PIROXICAM CAPSULES 20MG

Active substance: PIROXICAM

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piroxicam
capsules
#20 mg
20
mg

Piroxicam
Capsules

piroxicam
capsules
#20 mg

28 Capsules
Each capsule contains: Piroxicam USP 20 mg.
Dosage: For oral use as directed by a doctor.
Read the enclosed leaflet.
Keep out of the sight and reach of children.
Store in a dry place below 25°C.
PL 4569/0151 POM
10005115 00000000
Mylan, Potters Bar, Herts, EN6 1TL, U.K.

30

20
mg

• weight increase or decrease
• changes in the amount of sugar in the blood
• raised levels of ANA (antibodies found when your
body's immune system reacts against your body)
• numbness or pins and needles in the arms or legs
• vertigo
• hair loss
• loosening of the finger or toe nails from the nail bed.
Not known (frequency cannot be estimated from the
available data):
• inflamed blood vessels
• sore tongue
• swollen eyes, blurred vision, eye irritations
• ringing in the ears
• changes in the way your liver works, changes to
liver enzymes

Piroxicam
Capsules
28 Capsules

Each capsule contains: Piroxicam USP 20 mg.
Dosage: For oral use as directed by a doctor.
Read the enclosed leaflet.
Keep out of the sight and reach of children.
Store in a dry place below 25°C.
PL 4569/0151 POM
10005115 00000000

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Mylan, Potters Bar, Herts, EN6 1TL, U.K.

Piroxicam Capsules are available in PVC/aluminium
blister strips in packs of 5, 7, 10, 14, 15, 20, 21, 25, 28,
30, 56, 60, 84, 90, 100, 112, 120, 168 and 180 tablets;
or in plastic bottles of 5, 7, 10, 14, 15, 20, 21, 25, 28,
30, 56, 60, 84, 90, 100, 112, 120, 168, 180, 250, 500
and 1000 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
Manufacturers:
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
Generics [UK] Ltd., Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
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This leaflet was last revised in 05/2013.

• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet.
In this leaflet:
1. What Piroxicam is and what it is used for.
2. What you need to know before you take Piroxicam.
3. How to take Piroxicam.
4. Possible side effects.
5. How to store Piroxicam.
6. Contents of the pack and other information.
1. WHAT PIROXICAM IS AND WHAT IT IS USED FOR
Piroxicam belongs to a group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs).
Piroxicam is used to relieve some symptoms

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25
02

(piroxicam)

If any of these apply to you, you should not take
Piroxicam. Tell your doctor immediately.

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
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• The other ingredients are: maize starch, talc. The
capsule shell contains: gelatin and erythrosine
(E127), indigotine (E132), titanium oxide (E171),
shellac, iron oxide black (E172), propylene glycol.
The 10 mg capsules also contain patent blue (E131).

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Warnings and precautions
Talk to your doctor or pharmacist before taking
Piroxicam.
Before prescribing Piroxicam, your doctor will assess
the benefits this medicine may give you against your
risk of developing side effects. Your doctor may need
to give you check-ups and will tell you how often you
need to be checked, due to your taking Piroxicam.

Not known (frequency cannot be estimated from the
available data):
• fast or pounding heartbeat, high blood pressure,
swollen ankles and/or feet (oedema). Medicines
such as Piroxicam may be associated with a
small increased risk of heart attack (myocardial
infarction) or stroke.
Other side effects which may occur include:
Common side effects (may affect up to 1 in 10 people):
• diarrhoea or constipation, wind
• feeling sick (nausea), vomiting, loss of appetite
• stomach ache, heartburn or indigestion,
abdominal pain/discomfort
• sore mouth and/or lips with mouth ulcers and cold
sores.

What Piroxicam Capsules look like and contents of
the pack
Each 10 mg capsule: Opaque blue body/opaque pink
cap size 2 capsule marked 'PM10' and 'G' containing
a white powder.
Each 20 mg capsule: Opaque blue body/opaque pink
cap size 2 capsule marked 'PM20' and 'G' containing
a white powder.

Rare side effects (may affect up to 1 in 1000 people):
• palpitations (when you feel your heart beat),
tightness in the chest, difficulty in breathing or
wheeziness
• stomach (peptic) ulcers
• rash with blisters
• blisters or raised bumps on the skin that contain
fluid
• skin rash or itchy skin
• dizziness
• headache
• drowsiness or difficulty in getting to sleep
• depression, nervousness, mood changes,
hallucinations, vivid dreams, confusion
• immune reaction called serum sickness-like
reaction, which causes fever, joint pain and hives
• loss of hearing

Medicines such as Piroxicam may be associated with
a small increased risk of heart attack (myocardial
infarction) or stroke. Any risk is more likely with
high doses and prolonged treatment or if you are a
smoker. Do not exceed the recommended dose or
duration of treatment.
Like all NSAIDs, this medicine can cause serious
reactions in the stomach and intestines, such as pain,
bleeding, ulceration, and perforation.

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6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Piroxicam Capsules contain
• The active substance is piroxicam. Each capsule
contains either 10 mg or 20 mg piroxicam.

• 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 cancers, diverticulitis (inflamed or
infected pouches/pockets in the colon)
• are taking other NSAIDs (such as ibuprofen),
including COX-2 selective NSAIDs (such as
celecoxib) and acetyl-salicylic acid (aspirin), a
substance present in many medicines used to
relieve pain and lower fever

caused by osteoarthritis (arthrosis, degenerative
joint disease), rheumatoid arthritis and ankylosing
spondylitis (rheumatism of the spine), such as
swelling, stiffness and joint pain. It does not cure
arthritis and will help you only as long as you
continue to take it.
Your doctor will prescribe Piroxicam to you only
when you have had unsatisfactory relief of symptoms
with other non-steroidal anti-inflammatory
medicines (NSAIDs).

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Do not take Piroxicam if you:
• are allergic to piroxicam, or to any of the other
ingredients of this medicine (listed in section 6)

• feeling unwell, unusual weakness or tiredness
without any other symptoms
• blood disorders such as low red cell count
(anaemia) and low levels of haemoglobin and
white blood cells.
Piroxicam may cause changes in the amount of sugar
in the blood which may cause some of the above
side effects.
If you get any side effects, talk to your doctor. This
includes any possible side effects not listed in this
leaflet.

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

Keep this medicine out of the sight and reach of
children.

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Other medicines and Piroxicam
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Medicines can sometimes interfere with each other.
Your doctor may limit your use of Piroxicam or
other medicines, or you may need to take a different
medicine.
The following medicines must not be taken with
Piroxicam:
• aspirin or other non-steroidal anti-inflammatory
drugs for pain relief
• anticoagulants such as warfarin to prevent blood
clots.

You should immediately stop taking Piroxicam and
tell your doctor if:
• you have stomach pain, or any sign of bleeding in
the stomach or intestines, such as passing black
or blood-stained bowel movements (stools), or
vomiting blood

• inflammed pancreas causing symptoms such as
severe pain in the upper abdomen or back
• abnormalities in the blood which may cause
symptoms such as unusual bruising or bleeding
of the skin, feeling feverish or unusually tired, sore
throat, mouth ulcers, nose bleeds, increased risk of
infection.
Very rare side effects (may affect up to 1 in 10,000
people):
• potentially life-threatening skin rashes (StevensJohnson syndrome, toxic epidermal necrolysis)
have been reported very rarely (see section 2).
Symptoms include a rash, with peeling of the skin
or blistering of skin, mouth, eyes or genitals.

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Piroxicam can make it more difficult for women to
become pregnant. Tell your doctor before taking this
medicine if you have problems becoming pregnant.
Driving and using machines
Piroxicam is not known to affect your ability to drive
or use machines. However, some side effects such
as dizziness, drowsiness and blurred vision may
occasionally occur. Do not drive or use machines if
your ability to drive and use machines is reduced.

3. HOW TO TAKE PIROXICAM
Always take Piroxicam exactly as your doctor has told
you. You should check with your doctor or pharmacist
if you are not sure.

You should not take this medicine if you are older
than 80 years.

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• ciclosporin or tacrolimus (to prevent organ
rejection after transplant surgery)
• quinolone antibiotics (e.g. nalidixic acid)
• medicines to treat high blood pressure (e.g.
atenolol, enalapril)
• cardiac glycosides (medicines to treat heart failure
e.g. digoxin)
• methotrexate (for psoriasis and also a cancer
medicine)
• mifepristone (for abortion) within the last 12 days.

Talk to your doctor before taking Piroxicam:
• if you suffer from or have a previous history of
asthma
• if you have liver or kidney problems
• if you have high blood pressure, heart problems or
stroke
• if you have a history of problems with your
stomach or gut
• if you have recently undergone major surgery
• if you have risk factors for developing heart
disease (e.g. you have diabetes or high cholesterol,
or hardening of the arteries).

If any of these apply to you tell your doctor
immediately.
Piroxicam with food and drink
You should take this medicine with or after food to
reduce the chance of a tummy upset.

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created 01-MAY-2013

Job No. 37008205v2

modified 10-MAY-2013

product category Piroxicam
market UK
packing site Gerard
product Piroxicam 20mg Capsules x 28
component type Fix-a-Form

Black

PMS 306

artwork code 10005115
superseded code 10004902

PMS 459

PMS 498
MA no. 4569/0151

new/revised Revised

change control ref. 1758
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4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Tell your doctor or go to your nearest hospital
casualty department straight away if you have any
of the following serious side effects; you may need
medical attention:

These potentially life-threatening skin rashes are
often accompanied by flu-like symptoms. The rash
may progress to widespread blistering or peeling of
the skin.
The highest risk for occurrence of serious skin
reactions is within the first weeks of treatment.
If you have developed Stevens-Johnson syndrome or
toxic epidermal necrolysis with the use of Piroxicam
you must not be re-started on Piroxicam at any time.
If you develop a rash or these skin symptoms, stop
taking Piroxicam, seek urgent advice from a doctor
and tell him that you are taking this medicine.
If you develop problems with your vision during
treatment you should have your eyes tested.

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Your doctor will give you a regular check-up to make
sure you are taking the optimal dose of Piroxicam.
Your doctor will 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.
Your doctor will decide what dose you need. This
will depend on your age and the severity of your
condition.
Adults: The maximum recommended daily dose is
20 mg of Piroxicam as one single dose.
Elderly
If you are more than 70 years old, your doctor may
prescribe a lower daily dose and reduce the duration
of treatment.

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Tell your doctor before you take Piroxicam if you
are taking any of the following medicines:
• corticosteroids, which are drugs given to treat
a variety of conditions such as allergies and
hormone imbalances
• certain drugs for depression called selective
serotonin re-uptake inhibitors (SSRIs, e.g.
sertraline, paroxetine)
• drugs such as acetylsalicylic acid to prevent
platelet clumping
• diuretics ('water' tablets)
• lithium (for mental illness). Your doctor may
need to monitor the levels of lithium in your
blood when starting, adjusting the dose of, or
discontinuing Piroxicam

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Rare side effects (may affect up to 1 in 1000 people):
• you have stomach pain, or any sign of bleeding in
the stomach or intestines, such as passing black
or blood-stained bowel movements (stools), or
vomiting blood. This bleeding can be fatal.
• sudden wheeziness, difficulty in breathing, fever,
swelling of eyelids, face or lips, rash or itching
(especially affecting the whole body)
• yellowing of the skin and the whites of your eyes
(jaundice), abdominal pain and sickness which
may be a sign of hepatitis or other liver problems
and can be fatal
• kidney inflammation, kidney failure or kidney
damage, change in your urine output or
appearance, possibly accompanied by kidney
pain, or pain in your abdomen or back

5. HOW TO STORE PIROXICAM

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If you stop taking Piroxicam
Do not stop taking Piroxicam without talking to your
doctor. If you stop your medicine before finishing
your course of treatment this may cause your pain or
inflammation to get worse.
If you have any further questions about this
medicine, ask your doctor or pharmacist.

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• you have any allergic reaction such as skin
rash, swelling of the face, wheezing or difficulty
breathing.
If you are over 70 years old, your doctor may wish to
minimise treatment duration and to see you more
often while you are taking Piroxicam.
If you are over 70 years old, or you are taking other
medicines like corticosteroids or certain drugs for
depression called selective serotonin reuptake
inhibitors (SSRIs), or acetyl-salicylic acid (aspirin) to
prevent blood clotting, your doctor may prescribe
you a medicine for protecting your stomach and
intestines, to take together with Piroxicam. For
example, misoprostol, or a type of medicine called a
proton pump inhibitor (e.g. omeprazole).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PIROXICAM

Your doctor may prescribe Piroxicam with another
medicine to protect your stomach and intestine from
potential side effects. Do not increase the dose. If you
feel that your medicine is not very effective, always
talk to your doctor.
If you take more Piroxicam than you should
Contact your nearest hospital casualty department
immediately. Take the container and any remaining
medicine with you.

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Do not use this medicine after the expiry date, which
is stated on the blister, carton or bottle after 'EXP'.
The expiry date refers to the last day of that month.
Store the capsules in a dry place below 25 °C. Keep
the bottle tightly closed. Keep the blister strip in the
outer carton.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

If you have any medical problems or any allergies or if
you are not sure as to whether you can use Piroxicam,
tell your doctor before taking this medicine.
You should take the lowest dose of Piroxicam that
controls your symptoms, and for the shortest length
of time. This will minimise undesirable effects.
Potentially life-threatening skin rashes (StevensJohnson syndrome, toxic epidermal necrolysis) have
been reported with the use of Piroxicam, appearing
initially as reddish target-like spots or circular patches
often with central blisters on the trunk.
Additional signs to look for include ulcers in the
mouth, throat, nose, genitals and conjunctivitis (red
and swollen eyes).
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the face, lips, mouth, tongue or throat which may
cause difficulty in swallowing or breathing) or
urticaria (hives) following treatment with aspirin
and other NSAIDs
• have severe heart failure
• are in the last three months of pregnancy.

PIROXICAM CAPSULES
10 mg AND 20 mg

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• are taking anticoagulants, such as warfarin, to
prevent blood clots
• previously had an allergic drug reaction to
piroxicam (the active ingredient in this medicine)
or any of the other ingredients of this medicine,
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),
Stevens-Johnson syndrome (symptoms are a rash,
blistering or peeling of the skin, mouth, eyes or
genitals) and toxic epidermal necrolysis, (a disease
with blistering and peeling of the top layer of skin)
• have previously had asthma, nasal polyps
(abnormal tissue that grows inside passages of
the nose and sinuses), angioedema (swelling of

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Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before
taking this medicine.
If you are pregnant or breast-feeding tell your doctor
before you take Piroxicam. Do not take Piroxicam
if you are in the last three months of pregnancy
because it might cause problems to the unborn child
or complications during delivery. It is not usually
recommended at other stages of pregnancy, but you
may be able to take it if your doctor advises that it is
necessary for you.
Piroxicam may reach your baby through the breast
milk. Therefore, you must not take Piroxicam if you
are breast-feeding.

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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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