naproxen.

• Active ingredient — Naproxen
• Registration number — W/3.1/0436; W/3.1/0437; W/3.1/436; W/3.1/437
• Registration holder — Biotech Laboratories (Pty) Ltd

It is approved for:

• Naproxen, the active ingredient in BIO-NAPROXEN 250 and BIO-NAPROXEN 500, belongs to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and pain in joints and muscles
• BIO-NAPROXEN is used to give relieve to some of the symptoms (inflammation, swelling, stiffness and joint pain) of diseases of the joints such as rheumatoid arthritis, osteoarthritis and ankylosing spondylitis (form of spinal arthritis)
• BIO-NAPROXEN is also used to treat acute gout, mild to moderate pain associated painful periods, inflammation in shoulder joint (bursitis) and inflammation of a tendon (tendonitis)

Common side effects of Vimovo 500/20

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

• confusion
• dizziness
• drowsiness
• headache
• light-headedness
• visual disturbances
• changes to your hearing, which can include ringing in the ears (tinnitus)
• swelling caused by the accumulation of fluid in a part of the body
• ecchymoses (a discoloration of the skin resulting from bleeding underneath, typically caused by bruising)
• severe itching of the skin (pruritis)
• a rash of purple spots on the skin caused by internal bleeding from small blood vessels (purpura)
• skin eruptions
• sweating
• extreme tiredness (fatigue)

Less frequent side effects

• depression
• has trouble remembering, learning new things, concentrating, or making decisions that affect their everyday life (cognitive dysfunction)
• trouble falling or staying asleep (insomnia)
• loss of concentration
• abnormal dreams
• hearing impairment
• inflammation of the pancreas (pancreatitis)
• yellowing of the skin and white of the eyes, pale coloured stools (jaundice)
• Muscle pain
• muscle weakness
• Blood in the urine (haematuria)
• skin immune reaction that an infection or medication can trigger (erythema multiforme)
• a rash of round, red welts on the skin that itch intensely, sometimes with dangerous swelling, caused by an allergic reaction, typically to specific foods (urticaria)
• partial or complete absence of hair from areas of the body where it normally grows (alopecia)
• photosensitivity reaction including cases of porphyria cutanea tarda (a rare disorder characterized by painful, blistering skin lesions that develop on sun-exposed skin)
• Unexplained vaginal bleeding and/or heavy menstrual bleeding
• increased potassium in the blood Side effects with unknown frequency:
• laryngeal oedema (abnormal accumulation of fluid in tissues of any part of the larynx)
• serum sickness-like reaction (an acute inflammatory condition affecting children and adults characterised by the development of erythematous skin lesions and joint swelling with or without fever)
• lymphadenopathy (a disease affecting the lymph nodes)
• aspirin hypersensitivity (harmful reaction to aspirin. Reactions include breathing, nasal/sinus and skin problems)
• hallucinations
• malaise (a general feeling of discomfort and illness)
• nervousness
• headache
• vertigo (loss of balance)
• abnormal feeling of pins and needles (paraesthesia)
• blurred vision
• corneal opacity (eye problems that can lead to scarring or clouding of the cornea, which decreases vision)
• papillitis (inflammation and deterioration of the portion of the optic nerve known as the optic disk)
• retrobulbar (abscess behind the eyeball)
• swelling and inflammation to the optic nerve (optical neuritis)
• increased pressure in or around the brain causes the part of the optic nerve inside the eye to swell (papilloedema)
• inflammation of the mucous membrane of the nose (rhinitis)
• haemoptysis (the coughing up of blood)
• feel a need to drink something (thirst)
• nausea
• vomiting
• diarrhoea
• accumulation of gas (flatulence)
• constipation
• difficulty in digesting of food with symptoms tant my include pain or discomfort, bloating, feeling of fullness (dyspepsia)
• abdominal pain
• dark sticky faeces containing partly digested blood (melaena)
• vomiting of blood (haematemesis)
• painful sores in the mouth (ulcerative stomatitis)
• colitis (inflammation of the lining of the colon)
• inflammation of the lining of the stomach (gastritis)
• oesophagitis (inflammation of the oesophagus)
• non-peptic gastrointestinal ulceration
• abdominal discomfort
• abnormal liver functions
• erythema nodosum (skin inflammation that is located in a part of the fatty layer of skin)
• fixed drug eruption (is an eruption that is characterized by its round shape)
• inflammatory disorder that appears as purplish, flat-topped bumps when it affects the skin (lichen planus)
• pustular reaction (when your skin becomes inflamed as a result of an allergic reaction to food, environmental allergens)
• Systemic lupus erythematosus (SLE) (long-term condition that can cause inflammation in the skin, organs, and in various other places in the body)
• swelling beneath your skin (angio-oedema)
• redness and peeling of the skin over large areas of the body (exfoliative and bullous dermatoses)
• flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• increased potassium in the blood
• increase in creatinine in the blood and fluid retention
• Woman who had unsuccessfully tried to conceive a baby for over a year (impaired female fertility)
• swelling of the lower legs and hands (mild peripheral oedema)
• fever

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, naproxen sodium, aspirin, other non-steroidal anti- inflammatory agents or any of the other ingredients of BIO-NAPROXEN (listed in section 6)
• If you are hypersensitive (allergic) to aspirin, other non-steroidal anti-inflammatory medicines or any other pain relief medicines (such as ibuprofen and diclofenac). If these medicines have given you asthma, a runny nose, sac-like growths of inflamed tissue lining of your nose or sinuses or skin hives, you may also experience severe allergic reaction with BIO-NAPROXEN, which can be fatal
• If you are pregnant or breastfeeding your baby
• If you have severe heart problems
• If you have severe kidney problems
• If you have previously experienced bleeding or perforation in your stomach while taking non-steroidal anti-inflammatory medicines
• If you have now or have ever had any problems with your stomach or gut (intestine) like an ulcer or any bleeding
• If you have porphyria
• If you are a child under the age of 16 years

Use with care, and tell your doctor, if

• If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist
• Medicines such as BIO-NAPROXEN may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment
• If you have a history of stomach problems such as ulcerative colitis or Crohn’s disease (conditions causing inflammation of the bowel, bowel pain, diarrhoea, vomiting and weight loss), heart burn or reflux as the condition can be made worse by the use of BIO-NAPROXEN
• you have a liver/kidney disease or your liver/kidney is not working properly
• If you have a blood clotting disorder
• If you are an elderly patient (as you will be more likely to experience side effects with BIO-NAPROXEN especially bleeding and perforation of the gut)
• If you have or have had bronchial asthma, or other breathing problems or nasal polyps
• if you have systemic lupus erythematosus
• if you develop any skin rash or other sign of hypersensitivity. You should then immediately stop taking BIO-NAPROXEN
• if you develop flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• if you are planning to become pregnant
• if you might have a bleeding problem or problem relating to blood clotting
• Naproxen tablets may hide the symptoms of an infection
• If you need any blood or urine tests tell your doctor you are taking BIO-NAPROXEN tablets. The tablets may need to be stopped 48 hours before a test, as they may interfere with the results
• Taking a painkiller for headaches too often or for too long can make them worse
• If you are 20 weeks or later pregnant, the use of BIO-NAPROXEN can cause serious kidney problems in the unborn baby Children Do not give BIO-NAPROXEN to children under the age of 16 years

Pregnancy and breastfeeding

• You should not take BIO-NAPROXEN in the first 6 months of pregnancy and must not take BIO- NAPROXEN in the last 3 months of pregnancy or during labour
• Do not use BIO-NAPROXEN if you are breastfeeding your baby
• BIO-NAPROXEN may make it more difficult to become pregnant
• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking BIO-NAPROXEN
• Driving and using machinery: BIO-NAPROXEN may make you feel dizzy, drowsy or tired and may cause blurred vision
• Make sure you are not affected before you drive or operate machinery

Interactions and medicines to check

The approved leaflet names these interactions.

• hydantoins (e.g. phenytoin)
• sulfonamides (e.g. sulfamethoxazole)
• Sulphonylurea antidiabetics such as glimepiride or glipizide
• medicines which thin the blood, or which prevent blood clotting (e.g. heparin or warfarin)
• lithium (medicine for depression)
• diuretics (furosemide) and antihypertensive medicines (medicine used to lower blood pressure)
• probenecid for gout
• methotrexate (medicine for the treatment of skin problems, cancer or to treat auto-immune diseases)
• cardiac glycosides (medicine used to treat heart failure and certain irregular heartbeats such as digoxin.)
• ciclosporin (medicine that suppress the immune system used after organ transplant)
• mifepristone (medicine used to end pregnancy)
• corticosteroids (such as hydrocortisone, prednisolone and dexamethasone.), if needed the doctor will reduce the dose of the steroid slowly and monitor for side effects
• other NSAIDs including cyclooxygenase-2 inhibitors (medicine such as aspirin, ibuprofen or indomethacin)
• quinolone antibiotics (such as ciprofloxacin, moxifloxacin, norfloxacin, gatifloxacin or levofloxacin to treat bacterial infections)
• anti-platelet medicines (medicine such as aspirin, clopidogrel or prasugrel)
• antidepressants that are known as selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine and paroxetine
• tacrolimus (an immunosuppressive drug used mainly in organ transplants)
• Zidovudine
• bisphosphonates
• Antacids used for heartburn or cholestyramine used to bind bile in the stomach
• aspirin/acetylsalicylic acid to prevent blood clots BIO-NAPROXEN with food and alcohol BIO-NAPROXEN should be taken with food

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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