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Active substance(s): PIROXICAM

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• stomach or intestinal bleeding,
ulceration or perforation: pass blood in
your faeces (stools/motions), pass black
tarry stools, vomit blood or dark particles
that look like coffee grounds.
• liver disease (fatigue, weakness, loss
of appetite, weight loss, abdominal
pain, fever) or abnormal liver function
(abnormal test results continue or
worsen), liver disease causing yellowing
of the skin or whites of the eyes
(jaundice), inflammation of the liver
• kidney disease or failure.
• heart: water retention, high blood
pressure, heart failure. Medicines such
as Piroxicam may be associated with
a small increased risk of heart attack
(“myocardial infarction”) or stroke.
• aseptic meningitis may occur with
symptoms such as headache, fever, stiff
neck, feeling or being sick.
• indigestion or heartburn. Abdominal
pain (pains in your stomach) or other
abnormal stomach symptoms.

Tell your doctor if you notice any of the
following side effects or notice any other
effects not listed:
• skin reactions: rash, itching, loosening
of a finger or toe nail, hair loss, sensitivity
to sunlight or artificial light (e.g. sun
• stomach and intestines: abdominal
discomfort, loss of appetite, constipation,
diarrhoea, wind, feeling or being sick,
inflammation of the mouth, ulcerative
stomatitis (inflammation and ulcers
of the bowel), worsening of colitis or
Crohn’s disease, inflammation of the
pancreas or stomach.
• nervous system: dizziness, headache,
a spinning sensation, drowsiness,
tiredness, anxiety, fits, depression,
disorientation, visual disturbances
(blurred or double vision), impaired
hearing, inability to sleep, irritability,
confusion, hallucinations, memory
disturbance, nightmares, ‘pins and
needles’, psychotic reactions, ringing
or buzzing in the ears, tremor, taste
• kidneys: increases in the levels of
nitrogen in the blood and creatinine.
• blood: decreases in haemoglobin and
haematocrit, disturbance of blood
count (anaemia, thrombocytopenia,
leucopenia, neutropenia, agranulacytosis,
eosinophilia, aplastic anaemia, haemolytic
anaemia), disorder characterised by blood
spots, bruising and discolouring to the
skin, joint inflammation and stomach
pain (Henoch-Schoenlein purpura),

• other: palpitations, difficulty breathing,
positive anti-nuclear antibody test,
hearing impairment, low blood sugar,
increase or decrease in weight, swollen
eyes, blurred vision, eye irritation, a
feeling of general discomfort and illness,
ringing or buzzing in the ears.

Package leaflet: information for the user

Piroxicam 10mg and 20mg

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.

How to store Piroxicam


Keep out of the sight and reach of children.
Store below 25°C in a dry place. Protect
from light.
Do not use Piroxicam capsules after the
expiry date which is stated on the label/
Ask your pharmacist how to dispose of
medicines no longer required.

Contents of the pack and other

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50898648 AAAI9960


What Piroxicam capsules contain

• The active substance (the ingredient that
makes the medicine work) is piroxicam.
Each capsule contains either 10mg or
20mg of the active ingredient.
• The other ingredients are carmellose
sodium, gelatin, lactose, magnesium
stearate, maize starch, polysorbate,
shellac glaze, E127, E132 (10mg only),
E171, E172 and propylene glycol.

What Piroxicam capsules look like
and contents of the pack

Piroxicam 10mg capsules are pink and
turquoise hard gelatin capsules printed “C”
and the identifying letters “YA” in black and
are in pack sizes of 56.
Piroxicam 20mg capsules are pink hard
gelatin capsules printed “C” and the
identifying letters “YB” in black and are in
pack sizes of 28.
Marketing Authorisation Holder and
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in June 2016.

Actavis, Barnstaple, EX32 8NS, UK

page 4

Read all of this leaflet carefully before
you start taking this medicine because
it contains important information for
• 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.
• If you get any side effects, talk to your
doctor or pharmacist. This includes
any possible side effects not listed in
this leaflet. See section 4.

2 W
 hat you need to know before

What is in this leaflet:
1 W
 hat Piroxicam capsules are
and what they are used for
2 W
 hat you need to know before
you take Piroxicam capsules
3 H
 ow to take Piroxicam capsules
4 P
 ossible side effects
5 H
 ow to store Piroxicam
6 C
 ontents of the pack and other
1 W
 hat Piroxicam capsules are

and what they are used for

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.
Piroxicam belongs to a group of pain killers
called Non-Steroidal Anti-Inflammatory
Drugs (NSAIDs) and is used to relieve
some symptoms 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 NSAIDs.

page 1

you take Piroxicam capsules

Do not take Piroxicam capsules if

• are allergic to piroxicam or any of the
other ingredients of this medicine (listed
in section 6).
• are allergic to aspirin or previously
had a serious allergic drug reaction to
piroxicam, 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
• potentially life-threatening skin rashes
(Steven-Johnsons 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).
These potentially life-threatening skin
rashes are often accompanied by flulike 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, seek
immediate advice from a doctor and tell
them that you are taking this medicine.
• have ever experienced symptoms of
swelling of face or hands (angioneurotic
oedema), asthma, hayfever, swelling of
nasal passage (nasal polyps) or hives with
aspirin or NSAIDs.
• have a peptic ulcer (ulcer in your
stomach or duodenum) or bleeding
in your stomach, or have had two or
more episodes of peptic ulcers, stomach
bleeding or perforation.

Continued over page

• 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, including
COX-2 selective NSAIDs and aspirin, a
substance presents in many medicines
used to relieve pain and lower fever.
• are taking anticoagulants, such as
warfarin, to prevent blood clots.
• suffer from severe heart failure.

• are suffering from frequent headaches
and regular use of analgesic drugs
does not help you, you should contact
your doctor. To prevent a possible
deployment of chronic headache (MOH),
recommended daily doses must be
followed carefully and especially avoid
high monthly consumption of migraine

• medicines which increase the risk of
bleeding such as pentoxifylline.
• penicillamine for rheumatic disease.
• immunosupressants such as tacrolimus
• antiviral drugs to treat AIDs such as

Side effects may be minimised by using
the lowest effective dose for the shortest
duration necessary.

Pregnancy, breast-feeding and

If any of these applies to you tell your
doctor immediately.

Piroxicam 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. Piroxicam should
not be taken during the first 6 months and
must not be taken in the last 3 months of
pregnancy. If you are breast-feeding, you
should not take Piroxicam capsules.

Children and adolescents

Piroxicam capsules is not recommended in
children under 12 years of age.

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

Other medicines and Piroxicam

Warnings and precautions

Talk to your doctor or pharmacist before
taking Piroxicam capsules if you:
• have or have had any heart problems
or high blood pressure. 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. Do
not exceed the recommended dose or
duration of treatment. If you have heart
problems, previous 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) you should discuss
your treatment with your doctor or
• have any liver or kidney problems.
• are elderly as you have an increased risk
of getting side effects. If you are over
70 years old, your doctor may wish to
minimise treatment duration and see
you more often while you are taking
piroxicam. You should not take this
medicine if you are older than 80 years.
Your doctor may like to prescribe you a
medicine for protecting your stomach
and intestines.
• have or have had asthma.have ever
had gastrointestinal complications such
as ulceration, bleeding or a history of
ulcerative colitis or Crohn’s disease
• suffer with systemic lupus
erythematosus or other connective
tissue disorders.
• take a painkiller for headaches for more
than 3 days it can make them worse.

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page 2

Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines. Your doctor may limit
your use of Piroxicam or other medicines,
you may need to take a different medicine
or your doctor may prescribe another
medicine to protect your stomach and
intestine against side effects. It is especially
important to mention:
• any diuretic medicine (“water tablets”)
e.g. furosemide, bendroflumethiazide
• anticoagulants (which prevent blood
clotting) e.g. warfarin.
• aspirin, non-steroidal antiinflammatory drugs (NSAIDs) or CoxII-Inhibitors for pain (e.g. ibuprofen or
• medicines to treat high blood pressure
such as lisinopril, iloprost or losartan.
• cardiac glycosides (e.g. digoxin) to treat
some heart conditions.
• methotrexate, to treat some types of
cancer or rheumatoid arthritis.
• corticosteroids, which are drugs given
to treat a variety of conditions such as
allergies and hormone imbalances.
• mifepristone, used for termination of
pregnancy. Piroxicam capsules should
not be taken within 8-12 days of taking
• ciclosporin or tacrolimus, to prevent
the rejection of transplants.
• quinolone antibiotics (e.g.
ciprofloxacin) or zidovudine (an
antiviral), to treat infections.
• lithium, used to treat depression. Your
doctor should check your blood levels of
lithium when you start, stop or change
your dose of piroxicam.
• cimetidine, to treat stomach ulcers.
• antidepressants such as selective
serotonin re-uptake inhibitors (SSRI) or
• any drug to prevent platelet clumping
such as aspirin or clopidogrel.

• Adults (including the elderly): Initially
20mg a day as a single dose. The
maintenance dose is 10-20mg a day as a
single dose.
The maximum daily dose is 20mg of
piroxicam as one single dose.
• Elderly: If you are older than 70 years
your doctor may prescribe a lower
daily dose and reduce the duration of
• Children under 12 years: Piroxicam
capsules should not be taken by children
under 12 years of age.

If you take more Piroxicam capsules
than you should
It is important not to take too many
capsules. If you have taken more than you
should, contact your doctor, pharmacist
or nearest hospital casualty department
immediately. Signs of an overdose include
headache, dizziness, , drowsiness, fainting,
ringing in the ears, feeling or being sick,
diarrhoea, stomach pain or bleeding,
feeling disorientated or excited, coma or

Driving and using machines

Piroxicam capsules may make you feel
dizzy, drowsy, tired or affect your vision.
Make sure you are not affected before you
drive or operate machinery.

If you forget to take Piroxicam

Piroxicam capsules contains lactose
If a doctor has told you that you have an
intolerance to some sugars, contact your
doctor before taking this medicine, as it
contains lactose.

If you forget to take your capsules, take
it as soon as you remember, unless it is
nearly time for your next dose, do not take
the dose you have missed. Do not take a
double the dose to make up for a forgotten

Eye test

If you develop problems with your eyes
you should have an eye test.


How to take Piroxicam capsules


Always take this medicine exactly as your
doctor has told you. Check with your
doctor or pharmacist if you are not sure.

Swallow the capsules with water, with or
after food.
Drink plenty of water while taking
Piroxicam to avoid dehydration.
Your doctor will give you regular check-ups
to make sure you are taking the best dose
of piroxicam and will adjust your treatment
to the lowest dose that best controls your
Under no circumstances should you
change the dose without first speaking to
your doctor.
Your doctor may prescribe another
medicine to protect your stomach and
intestines from potential side effects.
Do not increase the dose. If you feel that
the medicine is not very effective, always to
your doctor.

Possible side effects

Like all medicines, Piroxicam capsules can
cause side effects, although not everybody
gets them.
Stop taking Piroxicam capsules and
contact your doctor immediately if you
notice signs of:
• an allergic reaction: asthma or
worsening of asthma, narrowing of the
airways causing difficulty breathing/
wheezing, rash, irregular raised patches
with severe itching (hives), swelling of
the face, lips, throat or tongue, blood
vessel inflammation, serum sickness
(rash, fever, joint pain, enlarged lymph
• skin reactions such as severe rash
involving reddening, peeling and
swelling of the skin that resembles
severe burns (toxic epidermal necrolysis),
severe form of skin rash with flushing,
fever, blisters or ulcers (Stevens-Johnson
syndrome). See section 2.

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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.