Patient leaflet - Piroxicam 10 mg capsules BP
What Piroxicam is and what it is used for
Piroxicam is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It will help to relieve pain and reduce swelling affecting joints.
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 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 Non-steroidal anti- inflammatory medicines (NSAIDs).
2.
What you need to know before you take Piroxicam
Do not take Piroxicam Capsules if you:
- are allergic (hypersensitive) to Piroxicam or any of the other ingredients of these capsules (see section 6)
- have or had a stomach or intestinal ulcer, bleeding or perforation
- have or had a history of gastrointestinal disorders (inflammation of the stomach or intestines) that pre- dispose 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 acetyl-salicylic acid, a substance present in many medicines used to relieve pain and lower fever
- are taking anti-coagulants, such as warfarin to prevent blood clots
- previously had a serious allergic drug reaction to Piroxicam, other NSAIDs, or any other medications, especially serious skin reactions (regardless of severity) such as exfolative dermatitis (intense reddening of skin, with skin peeling off in scales or layers), vesiculo-bullous reaction (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)
- are in the last three months of your pregnancy
- have severe heart problems
If any of these applies to you, you should not be given piroxicam. Tell your doctor immediately.
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.
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 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 him that you are taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking these Capsules if you:
- have or had asthma
- suffer with systemic lupus erythematosus or other connective tissue disorders
have or had any heart problems or high blood pressure
- have liver or kidney problem
- high cholesterol or hardening of the arteries
- diabetes
Like all non-steroidal anti-inflammatory drugs, Piroxicam 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. You should immediately stop taking Piroxicam and tell your doctor if you have any allergic reaction such as a skin rash, swelling of the face, wheezing or difficulty breathing.
Patients over 70 years of age: If you are over 70 years old, your doctor may wish to minimize 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 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.
If you have or 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.
Make sure you have told your doctor about any other medicines that you are taking, including those that you have bought without prescription. 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.
Other medicines and Piroxicam Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Piroxicam can affect the way some other medicines work, also some other medicines may change the way Piroxicam works. Your doctor may limit your use of Piroxicam or other medicines, or you may need to take a different medicine.
The following medicines must not be taken with Piroxicam:
- aspirin or other non-steroidal anti-inflammatory drugs for pain relief
- anticoagulants such as warfarin to prevent blood clots
Tell your doctor if you are taking:
- corticosteroids, which are drugs given to treat a variety of conditions such as allergies and hormone imbalances
- low dose aspirin (75 mg) to help prevent heart attack or stroke
- certain drugs for depression called selective serotonin reuptake inhibitors (SSRI) or lithium
- any drugs, such as acetylsalicylic acid to prevent platelet clumping
- diuretics (water capsules such as hydrochlorothiazide) and other drugs used to treat high blood pressure
- methotrexate, a drug used in cancer, psoriasis and rheumatoid arthritis
- ciclosporin or tacrolimus, a drug used following organ transplants
- quinoline antibiotics, which are used to treat bacterial infections (e.g. ciprofloxacin)
- mifepristone, a drug used for terminating pregnancy
- zidovudine (used to treat HIV and AIDs)
- certain medicines used to treat heart conditions known as cardiac glycosides, such as digoxin
- cimetidine or any other antacids for heartburn or stomach ulcer If you are not sure, talk to your doctor or pharmacist before taking Piroxicam.
Pregnancy and breast-feeding
Piroxicam may make it more difficult to become pregnant. If you are pregnant, planning pregnancy or breast-feeding tell your doctor before you take Piroxicam. . 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 trying to become pregnant or being investigated for infertility, withdrawal of Piroxicam should be considered. Piroxicam may increase the risk of miscarriage in early pregnancy. Ask your doctor or pharmacist for advice before taking any medicine
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 Capsule contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine as it contains lactose. Test
If you have a blood or urine test, tell the doctor that you are taking Piroxicam because the medicine may affect the result.
3. How to take Piroxicam
Always take Piroxicam exactly as your doctor has told you. Check with your doctor 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. Swallow your capsule whole with a glass of water. It is best to take your capsules at the same time each day with food or soon after eating.
The recommended doses are as follows:
Adults (including the elderly): The maximum daily dose is 20mg of Piroxicam as one single daily dose.
Elderly: 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.
The pharmacist’s label should tell you how much to take and how often. If it does not or you are not sure ask your doctor or pharmacist.
If you take more Capsules than you should
If you or a child accidentally takes too many Capsules, contact your nearest hospital casualty department or contact your doctor immediately. Bring any remaining Capsules with you to show the doctor. 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 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 to make up for a forgotten dose..
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Piroxicam Capsules can cause side effects, although not everybody gets them.
Stop taking these Capsules and see a doctor or go to a hospital straight away if you notice the following serious side effects:
- 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
- pancreatitis (severe pain in the upper abdomen or back)
- skin rashes including itching, "nettle" rash or hives, a serious reaction causing swelling of the face or throat, a serious illness with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson Syndrome), unusual bruising, intense reddening with skin peeling off in scales or layers, blistering and peeling of the top layer of skin
- changes in the red blood cells which may result in unusual bruising or bleeding
- changes in the white blood cells which may result in increased risk of infection
- difficulty in passing urine or blood in the urine
- increased sensitivity of the skin to sunlight
- allergic reactions like sudden wheeziness, difficulty in breathing, fever, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body)
- swelling of blood vessels which may be associated with fever, rash and joint pains, Persistent sore throat or high temperature
- aseptic meningitis may occur with symptoms such as headache, fever, stiff neck, tiredness, feeling ill and your eyes become very sensitive to bright light
- yellowing of your skin or the whites of your eyes (jaundice), inflammation of the liver (hepatitis) or other liver problems
- kidney failure
Other side effects: Tell your doctor or pharmacist if you notice any of the following side effects:
Common (may affect up to 1 in 10 people):
- loss of appetite
- indigestion or heartburn, abdominal pain (pains in your stomach) or other abnormal stomach symptoms
- increase in blood sugar levels
- headache, vertigo (a spinning sensation), dizziness, drowsiness
- ringing in ears (tinnitus)
- constipation, diarrhoea, flatulence
- feeling sick (nausea), being sick (vomiting)
- swollen ankles
- weight increase
Uncommon (may affect up to 1 in 100 people):
- blurred vision
palpitations
- inflammation of the stomach lining (gastritis)
- decreased/low blood sugar level resulting in tremors, sweating and raised pulse rate
Rare (may affect up to 1 in 1,000 people):
- abnormal dreams, nightmares, hallucinations
- mental confusion, mood alterations, nervousness
- loosening or splitting of fingernails, hair loss
- inflammation of the blood vessels
- kidney inflammation, change in urine output or appearance
Very Rare (may affect up to 1 in 10,000 people):
- taste disturbances
- anxiety, fits
Not known (frequency cannot be estimated from the available data):
- fluid retention, pins and needles
- depression, difficulty in sleeping
- eye irritations, swollen eyes
- hearing impairment
- high blood pressure
- constriction of the muscles lining the airways of lungs (bronchial)
- nose bleeds, mouth ulcers, stomach (peptic) ulcers, upset stomach
- allergic reaction involving purple spots on the skin, joint pain, abdominal pain and kidney dysfunction (Henoch-Schoenlein purpura)
- decreased fertility
- anaemia (feeling tired after exercising, giddiness, looking pale), other blood disorders characterized by blood spots, discolouring of skin, joint inflammation
- increased risk of heart attack (myocardial infarction)
- increased risk of 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. How to store Piroxicam
Keep all medicines out of the sight and reach of children
- Do not use the Capsules after the expiry date stated on the label after ‘EXP’. The expiry date refers to the last day of that month.
- Do not store above 30˚C.
- Keep container tightly closed.
- Store in original container.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Piroxicam Capsules contain
- The active substance is 10mg or 20mg of Piroxicam.
The other ingredients are lactose, maize starch, sodium lauryl sulphate, crosspovidone, magnesium stearate and gelatin. The 10mg capsule contains the colors indigotine (E132), erythrosin (E127), black iron oxide (E172) and titanium dioxide (E171). The 20mg capsule contains the colors amaranth (E123) and titanium dioxide (E171). The 10mg and 20mg capsules also contain the printing ink ingredients shellac, soya lecithin (E322), dimeticone and titanium dioxide (E171). Each capsule contains 160 micrograms of sodium.
See end of section 2 for further information on lactose.
What Piroxicam Capsules looks like and contents of the pack
- Piroxicam capsules 10mg: Violet and turquoise coloured capsules printed with company logo PV and Piroxicam 10.
- Piroxicam Capsules 20mg: Maroon coloured capsules printed with company logo PV and Piroxicam 20.
Piroxicam Capsules packs sizes are
Container Pack: 28, 30, 56, 60 capsules and dispensing packs 100, 250 and 500 capsules are available in polypropylene tubes with caps. Blister Packs: 28, 30, 56 and 60 capsules are available in blister packs consisting of clear PVC and aluminum foil contained in a carton. Tracer Packs: 28, 30, 56 and 60 capsules are available in child resistant containers consisting of polypropylene tubes and caps. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Pharmvit Ltd, 177 Bilton Road, Perivale,
Greenford, Middlesex UB6 7HQ.
Telephone: 0208 997 5444
Fax: 0208 997 5433
To request a copy of this leaflet in large print or audio format or additional copies, please contact the licence holder at the address (or telephone, fax) above.
PL 04556 / 0050 & 04556 / 0051 POM
Reference: 0050510617/01
This leaflet was last revised in June 2017