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PIROXICAM 20MG TABLETS

Active substance(s): PIROXICAM BETADEX

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CUSTOMER: Waymade
PRODUCT: Brexidol 20mg tabs
CODE:

6464/1547E

PRE-PRESS NO.:

06 1257

ARTWORKER:

DT

DATE OF PROOF:

27/01/14

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

DATE:

PROOF HISTORY:
v.1 - waymade - 27/01/14

«PAdBì
Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED JANUARY 2009
REPORTING OF SIDE EFFECTS

Pg 1

Pg 4

5. How to store Brexidol
Brexidol 20mg tablets/Piroxicam 20mg tablets should not be stored above 25°C.
Do not use after the expiry date printed on the carton or blister label. The expiry date refers to the last day of
that month.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop using this medicine, please take it back to the pharmacist for safe disposal.
Only keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your
pharmacis tbefore using them.
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
Your medicine is called Brexidol 20mg tablets/Piroxicam 20mg tablets. It contains 20mg of the active
ingredient, piroxicam present as a fast acting form called piroxicam betadex in a pale yellow hexagonalshaped tablet, which has a breakline on one side.
Brexidol 20mg tablets/Piroxicam 20mg tablets also contain the following:
Lactose, sodium starch glycollate, crospovidone, colloidal silicon dioxide, pregelatinised maize starch and
magnesium stearate.
Brexidol 20mg tablets/Piroxicam 20mg tablets are available as packs of 30 tablets.
POM

PL No: 6464/1547

This product is manufactured by Chiesi Farmaceutici S.p.A., Officina di Parma, Via San Leonardo 96, Italy and
procured from within the EU and repackaged by the Product Licence holder who is:
Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR.
Leaflet revision and issue date (Ref.) 27.01.2014
Brexidol is a registered trademark of Trinity Pharmaceuticals Ltd.

BREXIDOL® 20mg TABLETS
PIROXICAM 20mg TABLETS
(Piroxicam betadex)
Patient Information Leaflet

This product is known as the above names but will be referred to as Brexidol throughout this leaflet
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 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 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.
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
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 Tablets relieve 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.

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 otheringredients 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), 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 (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 torelieve 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 reuptake
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.
Pg 2 !

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

-7Æ7»³
û¬ET).

XÆE)f

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER: Waymade
PRODUCT: Brexidol 20mg tabs
CODE:

6464/1547E

PRE-PRESS NO.:

06 1257

ARTWORKER:

DT

DATE OF PROOF:

27/01/14

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

DATE:

PROOF HISTORY:
v.1 - waymade - 27/01/14

«PAdBì
Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED JANUARY 2009
REPORTING OF SIDE EFFECTS

Pg 2

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 difficulty 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
treatment.
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

acetylsalicylic 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.
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. 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.
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.

Pg 3

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.

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, fever and if severe, shock and 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 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 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 maybe associated with a small increased risk of heart attack (myocardial
infarction) or stroke.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
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: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

Pg 4 !

Pg 3 !

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

-7Æ7»³
û¬ET).

XÆE)f

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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