Piroxicam Capsules 20mg
PATIENT INFORMATION LEAFLET
PIROXICAM Capsules lOmg & 20mg
Please read all of this leaflet carefully before you start taking this medicine.
Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Piroxicam Capsules are and what they are used for
2. Before you take Piroxicam Capsules
3. How to take Piroxicam Capsules
4. Possible side effects
5. How to store Piroxicam Capsules
6. Further information
1. What Piroxicam Capsules are and what they are used for
This medicine belongs to a group of drugs known as non-steroidal anti-inflammatory drugs (NSAIDs). These are used for the relief of pain and inflammation associated with muscle and joint disorders and other painful conditions.
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 you taking piroxicam.
Piroxicam Capsules are 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 non-steroidal anti-inflammatory medicines (NSAIDs).
2. Before you take Piroxicam Capsules
Do not take these capsules if:
■ you previously had a stomach or intestinal ulcer, bleeding or perforation
• you currently have stomach or intestinal ulcer, bleeding or perforation
■ you 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)
■ you are allergic to piroxicam or to any of the other ingredients in the capsules (see section 6)
■ you 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), vesiculo-bullous reactions (Stevens-Johnson syndrome, a condition with red blistered, eroded, bloody or crusted skin) and toxic epidermal necrolysis, (a disease with blistering and peeling of the top layer of skin)
■ you have had any form of allergic reaction (such as asthma, blocked or runny nose, nasal polyps, swelling of the face or throat, skin rash or itching) to ibuprofen, aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
■ you are taking other NSAIDs, including COX-2 selective NSAIDs and acetyl-salicylic acid (aspirin)
■ you are taking anticoagulants, such as warfarin, to prevent blood clots
■ you have severe heart, liver or kidney problems
• you are more than 6 months pregnant.
If any of these applies to you, you should not be given piroxicam. Tell your doctor immediately.
Check with your doctor before taking these capsules if:
* you have heart, liver or kidney problems or high blood pressure
* you have, or have ever had asthma as piroxicam might bring on an attack
* you are elderly, as you may be more likely to suffer side effects. If you are over 70 years old, your doctor may wish to minimise treatment duration and to see you more often while you are taking piroxicam. If you are over 70 years old, or you are taking other medicines like corticosteroids or certain drugs for depression called selective serotonin reuptake inhibitors (SSRIs), or acetylsalicylic acid (aspirin) to prevent blood clotting, your doctor may like to prescribe you, together with piroxicam, a medicine for protecting your stomach and intestines. You should not take this medicine if you are older than 80 years
■ you have systemic lupus erythematosus (SLE) or mixed connective tissue disorder (an immune system disorder)
• you are in the first 6 months of pregnancy or you are breastfeeding.
Taking other medicines
Tell your doctor about any other medicines you are taking or took recently
(in the last week) - even medicines you bought yourself without a prescription.
Medicines can sometimes interfere with each other. Your doctor may limit
your use of piroxicam or other medicines, or you may need to take a different
medicine. It's especially important to mention if you are taking:
* aspirin or other non-steroidal anti-inflammatory drugs for pain relief e.g diflunisal, ibuprofen, naproxen, diclofenac
■ corticosteroids, which are drugs given to treat a variety of conditions such as allergies and hormone imbalances
■ anticoagulants such as warfarin (used to prevent blood clots)
- certain drugs for depression called selective serotonin re-uptake inhibitors (SSRIs)
■ any drugs such as acetylsalicylic acid (aspirin) to prevent platelet clumping
■ diuretics (water tablets) such as triamterene, thiazides and furosemide
* digoxin or digitoxin (used to treat heart failure)
■ cimetidine (used to treat ulcers)
- lithium (used to treat depressive illness)
* antihypertensives (used to treat high blood pressure)
■ methotrexate (used to treat cancer, psoriasis, rheumatoid arthritis etc)
■ ciclosporin or tacrolimus (to prevent rejection following organ or bone marrow transplants)
■ mifepristone (used to terminate a pregnancy)
■ quinolone antibiotics such as ciprofloxacin or ofloxacin
* zidovudine (to treat HIV infection).
If any of these applies to you tell your doctor immediately.
Other special warnings
■ Like all non-steroidal anti-inflammatory drugs, piroxicam capsules can cause serious reactions in the stomach and intestines, such as pain, bleeding, ulceration and perforation. You should immediately stop taking piroxicam and tell your doctor if you have stomach pain, or any sign of bleeding in the stomach or intestines, such as passing black or bloodstained bowel movements, or vomiting blood.
■ Potentially life-threatening skin rashes (Stevens-Johnson 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 of the body.
- 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 flu-like 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 month of treatment.
* If you develop a rash or these skin symptoms, wheezing or difficulty breathing, stop taking piroxicam, seek urgent advice from a doctor and tell him that you are taking this medicine.
* 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 have or have had any medical problems or any allergies or if you are not sure as to whether you can use piroxicam tell your doctor before using this medicine.
* 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.
- This medicine can affect the results of laboratory tests, including bleeding times. Before you have any tests, tell your doctor you are taking this medicine.
Pregnancy and breastfeeding
Do not take this medicine if you are more than 6 months pregnant. Check with your doctor before taking if you are in the first 6 months of pregnancy or you are breastfeeding.
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.
Effects on driving or operating machinery
Piroxicam Capsules may make you feel dizzy, tired, drowsy or might affect your vision. If you think this medicine has affected you do not drive or operate machinery.
Important information about an ingredient of Piroxicam Capsules
These capsules contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these capsules.
3. Howto take Piroxicam Capsules
Swallow the capsules whole with water. Take with or after food.
Always use piroxicam exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will give you a regular check-up to make sure you are taking the optimal dose of piroxicam. Your doctor 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.
Adults and Elderly:
The maximum daily dose is 20 milligrams of piroxicam as one single daily dose. If you are older than 70 years your doctor may prescribe a lower daily dose and reduce the duration of treatment.
Your doctor may prescribe piroxicam with another medicine to protect your stomach and intestine for potential side effects.
Do not increase the dose.
If you feel that the medicine is not very effective, always talk to your doctor. Children:
This medicine is not recommended for children.
If you have taken too many capsules:
If you think you have taken too many capsules, contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining capsules and the pack so that the medicine can be identified.
If you forget to take a dose:
Take it as soon as you remember. If it is almost time for your next dose, do not take the dose you have missed, just take the next dose at the correct time.
Do not double the dose.
If you have any further questions on the use of this product, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
There will be fewer side effects if you take the lowest effective dose for the shortest time necessary.
If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and seek immediate medical help:
• pass blood in your faeces (stools/motions)
• pass black tarry stools
■ vomit any blood or dark particles that look like coffee grounds.
These may be signs of a stomach ulcer or bleeding in your stomach.
STOP TAKING the medicine and tell your doctor if you experience:
• indigestion or heartburn
• abdominal pain (pains in your stomach) or other abnormal stomach symptoms
■ allergic reactions which can include skin rash, itching, bruising, painful red areas, peeling or blistering, dizziness, difficulty in breathing, wheezing or shortness of breath, swollen face, throat, lips, hands or fingers, fever or joint pain
• yellowing of your skin or the whites of your eyes and/or pale stools, dark urine, loss of appetite as these may be signs of liver problems
■ passing more or less urine than normal, cloudy urine, blood in urine, pain in the back, swelling (particularly of the ankles) as these may be signs of kidney problems.
If you experience any of the following very rare effects, STOP TAKING the capsules and tell your doctor as soon as possible:
• inflammation of the pancreas causing severe pain in the abdomen and back
■ potentially life-threatening skin rashes Stevens-Johnson syndrome (serious illness causing blistering of the skin, mouth, eyes and genitals), toxic epidermal necrolysis (serious illness causing blistering of the skin) have been reported (see section 2).
Tell your doctor or pharmacist if you notice any of the side effects listed in the sections below:
Other effects which have been reported commonly are:
■ blood disorders including severe reduction in the number of white or red blood cells which may cause pale skin, weakness or breathlessness and increase the risk of bleeding or bruising or make infections more likely
■ raised blood sugar levels
• feeling or being sick, loss of appetite, diarrhoea, constipation, flatulence (wind)
■ headache, feeling of dizziness or “spinning”
■ ringing in the ears.
The following have been reported less commonly:
■ high blood pressure, oedema (water retention), heart failure (which can cause shortness of breath or swollen ankles)
• worsening of the symptoms of colitis and Crohn's disease
■ inflammation of the blood vessels, often with skin rash
■ aseptic meningitis (especially in patients with auto-immune disorders such as systemic lupus erythematosus and mixed connective tissue disease). Symptoms include fever, headache, stiff neck and back, feeling sick or being sick, skin rash, eyes being very sensitive to bright light, disorientation and muscle pain
■ decreased fertility
■ sore mouth, nosebleed, increased sensitivity to light, loosening or loss of fingernails, loss of hair
■ tiredness, drowsiness, confusion, eyesight problems (such as blurred, partial or complete loss of vision, blind spots, halos around lights), irritated or swollen eyes
■ tingling or numbness in the hands or feet, depression, hallucinations
■ difficulty sleeping, dream abnormalities, mood changes, nervousness
• palpitations, hearing problems, lowered blood sugar levels, weight changes
■ medicines such as piroxicam may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.
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/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. Howto store Piroxicam Capsules
Store in a cool, dry place below 30°C and protect from light.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN Do not take the capsules if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal.
6. Further information
Ingredients
Piroxicam Capsules are available in two strengths and contain either 10mg or 20mg of piroxicam as the active ingredient. They also contain the inactive ingredients: maize starch, lactose monohydrate, magnesium stearate and sodium laurilsulfate.
The capsule shells contain gelatin, titanium dioxide (E171), erythrosine (E127) and white printing ink. The 10mg capsules also contain indigo carmine (E132) and iron oxide black (E172).
What Piroxicam Capsules look like:
Piroxicam Capsules 10mg are dark blue and red, and are printed with PRX10 and the Crescent moon logo.
Piroxicam Capsules 20mg are red and are printed with PRX20 and the Crescent moon logo.
The capsules are available in packs of 28,30,56 and 60 capsules (not all pack sizes may be marketed).
Who makes this medicine and holds the Product Licence:
Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED, UK.
Date leaflet revised: March 2015