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PIROXICAM CAPSULES 20MG

Active substance: PIROXICAM

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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 beds).
• stomach and intestines: abdominal
discomfort, loss of appetite,
constipation, diarrhoea, wind, feeling or
being sick, inflammation of the mouth,
ulcerative stomatitis, 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,
impaired hearing, inability to sleep,
irritability, confusion, hallucinations,
memory disturbance, nightmares,
‘pins and needles’, psychotic reactions,
ringing or buzzing in the ears, tremor,
taste disturbances.
• 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),
nosebleeds.
• other: palpitations, inflammation of
the blood vessels, difficulty breathing,
positive anti-nuclear antibody test,
low blood sugar, increase or decrease
in weight, swollen eyes, eye irritation,
a feeling of general discomfort and
illness.

5 How to store Piroxicam

capsules

Keep out of the reach and sight 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/
carton/bottle.
Ask your pharmacist how to dispose of
medicines no longer required.

6 Further information

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 and are
in pack sizes of 56.
Piroxicam 20mg capsules are pink hard
gelatin capsules and are in pack sizes
of 28.
Marketing Authorisation Holder and
Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.

Piroxicam 10mg and 20mg
Capsules
Read all of this leaflet carefully
before you start taking this
medicine.
•  eep this leaflet. You may need to
K
read it again.
•  f you have any further questions, ask
I
your doctor or pharmacist.
•  his medicine has been prescribed
T
for you. Do not pass it on to others.
It may harm them, even if their
symptoms are the same as yours.

In this leaflet:
1  What Piroxicam capsules are
and what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information
1 What Piroxicam capsules are

and what they are used for

This leaflet was last revised in
November 2014.

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 and will tell you
how often you need to be checked.
Piroxicam belongs to a group of pain
killers called Non-Steroidal AntiInflammatory 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.

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.

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50826901 AAAH4241

Actavis, Barnstaple, EX32 8NS, UK

2 Before you take Piroxicam

capsules

Do not take Piroxicam capsules
and tell your doctor or pharmacist
if you:

• are allergic (hypersensitive) to

piroxicam or any of the other
ingredients in Piroxicam capsules (see
section 6).
• are allergic to aspirin or other
non-steroidal anti-inflammatory
medicines (NSAIDs) and have
developed signs of asthma, nasal
polyps, runny nose, swelling of the
face, lips, throat or tongue or a serious
skin reactions such as exfoliative
dermatitis (intense reddening of skin,
with skin peeling off ), Stevens-Johnson
syndrome (red blistered, eroded,
bloody or crusted skin) and toxic
epidermal necrolysis, (blistering and
peeling of the top layer of skin).
• suffer from severe heart failure.
• have or have had a stomach or
intestinal ulcer, bleeding or
perforation.
• have or have had a history of
gastrointestinal disorders with a
tendancy 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.
• are taking anticoagulants, such as
warfarin, to prevent blood clots.

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260x210 Leaflet Reel Fed Bi Fold Profile (BST)

Piroxicam Capsules
10 & 20mg x 28 & 56’s (UK)
JDE No.:

Piroxicam 10mg & 20mg 28 & 56 Capsules PIL - UK
item no: AAAH4241
print proof no: 2

Dimensions: 260x210 (Reel Fed)
Component: Leaflet for Bottle

pharmacode:

origination date: 13.11.14

50826901

dimensions: 260 x 210 reel fed

min pt size: 7.5

Pharmacode: 2101

revision date: 20.11.14

Technical Approval

Date Sent:
02/10/14
Technologist: R.Wrey

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date:

Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

Non Printing Colours
1.
2.
3.

• cardiac glycosides (e.g. digoxin) to

Check with your doctor or
pharmacist before taking
Piroxicam capsules if you:

• have or have had asthma.
• 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
pharmacist.
• have any liver or kidney problems.
• have any eye problems.
• suffer with systemic lupus
erythematosus or other connective
tissue disorders.
• 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.

Taking other medicines

Please tell your doctor or pharmacist if
you are taking, or have recently taken any
other medicines, including medicines
obtained without a prescription. 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
celicoxib).
• medicines to treat high blood
pressure such as lisinopril, iloprost or
losartan.

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
mifepristone.
• 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
venlafaxine
• any drug to prevent platelet
clumping such as aspirin or
clopidogrel.
• colestyramine to reduce cholesterol
levels.
• medicines which increase the risk
of bleeding such as sibutramine or
pentoxifylline.
• penicillamine for rheumatic disease.

3 How to take Piroxicam

4 Possible side effects

Like all medicines, Piroxicam capsules
can cause side effects, although not
everybody gets them.

capsules

Always take Piroxicam capsules exactly
as your doctor has told you. If you are
not sure, check with your doctor or
pharmacist.
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 checkups to make sure you are taking the best
dose of piroxicam and 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 may prescribe another
medicine to protect your stomach and
intestines from potential side effects.
Dose
• 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
treatment.
• Children under 12 years: Piroxicam
capsules should not be taken by
children under 12 years of age.

Pregnancy and breast-feeding

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 breastfeeding, you should not take Piroxicam
capsules.

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 fits.

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.

Stop taking Piroxicam capsules and
contact your doctor immediately if you
notice signs of:
• 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.
• indigestion or heartburn. Abdominal
pain (pains in your stomach) or other
abnormal stomach symptoms.
• 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
(hepatitis).
• kidney disease or failure.
• an allergic reaction: narrowing of the
airways causing difficulty breathing or
swallowing, 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
nodes).
• 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).
• 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, tiredness, feeling ill and your eyes
become very sensitive to bright light.

If you forget to take Piroxicam
capsules

Sugar intolerance

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
double the dose to make up for one you
have missed.

Eye test

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

Continued over page

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50826901 AAAH4241

Continued top of next column

page 2

page3

260x210 Leaflet Reel Fed Bi Fold Profile (BST)

Piroxicam Capsules
10 & 20mg x 28 & 56’s (UK)
JDE No.:

Piroxicam 10mg & 20mg 28 & 56 Capsules PIL - UK
item no: AAAH4241
print proof no: 2

Dimensions: 260x210 (Reel Fed)
Component: Leaflet for Bottle

pharmacode:

origination date: 13.11.14

50826901

dimensions: 260 x 210 reel fed

min pt size: 7.5

Pharmacode: 2101

revision date: 20.11.14

Technical Approval

Date Sent:
02/10/14
Technologist: R.Wrey

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date:

Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

Non Printing Colours
1.
2.
3.

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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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