Cataflam Side Effects

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

What is Cataflam?

Cataflam contains the active ingredient Diclofenac Sodium.

• Active ingredient — Diclofenac Sodium
• Registration number — 57/3.1/0526
• Registration holder — Austell Pharmaceuticals (Pty) Ltd

It is approved for:

• CANOROF contains the active ingredient diclofenac sodium (75 mg/3 mL ampoule)
• Diclofenac sodium belongs to a group of medicines called non-steroidal anti- inflammatory drugs (NSAIDs)
• NSAIDs reduce pain and inflammation
• CANOROF is used as an intramuscular injection for: Treating inflammation of muscles, joints and tissues and pain associated with inflammation

Common side effects of Cataflam

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

• Stomach pain, heartburn, nausea, vomiting, diarrhoea, indigestion, wind, loss of appetite
• Headache, dizziness, vertigo
• Skin rash or spots
• Raised levels of liver enzymes in the blood
• Vision disturbed/blurred, diplopia (double vision)

Less frequent side effects

• Stomach ulcers or bleeding (there have been very rare, reported cases resulting in death, particularly in the elderly)
• Disorientation, depression, insomnia (struggle to sleep), nightmare, irritability, psychotic disorder
• Drowsiness, tiredness, paraesthesia (needles and pins), memory impairment, convulsion, anxiety, tremor, aseptic meningitis, taste disturbances, cerebrovascular haemorrhage
• Hypotension (low blood pressure, symptoms of which may include faintness, giddiness or light headedness) or hypertension (high blood pressure)
• Skin rash and itching
• Fluid retention, symptoms of which include swollen ankles
• Liver function disorders, including hepatitis and jaundice
• Impaired hearing
• Asthma or breathing problems
• Haematuria (blood in urine), proteinuria (protein in urine) and renal function disorders
• Impotence. Side effects with frequency unknown:
• Injection site necrosis
• Confusion, hallucinations, disturbances of sensation, malaise (feeling unwell)
• Optic neuritis (inflammation of the nerves of the eye causing pain/vision disturbances)
• Chest pain signalling acute coronary artery syndrome associated with allergic reaction also called Kounis syndrome
• Ischaemic colitis (inflammatory bowel disease)
• 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)), Effects on the nervous system: Tingling or numbness in the fingers, tremor, blurred or double vision, hearing loss or impairment, tinnitus (ringing in the ears), sleeplessness, nightmares, mood changes, depression, anxiety, mental disorders, confusion, hallucinations, malaise, disorientation and loss of memory, fits, headaches together with a dislike of bright lights, fever and a stiff neck, disturbances in sensation. Effects on the stomach and digestive system: Constipation, inflammation of the tongue, mouth ulcers, taste changes, lower gut disorders (including inflammation of the colon). Effects on the heart, chest or blood: Palpitations (fast or irregular heartbeat), chest pain, hypertension (high blood pressure), inflammation of blood vessels (vasculitis), inflammation of the lung (pneumonitis), congestive heart failure, blood disorders (including anaemia). Effects on the liver or kidneys: Kidney or liver disorders, presence of blood or protein in the urine. Effects on skin or hair: Serious skin rashes including Stevens-Johnson syndrome and Lyell’s syndrome and other skin rashes which may be made worse by exposure to sunlight. Also refer to the DRESS syndrome above. Hair loss. Other Effects: Inflammation of the pancreas, impotence. Medicines containing diclofenac, such as CANOROF, may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Do not be alarmed by this list – most people have an injection of CANOROF without any problems

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

• You are hypersensitive (allergic) to diclofenac sodium, aspirin, ibuprofen or any other NSAIDs or any of the other ingredients of CANOROF (listed in section 6). Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing problems, runny nose, skin rash or any other allergic type reaction
• You have now, or have ever had, a stomach (gastric) or duodenal (peptic) ulcer, or bleeding in the digestive tract (this can include blood in vomit, bleeding when emptying bowels, fresh blood in stools or black, tarry stools)
• You have had stomach or bowel problems after you have taken other NSAIDs
• You have moderate or severe heart, kidney or liver failure
• You are more than more or less 20 weeks pregnant
• You are breastfeeding
• You have porphyria

Use with care, and tell your doctor, if

• You should receive the lowest dose of CANOROF for the shortest possible time, particularly if you are underweight or elderly
• You should be aware that medicines such as diclofenac 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
• Whilst you are taking these medicines your doctor may want to give you a check-up from time to time
• If you have a history of stomach problems when you are taking NSAIDs, particularly if you are elderly, you must tell your doctor straight away if you notice any unusual symptoms
• Because it is an anti-inflammatory medicine, CANOROF may reduce the symptoms of infection, for example, headache and high temperature. If you feel unwell and need to see a doctor, remember to tell him or her that you are receiving CANOROF
• CANOROF contains the preservative, sodium metabisulphite. This can sometimes cause allergic reactions and breathing difficulties
• CANOROF should not be used in children
• Patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported with CANOROF therapy. Children and adolescents CANOROF is not suitable for children and adolescents below 14 years of age

Pregnancy and breastfeeding

• • Using pain-relieving and fever-reducing nonsteroidal anti-inflammatory drugs (NSAIDs) around 20 weeks or later in pregnancy may cause kidney problems in your unborn baby, which can lead to low levels of amniotic fluid that surrounds your baby
• This fluid provides a protective cushion and helps the unborn babies’ lungs, digestive system, and muscles develop
• Complications can occur with low levels of this fluid
• • The use of CANOROF during the third trimester of pregnancy is contraindicated may result in closure of the foetal ductus arteriosus in utero and possible persistent pulmonary hypertension (high blood pressure) of the newborn
• • Diclofenac passes into breast milk in small amounts
• • The use of diclofenac may make it more difficult to become pregnant

Interactions and medicines to check

The approved leaflet names these interactions.

• Medicines used to treat diabetes
• Anticoagulants (blood thinning tablets like warfarin)
• Diuretics (water tablets)
• Lithium (medicine used to treat some mental problems)
• Methotrexate (medicine used for inflammatory diseases and cancers)
• Ciclosporin and tacrolimus (used to treat some inflammatory diseases and after transplants)
• Quinolone antibiotics (for infections)
• Any other NSAIDs or COX-2 (cyclo-oxygenase-2) inhibitors, for example aspirin or ibuprofen
• Mifepristone (a medicine used to terminate pregnancy)
• Cardiac glycosides (for example digoxin), used to treat heart problems
• Medicines known as SSRIs used to treat depression
• Oral steroids (an anti-inflammatory drug)
• Medicines used to treat heart conditions or high blood pressure, for example betablockers or ACE inhibitors. These medicines should not be taken together with CANOROF

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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