Piroxicam 10Mg and 20Mg Capsules Celecoxib Or Acetylsalicylic Acid (Aspirin), a Not Known (Frequency Cannot Be Estimated No Longer Use

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• 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. your doctor immediately if you notice signs associated with a small increased risk of heart yourself without a prescription. Medicines of: attack (myocardial infarction) or stroke. Any risk can sometimes interfere with each other. Your Piroxicam capsules contain lactose • an allergic reaction: asthma or worsening is more likely with high doses and prolonged doctor may limit your use of Piroxicam capsules If you have been told by your doctor that you of asthma, narrowing of the airways causing treatment or if you are a smoker. Do not or other medicines, or you may need to take a have an intolerance to some sugars, contact difficulty breathing/wheezing, rash, irregular exceed the recommended dose or duration of different medicine. your doctor before taking this medicinal raised patches with severe itching (hives), treatment. product. swelling of the face, lips, throat or tongue, The following medicines must not be taken blood vessel inflammation, serum sickness Warnings and precautions with Piroxicam capsules: This medicine contains less than 1 mmol (rash, fever, joint pain, enlarged lymph nodes) Talk to your doctor or pharmacist before • aspirin or other non-steroidal anti- sodium (23 mg) per capsule, that is to say • allergic reaction involving purple spots on taking Piroxicam capsules if you suffer from inflammatory drugs for pain relief essentially ‘sodium-free’. the skin, joint pain, abdominal pain and or have suffered in the past from any of the • anticoagulants such as warfarin to prevent kidney dysfunction (Henoch-Schoenlein following conditions: blood clots. 3 How to take Piroxicam capsules purpura) • liver disease • skin reactions such as severe rash involving • kidney disease Tell your doctor before you take Piroxicam Always take this medicine exactly as your reddening, peeling and swelling of the skin • high blood pressure, heart problems or capsules if you are taking any of the following doctor or pharmacist has told you. Check with that resembles severe burns (toxic epidermal stroke medicines: your doctor or pharmacist if you are not sure. necrolysis), severe form of skin rash with • high cholesterol or hardening of the arteries • corticosteroids, which are medicines flushing, fever, blisters or ulcers (Stevens- • asthma given to treat a variety of conditions such as Your doctor will give you a regular check-up to Johnson syndrome). See section 2 • diabetes. allergies and hormone imbalances make sure you are taking the optimal dose of • stomach or intestinal bleeding, ulceration If you have or have had any other medical • low dose aspirin (75 mg) to help prevent Piroxicam capsules. Your doctor will adjust your or perforation: pass blood in your faeces problems or any allergies, or if you are not sure heart attack or stroke treatment to the lowest dose that best controls (stools/motions), pass black tarry stools, as to whether you can take Piroxicam capsules, • certain medicines used to treat heart your symptoms. Under no circumstances vomit blood or dark particles that look like tell your doctor before taking this medicine. conditions known as cardiac glycosides, should you change your dose without first coffee grounds such as digoxin speaking to your doctor. • liver disease (fatigue, weakness, loss of You should stop taking Piroxicam capsules • certain medicines for depression such as appetite, weight loss, abdominal pain, fever) immediately and tell your doctor if you lithium or selective serotonin re-uptake Swallow your capsules whole with a glass of water. It is best to take your capsules at the or abnormal liver function (abnormal test have any allergic reaction such as a skin rash, inhibitors (SSRIs) results continue or worsen), liver disease swelling of the face, wheezing or difficulty • antihypertensives to treat high blood same time each day with food or soon after eating. causing yellowing of the skin or whites of breathing. pressure the eyes (jaundice), inflammation of the liver • methotrexate, which can be given to treat The recommended dose is: (hepatitis). Take special care with Piroxicam capsules various conditions such as cancers, psoriasis • kidney disease or failure as like all NSAIDs, Piroxicam capsules can and rheumatoid arthritis Adults • heart: water retention, high blood pressure, cause serious reactions in the stomach and • ciclosporin or tacrolimus, which are given The maximum daily dose of Piroxicam capsules heart failure. Medicines such as intestines, such as pain, bleeding, ulceration to help prevent rejection of transplanted is 20mg taken as one single daily dose. Piroxicam may be associated with a small and perforation. organs increased risk of heart attack (“myocardial • quinolone antibiotics e.g.ciprofloxacin, Elderly infarction”) or stroke You should stop taking Piroxicam capsules which are used to treat various infections immediately and tell your doctor if you have If you are older than 70 years, your doctor • indigestion or heartburn. Abdominal pain • mifepristone, a medicine used to terminate may prescribe a lower daily dose and reduce (pains in your stomach) or other abnormal stomach pain or any sign of bleeding in the pregnancy stomach or intestines, such as passing black or the duration of treatment. If you feel that the stomach symptoms • diuretics such as hydrochlorothiazide medicine is not very effective, always talk to • inflamed pancreas (which may lead to bloodstained bowel movements or vomiting to treat high blood pressure or kidney blood. your doctor. Do not increase the dose. severe pain in the upper abdomen or back) problems. • hallucinations (seeing or hearing things that Your doctor may prescribe Piroxicam capsules If you take more Piroxicam capsules than are not there). together with another medicine to protect Piroxicam capsules with food and drink you should your stomach and intestines from side effects, Piroxicam capsules should be taken with or If you accidentally take too many Piroxicam Tell your doctor if you notice any of the particularly if you are over 70 after food. capsules, contact your doctor at once or go following side effects or notice any other effects years old, or you are taking other medicines like to the nearest hospital casualty department. not listed: Pregnancy, breast-feeding and fertility Always take the labelled medicine package corticosteroids (medicines given to treat If you are pregnant or breast-feeding, think Common (may affect up to a variety of conditions such as allergies and with you, whether there is any Piroxicam you may be pregnant or are planning to have capsules left or not. 1 in 10 people): hormone imbalances), certain medicines a baby, ask your doctor or pharmacist for • changes in the red blood cells which may for depression called selective serotonin advice before taking this medicine. Do not result in unusual bruising or bleeding reuptake inhibitors (SSRIs) or low dose If you forget to take Piroxicam capsules take Piroxicam capsules if you are in the last If you forget to take a dose, take it as soon as • changes in the white blood cells which may acetylsalicylic acid (aspirin) to help prevent three months of pregnancy. It is not usually result in increased risk of infection heart attacks or stroke. you remember unless it is time for your next recommended at other stages of pregnancy, dose. Do not take a double dose to make • anorexia Piroxicam capsules may make it more difficult but you may be able to take it if your doctor up for a forgotten dose. • increase in blood sugar levels to become pregnant. You should inform your advises that it is necessary for you. • dizziness doctor if you are planning to become pregnant • headache or if you have problems becoming pregnant • vertigo (a spinning sensation) Continued top of next column Continued top of next column Continued over page

page 2 page3 260x210 Leaflet Reel Fed Bi Fold Profile (BST) Piroxicam 10 & 20mg hard capsule PIL - UK