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PATIENT INFORMATION LEAFLET

Please read this leaflet carefully before you start to take this medicine. If you have further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them even if their symptoms are the same as yours.

Keep this leaflet; you may need to read it again.

The name of your medicine is Piroflex Capsules 10mg and 20mg. Piroflex belongs to a group of medicines called non-steroidal anti-inflammatory drugs. It works by causing a reduction in the level of prostaglandins, substances believed to be responsible for causing pain and inflammation.

Piroflex is used to relieve some symptoms such as swelling, stiffness and joint pain caused by:

•    Osteoarthritis (degenerative joint disease)

•    Rheumatoid arthritis

•    Ankylosing spondylitis (rheumatism of the spine)

It does not cure arthritis and will help you only as long as you continue to take it. Your doctor will prescribe Piroflex Capsules to you only when you have had unsatisfactory relief from symptoms with other non-steroidal anti-inflammatory medicines (NSAIDs)

Do not take your medicine if you:

•    Previously had a stomach or intestinal ulcer, bleeding or perforation

•    Currently have a stomach or intestinal ulcer, bleeding or perforation

•    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 cancer, divertculitis (inflamed or infected pouches/pockets in the colon)

•    Are taking other NSAIDs (such as ibuprofen), including COX-2-selective NSAIDs (such as celecoxib) or acetylsalicylic acid (aspirin), a substance present in many medicines to relieve pain and lower fever

•    Are taking anticoagulants, such as warfarin, to prevent clots

•    Previously had an allergic drug reaction to Piroflex, 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)

•    Have severe heart failure

Are in the last 3 months of pregnancy

Are allergic to any of the other ingredients in this medicine, see section 6, more information

If any of these apply to you, you should not be given Piroflex Capsules. Tell your doctor immediately.

Take special care with your medicine

Always tell your doctor before using this medicine. Your doctor may need to give you regular check-ups while you are taking this medicine:

•    If you have or have had medical problems or any allergies e.g. asthma

•    If you suffer from liver cirrhosis or kidney problems

•    If you suffer from heart problems or high blood pressure

•    If you have or have had stomach problems such as ulcers

Please Note: if you have heart problems, have had a previous stroke, or think you may be at risk (for example, have high blood pressure, diabetes or high cholesterol), discuss this with your doctor as Piroflex may be associated with a small increased risk of heart attack or stroke. Any risk is greater with high doses and prolonged treatment or if you are a smoker.

Taking other medicines

Tell your doctor about any other medicines you are taking or have taken 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 Piroflex or other medicines, or you may need to take a different medicine. The following medicines must not be taken with Piroflex:

•    Aspirin or other non-steroidal anti-inflammatory drugs for pain relief e.g. ibuprofen

•    Anticoagulants e.g. warfarin, to treat blood clots

Tell your doctor before taking Piroflex if you are also taking the following:

•    Corticosteroids, drugs to treat allergies and hormone imbalances

•    Lithium and other drugs to treat depression

•    Acetylsalicylic acid (aspirin even low dose aspirin to prevent platelet clumping)

•    Diuretics (water tablets) and other drugs to treat high blood pressure

•    Medicines to treat some heart rhythm problems such as cardiac glycosides, like digoxin

•    Methotrexate, a drug used in cancer treatment

•    Cyclosporin or Tacrolimus, drugs used following organ transplant

•    Quinilone antibiotics, which are used to treat bacterial infections e.g. ciproflaxin

•    Mifepristone, a drug used for terminating pregnancy

•    Antihypertensives, drugs used to treat high blood pressure

•    Ritonavir, an antiviral medicine

Your doctor may need to prescribe another medicine to protect your stomach from some of the side effects of Piroflex, If any of these apply to you, tell your doctor immediately.

If you have a blood or urine test, tell your doctor you are taking Piroflex Capsules because the medicine may affect the result.

Pregnancy and breast-feeding

Do not take this medicine without firstly consulting your doctor if you are pregnant, planning to become pregnant or are breast-feeding. Do not take this medicine in the last 3 months of pregnancy. It is not usually recommended at any time during pregnancy, but may be taken if your doctor advises it is necessary for you. Piroflex tablets may make it more difficult to conceive. If you are trying to get pregnant you should discuss this with your doctor.

Driving and using machines

This medicine can make some people feel dizzy, drowsy, or have problems with vision. If you are affected in this way you should not drive or operate machines.

Important information about some of the ingredients of your medicine

This medicine contains:

•    Lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

•    Colour amaranth (E123).The 20mg capsules contain this colour. It may cause allergic-type reactions including asthma. Allergy is more common in those people who are allergic to aspirin.

•    Sodium. Each capsule contains 160 micrograms of sodium. This is to be taken into consideration by patients on a controlled sodium diet.

Always use your medicine 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 Piroflex Capsules.

Your doctor will adjust your treatment to the lowest dose that best controls your symptoms.

Dosage: The capsules should be swallowed with a drink of water and should be taken with food.

Adults

The maximum daily dose is 20mg as one single daily dose.

Your doctor may prescribe Piroflex Capsules with another medicine to protect your stomach and intestine from potential side effects, particularly if you are aged over 70 years, or are taking other medicines like corticosteroids (medicines to treat allergies and other immune conditions), some medicines to treat depression (like SSRIs) or low dose aspirin to prevent heart attacks or stroke.

Under no circumstances should you change the dose without first speaking to your doctor.

Elderly

Your doctor may wish to minimise treatment duration and to see you more often while you are taking this medicine. You should not take this medicine if you are over 80 years of age.

Children

This medicine is not recommended for children under 12 years of age.

Overdose: if you take more of your medicine than you should

If you or anyone else has swallowed a lot of the capsules all together, contact your nearest hospital casualty department or doctor immediately.

If you forget to take your medicine

If you forget to take a dose of your medicine at the correct time, take it as soon as you remember. If it is almost time for your next dose, do not take the dose you have missed. Do not take a double dose.

If you stop taking your medicine

Keep taking this medicine until your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking this medicine, your condition may re-occur or get worse.

Like all non-steroidal anti-inflammatory drugs, Piroflex Capsules can cause serious reactions in the stomach and intestines, such as pain, bleeding, ulceration and perforation.

Stop taking your medicine and tell your doctor IMMEDIATELY if you experience any of the following side effects.

•    Stomach pain, or any sign of bleeding in the stomach or intestines, such as passing black or bloodstained bowel movements or vomiting blood

•    Allergic reaction such as skin rash, itching (particularly of the whole body), swelling of the face, wheezing or difficulty breathing

•    Difficulty in passing urine or blood in the urine

•    Persistent sore throat or high temperature

•    Yellowing of your skin or the whites of your eyes

•    Unusual bruising or bleeding, for example nose bleeds

Tell your doctor as soon as possible if you notice any of the following side effects:

•    Swollen eyes, blurred vision or eye irritations

•    Palpitations

•    Sore mouth

•    Swollen ankles

•    Hallucinations

•    Your skin may become more sensitive to light

•    Anaemia (feeling tired after exercising, giddiness, looking pale)

•    Peeling, blistering or burning of the skin

•    Hearing impairment

The following side effects are often mild and may wear off after a few day’s treatment. If they are severe or last more than a few days, tell your doctor.

•    Abdominal pain or discomfort

•    Nausea, indigestion, diarrhoea

•    Constipation, flatulence, vomiting

•    Headaches, feeling unwell

•    Pins and needles, a ringing in the ears

•    Loss of appetite

•    Abnormal dreams, mood alterations

Other rare side effects include:

•    Confusion

•    Depression

•    Nervousness

•    Sleeping problems

•    Dizziness

•    Vertigo (spinning sensation)

•    Hair loss

•    Blood disorders

•    Loss or gains in weight

•    Severe skin disorders including lumps, or itchy red spots

•    Loosening or splitting of fingernails

•    Changes in the amount of sugar in the blood

If you experience any of the above or are concerned about anything or you notice anything unusual contact your doctor.

Do not use your medicine after the expiry date shown on the pack.

KEEP OUT OF REACH AND SIGHT OF CHILDREN

Store your medicine below 30°C. Store in a dry place and protect from light. Store in the original container. If your doctor tells you to stop the treatment, return any left over to the pharmacist. Only keep it if the doctor tells you to.

What your medicine looks like

Piroflex Capsules 10mg are violet and turquoise coloured capsules printed with P10. Each capsule contains10mg of Piroxicam, the active ingredient.

Piroflex Capsules 20mg are maroon coloured capsules printed with P20. Each capsule contains 20mg of Piroxicam, the active ingredient.

What your medicine contains

The other ingredients are lactose, maize starch, sodium lauryl sulphate, crospovidone, magnesium stearate and gelatin.

The 10mg capsules contain the colours indigotine (E132), erythrosin (E127), black iron oxide (E172) and titanium dioxide (E171). The 20mg capsules contain the colours amaranth (E123) and titanium dioxide (E171).

Each capsule contains 160 micrograms of sodium.

Piroflex Capsules 10mg and 20mg are available in pack sizes of 28, 30, 56, 60, 100, 250 and 500 capsules.

This leaflet is a summary. It does not contain the complete information about your medicine. If you have any further questions or are not sure about anything, ask your doctor or pharmacist who have access to additional information.

The holder of the product licence

Athlone Pharmaceuticals Limited, Ballymurray, Co.Roscommon, Ireland.

Piroflex Capsules 10mg: PL 30464/0033 Piroflex Capsules 20mg: PL 30464/0034

This leaflet was revised in December 2011.