• drowsiness Reporting of side effects • ringing in ears (tinnitus) If you get any side effects, talk to your doctor, • abdominal pain/discomfort pharmacist or nurse. This includes any possible • constipation side effects not listed in this leaflet. • diarrhoea Package leaflet: Information for the patient • wind You can also report side effects directly via the • feeling sick (nausea) Yellow Card Scheme at: Piroxicam 10mg and 20mg • being sick (vomiting) www.mhra.gov.uk/yellowcard or search for • indigestion MHRA Yellow Card in the Google Play or Apple Capsules • itching App Store. Read all of this leaflet carefully before 2 What you need to know before • skin rash By reporting side effects you can help provide • swelling of the feet, hands or other parts of you start taking this medicine because it you take Piroxicam capsules more information on the safety of this contains important information for you. the body (oedema) medicine. • weight increase. • Keep this leaflet. You may need to read Do not take Piroxicam capsules if you: it again. • are allergic to piroxicam or any of the other 5 How to store Piroxicam capsules Uncommon (may affect up to • If you have any further questions, ask ingredients of this medicine (listed in section 1 in 100 people): Keep this medicine out of the sight and reach 6); an allergic reaction to other NSAIDs or • blurred vision your doctor or pharmacist. of children. • This medicine has been prescribed for any other medications, especially serious • fast or pounding heartbeat Store below 25°C in a dry place. Protect from skin reactions (regardless of severity) such as • sore mouth and/or lips you only. Do not pass it on to others. It exfoliative dermatitis (intense reddening of light. may harm them, even if their signs of • decreased/low blood sugar level. Do not take this medicine after the expiry date skin, with skin peeling off in scales or layers), which is stated on the label/carton/bottle after illness are the same as yours. Stevens-Johnson syndrome (symptoms are a Rare (may affect up to • If you get any side effects, talk to your rash, blistering or peeling of the skin, mouth, 1 in 1,000 people): ‘EXP’ . The expiry date refers to the last day of that month. doctor or pharmacist. This includes any eyes or genitals) or toxic epidermal necrolysis • kidney inflammation (a disease with blistering and peeling of the • kidney damage possible side effects not listed in this Do not throw away any medicines via leaflet. See section 4. top layer of skin). • change in urine output or appearance • are taking other NSAIDs such as ibuprofen, • kidney pain or pain in abdomen. wastewater or household waste. Ask your • The full name of this medicine is pharmacist how to throw away medicines you Piroxicam 10mg and 20mg Capsules celecoxib or acetylsalicylic acid (aspirin), a Not known (frequency cannot be estimated no longer use. These measures will help protect substance present in many medicines used but within this leaflet it will be referred to relieve pain and lower fever. from the available data): the environment. to as Piroxicam capsules. • abnormalities in the blood e.g. decreased • have previously had or currently have a stomach or intestinal ulcer, bleeding or haemoglobin 6 Contents of the pack and other • fluid retention information What is in this leaflet: perforation. • depression 1 What Piroxicam capsules are and • have, or have previously had disorders of • dream abnormalities What Piroxicam capsules contain what they are used for the stomach or intestines such as ulcerative • changes in sleep patterns • The active substance (the ingredient that colitis, Crohn’s disease, gastrointestinal 2 What you need to know before • mental confusion makes the medicine work) is piroxicam. Each cancers or diverticulitis (inflamed or infected • mood alterations capsule contains either 10mg or 20mg of the you take Piroxicam capsules pouches/pockets in the colon). • nervousness active ingredient. 3 How to take Piroxicam capsules • are taking anticoagulants, such as warfarin, to prevent blood clots. • pins and needles • The other ingredients are carmellose sodium, 4 Possible side effects • suffer from severe heart failure. • eye irritations gelatin, lactose, magnesium stearate, maize 5 starch, polysorbate, shellac glaze, E127, E132 How to store Piroxicam capsules • are in the last three months of pregnancy. • swollen eyes 6 • hearing impairment (10mg only), E171, E172 and propylene Contents of the pack and other glycol. If any of the above apply to you, tell your • high blood pressure information doctor immediately and do not take • inflammation of the blood vessels Piroxicam capsules. • shortness of breath What Piroxicam capsules look like and • constriction of the muscles lining the airways contents of the pack Piroxicam 10mg capsules are pink and 1 What Piroxicam capsules are and Potentially life-threatening skin rashes (DRESS of lungs (bronchial) syndrome, Stevens-Johnson syndrome, toxic • nose bleeds turquoise hard gelatin capsules printed “C” and what they are used for the identifying letters “YA” in black and are in epidermal necrolysis) have been reported • inflammation of the stomach lining (gastritis) Piroxicam belongs to a group of medicines with the use of piroxicam, appearing initially • stomach (peptic) ulcers pack sizes of 56. Piroxicam 20mg capsules are pink hard gelatin called Non-Steroidal Anti-Inflammatory Drugs as reddish target-like spots or circular patches • upset stomach (NSAIDs). This means it will help to relieve pain often with central blisters on the trunk. • kidney inflammation possibly causing blood capsules printed “C” and the identifying letters “YB” in black and are in pack sizes of 28. and reduce swelling affecting joints. Piroxicam Additional signs to look for include: ulcers in the in the urine or pinkish urine, rashes, joint is used to relieve some symptoms caused by mouth, throat, nose, genitals and conjunctivitis pain, breathing problems or tiredness Marketing Authorisation Holder and osteoarthritis (joint disease), rheumatoid (red and swollen eyes). These potentially life- • hair loss Manufacturer arthritis and ankylosing spondylitis threatening skin rashes are often accompanied • rashes, peeling, redness, tenderness, Accord, Barnstaple, EX32 8NS, UK. (rheumatism of the spine), such as swelling, by flu-like symptoms. The rash may progress thickening or scaling of skin stiffness and joint pain. This medicine does not to widespread blistering or peeling of the skin. • fixed drug eruption (may look like round or This leaflet was last revised in July 2021. cure arthritis and will help you only as long as The highest risk for occurrence of serious skin oval patches of redness and swelling of the you continue to take it. reactions is within the first weeks of treatment. skin), blistering (hives), itching Your doctor will only prescribe Piroxicam to If you have developed Stevens-Johnson • loosening or splitting of fingernails you when you have had unsatisfactory relief of syndrome or toxic epidermal necrolysis with • increased sensitivity of the skin to sunlight symptoms with other NSAIDs. the use of Piroxicam, you must not be re- • decreased fertility started on Piroxicam at any time. • feeling unwell, general aches and pains If you develop a rash or skin symptoms, • weight decrease. you should stop taking Piroxicam capsules immediately, seek prompt medical advice and tell your doctor that you are taking this Continued top of next column medicine. 51000959 BBBB1679 Continued over page page 4 page 1 260x210 Leaflet Reel Fed Bi Fold Profile (BST) Piroxicam 10 & 20mg hard capsule PIL - UK Piroxicam Capsules approved for print/date Item number: BBBB1679 Colours Non Printing Colours 10, 20mg x 28, 56 (UK) 1. Black 1. Profile Originator: RH Dimensions: 260x210 JDE No.: 51000959 Origination Date: 22-06-21 Min Body Text Size: 8pts 2. 2. Revision Date: 02-07-21 Supplier: Accord Barnstaple 3. 3. Dimensions: 260x210 (Reel Fed) Revised By: RH 4. Component: Leaflet for Bottle 5. Proof Round Technical Date sent: n/a Pharmacode: 7347 6. 02 Approval Date received: n/a Date Sent: 27/05/21 [email protected] Technologist: T. Hull Cartons and label leaflets only Technically Approved (labels only when specified) German GTIN 14 (incorporating PZN): * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 7 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 12.02.2020 Take special care with Piroxicam Patients over 70 years of age If you are trying to become pregnant or If you have any further questions on the capsules If you are over 70 years old, your doctor may being investigated for infertility, withdrawal use of this medicine, ask your doctor or Before prescribing Piroxicam capsules, your wish to minimise the length of your treatment of Piroxicam capsules should be considered. pharmacist. doctor will assess the benefits this medicine and to see you more often while you are taking Piroxicam capsules may increase the risk of may give you against your risk of developing Piroxicam capsules. You should not take this miscarriage in early pregnancy. 4 Possible side effects side effects. Your doctor may need to give you medicine if you are over 80 years of age. check-ups and will tell you how often you need Driving and using machines Like all medicines, this medicine can cause side to be checked during treatment with Piroxicam Other medicines and Piroxicam capsules These capsules can cause some people to feel effects, although not everybody gets them. capsules. Tell your doctor or pharmacist if you are dizzy, drowsy, tired or have problems with taking, have recently taken or might take any their vision. If you are affected, do not drive or Stop taking Piroxicam capsules and contact Medicines such as Piroxicam capsules may be other medicines, even medicines you bought operate machinery.