Xefo ® Rapid 8 mg Film-Coated Tablets

XEFO ® RAPID is a non - steroidal anti - inflammatory drug (NSAID). It is intended for short term treatment of acute mild to moderate pain, where intra - muscular use is inappropriate (not exceeding 72 hours).

Do not take XEFO ® RAPID • If you are hypersensitive (allergic) to lornoxicam or any of the other ingredients of XEFO ® RAPID (listed in section 6). • If you are hypersensitive to other NSAIDs including aspirin. • If you suffer from gastro - intestinal bleeding or perforation, related to previous NSAIDs therapy • If you are dehydrated • If you suffer from any bleeding disorders. • If you suffer from an active, or have a history of, recurrent peptic ulcer. • If you have serious liver or kidney problems • If you have a decrease in platelet count. • If y ou suffer from severe heart failure. • If you are older than 65 years, weigh less than 50 kg or are undergoing acute surgery • If you are pregnant or breastfeeding • If you are less than 18 years of age

Warnings and precautions

Special care should be taken with XEFO ® RAPID: • If you have a history or experience any unusual abdominal symptoms such as abdominal bleeding • If you have heart problems, have had a previous stroke or think that you might be at risk of these conditions (e.g., if you have high blood pressure, diabetes or high cholesterol or are a smoker). • If you have skin reactions such as skin rash, or mucosal lesions or other signs of hypersensitivity

Do not share medicines prescribed for you with any other person. Always take XEFO ® RAPID exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. XEFO ® RAPID tablets are supplied for oral administration and should be taken before meals with sufficient quantity of liquid. Your doctor wi ll decide on the correct dose you should take. The lowest effective dose for the shortest possible duration of treatment will be used. Your doctor may adjust the dose if necessary. Treatment of pain

XEFO ® RAPID should be taken in doses of 8 mg (one tablet), and the daily dose should in general not exceed 16 mg (two tablets). In some patients, an additional 8 mg (one tablet) may be taken within the first 24 hours, if necessary. Dose reduction in special gr oups For patients with kidney or liver impairment, your doctor may alter your daily dosage. Elderly No special dosage modification is required for elderly patients ( ＞ 65 years), unless kidney or liver function is impaired, in which case the daily dosage should be restricted Your doctor will tell you how long your treatment with XEFO ® RAPID will last. If you have the impression that the effect of XEFO ® RAPID is too strong or too weak, tell your doctor or pharmacist. If you take more XEFO ® RAPID than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. If you forget to take XEFO ® RAPID If you miss a dose of XEFO ® RAPID, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for forg otten doses.

XEFO ® RAPID can have side effects. Not all side effects reported for XEFO ® RAPID are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking XEFO ® RAPID please consult your health care provider for advice. XEFO ® RAPID may be associated with a small increased risk of hear t attack or stroke. If you develop symptoms such as fever, rash, swelling of lymph nodes (DRESS), you should stop taking XEFO ® RAPID and contact you r doctor immediately . Tell your doctor if you notice any of the following: Common Mild and transient headache, dizziness, nausea, abdominal pain, indigestion, diarrhoea, vomiting. Uncommon Loss of appetite, difficulty with sleeping, depression, eye infection, dizziness, ringing in the ears, palpitations, increased rate of the heart, flushing, constipation, excess amount of gas in the stomach, burping, dry mouth, inflammation of the stomach, gastric ulcer, duodenal ulcer, mouth ulceration, increase in liver function test results, rash, itching, allergic skin reaction, hair loss, muscle pain, swollen face, weight change, allergy of the nose Rare Prolonged bleeding time, allergic reactions, low blood platelet count, confusion, nervousness, irritability, migraine, tremor, difficulty to sleep, taste disorder, tingling or pricking feeling, visual disturbances, high blood pressure, hot flush, bruising, shortness of breath, cough, dark sticky faeces, vomiting blood, inflammation of the mucous membrane of the mouth or oesophagus, difficulty swallowing, swollen tongue, perforated peptic ulcer, l iver problems, itchy, dry skin, rash, swollen, reddened skin, bone pain, muscle pain, muscle spasms, urination at night, urination disorders, physical weakness or lack of energy. Very rare Liver damage, swelling, Stevens - Johnson syndrome, which is charact erised as extremely serious allergic skin reaction, discolouration of the skin, liver toxicity resulting in jaundice and liver failure, kidney failure Some side effects may disappear during treatment as your body adjusts to the medicine. These do not need medical attention. Reporting of side effects If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “ 6.04 Adverse Drug Reactions & Quality Problem Reporting Form ”, found online under SAHPRA’s publications: https://sahpra.org.za/wp - content/uploads/2020/01/6.04_ARF1_v5.1_ 27Jan2020.pdf . By reporting side effects, you can help provide more information on the safety of XEFO ® RAPID.

Store all medicines out of reach of children. • Store at or below 25 °C • Do not store in a bathroom • Do not use after the expiry date stated on the container Return all unused medicine to your pharmacist for correct disposal Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).