PIROXICAM CAPSULES 20MG

Active substance: PIROXICAM

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PIROXICAM
Capsules
20mg

For further information, see
Patient Information Leaflet.
KEEP OUT OF THE REACH
AND SIGHT OF CHILDREN
Store in a cool, dry place
below 30°C and protect
from light.

Each capsule contains:
Piroxicam 20mg

28 Capsules

M0167TB

Page 1

POM

5 017123 092138

Also contains lactose.

PL20416/0138

For oral administration, as
directed by the doctor.

3. How to take Piroxicam Capsules
Swallow the capsules whole with water. Take with or after food.
Always use piroxicam exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
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.

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Adults and Elderly:
The maximum daily dose is 20 milligrams of piroxicam as one single
daily dose.
If you are older than 70 years your doctor may prescribe a lower daily
dose and reduce the duration of treatment.
Your doctor may prescribe piroxicam with another medicine to protect
your stomach and intestine for potential side effects.
Do not increase the dose.
If you feel that the medicine is not very effective, always talk to your

doctor.
Children: This medicine is not recommended for children.
Remember, this medicine is for YOU. Do not give it to someone else,
even if their symptoms are the same as yours. This medicine may
harm them.
If you forget to take a dose:
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.

If you have any further questions on the use of this product, ask
your doctor.
If you have taken too many capsules:
If you think you have taken too many capsules, contact your doctor
straight away or go to the nearest hospital casualty department. Take
with you any remaining capsules and the pack so that the medicine
can be identified.
Some people may have side effects when taking this medicine. If you

have any unwanted side effects you should seek advice from your
doctor, pharmacist or healthcare professional. Also you can help to
make sure medicines remain as safe as possible by reporting any
unwanted side effects via the internet at www.yellowcard.gov.uk;
alternatively you can call Freephone 0808 100 3352 (available
between 10am-2pm Monday-Friday) or fill in a paper form available
from you local pharmacy. There will be fewer side effects if you take
the lowest effective dose for the shortest time necessary.
If you suffer from any of the following at any time during your
treatment STOP TAKING the medicine and seek immediate medical

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4. Possible side effects

help:
pass blood in your faeces (stools/motions)
pass black tarry stools
● vomit any blood or dark particles that look like coffee grounds
These may be signs of a stomach ulcer or bleeding in your stomach.
STOP TAKING the medicine and tell your doctor if you experience:
● indigestion or heartburn
● abdominal pain (pains in your stomach) or other abnormal stomach
symptoms
● allergic reactions which can include skin rash, itching, bruising,

painful red areas, peeling or blistering, dizziness, difficulty in
breathing, wheezing or shortness of breath, swollen face, throat, lips,
hands or fingers, fever or joint pain
● yellowing of your skin or the whites of your eyes and/or pale stools,
dark urine, loss of appetite as these may be signs of liver problems
● passing more or less urine than normal, cloudy urine, blood in urine,
pain in the back, swelling (particularly of the ankles) as these may be
signs of kidney problems.
If you experience any of the following very rare effects, STOP TAKING
the capsules and tell your doctor as soon as possible:

inflammation of the pancreas causing severe pain in the abdomen
and back
Stevens-Johnson syndrome (serious illness causing blistering of the
skin, mouth, eyes and genitals)
● toxic epidermal necrolysis (serious illness causing blistering of the
skin).
Tell your doctor or pharmacist if you notice any of the side effects
listed in the sections below:
Other effects which have been reported are:
● high blood pressure, oedema (water retention), heart failure (which

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can cause shortness of breath or swollen ankles)
feeling or being sick, loss of appetite, diarrhoea, constipation, flatulence
(wind) or sore mouth
● worsening of the symptoms of colitis and Crohn’s disease.
The following have been reported less commonly:
● blood disorders including severe reduction in the number of white or
red blood cells which may cause pale skin, weakness or breathlessness
and increase the risk of bleeding or bruising or make infections more
likely
● nosebleed, increased sensitivity to light, loosening or loss of


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fingernails, loss of hair
headache, feeling of dizziness or “spinning”, tiredness, drowsiness,
confusion, eyesight problems (such as blurred, partial or complete loss
of vision, blind spots, halos around lights), irritated or swollen eyes,
tingling or numbness in the hands or feet, depression or hallucinations
● difficulty sleeping, dream abnormalities, mood changes or nervousness
● palpitations, hearing problems or ringing in the ears, raised or lowered
blood sugar levels, or weight changes
● inflammation of the blood vessels, often with skin rash
● aseptic meningitis (especially in patients with auto-immune disorders

such as systemic lupus erythematosus and mixed connective tissue
disease). Symptoms include fever, headache, stiff neck and back,
feeling sick or being sick, skin rash, eyes being very sensitive to
bright light, disorientation and muscle pain
● medicines such as piroxicam may be associated with a small
increased risk of heart attack ("myocardial infarction") or stroke.

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5. How to store Piroxicam Capsules
Store in a cool, dry place below 30°C and protect from light.
Do not take the capsules if the expiry date on the pack has passed. If

you have any medicines that are out of date, return them to your
pharmacist for safe disposal.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF
CHILDREN

6. Further information
Ingredients
Piroxicam Capsules contain 20mg of piroxicam as the active
ingredient. They also contain the inactive ingredients: maize starch,
lactose monohydrate, magnesium stearate, and sodium laurilsulfate.
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The capsule shells contain gelatin, titanium dioxide (E171),
erythrosine (E127) and white printing ink.
What Piroxicam Capsules look like:
The capsules are red and are printed with PRX20 and the Crescent
moon logo.
The capsules are available in packs of 28, 30, 56 and 60 capsules (not
all pack sizes may be marketed)
Who makes this medicine and holds the Product Licence:
Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units,
Polhampton Lane, Overton, Hants, RG25 3ED

Date leaflet revised: August 2012
If you would like this leaflet in a different format please contact the
licence holder at the above address.

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PATIENT INFORMATION LEAFLET

PIROXICAM Capsules 20mg
Please read all of this leaflet carefully before you start taking this
medicine.
Keep the leaflet; you may need to read it again. If you have any
questions or are not sure about anything, ask your doctor or
pharmacist.

In this leaflet:

2.
3.
4.
5.
6.

Before you take Piroxicam Capsules
How to take Piroxicam Capsules
Possible side effects
How to store Piroxicam Capsules
Further information

1. What Piroxicam Capsules are and what they are used
for
The name of this medicine is Piroxicam Capsules 20mg. Each 20mg
capsule contains 20mg of piroxicam as the active ingredient.

1. What Piroxicam Capsules are and what they are used for
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This medicine belongs to a group of drugs known as non-steroidal
anti-inflammatory drugs (NSAIDs). These are used for the relief of
pain and inflammation associated with muscle and joint disorders and
other painful conditions.
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 you taking piroxicam.
Piroxicam Capsules are used to relieve some symptoms caused by
osteoarthritis (arthrosis, degenerative joint disease), rheumatoid
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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 antiinflammatory medicines (NSAIDs).

2. Before you take Piroxicam Capsules
Do not take these capsules if:
you previously had a stomach or intestinal ulcer, bleeding or



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perforation
you currently have stomach or intestinal ulcer, bleeding or perforation
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)
● you are allergic to piroxicam or to any of the other ingredients in the
capsules (see section 6)
● you 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 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)
● you have had any form of allergic reaction (such as asthma, blocked or
runny nose, nasal polyps, swelling of the face or throat, skin rash or
itching) to ibuprofen, aspirin or other non-steroidal anti-inflammatory
drugs (NSAIDs)

you are taking other NSAIDs, including COX-2 selective NSAIDs and
acetyl-salicylic acid (aspirin)
you are taking anticoagulants, such as warfarin, to prevent blood
clots
● you have severe heart, liver or kidney problems
● you are more than 6 months pregnant.
If any of these applies to you, you should not be given piroxicam. Tell
your doctor immediately.
Check with your doctor before taking these capsules if:
● you have heart, liver or kidney problems or high blood pressure

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you have, or have ever had asthma as piroxicam might bring on an
attack
you are elderly, as you may be more likely to suffer side effects. 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 acetylsalicylic acid
(aspirin) to prevent blood clotting, your doctor may like to prescribe
you, together with piroxicam, a medicine for protecting your stomach

and intestines. You should not take this medicine if you are older
than 80 years.
you have systemic lupus erythematosus (SLE) or mixed connective
tissue disorder (an immune system disorder)
● you are in the first 6 months of pregnancy or you are breastfeeding.
Taking other medicines
Tell your doctor about any other medicines you are taking or took
recently (in the last week) – even medicines you bought yourself
without a prescription. 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. It’s
especially important to mention if you are taking:
● aspirin or other non-steroidal anti-inflammatory drugs for pain
relief e.g diflunisal, ibuprofen, naproxen, diclofenac
● corticosteroids, which are drugs given to treat a variety of
conditions such as allergies and hormone imbalances
● anticoagulants such as warfarin (used to prevent blood clots)
● certain drugs for depression called selective serotonin re-uptake
inhibitors (SSRIs)
● any drugs such as acetylsalicylic acid (aspirin) to prevent platelet

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clumping
diuretics (water tablets) such as triamterene, thiazides and
furosemide
● digoxin or digitoxin (used to treat heart failure)
● cimetidine (used to treat ulcers)
● lithium (used to treat depressive illness)
● antihypertensives (used to treat high blood pressure)
● methotrexate (used to treat cancer, psoriasis, rheumatoid arthritis
etc)
● ciclosporin or tacrolimus (to prevent rejection following organ or


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bone marrow transplants)
mifepristone (used to terminate a pregnancy)
quinolone antibiotics such as ciprofloxacin or ofloxacin
● zidovudine (to treat HIV infection).
If any of these applies to you tell your doctor immediately.
Other special warnings
● Like all non-steroidal anti-inflammatory drugs, piroxicam capsules
can cause serious reactions in the stomach and intestines, such as
pain, bleeding, ulceration and perforation. You should immediately
stop taking piroxicam and tell your doctor if you have stomach



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pain, or any sign of bleeding in the stomach or intestines, such as
passing black or bloodstained bowel movements, or vomiting blood.
You should immediately stop taking piroxicam and tell your doctor if
you have any allergic reaction such as a skin rash, swelling of the
face, wheezing or difficulty breathing.
● If you have or have had any medical problems or any allergies or if
you are not sure as to whether you can use piroxicam tell your
doctor before using this medicine.
● Medicines such as piroxicam may be associated with a small
increased risk of heart attack ("myocardial infarction") or stroke. Any


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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 pharmacist.
● 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.
● This medicine can affect the results of laboratory tests, including

bleeding times. Before you have any tests, tell your doctor you are taking
this medicine.
These capsules contain lactose. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before taking
these capsules.
Effects on driving or operating machiner y
Piroxicam Capsules may make you feel dizzy, tired, drowsy or might affect
your vision. If you think this medicine has affected you do not drive or
operate machinery.

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28 Capsules

Capsules
20mg

For further information, see
Patient Information Leaflet.
KEEP OUT OF THE REACH
AND SIGHT OF CHILDREN
Store in a cool, dry place
below 30°C and protect
from light.

Each capsule contains:
Piroxicam 20mg

28 Capsules

M0167TB

POM

5 017123 092138

Expiry Date:

Each capsule contains:
Piroxicam 20mg

Batch No.:

Capsules
20mg

PL20416/0138

Also contains lactose.

PIROXICAM

PIROXICAM
M0167TB

Peel here to open but do not remove ▲

Crescent Pharma Limited, Units 3 & 4,
Quidhampton Business Units, Polhampton Lane,
Overton, Hampshire RG25 3ED

For oral administration, as
directed by the doctor.

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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