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C Chiesi

PACKAGE LEAFLET: INFORMATION FOR THE USER

Brexidol® 20 mg Tablets

piroxicam betadex

Important things you need to know about Brexidol.

*    Brexidol is a non-steroidal anti-inflammatory medicine, prescribed to relieve the symptoms of arthritis.

*    You need to take it regularly to get the maximum benefit. Do not stop

taking it without talking to your doctor.

*    Brexidol can cause side effects in some people (read Section 4 for details).

If you have any signs of bleeding in the stomach or intestines or vomit blood, stop taking your tablets and contact your doctor immediatly.

*Your doctor will regularly monitor your condition to check you are taking the correct dose of Brexidol.

*    Your doctor may prescribe other medicines for you to take at the same time as Brexidol to protect your stomach and intestines.

*    Taking other medicines, including other NSAIDs, may sometimes cause problems.Check with your doctor or pharmacist before taking any other medicines.

Now read the rest of this leaflet. It includes other important information on the safe use of this medicine that might be especially important for you.This leaflet was last updated on 01/2009.

In this leaflet:

1.    What Brexidol is and what it is used for

2.    Before you take Brexidol

3.    How to take Brexidol

4.    Possible side effects

5.    How to store Brexidol

6.    Further information

1. What Brexidol is and what it is used for

Brexidol Tablets contain piroxicam which belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs) that reduce pain and inflammation. The piroxicam is present as a fast acting form called piroxicam betadex, allowing quicker absorption by the body to give rapid pain relief.

Before prescribing Brexidol, your doctor will assess the benefits this medicine may give you against your risk ofdeveloping side effects and may need to give you check-ups from time to time.

Yourdoctorwill prescribe Brexidol only when you have had unsatisfactory reliefofsymp-toms from other non-steroidal anti-inflammatory medicines (NSAIDs).

Brexidol Tablets relieve swelling, stiffness and joint pain in the following conditions:

•    osteoarthritis (arthrosis, degenerative joint disease)

•    rheumatoid arthritis

•    ankylosing spondylitis (form ofspinal arthritis)

These tablets do not cure arthritis but will help you only as long as you continue to take them.

2. Before you take Brexidol

Do not take Brexidol:

•    if you previously had a serious allergic drug reaction to piroxicam, other NSAIDs, other medications or any of the other ingredients in the tablets (these are listed in Section 6,Further Information), especially serious skin reactions (regardless of severity) such as exfoliative dermatitis (intense reddening ofskin, 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)

•    if you have, or have ever had a stomach or intestinal ulcer, bleeding or perforation

•    if 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 (inflammed or infected pouches/pockets in the colon)

•    if you suffer from porphyria, an inherited blood disorder that can cause increased sensitivity to light

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or could become pregnant, talk to your doctor before taking your tablets.

Brexidol 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.

Driving and using machines:

If you experience headaches, blurred vision, dizziness or drowsiness after taking these tablets, then do not drive or operate machinery.

Important information about some of the ingredients of Brexidol

Brexidol contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3.    How to take Brexidol

Always take your tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will regularly monitor your condition to check you are taking the correct dose of Brexidol and 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. If you feel this medicine is not effective, talk to your doctor.

You should take the lowest dose for the shortest time necessary to minimise side effects. Dosage

•    Brexidol is formulated so that you only have to take your tablets once a day. The label on the carton will tell you how many tablets you should take and when.

•    Your doctor may tell you to take half a tablet. To halve a tablet, place it on a flat surface so that you can see the score line and press gently with your thumb.

•    Take your tablets at the same time each day, with or after food.

•    Your doctor may prescribe other medicines for you to take at the same time as Brexidol to protect your stomach and intestines.

•    Do not stop treatment or change your dose even if you feel better unless told to do so by your doctor.

Adults and the elderly

The maximum daily dose is one Brexidol 20 mg tablet once a day

If you are older than 70 years of age your doctor may prescribe a lower daily dose for you to take and reduce your duration of treatment.

Children must not take this medicine.

Ifyou take more Brexidol than you should

If you accidentally take more Brexidol than you should, contact your nearest casualty department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you.

Ifyou forget to take Brexidol

Do not worry. Simply leave out that dose completely and then take your next dose at the right time. Do not take a double dose to make up for a missed dose.

If you have any futher questions on the use of this product, ask your doctor or pharmacist.

4.    Possible side effects

Like all medicines, Brexidol can cause side effects, although not everyone gets them.

Allergic reactions have been reported. If you experience any of these, contact your doctor or nearest casualty department immediately.

-    tight chest, severe difficulty in breathing or anaphylaxis where symptoms may be a rapid pulse, profuse sweating, feverand ifsevere, shockand collapse

-    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

-    loosening and splitting of nails and hair loss

-    swelling of blood vessels which may be associated with fever, rash and joint pains.

•    if you have heart failure

•    if you are taking anticoagulants, such as warfarin, to prevent blood clots

•    if you are taking any other NSAIDs, including COX-2 selective NSAIDs and aspirin, present in many medicines used to relieve pain and lower fever

•    if you are over 80 years of age

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

Brexidol must not be given to children.

Take special care with Brexidol and always tell your doctor if:

•    you have kidney or liver problems

•    you have a history of any blood or bleeding disorder

•    you have, or have ever suffered from asthma

•    you have heart problems, previously had a 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)

•    if you have any medical condition or allergies you are unsure about

• you are over 70 years of age. Your doctor may reduce the duration of your treatment.

• you are over 70 years of age and taking other medicines such as selective serotonin re-uptake inhibitors-SSRIs (to treat depression), steroids or aspirin (to prevent blood clotting). Your doctor may prescribe other medicines for you to take at the same time as Brexidol to protect your stomach and intestines.

If any of these apply to you, your doctor may want to perform regular tests to monitor your condition and may need to carry out blood tests from time to time.

You should immediatly stop taking Brexidol and tell your doctor ifyou have any allergic reaction such as a skin rash, swelling of the face, wheezing or difficultly breathing.

Like all NSAIDs, Brexidol can cause serious reactions in the stomach and intestines, such as pain, bleeding, ulceration and perforation. Immediatly stop taking Brexidol 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.

Medicines such as Brexidol may be associated with a small increased risk of heart attack or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

Taking other medicines

Before starting treatment, please tell your doctor or pharmacist ifyou are taking or have recently taken any other medicines, including medicines obtained without a prescription.

If you have to go to a doctor, dentist or hospital for any reason, tell them that you are taking Brexidol.

In particular, tell your doctor if you are taking:

•    lithium, to treat depression

•    methotrexate, to treat some inflammatory diseases and cancers

•    aspirin, ibuprofen or any other NSAIDs for pain relief

•    ciclosporin, to treat some inflammatory diseases and after transplants

•    quinolone antibiotics, such as ciprofloxacin to treat bacterial infections

•    water tablets (diuretics), such as amiloride

•    anticoagulants, such as warfarin to stop the blood clotting

•    medicines to treat diabetes, such as gliclazide

•    aminoglycosides, such as gentamycin to treat bacterial infections

•    probenecid, to treat gout

•    medicines to treat high blood pressure, such as beta-blockers

•    cardiac glycosides, such as digoxin to treat heart problems

•    mifepristone, used to terminate pregnancy

•    oral steroids e.g. prednisolone, used to treat many conditions such as allergies and hormone imbalances

•    cimetidine, to treat stomach ulcers

•    sulphonamides, to treat bacterial infections

•    hydantoins, such as phenytoin to treat seizures

•    selective serotonin re-uptake inhibitors (SSRI), to treat depression

•    acetylsalicyclic acid, such as aspirin to prevent platelet clumping

•    zidovudine, used to treat viral infections

•    tacrolimus, used to dampen down the body’s immune response and maybe used for severe skin complaints and following organ transplantation.

If you experience any of the following serious side effects stop taking your tablets and contact your doctor or nearest casualty department immediately.

• blood in the stools or    • perforation or ulcers of the • vomiting blood

bloody diarrhoea    stomach or small intestine • abdominal or stomach pain

The following side effects have also been reported, tell your doctor or pharmacist if you notice any of these:

•    sensitivity to sunlight

•    changes in the way your kidneys work, including kidney failure

•    reduction in red blood cells which can make the skin pale and cause weakness or breathlessness

•    reduction in blood platelets, which increases risk of bleeding or bruising

•    severe reduction in blood cells which can cause weakness, bruising or make infections more likely

•    reduction in number of white blood cells which make infection more likely

•    nosebleed

•    swelling of your feet and ankles

Medicines such as Brexidol maybe associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Ifany ofthe side effects gets serious, or ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Brexidol

•    Keep out of the reach and sight of children.

•    Do not use Brexidol after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.

•    This medicinal product does not require any special storage conditions.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Further Information

What Brexidol contains:

The active substance in your tablets is piroxicam. Each tablet contains 20 mg of piroxicam betadex.

The other ingredients are lactose monohydrate, crospovidone, sodium starch glycollate, colloidal silicon dioxide, pregelatinised starch and magnesium stearate.

What Brexidol looks like and the contents ofthe pack:

Brexidol 20 mg tablets are pale yellow, hexagonal tablets, marked with a score line in the middle on one side. They are packed in blister packs of 30 tablets.

Marketing Authorisation Holder:

Chiesi Limited, Cheadle Royal Business Park, Highfield, Cheadle, SK8 3GY, UK. Manufacturer:

Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43100 Parma, Italy.

Is this leaflet hard to see or read? Phone 0161 488 5555 for help.

CP0003/8

Please read the back of this leaflet