Xefo Rapid Side Effects

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

What is Xefo Rapid?

Xefo-Rapid contains the active ingredient Lornoxicam.

• Active ingredient — Lornoxicam
• Registration number — 48/3.1/0735; 48/3.1/0736
• Registration holder — PHARMACARE LIMITED

It is approved for:

• LORNBLOC is a non-steroidal anti-inflammatory drug (NSAID) and antirheumatic medicine of the oxicam class
• It is intended for short term treatment of mild to moderate pain associated with inflammation outside the joints as well as symptoms of rheumatoid arthritis and osteoarthritis such as pain and inflammation of joints

Common side effects of Xefo Rapid

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 and dizziness
• nausea, stomach pain, indigestion (dyspepsia), diarrhoea, vomiting

Less frequent side effects

• Lack/loss of appetite (anorexia) or weight changes
• inability to sleep (insomnia), feeling abnormally sad or down (depression), confusion, nervousness, agitation
• sleepiness (somnolence); abnormal taste (dysgeusia), an unintentional muscle movement involving to-and-fro movements (oscillations) of one or more parts of the body (tremor), migraine
• inflammation of conjunctiva/membrane of the eye (conjunctivitis); visual disturbances
• light-headedness and loss of balance (vertigo); ringing in the ears (tinnitus)
• reddening of the face and/or neck (flushing); bleeding (haemorrhage); collection of blood outside the blood vessels, usually in liquid form within the tissue (haematoma)
• runny nose; cough
• difficulty passing stools (constipation)
• excess amount of air/gas in the stomach (flatulence)
• burping (eructation), dry mouth
• inflammation of the stomach (gastritis)
• sores in the mouth
• inflammation of the tongue (glossitis)
• difficulty in swallowing (dysphagia)
• joint pains (arthralgia), bone pain, muscle spasms/ pain (myalgia)
• increased need to urinate at night (nocturia)
• problems with bladder control, frequency of urination, as well as the volume and composition of urine (micturition). Side effects with an unknown frequency
• cramps in legs
• changes in appetite
• increased sweating

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 LORNBLOC (listed in section 6)
• If you are taking other nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin or e.g. diclofenac, ibuprofen and COX-2 inhibitors (e.g. celecoxib)
• If you have had pervious hypersensitivity reactions such as pain, tightness, and a feeling of constriction in the chest and back (bronchospasm), include runny nose congestion and sneezing (rhinitis), swelling and welts on the surface of the skin (angioedema) or itchy, raised, red or skin-coloured welts on the skin’s surface (urticaria) when using non-steroidal anti-inflammatory medicines, including acetylsalicylic acid a medicine that treats fever and relieves mild to moderate pain
• If you suffer from thrombocytopenia (low blood platelet count which increases risk of bleeding or bruising)
• If you have heart problems
• If you suffer from digestive tract bleeding and/or bleeding of a blood vessel in the brain (cerebrovascular bleeding), or other bleeding disorders
• If you have a medical history of gastrointestinal bleeding or perforation, related to previous therapy with NSAIDs
• If you suffer from an active stomach ulcer or have a history of recurrent digestive tract ulcers
• If you have liver problems
• If you have kidney problems
• If you are older than 65 years and weight less than 50 kg
• If you have or need to undergo a surgical procedure
• If you are pregnant or breastfeeding your baby
• If you are under the age of 18 year

Use with care, and tell your doctor, if

• If you experience any unusual abdominal symptoms such as abdominal bleeding, skin reactions such as skin rash especially if this presents with fever and swelling of the glands and/or face, damage to the internal lining of the nostrils, mouth, eyelids, ears, genitals or anus, or other signs of hypersensitivity, you should stop taking LORNBLOC and contact your doctor immediately
• If you have kidney problems
• If you have a history of high blood pressure and have heart problems
• If you suffer from ulcerative colitis or Crohn’s disease
• If you have a history of bleeding tendency
• If you have a history of asthma
• If you suffer from SLE (lupus erythematosus, a rare immunological disease)
• Your doctor may have to monitor you by laboratory tests on a frequent basis if
• you suffer from blood coagulation disorder
• you suffer from impaired liver function
• you are elderly (65 years and above)
• or you will be treated with LORNBLOC for more than 3 months
• If you have an inherited disorder which causes a build-up of certain chemicals in your body (porphyria)
• Medicines such as LORNBLOC may be associated with an increase in the risk of having a heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or the duration of treatment. You should discuss your treatment with your doctor or pharmacist if:
• you have heart problems
• you had previously a stroke
• or you think that you might be at risk of developing these conditions (for example, if you have high blood pressure, diabetes or high cholesterol, or you are a smoker)
• Avoid using LORNBLOC during varicella (chickenpox) infections
• Use with caution if concomitant use is required with the following medicines:
• Other NSAIDs (used to treat inflammatory conditions)
• Heparin (used to prevent blood clotting)
• Tacrolimus (used in patients who had organ transplants)

Pregnancy and breastfeeding

• You should not take LORNBLOC 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 taking LORNBLOC

Interactions and medicines to check

The approved leaflet names these interactions.

• Cimetidine, used in the treatment of heartburn and peptic ulcers, as concomitant use may result in higher concentrations of lornoxicam as contained in LORNBLOC
• Anticoagulants, such as heparin (e.g. warfarin) used to prevent the formation of blood clots, as you may experience prolonged bleeding
• Corticosteroids, other non-steroidal anti-inflammatory medicines and aspirin , used to reduce inflammation, as this may lead to an increased risk of developing holes and sores in the lining of your digestive tract
• Methotrexate, used in treatment of cancer and immunological diseases, as this may lead to an increased concentration of methotrexate which may lead to toxicity
• Immunosuppressive medicines, such as ciclosporin or tacrolimus, as this may lead to an increased risk of kidney toxicity
• Heart medicines such as digoxin, ACE inhibitors (e.g. perindopril), Angiotensin II receptor blockers (e.g. telmisartan), beta-adrenergic blockers (e.g. atenolol), water tablets (e.g. furosemide) and amiodarone, as there may be a decreased effect of these heart medicines
• Lithium, used for mood disorders, as this may lead to lithium toxicity
• Medicines used to treat tuberculosis (TB) such as rifampicin
• Sulphonylureas, used in the management of diabetes, as this may lead to a decrease in the blood sugar lowering effect of sulfonylureas
• Antimicrobial medicines and antifungal medicines such as miconazole
• Other non-steroidal anti-inflammatory medicines such as diclofenac, ibuprofen and aspirin
• SSRI (Selective Serotonin Reuptake Inhibitors), used in the treatment of depression, as you may experience prolonged bleeding
• Tranylcypromine, used in the treatment of depression
• Quinolone antibiotics which treat respiratory tract infections, skin infections and urinary tract infections such as ciprofloxacin and/or moxifloxacin, and phenytoin (used to treat epilepsy), as this may lead to an increase in the risk to develop seizures (convulsions)
• Pemetrexed, used in the treatment of e.g. lung cancer

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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