Xefo Side Effects

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

What is Xefo?

Xefo contains the active ingredient Lornoxicam.

• Active ingredient — Lornoxicam
• Registration number — 33/3.1/0249
• Registration holder — Acino Pharma (Pty) Ltd

It is approved for:

• XEFO is a non-steroidal anti-inflammatory drug and antirheumatic drug (NSAID) of the oxicam class
• It is intended for treatment of short-term mild to moderate pain when oral administration is inappropriate

Common side effects of Xefo

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

• Mild and transient headache, dizziness, nausea, abdominal pain, dyspepsia, diarrhoea, vomiting

Less frequent side effects

• Pharyngitis, anaemia, thrombocytopenia, leukopenia, hypersensitivity, confusion, nervousness, agitation, somnolence, paraesthesia, dysgeusia, tremor, migraine, visual disturbances, hypertension, hot flush, haemorrhage, haematoma, dyspnoea, cough, melaena, haematemesis, stomatitis, oesophagitis, gastrooesophageal reflux, dysphagia, aphthous stomatitis, glossitis, hepatic function abnormal, dermatitis, bone pain, muscle spasms, myalgia, nocturia, micturition disorders, asthenia, prolonged bleeding time, purpura, bronchospasm, increase in blood urea nitrogen and creatinine levels, perforated peptic ulcer
• Anorexia, insomnia, depression, conjunctivitis, vertigo, tinnitus, palpitations, tachycardia, flushing, constipation, flatulence, eructation, dry mouth, gastritis, gastric ulcer, abdominal pain upper, duodenal ulcer, mouth ulceration, increase in liver function tests, SGPT (ALT) or SGOT (AST), rash, pruritus, hyperhidrosis, rash erythematous, urticaria, alopecia, arthralgia, malaise, face oedema, weight changes, oedema, rhinitis
• Hepatocellular damage, ecchymosis, oedema and bullous reactions, Stevens-Johnson syndrome, Toxic epidermal necrolysis

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 Lornoxicam or any of the other ingredients of XEFO (listed in section 6). S3
• if you are hypersensitive to other NSAIDs including acetylsalicylic acid
• if you suffer from hypovolemia or dehydration
• if you suffer from gastro-intestinal bleeding, cerebrovascular bleeding or other bleeding disorders
• if you have a history of gastrointestinal bleeding, ulceration, or perforation, related to previous NSAIDs therapy
• if you suffer from an active or have a history of recurrent peptic ulcer
• if you suffer from severe liver impairment
• if you suffer from severe renal impairment
• if you suffer from thrombocytopenia
• if you suffer from severe heart failure
• if you are pregnant or breastfeeding
• if you are under the age of 18 years old
• if you are elderly (> 65 years)

Use with care, and tell your doctor, if

• If you have impaired kidney or liver function
• If you have had a recent operation
• if you have a history of hypertension and/or heart failure as fluid retention and oedema may occur
• if you suffer from gastric ulcers and gastric bleeding
• if you are taking other medication that might cause gastric ulcers and gastric bleeding
• if you suffer from any gastric diseases such as ulcerative colitis or Crohn’s disease
• if you have a history of bleeding tendency
• If you suffer from blood coagulation disorder, impaired liver function, such as liver cirrhosis, are elderly or you will be treated with XEFO for more than 3 months, your doctor may monitor you by laboratory test on a frequent basis
• If you are going to be treated with heparin or tacrolimus concomitantly with XEFO, please inform your doctor about your current medicine
• XEFO should not be used concomitantly with other NSAIDs such as acetylsalicylic acid, ibuprofen and COX-2 inhibitors. Ask your doctor or pharmacist if you are uncertain
• If you experience any unusual abdominal symptoms such as abdominal bleeding, skin reactions such as skin rash, mucosal lesions or other signs of hypersensitivity, you should stop taking XEFO and contact you doctor immediately
• Medicines such as XEFO 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 of duration of treatment
• 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. Children and adolescents XEFO is contraindicated in children under the age of 18 years

Pregnancy and breastfeeding

• 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 health care provider for advice before taking this medicine
• XEFO must not be taken if you are pregnant or breastfeeding
• The use of XEFO may impair fertility and is not recommended in women attempting to fall pregnant
• In women who have difficulties conceiving, or who are undergoing investigation of infertility, withdrawal of XEFO should be considered

Interactions and medicines to check

The approved leaflet names these interactions.

• Cimetidine
• Digoxin
• Anticoagulant such as heparin, warfarin, phenprocoumon
• Corticosteroids
• Methotrexate
• Lithium
• Immunosuppressive agents as cyclosporine, tacrolimus
• Heart medicine such as digoxin, ACE-inhibitors, beta-adrenergic blockers
• Diuretics
• Quinolone antibiotics
• Anti-platelet agents
• NSAIDs such as aspirin, ibuprofen, acetylsalicylic acids
• SSRI
• Sulphonylureas (e.g., glibenclamide)
• Inducer and inhibitors of CYP2C9-isoenzymes XEFO with food and drink and alcohol Not Applicable

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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