Arthrexin Side Effects

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

What is Arthrexin?

Arthrexin contains the active ingredient Indomethacin.

• Active ingredient — Indomethacin
• Registration number — K/3.1/222
• Registration holder — PHARMACARE LIMITED

It is approved for:

• Rheumatoid arthritis (disease mainly of the joints)
• Osteoarthritis (disease of the joints)
• Ankylosing spondylitis (a form of arthritis which mainly affects the back)
• Musculoskeletal disorders (muscle and bone disorders, such as tendonitis, inflammation in the joints, sprains and strains)
• Pain and swelling in gout (a form of arthritis in which crystals build up in the joints)
• Fever in Hodgkin’s disease (a type of cancer)
• Pain, inflammation and swelling following orthopaedic surgery or nonsurgical procedures (associated with repositioning bones after dislocation or fracture)
• Pain, inflammation and swelling following dental surgical procedures
• Period pain
• Low back pain
• A disease where the cartilage that serves as a cushion in the joints of the hips deteriorates (degenerative joint disease of the hip)
• Fever, the reduction of symptoms in some conditions which may produce fever (febrile conditions)

Common side effects of Arthrexin

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

• Bruising (bleeding into the skin)
• nausea, vomiting, constipation, diarrhoea, loss of appetite (anorexia), stomach ulcers, abdominal pain
• tiredness (including feeling unwell and listlessness)
• headache
• dizziness and light-headedness
• sensation that things around you are moving (vertigo)

Less frequent side effects

• High blood sugar presenting with symptoms like frequent urination, increased thirst, blurred vision, fatigue (hyperglycaemia)
• sugar in the urine, confirmed by laboratory test or dipstick test (glycosuria)
• mental disorders including a loss of personal identity
• bleeding from the nose
• sleeplessness
• anxiety
• drowsiness
• involuntary muscle movements
• pins and needles (paraesthesia)
• speech problems (dysarthria)
• worsening of epilepsy and parkinsonism symptoms (symptoms that mimic those of Parkinson’s disease such as tremor or abnormal movements)
• blurred vision, double vision, pain in the eye, other visual disturbances
• ringing in the ears (tinnitus)
• the feeling that you need to pass stools, even though your bowel is already empty (tenesmus)
• trapped wind
• indigestion or heartburn (dyspepsia)
• hair loss (alopecia)
• increased sensitivity of the skin to sun and ultraviolet light (photosensitivity)
• a rash of purple and/or tiny brown-purple spots or discolouration of the skin
• scaly and peeling skin (exfoliative dermatitis)
• sweating
• flushing
• bleeding from the vagina in woman
• swelling (oedema)
• weight gain
• breast changes including enlargement and tenderness in men and women (gynaecomastia)
• high or low blood pressure (hypertension or hypotension)
• protein and blood in the urine as well as increased levels of urea in the blood. These changes in urine and blood composition would normally be picked up in urine or blood tests. Side effects with an unknown frequency:
• Diarrhoea (if severe), weight loss, fever and/or abdominal pain (regional ileitis)
• abnormal liver function
• aggravation of psoriasis (inflamed patches get bigger and spread faster)
• accelerated breakdown of cartilage in the joints
• muscle weakness
• abnormal laboratory test results

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 indomethacin or any of the other ingredients of ARTHREXIN (listed in section 6)
• if you have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had episodes of peptic ulcers, stomach bleeding or perforation
• if you suffer from inflammation of the rectum causing soreness and bleeding from your anus (back passage)
• if you are taking medicine called triamterene for swelling and high blood pressure
• if you are taking a medicine called diflunisal for pain, swelling, stiffness or joint pain
• if you have nasal polyps (teardrop-shaped, non-cancerous growths) due to swelling of the area under the skin
• if you have had a history of asthma attacks, hives or inflammation of the inside of the nose after taking aspirin or other NSAIDs, including ARTHREXIN
• if you have a history of sensitivity (allergy) that causes swelling of the face and mouth (angioedema) after taking NSAIDs, including ARTHREXIN and/or aspirin
• if you have heart failure or heart disease and/or cerebrovascular disease, e.g. if you have had a heart attack, stroke, or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages
• if you have or have had problems with your blood circulation (peripheral arterial disease)
• if you have kidney or liver failure
• if you are pregnant, do not use NSAIDs such as ARTHREXIN, at 30 weeks or later in your pregnancy because these medicines may cause problems in your unborn baby
• if you are breastfeeding your baby. Safety of ARTHREXIN in children has not been established

Use with care, and tell your doctor, if

• if you develop a fever, severe skin rash or skin reaction or any unusual reaction such as facial swelling when starting treatment with ARTHREXIN, stop using ARTHREXIN and tell your doctor immediately. These serious events may occur without warning and may be fatal, they include DRESS (drug rash with eosinophilia and systemic symptoms), Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN)
• if you have high blood pressure or have a tendency for fluid retention you should only be treated with ARTHREXIN after very careful consideration
• if you have kidney or liver problems you should be closely monitored by your doctor to ensure that your kidney and liver function does not get worse
• if you have high levels of sugar in the blood (diabetes)
• if you smoke or have high levels of bad cholesterol in the blood
• if you are taking a diuretic (water tablet) to increase the amount of urine that is excreted
• if you are feeling thirsty, tired, have a dry mouth, feeling dizzy or light-headed, you may be dehydrated
• if you experience heart palpitations, shortness of breath, chest pain, nausea, or vomiting, you may have high levels of potassium in your blood (hyperkalaemia)
• if you have asthma
• if you are epileptic (have seizures), as you may need to stop treatment with ARTHREXIN
• if you have Parkinson’s disease, as you may need to stop treatment with ARTHREXIN
• if you have any psychiatric disease
• if you suffer from systemic lupus erythematosus (SLE), an auto immune disorder, you may have an increased risk of inflammation of the membrane covering the brain (aseptic meningitis)
• if you suffer from rectal bleeding (bleeding from the back passage)
• if you experience dizziness and headaches with the use of ARTHREXIN you may need to stop using ARTHREXIN as ARTHREXIN can aggravate the headaches
• if you experience a recurrent inclination to empty the bowel, or irritation in the anus (back passage) area with the use of ARTHREXIN
• if you have an infection, since symptoms such as fever and inflammation may be masked. If you use this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay
• if you notice any change in your vision, you should see your doctor.If you have rheumatoid arthritis your doctor may want to examine your eyes at intervals during your treatment with ARTHREXIN
• if you are having blood tests done, make sure that the doctor doing them knows that you are using ARTHREXIN. Misleading results have been seen with patients having a dexamethasone suppression test (DST) while using ARTHREXIN
• if you are elderly or you have previously had stomach ulcers, you have a higher risk of getting side effects, especially from the stomach. Your doctor should therefore prescribe the lowest dose that gives you sufficient relief. If you experience any unusual symptoms from the stomach, you must tell your doctor about it
• if you have a digestive tract disorder
• if you have a problem with your blood clotting
• if you are anaemic (low red blood count that leaves you feeling very tired)
• Taking NSAIDs, such as ARTHREXIN, at around 20 weeks of pregnancy or later may harm your unborn baby. If you need to be treated with NSAIDs, such as ARTHREXIN, for more than 2 days when you are between 20 and 30 weeks of your pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not use NSAIDs, such as ARTHREXIN, around 30 weeks of pregnancy or later
• if you have difficulty becoming pregnant
• if you suffer from porphyria. Children ARTHREXIN must not be used in children

Pregnancy and breastfeeding

• You should not use ARTHREXIN if you are pregnant or breastfeeding your baby
• 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 using ARTHREXIN
• Pregnancy You should not use ARTHREXIN if you are already at 30 weeks or later in your pregnancy
• ARTHREXIN must not be used at 30 weeks or later in your pregnancy since it may cause major heart, lung and kidney disorders in the unborn child
• If used at the end of pregnancy, it may cause bleeding tendencies in both mother and child and weaken the strength of uterine contractions delaying the onset of delivery
• Breastfeeding You should not use ARTHREXIN if you are breastfeeding your baby

Interactions and medicines to check

The approved leaflet names these interactions.

• Anti-coagulants such as warfarin (used to prevent blood clots)
• Other non-steroidal anti-inflammatory medicines (NSAIDs) including diflunisal or aspirin (used to treat pain and inflammation). Avoid using two or more NSAID’s as this may increase the risk of experiencing adverse effects
• Antacids, that are used to neutralise stomach acidity and are used to relieve heartburn, indigestion or an upset stomach
• Sulfonylureas and other medicines used to treat diabetes, as your doctor may need to adjust the dose
• Probenecid (also used to treat gout)
• Methotrexate (used to treat certain types of cancer or autoimmune disorders)
• Ciclosporin (used to prevent rejection of a transplanted organ)
• Lithium (used to treat mood disorders)
• Diuretics such as furosemide and triamterene and other medicines used to treat high blood pressure
• Phenylpropanolamine (used in cold and flu medicines)
• Mifepristone (used to abort pregnancy)
• Medicines used to treat heart disorders (such as digoxin)
• Corticosteroids (used to treat painful or inflammatory conditions or allergies)
• Quinolone antibiotics (used to treat certain bacterial infections)
• Phenytoin (used to treat epilepsy/seizures)
• Antiretrovirals (used to treat viral infections such as HIV)
• Muscle relaxants
• Tacrolimus, medicine that lowers the risk of organ rejection after an organ transplant
• Tiludronic acid, medicine used to treat Paget’s disease (broken and deformed bones and pain in the affected area)
• Selective serotonin reuptake inhibitors (SSRIs), medicine used to treat depression
• Vancomycin used to treat bacterial infections such as colitis

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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