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Active substance(s): PIROXICAM BETADEX

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Brexidol® 20 mg Tablets


(piroxicam betadex)
Your medicine will be referred to as Brexidol throughout the following
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
- If you have any signs of bleeding in the stomach or intestines or vomit
blood, stop taking your tablets and contact your doctor immediately.
- 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
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.
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
Brexidol contains piroxicam which belongs to a group of medicines called
non- steroidal 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 of developing side effects and may need to
give you check-ups from time to time.
Your doctor will prescribe Brexidol only when you have had unsatisfactory relief
of symptoms from other non-steroidal anti-inflammatory medicines (NSAIDs).
Brexidol relieves swelling, stiffness and joint pain in the following conditions:
- osteoarthritis (arthrosis, degenerative joint disease)
- rheumatoid arthritis
- ankylosing spondylitis (form of spinal arthritis)
These tablets do not cure arthritis but will help you only as long as you
continue to take them.
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 of skin, with skin peeling off in scales or layers), vesiculobullous 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
- 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 (inflamed or infected pouches/pockets in the colon)
- if you suffer from porphyria, an inherited blood disorder that can cause
increased sensitivity to light
- 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
- 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
You should immediately stop taking Brexidol and tell your doctor if you
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. Immediately
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
Taking other medicines
Before starting treatment, please tell your doctor or pharmacist if you 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
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.

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.
- 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.
If you 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.
If you 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 further questions on the use of this product, ask your doctor
or pharmacist.
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, fever and if severe, shock and
- 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 experience any of the following serious side effects stop taking your
tablets and contact your doctor or nearest casualty department

blood in the stools or bloody diarrhoea
perforation or ulcers of the stomach or small intestine
vomiting blood
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

- changes in liver function that may cause yellowing of the skin or eyes or
affect the results from liver function tests
- high blood pressure
- heart failure
- headache
- tiredness and drowsiness
- difficulty in sleeping
- depression
- nervousness
- hallucinations
- mood changes
- nightmares
- confusion
- pins and needles
- dizziness or ‘spinning’
- blurred vision
- painful inflammation of the optic nerve in your eye
- ringing in the ears
- feeling generally unwell
- feeling your heartbeat
- low sugar levels in the blood resulting in tremors, sweating and raised
pulse rate
- weight loss or gain
- impaired hearing
- mouth ulcers
- loss of appetite
- feeling sick
- constipation
- flatulence
- diarrhoea
- indigestion
- vomiting
Medicines such as Brexidol may be associated with a small increased risk
of heart attack (myocardial infarction) or 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:
By reporting side effects, you can help provide more information on the
safety of this medicine.
Always keep these tablets in a safe place, out of the sight and reach of
Do not use these tablets after the expiry date printed on the packaging. The
expiry date refers to the last day of that month.
Do not store above 25oC. Store in the original package.
Medicines should not be disposed of via wastewater or household waste.
Ask you pharmacist how to dispose of medicines no longer required. These
measures will help protect the environment.
If your tablets become discoloured or any other signs of deterioration
please contact your doctor or pharmacist before taking this medicine.
What Brexidol contains:
Each tablet contains a 20 mg piroxicam (as betadex).
Other ingredients: lactose monohydrate, crospovidone, sodium starch
glycollate, colloidal silicon dioxide, pregelatinised starch and magnesium
What Brexidol looks like and the contents of the pack:
Pale yellow, hexagonal film-coated tablet with a median score line on one
side and plain on the reverse.
Available in blister strip packs of 30 tablets.
Manufactured by Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43100
Parma, Italy. Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1
1XD. Repackaged by Servipharm Ltd

PL No: 20636/2423

Leaflet revision and issue date (Ref) 13.09.12[2]
Brexidol is a trademark of Chiesi Farmaceutici S.p.A

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.