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PIROXICAM 20 MG CAPSULES HARD

Active substance(s): PIROXICAM

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Piroxicam
#20 mg
capsules
Piroxicam
#20 mg
capsules

GLUE AREA

20 Piroxicam 20 mg
mg capsules, hard

Marketing Authorisation Holder:
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United
Kingdom.

20 Piroxicam 20 mg
mg capsules, hard

28 capsules, hard

Manufacturers:
Gerard Laboratories, 35/36 Baldoyle Industrial
Estate, Grange Road, Dublin 13, Ireland.
Generics [UK] Ltd, Potters Bar, Hertfordshire, EN6
1TL, United Kingdom.

28 capsules, hard

Each capsule contains: Piroxicam 20 mg.
Dosage: For oral use as directed by a doctor.
Read the attached leaflet before use.
Keep out of the sight and reach of children.
Store below 25°C. Bottles: Keep the bottle tightly
closed in order to protect from moisture.

Each capsule contains: Piroxicam 20 mg.
Dosage: For oral use as directed by a doctor.
Read the attached leaflet before use.
Keep out of the sight and reach of children.
Store below 25°C. Bottles: Keep the bottle tightly
closed in order to protect from moisture.

PL 04569/0151 POM
463346 LL0432AG
Mylan, Potters Bar, Herts,
EN6 1TL, U.K.

PL 04569/0151 POM
463346 LL0432AG
Mylan, Potters Bar, Herts,
EN6 1TL, U.K.

21122222

TBC

Each 10 mg capsule: Opaque blue body/opaque
pink cap size 2 capsule marked ‘’PM10’’ and ‘’G’’
containing a white powder.

Package leaflet: Information for the patient

Each 20 mg capsule: Opaque pink body/opaque
pink cap size 2 capsule marked ‘’PM20’’ and ‘’G’’
containing a white powder.

PIROXICAM 10 mg AND 20 mg
CAPSULES, HARD
(piroxicam)

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 capsules; or in plastic bottles (which
may contain a plastic spacer at the top of the
pack) 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.

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.

1. What Piroxicam is and what it is used for

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.

Piroxicam belongs to a group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs).
Piroxicam 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.

Store below 25°C.
Blisters: Store in the original package in order to
protect from moisture.
Bottles: Keep the bottle tightly closed in order to
protect from moisture.
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.

Your doctor will prescribe Piroxicam to you
only when you have had unsatisfactory relief
of symptoms with other non-steroidal antiinflammatory medicines (NSAIDs).

• nose bleeds
• inflammation of the stomach lining (gastritis)
• feeling unwell, unusual weakness or tiredness
without any other symptoms.
• loosening of the finger or toe nails from the nail
bed
• sensitivity to sunlight
• decreased fertility (in women)
• weight decrease
• hair loss
• change in the amount of red blood cells as seen
in blood tests
• raised levels of ANA (antibodies found when
your body’s immune system reacts against your
body).

21TBC
122222

2. What you need to know before you take
Piroxicam

Warnings and precautions
Talk to your doctor or pharmacist before taking
Piroxicam.

Like all NSAIDs, this medicine can cause serious
reactions in the stomach and intestines, such as
pain, bleeding, ulceration, and perforation.

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.

Uncommon side-effects (may affect up to 1 in
100 people):
• blurred vision
• palpitations (when you feel your heart beat),
• low blood sugar level

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.

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
• you have any allergic reaction such as skin
rash, swelling of the face, wheezing or difficulty
breathing.

• abnormalities in the blood which may cause
symptoms such as unusual or bruising under
the skin or bleeding, feeling feverish or
unusually tired, an increase in the number of
infections such as sore throat, mouth ulcers or
wounds (lesions) in the mouth or other parts of
the body that you may get.

medicine.

Rare side effects (may affect up to 1 in 1000
people):
• kidney inflammation, kidney failure or kidney
damage - you may notice a change in your urine
output or appearance, possibly accompanied by
kidney pain, or pain in your abdomen or back.

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.

What Piroxicam Capsules look like and contents
of the pack

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any 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.

• if you are allergic to piroxicam, or any of the
other ingredients of this medicine (listed in
section 6)
• if you previously had a stomach or intestinal
ulcer, bleeding or perforation
• if you currently have 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,

drowsiness
vertigo
ringing in the ears
weight increase
diarrhoea or constipation, wind
feeling sick (nausea), vomiting, loss of appetite
stomach ache, heartburn or indigestion,
abdominal pain/discomfort
• changes in the way your liver works, changes to
liver enzymes as seen in blood tests

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

- The active substance is piroxicam. Each capsule
contains either 10 mg or 20 mg piroxicam.
- The other ingredients are: maize starch, talc. The
capsule shell contains: gelatin and erythrosine
(E127), indigo carmine (E132) and titanium
oxide (E171). The printing ink on the capsule
shell contains: shellac, iron oxide black (E172),
ammonium hydroxide (E527), and propylene
glycol. The 10 mg capsules also contain patent
blue (E131) in the capsule shell.

Do not take 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).

What Piroxicam Capsules contain

What is 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

epidermal necrolysis, (a disease with blistering
and peeling of the top layer of skin)
• if you have previously had asthma, nasal polyps
(abnormal tissue that grows inside passages of
the nose and sinuses), angioedema (swelling
of 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
• if you have severe heart failure
• if you are in the last three months of pregnancy.

to minimise treatment duration and to see you
more often while you are taking Piroxicam.

6. Contents of the pack and other information

• 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.

diverticulitis (inflamed or infected pouches/
pockets in the colon)
• if you are taking other NSAIDs (such as
ibuprofen), including COX-2 selective NSAIDs
(such as celecoxib) and acetylsalicylic acid
(aspirin), substances present in many medicines
used to relieve pain and lower fever
• if you are taking anticoagulants, such as
warfarin, to prevent blood clots
• if you previously had an allergic drug reaction
to other NSAIDs or any 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

be fatal. These symptoms may be a sign of
a stomach ulcer or other problems, such as
bleeding, in the stomach or gut
• inflamed pancreas causing symptoms such as
severe pain in the upper abdomen or back
• a weakness of the heart muscle (known as heart
failure). You may notice swollen ankles, feel very
short of breath, cough up frothy phlegm, or feel
very tired. Medicines such as Piroxicam may
also be associated with a small increased risk of
heart attack (“myocardial infarction”, you may
have severe chest pain which spreads to the left
arm and jaw) or stroke (you may collapse, feel
numbness and weakness in the arms and legs,
have difficulty speaking)
• sudden wheeziness, difficulty in breathing,
swelling of eyes, face or lips, red, raised, itchy

This leaflet was last revised in 10/2014.

5. How to store Piroxicam
Keep this medicine out of the sight and reach of
children.

Not known (frequency cannot be estimated from
the available data):
• immune reaction called serum sickness-like
reaction, which causes fever, joint pain and hives.
The symptoms may be delayed, and are similar to
those seen with allergic reactions or infections.
• depression, nervousness, mood changes,
hallucinations, vivid dreams, confusion
• difficulty in getting to sleep
• numbness or pins and needles in the arms or legs
• swollen eyes, eye irritations
• loss of hearing
• inflamed blood vessels
• high blood pressure
• shortness of breath
• constriction of the muscles lining the airways of
lungs (bronchial)

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

skin rash or hives (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
• allergic reaction involving purple spots
on the skin, joint pain, abdominal pain
and kidney dysfunction (Henoch-Schoenlein
purpura).
Other side effects which may occur include:
Common side effects (may affect up to 1 in 10
people):
• fluid retention (especially swollen ankles)
• increase in blood sugar levels
• dizziness
• headache

Patients over 70 years of age
If you are over 70 years old, your doctor may wish

Talk to your doctor before taking Piroxicam:
• if you suffer from or have a previous history of
asthma (See also the ‘Do not take’ sub-section
above)
• if you have liver or kidney problems
• if you have high blood pressure, heart problems
or have had a stroke
• if you have a history of any other problems with
your stomach or gut (see also “Do not take” above)
• 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 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

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.

If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

The highest risk for occurrence of serious skin
reactions is within the first weeks of treatment.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

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.

Tell your doctor immediately, stop taking
Piroxicam and go to your nearest hospital
casualty department straight away if you have
any of the following serious side effects; you
may need medical attention:

4. Possible side effects

Additional signs to look for include ulcers in the
mouth, throat, nose, genitals and conjunctivitis
(red and swollen eyes).

If you develop a rash or these skin symptoms,
stop taking Piroxicam, seek urgent advice from
a doctor and tell them that you are taking this
medicine.

If you take more Piroxicam than you should
Contact your nearest hospital casualty
department immediately. Take the container and
any remaining medicine with you.

If you develop problems with your vision during
treatment you should have your eyes tested.

• anticoagulants such as warfarin to prevent
blood clots.
Tell your doctor before you take Piroxicam if you
are taking any of the following medicines:

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 take a double dose to make up for a
forgotten capsule.

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.

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.

The following medicines must not be taken with
Piroxicam:

Very rare side effects (may affect up to 1 in
10,000 people):

3. How to take Piroxicam

Other medicines and Piroxicam

• acetylsalicylic acid (aspirin) or other nonsteroidal anti-inflammatory drugs for pain relief

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.

discontinuing Piroxicam
• ciclosporin or tacrolimus (to prevent organ
rejection after transplant surgery)
• quinolone antibiotics (e.g. nalidixic acid or
“floxacins” such as ciprofloxacin)
• 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.

Your doctor will decide what dose you need. This
will depend on your age and the severity of your
condition.

If any of these apply to you tell your doctor
immediately.
Pregnancy, breast-feeding and fertility

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

Affiliate Item Code 463346
Superceded Affiliate Item Code 345323
TrackWise PR No. 463346
MA No. PL 04569/0151
Packing Site/Printer N/A
Supplier Code LL0432AG
Sign-offs

SAP No. N/A
Vendor Job No. 233638
Proof No. 5
Client Market UK
Keyline/Drawing No. N/A
Barcode Info 5016695680286

Adults: The maximum recommended daily dose
is 20 mg of Piroxicam as one single dose.
Older people
If you are more than 70 years old, 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
from potential side effects. You also should take
this medicine with or after food to reduce the
chance of problems with your stomach occurring.
Do not increase the dose. If you feel that your
medicine is not very effective, always talk to your
doctor.

If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.

Breast-feeding
Piroxicam may reach your baby through the
breast milk. Therefore, you must not take
piroxicam if you are breast-feeding.

Pregnancy
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. However, piroxicam may increase the risk
of miscarriage in early pregnancy.

Fertility
If you are trying to become pregnant or being
investigated for infertility, stopping piroxicam
should be considered as piroxicam can make it
more difficult for women to become pregnant.

No. of colours

Pharma Code TBC

Common side effects (may affect up to 1 in 10
people):

• 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 (aspirin), 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

Date: 13 OCT 2014
Description Piroxicam 20mg 28
Component Type Label Leaflet

• potentially life-threatening skin rashes (StevensJohnson syndrome, toxic epidermal necrolysis)
have been reported (see section 2). Symptoms
include a rash, with peeling of the skin or
blistering of skin, mouth, eyes or genitals.
Other potentially serious skin reactions with
symptoms such as a measles-like rash with small
red spots (erythema multiforme), an eczema like
skin rash with peeling of the skin, or blisters or
raised bumps on the skin that contain fluid, may
occur.
Not known (frequency cannot be estimated from
the available data):
• 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

Driving and using machines
Some side effects such as dizziness, drowsiness,
tiredness and blurred vision may occasionally
occur. Do not drive or use machines if your ability
to drive and use machines is reduced.

Time: 09:48

4

Page Count

Colours

Black

PMS
459

PMS
498
xxx

Non-Print
Colours

Braille

Varnish
Free

Keyline

1/1

PMS
306

Equate CMYK
with
Main Font Myriad Pro
Dimensions 52 x 101 mm

Body Text Size 7.5pt

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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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