Celecoxib 100 mg Capsules

CELECOXIB BIOTECH belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), and specifically a sub-group known as cyclooxygenase-2 (COX-2) inhibitors. Your body makes substances called prostaglandins. Some prostaglandins cause pain and inflammation. In conditions such as rheumatoid arthritis and osteoarthritis your body makes more of these. CELECOXIB BIOTECH acts by reducing the production of prostaglandins, thereby reducing the pain and inflammation.

CELECOXIB BIOTECH is used in adults for the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis (progressive stiffening of the spine). CELECOXIB BIOTECH is also used in the treatment of pain following an operation, including dental surgery, musculoskeletal pain, primary dysmenorrhoea (painful menstrual periods).

Do not take CELECOXIB BIOTECH:

• if you are hypersensitive (allergic) to celecoxib or any of the ingredients of CELECOXIB BIOTECH (see section 6 “What this product contains”);
• if you have had an allergic reaction to a group of medicines called “sulphonamides” (medicines that prevent the growth of bacteria);
• if you have severe liver disease;
• if you have severe kidney disease;
• if you have had allergic reactions such as asthma, nose polyps, severe nasal congestion, or an itchy skin rash, swelling of the face, lips, tongue or throat, breathing difficulties or wheezing from aspirin or other NSAIDs (anti-inflammatory and pain-relieving medicines, such as diclofenac, ibuprofen);
• established ischaemic heart disease, or cerebrovascular disease, e.g., you have been diagnosed with a heart attack, stroke, or blockages of blood vessels to the heart or brain;
• if you are about to have coronary artery bypass graft surgery;
• if you currently have an ulcer in your stomach or intestines, or if you are bleeding in your stomach or intestines (you may notice that you have black sticky stools or bloody diarrhoea);
• if you have an inflammatory disease of the intestines such as ulcerative colitis or Crohn’s disease;
• if you are pregnant or it is possible that you could become pregnant;
• if you are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking CELECOXIB BIOTECH: Take special care with CELECOXIB BIOTECH:

• if you smoke, have diabetes, high blood pressure or high blood cholesterol;
• if you have had a serious allergic reaction or a serious skin reaction to any medicines;
• if you have previously had an ulcer or bleeding in your stomach or intestines. (Do not take CELECOXIB BIOTECH if you currently have an ulcer or bleeding in your stomach or intestine);
• if you are taking corticosteroid medicines (for example prednisone);
• if you are taking aspirin (even at low dose for heart protective purposes);
• if you use medicines to reduce blood clotting (e.g. warfarin/ warfarin-like anticoagulants or novel oral anti-clotting medicines, e.g. apixaban).
• if you are taking CELECOXIB BIOTECH at the same time as other non-aspirin NSAIDs such as ibuprofen or diclofenac. The use of these medicines together should be avoided;
• if you have fluid retention (such as swollen ankles and feet);
• if you have heart failure or other heart problems;
• if you have high blood pressure;
• if your liver or kidneys are not working well, as your doctor may want to keep a regular check on you;
• if you are dehydrated, for instance due to sickness, diarrhoea or the use of diuretics (medicines used to treat excess fluid in the body);
• if you feel ill due to an infection or think you have an infection, as CELECOXIB BIOTECH may mask a fever or other signs of infection and inflammation.

If you are above 65 years of age your doctor will want to monitor you regularly. The consumption of alcohol and NSAIDs may increase the risk of gastrointestinal problems. CELECOXIB BIOTECH may lead to an increase in blood pressure. Your doctor may want to monitor your blood pressure on a regular basis. Some cases of severe liver reactions, including severe liver inflammation, liver damage, liver failure (some with fatal outcome or requiring liver transplant), have been reported with celecoxib. Of the cases that reported time to onset, most severe liver reactions occurred within one month of start of treatment. CELECOXIB BIOTECH might increase the likelihood of developing renal tubal acidosis (RTA) (a kidney disease where your kidneys do not remove acids from your blood into the urine as they should) and hypokalaemia (low potassium levels in your blood causing weakness, confusion, tirednes, muscle cramps or changes in the way your heart beats).

Do not share medicines prescribed for you with any other person. Always take CELECOXIB BIOTECH exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

If you think or feel that the effect of CELECOXIB BIOTECH is too strong or too weak, talk to your doctor or pharmacist. Use the lowest effective dose for the shortest possible time. Your doctor will tell you what dose you should take. The recommended dose for osteoarthritis is 200 mg taken as a single dose, or as two divided doses. The recommended dose for rheumatoid arthritis is 100 mg or 200 mg twice daily. The recommended dose for pain following dental surgery is 100 mg or 200 mg twice daily. The recommended dose for pain following an operation is 200 mg once daily. The recommended dose for musculoskeletal pain is 200 mg twice daily. The recommended dose for primary dysmenorrhoea is 400 mg initially, followed by an additional 200 mg on the first day if needed. On subsequent days, the recommended dose is 200 mg twice daily. The recommended dose for ankylosing spondylitis is 200 mg daily, taken as a single dose or as 100 mg twice daily. If you have liver problems, or if you weigh less than 50 kg, your doctor will recommend the lowest recommended dose.

Children

No information is available on the use of CELECOXIB BIOTECH in children and it is therefore not recommended for use in children.

Method of administration

CELECOXIB BIOTECH is for oral use. Swallow the capsules whole with a glass of water at any time of the day, with or without food. However, try to take each dose of CELECOXIB BIOTECH at the same time each day. Do not chew or crush the granules.

Contact your doctor within two weeks of starting treatment if you do not experience any benefit. If you take more CELECOXIB BIOTECH than you should you should not take more capsules than your doctor tells you to. 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 CELECOXIB BIOTECH, if you forget to take a capsule, take it as soon as you remember. Do not take a double dose to make up for forgotten individual doses. If you stop taking CELECOXIB BIOTECH suddenly stopping your treatment with CELECOXIB BIOTECH may lead to your symptoms getting worse. Do not stop taking CELECOXIB BIOTECH unless your doctor tells you to. Your doctor may tell you to reduce the dose over a few days before stopping completely. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

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

• swelling of your hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing;
• a serious skin reaction with rash, blistering or peeling of the skin. These are all very serious side effects. If you have them, you may have had a serious reaction to CELECOXIB BIOTECH. 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:

• weakness or clumsiness of a hand, arm or leg, difficulties with speech and swallowing, vision problems and headache. These may be signs of a stroke or bleeding in the brain, which may be fatal;
• shortness of breath or difficulty breathing, sudden chest pain, cramping or tingling sensation up the left arm (heart attack);
• problems breathing, shortness of breath, chest pain. You may have a blood clot in the lung (pulmonary embolism) and will need urgent medical attention;
• throbbing or cramping pain in a leg, swelling in a leg, warm skin around painful area (deep vein thrombosis);
• severe stomach pain or any sign of bleeding in the stomach or intestines, such as passing black or bloodstained stools, or vomiting blood;
• liver failure (symptoms may include nausea (feeling sick), diarrhoea, jaundice (your skin or the whites of your eyes look yellow));
• bladder or kidney infections. Some signs may be fever, chills, blood in the urine or frequent urination;
• acute renal failure/nephrotic syndrome (decreased urine output, swelling of legs, fatigue, foamy urine, loss of appetite);
• painful blisters, sensitive to touch (shingles);
• red, swollen, painful skin with fever (a bacterial skin infection, known as erysipelas);
• ache or burning pain in your abdomen (Helicobacter infection).

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:

• infections of the airways such as sinusitis (swelling and redness of the nasal sinuses) or bronchitis (inflammation of the mucous membranes of the airways);
• worsening of existing allergies;
• weight gain;
• trouble sleeping;
• dizziness, abnormal muscle tension;
• headache;
• high blood pressure, worsening of existing high blood pressure. you may not know that you have high blood pressure unless you have your blood pressure tested;
• runny nose, sore throat, shortness of breath;
• nausea (feeling sick), vomiting (being sick);
• indigestion, windiness, pain on stomach;
• problem swallowing;
• sore teeth;
• skin rash, itching skin;
• accidental injury;
• flu-like illness;
• keeping fluid back in the body tissues, with swollen ankles, legs and/or hands.

Less frequent side effects:

• inflammation or infection of the inner ear (dizziness or feeling that everything is spinning around you);
• infection of the gums;
• blood disorders, such as anaemia (too few red blood cells or their haemoglobin content is too low), leukopenia (a lowered white blood cell count) or thrombocytopenia (deficiency of platelets in the blood)*; * You will only know that you have these disorders if your doctor orders blood tests. See your doctor if you are pale and tired, get more infections than usual or have problems to stop bleeding, or if you have unexpected bruising.
• increased sodium in blood, increased potassium in blood (determined by blood tests);
• feeling tired, confused;
• feeling anxious or depressed;
• seeing or hearing things that do not exist (hallucinations);
• blurred vision, eye inflammation and bloodshot eyes, vitreous floaters (seeing spots or strings that move when you move your eyes), bleeding in an eye, painful eyes;
• ringing in the ears, above normal hearing sense, voice disorder;
• irregular heart rhythm, increased heart rate;
• Flushing;
• inflammation of a blood vessel (you may feel unwell with fever, sweats and tiredness);
• tightness in the chest with coughing and wheezing (bronchospasm);
• shortness of breath, cough, fatigue (inflammation of the lung tissues - pneumonitis);
• abdominal pain, cramping, bloating, constipation;
• mouth ulcers, numbness, burning sensation in the mouth (stomatitis);
• hair loss;
• muscle spasms (leg cramps), muscle pain;
• lower limb fracture;
• kidney function disorders (shown by laboratory tests);
• frequent urination during the night (nocturia);
• menstrual disorders;
• swollen face;
• chest pain.

Frequency unknown:

• sleepiness;
• abnormal skin sensations (tingling or tickling or itching or burning);
• problems with coordination and speech (ataxia);
• no sense of smell or taste, or taste affected;
• worsening of existing epilepsy (seizure disorder);
• female fertility decreased;
• vaginal bleeding;
• tender breasts.

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, 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 CELECOXIB BIOTECH.

• Store at or below 25 °C.
• Keep the blister strips in the outer carton until required for use.
• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.
• Do not use after the expiry date printed on the carton or blister strips.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains and sewerage systems (e.g., toilets).