Piroxicam Capsules 20mg
• stomach or intestinal bleeding, ulceration or perforation: pass blood in your faeces (stools/motions), pass black tarry stools, vomit blood or dark particles that look like coffee grounds.
• liver disease (fatigue, weakness, loss of appetite, weight loss, abdominal pain, fever) or abnormal liver function (abnormal test results continue or worsen), liver disease causing yellowing of the skin or whites of the eyes (jaundice), inflammation of the liver (hepatitis).
• kidney disease or failure.
• heart: water retention, high blood pressure, heart failure. Medicines such as Piroxicam may be associated with
a small increased risk of heart attack ("myocardial infarction") or stroke.
• aseptic meningitis may occur with symptoms such as headache, fever, stiff neck, feeling or being sick.
• indigestion or heartburn. Abdominal pain (pains in your stomach) or other abnormal stomach symptoms.
Tell your doctor if you notice any of the
following side effects or notice any other
effects not listed:
• skin reactions: rash, itching, loosening of a finger or toe nail, hair loss, sensitivity to sunlight or artificial light (e.g. sun beds).
• stomach and intestines: abdominal discomfort, loss of appetite, constipation, diarrhoea, wind, feeling or being sick, inflammation of the mouth, ulcerative stomatitis (inflammation and ulcers
of the bowel), worsening of colitis or Crohn's disease, inflammation of the pancreas or stomach.
• nervous system: dizziness, headache, a spinning sensation, drowsiness, tiredness, anxiety, fits, depression, disorientation, visual disturbances (blurred or double vision), impaired hearing, inability to sleep, irritability, confusion, hallucinations, memory disturbance, nightmares, 'pins and needles', psychotic reactions, ringing or buzzing in the ears, tremor, taste disturbances.
• kidneys: increases in the levels of nitrogen in the blood and creatinine.
• blood: decreases in haemoglobin and haematocrit, disturbance of blood count (anaemia, thrombocytopenia, leucopenia, neutropenia, agranulacytosis, eosinophilia, aplastic anaemia, haemolytic anaemia), disorder characterised by blood spots, bruising and discolouring to the skin, joint inflammation and stomach pain (Henoch-Schoenlein purpura), nosebleeds.
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• other: palpitations, difficulty breathing, positive anti-nuclear antibody test, hearing impairment, low blood sugar, increase or decrease in weight, swollen eyes, blurred vision, eye irritation, a feeling of general discomfort and illness, ringing or buzzing in the ears.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/vellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
How to store Piroxicam capsules
Keep out of the sight and reach of children. Store below 25°C in a dry place. Protect from light.
Do not use Piroxicam capsules after the expiry date which is stated on the label/ carton/bottle.
Ask your pharmacist how to dispose of medicines no longer required.
^ Contents of the pack and other information
What Piroxicam capsules contain
• The active substance (the ingredient that makes the medicine work) is piroxicam. Each capsule contains either 10mg or 20mg of the active ingredient.
• The other ingredients are carmellose sodium, gelatin, lactose, magnesium stearate, maize starch, polysorbate, shellac glaze, E127, E132 (1omg only), E171, E172 and propylene glycol.
What Piroxicam capsules look like and contents of the pack
Piroxicam 10mg capsules are pink and turquoise hard gelatin capsules printed "C" and the identifying letters "YA" in black and are in pack sizes of 56.
Piroxicam 20mg capsules are pink hard gelatin capsules printed "C" and the identifying letters "YB" in black and are in pack sizes of 28.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in June 2016.
Package leaflet: information for the user
Read all of this leaflet carefully before you start taking this medicine because i it contains important information for j you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask I your doctor or pharmacist.
; • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
0 What Piroxicam capsules are and what they are used for 0 What you need to know before you take Piroxicam capsules [3 How to take Piroxicam capsules [jj Possible side effects 0 How to store Piroxicam capsules
0 Contents of the pack and other information
0 What Piroxicam capsules are and what they are used for
Before prescribing Piroxicam your doctor will assess the benefits this medicine may give you against your risk of developing side effects. Your doctor may need to give you check-ups and will tell you how often you need to be checked, due to your taking Piroxicam.
Piroxicam belongs to a group of pain killers called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and 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.
It does not cure arthritis and will help you only as long as you continue to take it.
Your doctor will prescribe Piroxicam to you only when you have had unsatisfactory relief of symptoms with other NSAIDs.
0 What you need to know before you take Piroxicam capsules Do not take Piroxicam capsules if you:
• are allergic to piroxicam or any of the
other ingredients of this medicine (listed in section 6).
• are allergic to aspirin or previously had a serious allergic drug reaction to piroxicam, other NSAIDs and other medications, especially serious skin reactions (regardless of severity) such as exfoliative dermatitis (intense reddening of skin, with skin peeling off in scales or layers),
• potentially life-threatening skin rashes (Steven-Johnsons syndrome, toxic epidermal necrolysis) have been reported with the use of piroxicam, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. Additional signs to look for include: ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These potentially life-threatening skin rashes are often accompanied by flulike symptoms. The rash may progress to widespread blistering or peeling of the skin. The highest risk for occurrence of serious skin reactions is within the first weeks of treatment. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Piroxicam, you must not be re-started on Piroxicam at any time. If you develop
a rash or these skin symptoms, seek immediate advice from a doctor and tell them that you are taking this medicine.
• have ever experienced symptoms of swelling of face or hands (angioneurotic oedema), asthma, hayfever, swelling of nasal passage (nasal polyps) or hives with aspirin or NSAIDs.
• have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation.
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• have or have had a history of gastrointestinal disorders
(inflammation of the stomach or intestines) that predispose to bleeding disorders such as ulcerative colitis, Crohn's disease, gastrointestinal cancers, diverticulitis (inflamed or infected pouches/pockets in the colon).
• are taking other NSAIDs, including COX-2 selective NSAIDs and aspirin, a substance presents in many medicines used to relieve pain and lower fever.
• are taking anticoagulants, such as warfarin, to prevent blood clots.
• suffer from severe heart failure.
If any of these applies to you, you should not be given piroxicam. Tell your doctor immediately.
Warnings and precautions
Talk to your doctor or pharmacist before taking Piroxicam capsules if you:
• have or have had any heart problems or high blood pressure. Medicines such as piroxicam may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment. If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.
• have any liver or kidney problems.
• are elderly as you have an increased risk of getting side effects. If you are over
70 years old, your doctor may wish to minimise treatment duration and see you more often while you are taking piroxicam. You should not take this medicine if you are older than 80 years. Your doctor may like to prescribe you a medicine for protecting your stomach and intestines.
• have or have had asthma.have ever had gastrointestinal complications such as ulceration, bleeding or a history of ulcerative colitis or Crohn's disease
• suffer with systemic lupus erythematosus or other connective tissue disorders.
• take a painkiller for headaches for more than 3 days it can make them worse.
• are suffering from frequent headaches and regular use of analgesic drugs does not help you, you should contact your doctor. To prevent a possible deployment of chronic headache (MOH), recommended daily doses must be followed carefully and especially avoid high monthly consumption of migraine drugs.
Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.
Children and adolescents
Piroxicam capsules is not recommended in children under 12 years of age.
Other medicines and Piroxicam capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may limit your use of Piroxicam or other medicines, you may need to take a different medicine or your doctor may prescribe another medicine to protect your stomach and intestine against side effects. It is especially important to mention:
• any diuretic medicine ("water tablets") e.g. furosemide, bendroflumethiazide
• anticoagulants (which prevent blood clotting) e.g. warfarin.
• aspirin, non-steroidal antiinflammatory drugs (NSAIDs) or Cox-II-Inhibitors for pain (e.g. ibuprofen or celicoxib).
• medicines to treat high blood pressure
such as lisinopril, iloprost or losartan.
• cardiac glycosides (e.g. digoxin) to treat some heart conditions.
• methotrexate, to treat some types of cancer or rheumatoid arthritis.
• corticosteroids, which are drugs given to treat a variety of conditions such as allergies and hormone imbalances.
• mifepristone, used for termination of pregnancy. Piroxicam capsules should not be taken within 8-12 days of taking mifepristone.
• ciclosporin or tacrolimus, to prevent the rejection of transplants.
• quinolone antibiotics (e.g. ciprofloxacin) or zidovudine (an antiviral), to treat infections.
• lithium, used to treat depression. Your doctor should check your blood levels of lithium when you start, stop or change your dose of piroxicam.
• cimetidine, to treat stomach ulcers.
• antidepressants such as selective serotonin re-uptake inhibitors (SSRI) or venlafaxine
• any drug to prevent platelet clumping
such as aspirin or clopidogrel.
• medicines which increase the risk of bleeding such as pentoxifylline.
• penicillamine for rheumatic disease.
• immunosupressants such as tacrolimus
• antiviral drugs to treat AIDs such as zidovudine
If any of these applies to you tell your doctor immediately.
Pregnancy, breast-feeding and fertility
Piroxicam may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant. Piroxicam should not be taken during the first 6 months and must not be taken in the last 3 months of pregnancy. If you are breast-feeding, you should not take Piroxicam capsules.
Driving and using machines
Piroxicam capsules may make you feel dizzy, drowsy, tired or affect your vision. Make sure you are not affected before you drive or operate machinery.
Piroxicam capsules contains lactose
If a doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains lactose.
Eye test
If you develop problems with your eyes you should have an eye test.
^1 How to take Piroxicam capsules
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Swallow the capsules with water, with or after food.
Drink plenty of water while taking Piroxicam to avoid dehydration.
Your doctor will give you regular check-ups to make sure you are taking the best dose of piroxicam and will adjust your treatment to the lowest dose that best controls your symptoms.
Under no circumstances should you change the dose without first speaking to your doctor.
Your doctor may prescribe another medicine to protect your stomach and intestines from potential side effects.
Do not increase the dose. If you feel that the medicine is not very effective, always to your doctor.
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Dose
• Adults (including the elderly): Initially 20mg a day as a single dose. The maintenance dose is 10-20mg a day as a single dose.
The maximum daily dose is 20mg of piroxicam as one single dose.
• Elderly: If you are older than 70 years your doctor may prescribe a lower daily dose and reduce the duration of treatment.
• Children under 12 years: Piroxicam capsules should not be taken by children under 12 years of age.
If you take more Piroxicam capsules than you should
It is important not to take too many capsules. If you have taken more than you should, contact your doctor, pharmacist or nearest hospital casualty department immediately. Signs of an overdose include headache, dizziness, , drowsiness, fainting, ringing in the ears, feeling or being sick, diarrhoea, stomach pain or bleeding, feeling disorientated or excited, coma or fits.
If you forget to take Piroxicam capsules
If you forget to take your capsules, take it as soon as you remember, unless it is nearly time for your next dose, do not take the dose you have missed. Do not take a double the dose to make up for a forgotten dose.
Possible side effects
Like all medicines, Piroxicam capsules can cause side effects, although not everybody gets them.
Stop taking Piroxicam capsules and contact your doctor immediately if you
notice signs of:
• an allergic reaction: asthma or worsening of asthma, narrowing of the airways causing difficulty breathing/ wheezing, rash, irregular raised patches with severe itching (hives), swelling of the face, lips, throat or tongue, blood vessel inflammation, serum sickness (rash, fever, joint pain, enlarged lymph nodes).
• skin reactions such as severe rash involving reddening, peeling and swelling of the skin that resembles severe burns (toxic epidermal necrolysis), severe form of skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson syndrome). See section 2.
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