Coxitec 7,5 mg/15 mg Tablets

COXITEC belongs to a group of medicines called non-steroidal anti-inflammatory medicines (NSAIDs) which are used to reduce fever, inflammation and pain in joints and muscles.

COXITEC is used for the symptomatic treatment of:

• Rheumatoid arthritis (inflammation of the joints)
• Painful osteoarthritis (non-inflammatory joint disease)
• Ankylosing spondylitis (form of degenerative joint disease that affects the spine)
• Episodes of acute sciatica (a syndrome characterized by pain radiating in the back into the buttock and into the lower extremity)

Do not take COXITEC:

• if you are hypersensitive (allergic) to meloxicam or any of the other ingredients of COXITEC (see section 6).
• if you have ever suffered asthma attacks (wheezing, chest tightness, breathlessness), urticaria (nettle rash), nasal polyps (nasal obstruction due to swellings in the lining in your nose), running nose when taking aspirin or other anti-inflammatory medicines.
• if you have experienced heart failure, heart disease caused by narrowing and/or blocking of blood vessels by cholesterol, stroke, and peripheral arterial disease which is a common circulation problem in which blood flow is reduced to the limbs because of narrowed arteries.
• if you have or have ever had a gastrointestinal ulcer (ulcer in the stomach or intestines)
• if you have serious liver disease
• if you have serious kidney disease and are not undergoing dialysis.
• if you are pregnant or planning to be pregnant or if you are breastfeeding (see Pregnancy and breastfeeding).
• if you have a history of bleeding in your stomach or intestines, recent or a history of stomach or bleeding ulcers.
• if you have been diagnosed with Crohn’s disease or ulcerative colitis (an inflammatory bowel disease with symptoms such as abdominal pain and cramping, rectal pain or bleeding, often bloody diarrhoea).
• if you suffer from any bleeding disorders.
• if you have recently undergone heart surgery (for narrowed or blocked).
• if you are a child below the age of 18 years.

Warnings and precautions

Take special care with COXITEC tablets:

• Elderly: The elderly have an increased frequency of adverse reactions to COXITEC, especially gastrointestinal bleeding and perforation which may be fatal or bleeding disorders.
• if you have a history of stomach ulcers/bleeding, your doctor may prescribe the lowest dose of COXITEC. When gastrointestinal bleeding or ulceration occurs in patients receiving COXITEC, treatment with COXITEC should be stopped.
• if you are receiving heparin or taking warfarin (used to thin your blood), aspirin or any other non-steroidal anti-inflammatory medicines – NSAIDs), you should not take COXITEC.
• COXITEC may cause you to have heart and/or blood vessel problems, stomach and/or intestine problems, or skin reactions which may be fatal. If you are taking COXITEC for longer than the recommended time or at higher than recommended doses you are at risk of serious harms. These include serious harm to the kidneys, as well as very low levels of potassium in your blood. These can be fatal (see section 4).
• if you notice a skin rash you should stop taking COXITEC. Serious skin reactions may occur, which can be fatal.
• COXITEC may be associated with an increased risk of myocardial infarction (heart attack) or stroke. The risk is more likely with prolonged duration of treatment. Do not exceed the recommended dose and duration of treatment.
• if any of the following heart or blood vessel risk factors apply to you, notify your doctor: high blood pressure, increased cholesterol levels, diabetes and smoking, as these may increase the risk of heart attack or stroke. If you have abnormal heart function, high blood pressure or any other conditions that may be worsened by fluid retention (excessive build-up of fluid in the body), notify your doctor. Fluid retention has been observed in patients taking COXITEC.
• if you suffer from kidney or liver problems or are taking diuretics medicines (water tablets) or if you are dehydrated, your kidney function should be monitored.
• if you are an elderly patient and suffer from congestive heart failure (your heart isn’t pumping enough blood to your body), are taking medicine to treat hypertension (high blood pressure) or have a reduced blood volume (hypovolaemia) as a result of recent surgery, blood loss, severe burns or low fluid intake
• if you have been diagnosed with high levels of potassium in your blood.
• if you have kidney problems and are taking a medicine called pemetrexed (used in the treatment of cancer), please notify your doctor so that the dose of COXITEC can be adjusted.
• when taking COXITEC, it may hide the symptoms of infection
• the regular use of COXITEC in the last three months of pregnancy may cause abnormally high blood pressure in the blood vessels of the baby’s lungs which makes it harder to pump blood into the lungs, and it may delay or lengthen labour in the mother.
• if you are taking lithium (a mood stabilizer).
• if you are diabetic, your potassium levels should be monitored regularly.
• if you have thyroid problems.
• if you are under the age of 18 years.
• if you have asthma.

Do not share medicines prescribed for you with any other person. Always take COXITEC exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

The maximum daily dose of COXITEC is 15 mg.

Adults:

• Acute sciatica: Take 7,5 mg once a day. If there is no improvement the dose can be increased to 15 mg a day.
• Ankylosing spondylitis: Take 15 mg once a day
• Osteoarthritis: Take 7,5 mg once a day. The dose can be increased to 15 mg a day.
• Rheumatoid arthritis: Take 15 mg once daily. Reduce the dose if possible to 7,5 mg/day (provided therapeutic response is maintained).

Your doctor will tell you how long your treatment with COXITEC will last. If you have the impression that the effect of COXITEC is too strong or too weak, talk to your doctor or pharmacist.

Special populations

Elderly patients and patients with increased risks for adverse reactions

In patients with an increased risk of adverse reactions e.g. the elderly, a history of stomach disease or risk factors for heart disease, treatment with COXITEC should be started at the dose of 7,5 mg/day.

Dosage in patients with renal insufficiency

The dose of COXITEC tablets in patients with end stage renal disease on haemodialysis should not be greater than 7.5 mg/day. In non-dialysed patients with severe renal impairment COXITEC is contraindicated. No dosage reduction is necessary in patients with mild to moderate renal impairment.

Paediatric Population

Use in paediatric patients is not recommended, as safety and efficacy have not been established.

If you take more COXITEC tablets than you should:

In the event of overdosage, consult your doctor or pharmacist immediately. If neither is available, seek help at the nearest hospital or poison control centre. Symptoms of overdose may include feeling tired or sleepy, nausea, vomiting, stomach pain and bleeding. In severe cases of overdose symptoms may result in high blood pressure, liver failure, kidney failure, coma, convulsions and heart failure.

If you forget to take COXITEC tablets:

If you forget to take COXITEC, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take COXITEC at the next regularly scheduled time. Do not take a double dose to make up for the forgotten individual doses.

COXITEC can have side effects. Not all side-effects reported for COXITEC are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while taking COXITEC, please consult your doctor, pharmacist or other health care professionals for advice.

If any of the following happens, stop taking COXITEC and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat which may cause difficulty in swallowing or breathing;
• rash or itching;
• fainting

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to COXITEC. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• bronchospasm or asthma;
• the presence of blood in your urine;
• increased heart beat (tachycardia);
• irregular or rapid heat beat (palpitations), chest pain (angina), abnormal heartbeat (dysrhythmia);
• heart disease with shortness of breath and swelling of face, feet or lower legs due to fluid build-up;
• colour of your urine becomes darker, you feel tired, sick and you have no appetite;
• swelling in any part of the body;
• gastrointestinal bleeding or ulceration (causing offensive, tar-coloured stools);
• inflamed liver (include symptoms such as abdominal pain, fatigue, nausea, fever, yellow eyes or skin, also called jaundice;
• blistering, peeling or bleeding on any part of the skin with or without a rash, flu-like symptoms (fever, chills or aching muscles) which are symptoms of a serious skin reaction (Steven Johnson Syndrome / toxic epidermal necrolysis (TEN)) which could be fatal;
• skin rash or skin lesions with a pink/red ring and a pale centre which may be itchy, scaly or filled with fluid. These could be signs of a serious skin allergy called ‘erythema multiforme’;
• passing less urine than normal;
• low white blood cell count, low platelet count, unusual bleeding or bruising;
• confusion and disorientation, mood changes, depression;
• inflamed pancreas – symptoms may include upper abdominal pain that radiates into the back, swollen and tender abdomen, nausea and vomiting, fever and increased heart rate);
• inflammation of the large bowel;
• severe, persistent abdominal pain.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• anaemia (low red blood cell count);
• swelling of your lower legs, hands, arms, feet, ankles and legs;
• headache, dizziness, light headedness;
• nausea, vomiting, diarrhoea, flatulence (excess wind), difficulty passing stools (constipation), indigestion, stomach pain;
• hearing loss;
• bronchospasm;
• itching, rash, flushing;

Less frequent side effects:

• weight increase or decrease;
• high blood pressure, low blood pressure, irregular heart beat;
• flushing, increased sensitivity of the skin to sunlight;
• nightmares, drowsiness, sleep disturbances;
• aseptic meningitis (symptoms include fever, chills, stomach pain, painful headache, body pain, loss of appetite and vomiting);
• dry mouth, abnormal taste, inflammation of oesophagus, heart burn;
• inflammation of the mouth, stomach or intestinal ulcer, inflammation of colon or Crohn’s disease;
• passing less or more urine than is normal for you, abnormal kidney function test results;
• abnormalities in tests of liver function;
• visual disturbances (such as blurred vision), inflammation of conjunctiva (conjunctivitis) or other eye problems;
• vertigo (feeling of unbalanced), ringing or buzzing in the ears;
• alopecia;
• delayed ovulation;

The following side effects have been reported but the frequency for them to occur is unknown:

• Peptic ulcer
• Female infertility

COXITEC, especially when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood (see section 2). This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and light-headedness.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of COXITEC.

Keep all medicines out of the reach and sight of children.

Keep well closed

Store at or below 25 °C

Do not use after the expiry date stated on the carton

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets)