Arthrexin 25 mg Capsules

ARTHREXIN belongs to a group of medicines called non - steroidal anti - inflammatory medicines or NSAIDs. These work by reducing the body’s ability to produce inflammation, which may cause pain and discomfort. ARTHREXIN reduces fever, pain and inflammation. Your doctor has prescribed ARTH REXIN for you because you are suffering from one of the following:

• Rheumatoid arthritis (disease mainly of the joints).
• Osteoarthritis (disease of the joints).
• Ankylosing spondylitis (a form of arthritis which mainly affects the back).
• Muscle and bone disorders (musculoskeletal disorders), such as tendonitis, inflammation of the joints, sprains and strains.
• Pain and swelling in gout (a form of arthritis in which crystals build up in the joints).
• Fever in Hodgkin’s disease (a type of cancer).
• Fever (ARTH REXIN is used in addition to the primary treatment for a short duration to assist in reducing the fever).
• Pain, inflammation and swelling following orthopaedic surgery or nonsurgical procedures (associated with repositioning bones after dislocation or fracture).
• Pain, inflammation and swelling following dental surgical procedures.
• Period pain.
• Low back pain.
• A disease where the cartilage that serves as a cushion in the joints of the hips deteriorates (degenerative joint disease of the hip).
• Fever, the reduction of symptoms in some conditions which may produce fever (febrile conditions).

Do not take ARTHREXIN:

• if you are hypersensitive (allergic) to indomethacin or any of the other ingredients of ARTHREXIN (listed in section 6),
• if you have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had episodes of peptic ulcers, stomach bleeding or perforation and bleeding related to previous use of NSAIDs,
• if you are taking a medicine called triamterene for swelling and high blood pressure,
• if you are taking a medication called diflunisal for pain, swelling, stiffness or joint pain,
• if you have polyps in your nose (teardrop - shaped, non - cancerous growths) due to swelling of the area under the skin,
• if you have had a history of asthma attacks, hives, or inflammation of the inside of the nose after taking aspirin or other NSAIDs, including ARTHREXIN,
• if you have a history of sensitivity (allergy) that causes swelling of the face and mouth (angioedema) after taking NSAIDs, including ARTHREXIN and/or aspirin,
• if you have heart failure or heart disease and/or cerebrovascular disease, e.g., if you have had a heart attack, stroke, or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages,
• if you have or have had problems with your blood circulation (peripheral arterial disease),
• if you have a bleeding disorder,
• if you have inflammation of the stomach and/or intestines (gastritis, regional enteritis, ulcerative colitis),
• if you have kidney and/or liver failure,
• if you are pregnant, do not take NSAIDs such as ARTHREXIN, at 30 weeks or later in your pregnancy because these medicines may cause problems in your unborn baby,
• if you are breastfeeding your baby.

Safety of ARTHREXIN in children has not been established.

Warnings and precautions

Take special care with ARTHREXIN: ARTHREXIN may lead to serious heart problems (cardiovascular events), stomach or intestinal problems (gastrointestinal events), or skin reactions (cutaneous reactions) which may lead to death.

• if you develop a fever, severe skin rash or skin reaction or any unusual reaction such as facial swelling when starting treatment with ARTHREXIN, stop taking ARTHREXIN and tell your doctor immediately. These serious events may occur without warning and may be fatal; they include DRESS (Drug Rash with Eosinophilia and Systemic Symptoms), Stevens - Johnson syndrome and toxic epidermal necrolysis (TEN).
• if you have, high blood pressure or have a tendency for fluid retention you should only be treated with ARTHREXIN after very careful consideration.
• if you have now, or ever had, a digestive tract disorder, bleeding in the digestive tract or an episode of stomach (gastric) ulcer (this can include blood in vomit, bleeding when emptying bowels, fresh blood in faeces).
• If bleeding or ulceration of the digestive tract occurs, stop taking ARTHREXIN and tell your doctor.
• if you have any liver or kidney problems you should be closely monitored by your doctor to ensure that your kidney or liver function does not get worse.
• if you have high levels of sugar in the blood (diabetes).
• if you smoke or have high levels of bad cholesterol in the blood.
• if you are taking a diuretic (water pills) to increase the amount of urine that is excreted.
• if you are feeling thirsty, tired, have a dry mouth, feeling dizzy or lightheaded, you may be dehydrated.
• if you experience heart palpitations, shortness of breath, chest pain, nausea, or vomiting, you may have high levels of potassium in your blood (hyperkalaemia).
• if you have asthma.
• if you are epileptic (have seizures), as you may need to stop treatment with ARTHREXIN.
• if you have Parkinson’s disease, as you may need to stop treatment with ARTHREXIN.
• if you have any psychiatric (mental) disease, talk to your doctor as your treatment may need to be changed.
• if you suffer from systemic lupus erythematosus (SLE), an autoimmune disorder, you may have an increased risk of inflammation of the membrane covering the brain (aseptic meningitis).
• if you experience dizziness and headaches while taking ARTHREXIN you may need to stop taking ARTHREXIN as ARTHREXIN can aggravate the headaches.
• if you have been taking ARTHREXIN for a long time and have frequent headaches you should stop taking ARTHREXIN and tell your doctor.
• if you have an infection, because symptoms such as fever and inflammation may be masked. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.
• if you notice any change in your vision, you should see your doctor. If you have rheumatoid arthritis your doctor may want to examine your eyes at intervals during your treatment with ARTHREXIN.
• if you are elderly or you have previously had stomach ulcers, you have a higher risk of getting side effects, especially related to the stomach. Your doctor should therefore prescribe the lowest dose that gives you sufficient relief. If you experience any unusual stomach problems, you must tell your doctor about it.
• if you have a problem with your blood clotting.
• if you are anaemic (low red blood count that leaves you feeling very tired).
• taking NSAIDs, such as ARTHREXIN, at around 20 weeks of pregnancy or later may harm your unborn baby. If you need to be treated with NSAIDs, such as ARTHREXIN, for more than 2 days when you are between 20 and 30 weeks of your pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs, such as ARTHREXIN, around 30 weeks of pregnancy or later (see Do not take ARTHREXIN).
• if you have difficulty becoming pregnant, treatment with ARTHREXIN is not recommended.
• if you suffer from porphyria.

Do not share medicines prescribed for you with any other person. Always take ARTHREXIN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Use the lowest effective dose for the shortest possible duration of treatment. The usual dose of ARTHREXIN is 25 mg two to three times per day taken with food. Do not take more than 200 mg of ARTHREXIN per day. Your doctor will tell you how long your treatment with ARTHREXIN will last. Do not stop treatment early because your doctor will monitor your recovery and advise you when to stop treatment.

If you have the impression that the effect of ARTHREXIN is too strong or too weak, tell your doctor or pharmacist.

If you take more ARTHREXIN than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. If you take high doses of ARTHREXIN, you may experience side effects such as headache, nausea, vomiting, indigestion, pain in the upper abdomen, ulceration and/or gastrointestinal bleeding, diarrhoea, disorientation, unusually excited, coma, drowsiness, dizziness, ringing in the ears, fainting, restlessness. In the event of overdose your doctor will monitor your symptoms and treat you according to your condition.

If you forget to take ARTHREXIN

Do not take a double dose to make up for forgotten individual doses. If you forget to take ARTHREXIN, take it as soon as you remember. If it is nearly time for your next dose, just carry on with the next dose as normal.

If you stop taking ARTHREXIN

You should take ARTHREXIN for as long as your doctor tells you to. You should not stop taking it without your doctor’s advice.

ARTHREXIN can have side effects. Not all side effects reported for ARTHREXIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ARTHREXIN, please consult your healthcare provider for advice. If any of the following happens, stop taking ARTHREXIN 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,
• blistering and/or peeling of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Stevens - Johnson Syndrome (SJS).
• eruption of lesions on the skin known as erythema multiforme,
• fever, flu - like symptoms, a painful red rash, may include purplish spots that spreads and blisters follow where the top part of the skin dies and peels off known as toxic epidermal necrolysis (TEN), or Drug Rash with Eosinophilia and System Symptoms (DRESS). These are all very serious side effects. If you have them, you may have had a serious reaction to ARTHREXIN. 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:
• Difficulty in breathing especially if you suffer from, or have a history of asthma or allergic disease (bronchospasm), coughing, feeling tired, wheezing (pulmonary oedema),
• swelling of legs, ankles and feet, feeling tired and weak, shortness of breath, lack of appetite, swelling of stomach, rapid or irregular/abnormal heartbeat, pain in the chest, neck, back or arms (heart failure),
• infection in the soft tissue that spreads rapidly and eats away at the flesh (necrotising fasciitis),
• increased thirst, increased need to urinate, tiredness, dry mouth, blurry vision, slow healing of cuts or sores (these may be symptoms of diabetes),
• sudden or unusual fatigue, weight loss, frequent infections and easy bleeding or bruising (these may be symptoms of leukaemia),
• pale skin, tiredness, fever, sore throat and mouth, small red spots on the skin, bruising or prolonged bleeding after injury, severe chills, mouth ulcers, headache, shortness of breath and dizziness, these may be symptoms of blood disorders,
• heart palpitations, shortness of breath or stomach pain and diarrhoea, chest pain, heart palpitations or irregular, fast or fluttering heartbeat, muscle weakness or numbness in limbs, nausea and vomiting, these may be signs of high levels of potassium in your blood (hyperkalaemia),
• feeling severely depressed or confused including thinking about suicide, seeing or hearing things that are not there (hallucinations), mental disorders; including a loss of personal identity (psychosis, psychiatric disturbances, depersonalisation),
• pain with eye movement (optic neuritis), temporary vision loss, cloudy or milky appearance in the eye,
• nausea, vomiting blood, tenderness when touching the stomach (pancreatitis),
• vomiting any blood or dark particles that look like coffee grounds (haematemesis),
• passing blood in your faeces (stools/motions),
• diarrhoea (particularly if severe), weight loss, fever and/or stomach pain (regional ileitis),
• inflammation of the bowel (Crohn’s disease),
• inflammation (swelling and redness) inside the mouth (ulcerative stomatitis),
• yellowing of the skin and eyes, dark urine, and tiredness which may be symptoms of liver problems known as jaundice,
• intense itching, dark urine, light coloured stools, pain in the upper right portion of your abdomen (gall stones),
• convulsions, coma, involuntary muscle movement, neck pain or stiffness, headache, altered mental status,
• deafness,
• shortness of breath, decreased urine output, drowsiness, fluid retention causing swelling in your legs, ankles or feet, confusion, nausea, chest pain or pressure (kidney failure),
• pink - red blotches and / or bumps on the skin (erythema), inflammation of the walls of small blood vessels (angiitis),
• redness, sudden swelling in the leg or arm with tenderness and feeling of increased warmth (thrombophlebitis),
• loss of sensation, numbness, tingling and pricking sensations (peripheral neuropathy),
• sudden and rapid fall in blood pressure. 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:

• Headache, dizziness, light headedness, anxiety,
• increased sensitivity to sun and ultraviolet light (photosensitivity),
• increased levels of urea in the blood. These changes in blood composition are normally be picked up in urine or blood tests.

Less frequent side effects:

• Drowsiness,
• difficulty sleeping (insomnia),
• sensation that things around you are moving (vertigo),
• tiredness (including feeling unwell and listlessness),
• bleeding from the nose (epistaxis),
• loss of appetite (anorexia),
• redness and peeling of the skin over large areas of the body (exfoliative dermatitis),
• speech problems (dysarthria),
• blurred vision, changes in vision, pain in the eye (orbital and peri - orbital pain),
• tiny round, brown - purple spots due to bleeding under the skin (petechiae),
• a discoloration of the skin resulting from bleeding underneath, typically caused by bruising (ecchymosis),
• sugar in the urine, confirmed by laboratory test or dipstick test (glycosuria), urinating more frequently.

Side effects with an unknown frequency:

• Flushing,
• ringing in the ears (tinnitus), hearing disturbances,
• indigestion or heartburn (dyspepsia),
• worsening of epilepsy and parkinsonism symptoms (symptoms that mimic those of Parkinson’s disease such as tremor or abnormal movements). If these side effects are severe you may need to stop treatment with ARTHREXIN. You should talk to your doctor,
• pins and needles (paraesthesia),
• visual field changes,
• dry cough, fever, general ill feeling, rapid breathing, shortness of breath, wheezing (pulmonary eosinophilia),
• high blood pressure (hypertension), low blood pressure (hypotension),
• hair loss (alopecia),
• sweating,
• aggravation of psoriasis (inflamed patches get bigger and spread faster),
• muscle weakness, accelerated breakdown of cartilage in the joints,
• blood in the urine (haematuria),
• vaginal bleeding,
• breast changes including enlargement and tenderness in men and women (gynaecomastia),
• weight gain,
• fluid retention (oedema).

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: https://www.sahpra.org.za/health-products-vigilance/ Aspen Pharmacare: E - mail: [email protected] Tel: 0800 118 088 /+27 (0)11 239 - 6200 By reporting side effects, you can help provide more information on the safety of ARTHREXIN.

Store all medicines out of reach of children. Store at or below 25 °C. Protect from light and moisture. Keep in original packaging until required for use.

• Do not store in a bathroom.
• Do not use after the expiry date stated on the label.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).