Pixicam® Dispersible Tablets

Each dispersible tablet contains piroxicam 20 mg. PIXICAM 20 is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). PIXICAM 20 is used to relieve some symptoms caused by osteoarthritis (arthrosis, degenerative joint disease), rheumatoid arthritis and ankylosing spondylitis (rheumatism of the spine), such as swelling, stiffness and joint pain. This medicine does not cure arthritis and will help you only as long as you continue to take it. Your doctor will only prescribe PIXICAM 20 to you when you have had unsatisfactory relief of symptoms with other NSAIDs.

Do not take PIXICAM 20:

• If you are hypersensitive (allergic) to piroxicam similar medicines called oxycams or any of the other ingredients in PIXICAM 20. (Please see What PIXICAM 20 contains).
• If you have blood formation disorders.
• If you have ever had allergy to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as diclofenac or ibuprofen. Allergic reactions can include wheezing (asthma attacks), itchy runny nose, rashes or swelling of the skin.
• If you have previously had or currently have a stomach or intestinal ulcer, bleeding or perforation.
• If you have or have previously had disorders of the stomach or intestines that predispose to bleeding disorders such as ulcerative colitis, Crohn’s disease, gastrointestinal cancers, or diverticulitis (inflamed or infected pouches/pockets in the colon).
• If you are taking other NSAIDs such as ibuprofen, including COX-2 selective NSAIDs such as celecoxib, or acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
• If you are taking anticoagulants, such as warfarin, to prevent blood clots.
• If you previously had an allergic skin reaction to any medicine, especially serious skin reactions (regardless of severity) such as exfoliative dermatitis (intense reddening of skin, with skin peeling off in scales or layers), Stevens-Johnson syndrome (symptoms are a rash, blistering or peeling of the skin, mouth, eyes or genitals) or toxic epidermal necrolysis (a disease with blistering and peeling of the top layer of skin).
• If you have bleeding in your brain or other active bleeding or tend to have bleeding in general.
• If you have moderate to severe heart failure.
• If you have severe liver or kidney dysfunction.
• If you have pain after a bypass surgery (CABG).
• If you are in the last three months of your pregnancy.
• If you are a child or adolescent (or you treat a child or adolescent) under the age of 15 years.

Warnings and precautions

Take special care/Special care should be taken with PIXICAM 20:

• If you have heart problems or high blood pressure
• If you suffer from mild to moderate liver disease. You should not take PIXICAM 20 if you have severe liver dysfunction (see Do not take PIXICAM 20).
• If you suffer from mild to moderate kidney disease. You should not take PIXICAM 20 if you have severe kidney dysfunction (see Do not take PIXICAM 20).
• If you have certain blood formation disorders called “porphyria”
• If you recently had major surgery
• If you suffer from allergies, hay fever, asthma. Your doctor may need to give you check-ups and will tell you how often you need to be checked during treatment with PIXICAM 20.

Do not share medicines prescribed for you with any other person. Always take PIXICAM 20 exactly as your doctor has instructed you. Check with your doctor or pharmacist if you are unsure. Your doctor will give you a regular check-up to make sure you are taking the optimal dose of PIXICAM 20. Your doctor will adjust your treatment to the lowest dose that best controls your symptoms in order to minimise potential side effects. Under no circumstances should you change your dose without first speaking to your doctor. The tablets may be swallowed whole with adequate water or may be dispersed in a small quantity of water, in a glass and the solution then swallowed.

Adults

The usual daily dose of PIXICAM 20 is 20 milligrams taken as one single daily dose. The maximum daily dose is 40 mg (in single or divided doses) for the short-term treatment of acute muscle and bone conditions or acute gout.

Older people

If you are older than 70 years your doctor may prescribe a lower daily dose and reduce the duration of treatment. Your doctor will tell you how long your treatment with PIXICAM 20 will last. If you have the impression that the effect of PIXICAM 20 is too strong or too weak, tell your doctor or pharmacist.

If you take more PIXICAM 20 than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Symptoms of overdose may include headache, dizziness, drowsiness, stomach pain, nausea, vomiting and hyperventilation.

If you forget to take PIXICAM 20: If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a missed dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

PIXICAM 20 can have side effects. Not all side effects reported for PIXICAM 20 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine please consult your doctor, pharmacist, or other healthcare professional for advice. Tell your doctor immediately and stop taking PIXICAM 20 if you experience any of the following symptoms after taking this medicine:

• any sign of bleeding in the stomach or intestines, such as passing black (tarry) or bloodstained bowel movements or vomiting blood
• sudden wheeziness, difficulty in breathing, fever, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body)
• potentially life-threatening skin rashes including peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) or extensive peeling of the skin (toxic epidermal necrolysis) (see “Take special care with PIXICAM 20”)
• yellowing of the skin and the whites of your eyes (jaundice) which may be a sign of hepatitis or other liver problems.

Other side effects that may be experienced while taking this medicine are:

Frequent side effects:

• reduction in red blood cells which can make the skin pale and cause weakness or breathlessness.
• high level of a specific type of white blood cells (eosinophilia)
• changes in the white blood cells which may result in increased risk of infection (leukopenia (reduction in blood platelets) which increases the risk of bleeding or bruising.
• loss of appetite.
• increase in blood sugar levels.
• dizziness, headache, sleepiness.
• a feeling of dizziness or “spinning”.
• ringing in ears (tinnitus)
• stomach pain/discomfort, constipation
• diarrhoea, wind, feeling sick (nausea), vomiting, indigestion.
• itching, skin rash
• swelling of the ankles, feet or fingers (oedema)
• increase in liver enzymes
• abnormal kidney function test results
• weight increase

Less-frequent side effects:

• decreased/low blood sugar level which may cause faintness, hunger, sweating or jitteriness.
• blurred vision
• feeling your heartbeat

Not known - frequency cannot be estimated from the available data:

• abnormalities in the blood such as severe reduction in blood cells which can cause weakness, bruising or make infections more likely (aplastic anaemia)
• reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness (haemolytic anaemia)
• serious allergic reaction which causes difficulty in breathing or dizziness (anaphylactic reactions) or swelling of the face or throat
• fluid retention
• depression, dream abnormalities, hallucinations, difficulty in sleeping, mental confusion, mood alterations, nervousness
• tingling or numbness (paraesthesia)
• eye irritation, swollen eyes
• difficulty hearing
• heart failure with signs such as breathlessness, difficulty breathing when lying down, swelling of the feet or legs.
• inflammation of the blood vessels
• high blood pressure
• forming of blood clots in blood vessels: heart attack (myocardial infarction) or stroke
• difficulty in breathing or wheezing
• nosebleed
• inflammation of the stomach lining (gastritis)
• gastro-intestinal bleeding including vomiting of blood and black, tarry stools.
• inflammation of the pancreas (which may lead to severe pain in the upper abdomen or back)
• gastro-intestinal ulcers and/or perforation
• worsening of colitis and Crohn’s disease
• ulcers in the mouth
• inflammation of the liver (fatal hepatitis)
• yellowing of the skin and the whites of your eyes (jaundice)
• hair loss
• sudden wheeziness, difficulty in breathing, fever, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body)
• rashes, blistering, peeling, itching, redness, tenderness, thickening or scaling of skin.
• allergic reaction involving purple spots on the skin, joint pain, abdominal pain and kidney dysfunction (Henoch-Schoenlein purpura)
• loosening or splitting of fingernails
• increased sensitivity of the skin to sunlight
• kidney disease, kidney inflammation, kidney failure
• decreased fertility of women
• generally feeling unwell

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 PIXICAM 20.

• Store all medicines out of reach of children.

• Store at or below 25 °C. Protect from light.

• Do not use the tablets after the expiry date printed on the container, blister or label.

• Return all unused medicine to your pharmacist.

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