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Active substance(s): PIROXICAM

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Package Leaflet: Information for the User



10mg and 20mg Capsules
Read all of this leaflet carefully before you
start taking this medicine.
• 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. Do

In this leaflet:
1. What Feldene is and what it is used for
2. Before you take Feldene
3. How to take Feldene
4. Possible side effects
5. How to store Feldene
6. Further information

Feldene is one of a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). This means it
will help to relieve pain and reduce swelling affecting
Feldene is used to relieve some symptoms caused by
osteoarthritis (joint disease), rheumatoid arthritis, and
ankylosing spondylitis (rheumatism of the spine) such as
swelling, stiffness and joint pain. This medicine does not
cure arthritis and will help you only as long as you
continue to take it.
Your doctor will only prescribe Feldene to you when you
have had unsatisfactory relief of symptoms with other

2. Before you take Feldene
Do not take Feldene
• If you have previously had or currently have a stomach
or intestinal ulcer, bleeding or perforation.

• If you have, or have previously had disorders

of the stomach or intestines such as ulcerative
colitis, Crohn’s disease, gastrointestinal cancers or
diverticulitis (inflamed or infected pouches/pockets in
the colon).
• If you are taking other NSAIDs such as ibuprofen,
celecoxib or acetylsalicylic acid (aspirin), a substance
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 reaction to piroxicam,

(the active ingredient in this medicine) or any of
the other ingredients, 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) or toxic epidermal necrolysis
(a disease with blistering and peeling of the top layer
of skin).
• If you have severe heart failure.
• If you are in the last three months of pregnancy.
If any of the above applies to you, tell your doctor
immediately and do not take Feldene.
Potentially life-threatening skin rashes (Stevens-Johnson
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
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, seek
immediate advice from a doctor and tell him that you are
taking this medicine.

Take special care with Feldene:
Before prescribing Feldene (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 during treatment with Feldene.
Medicines such as Feldene 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.
Tell your doctor before you take Feldene if you suffer
from or have suffered in the past from any of the
following conditions:
• liver disease
• kidney disease
• high blood pressure, heart problems or stroke
• high cholesterol or hardening of the arteries
• asthma
• diabetes
If you have or had any other medical problems or any
allergies or if you are not sure as to whether you can use
Feldene tell your doctor before taking this medicine.
You should stop taking Feldene immediately and tell
your doctor if you have any allergic reaction such as a
skin rash, swelling of the face, wheezing or difficulty

not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

1. What Feldene is and what it is used for

Continued overleaf


Before your take Feldene continued...
Take special care with Feldene as like all NSAIDs, Feldene
can cause serious reactions in the stomach and intestines,
such as pain, bleeding, ulceration and perforation.
You should stop taking Feldene immediately and tell your
doctor if you have stomach pain or any sign of bleeding in
the stomach or intestines, such as passing black or
bloodstained bowel movements or vomiting blood.
Your doctor may prescribe Feldene together with another
medicine to protect your stomach and intestines from side
effects, particularly if you are over 70 years old, or you are
taking other medicines like corticosteroids (medicines
given to treat a variety of conditions such as allergies and
hormone imbalances), certain medicines for depression
called selective serotonin reuptake inhibitors (SSRIs) or
low dose acetylsalicylic acid (aspirin) to help prevent heart
attacks or stroke.
Feldene 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
Patients over 70 years of age
If you are over 70 years old, your doctor may wish to
minimise the length of your treatment and to see you more
often while you are taking Feldene.
You should not take this medicine if you are over 80 years
of age.

your use of Feldene or other medicines, or you may need to
take a different medicine.
The following medicines must not be taken with Feldene:
• aspirin or other non-steroidal anti-inflammatory drugs
for pain relief
• anticoagulants such as warfarin to prevent blood clots
Tell your doctor before you take Feldene if you are taking
any of the following medicines:
• corticosteroids, which are medicines given to treat a
variety of conditions such as allergies and hormone
• low dose aspirin (75 mg) to help prevent heart attack or
• certain medicines used to treat heart conditions known
as cardiac glycosides, such as digoxin
• certain medicines for depression such as lithium or
selective serotonin re-uptake inhibitors (SSRIs)
• antihypertensives to treat high blood pressure
• methotrexate, which can be given to treat various
conditions such as cancers, psoriasis and rheumatoid
• ciclosporin or tacrolimus, which are given to help
prevent rejection of transplanted organs
• quinolone antibiotics e.g. ciprofloxacin, which are used
to treat various infections
• mifepristone, a medicine used to terminate pregnancy
• diuretics such as hydrochlorothiazide to treat high blood
pressure or kidney problems

Taking Feldene with food and drink

Feldene should be taken with or after food.

Pregnancy and breast-feeding
If you are pregnant, planning pregnancy or breast-feeding
tell your doctor before you take Feldene. Do not take
Feldene if you are in the last three months of pregnancy. 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.
If you are trying to become pregnant or being investigated
for infertility, withdrawal of Feldene should be considered.
Feldene may increase the risk of miscarriage in early
Ask your doctor or pharmacist for advice before taking any

Driving and using machinery

These capsules can cause some people to feel dizzy,
drowsy, tired or have problems with their vision. If you are
affected, do not drive or operate machinery.

Important information about some of the
ingredients of Feldene
Feldene contains lactose, a type of sugar. If you have been
told that you have an intolerance to some sugars, contact
your doctor before taking Feldene.

3. How to take Feldene
Always take Feldene 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 Feldene. Your doctor will
adjust your treatment to the lowest dose that best controls
your symptoms. Under no circumstances should you
change your dose without first speaking to your doctor.
Swallow your capsules whole with a glass of water. It is
best to take your capsules at the same time each day with
food or soon after eating.


The maximum daily dose of Feldene is 20 milligrams taken
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.
If you feel that the medicine is not very effective, always
talk to your doctor. Do not increase the dose.

If you take more Feldene than you should

If you accidentally take too much Feldene contact your
doctor at once or go to the nearest hospital casualty
department. Always take the labelled medicine package
with you, whether there is any Feldene left or not.

If you forget to take Feldene

Taking other medicines

If you forget to take a dose, take it as soon as you
remember unless it is time for your next dose. Do not take
a double dose to make up for a missed dose.
If you have any further questions on how to take this
product, ask your doctor or pharmacist.

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

For supplier use only (glued or folded area)

For supplier use only (glued or folded area)
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Tell your doctor immediately and stop taking Feldene if
you experience any of the following symptoms after taking
this medicine:
• any sign of bleeding in the stomach or intestines, such
as passing black or bloodstained bowel movements or
vomiting blood
• sudden wheeziness, difficulty in breathing, fever,
swelling of eyelids, face or lips, rash or itching
(especially affecting the whole body)
• a rash, blistering or peeling of the skin, mouth, eyes or
• yellowing of the skin and the whites of your eyes
(jaundice) which may be a sign of hepatitis or other liver
Common: may affect up to 1 in 10 people
• Changes in the red blood cells which may result in
unusual bruising or bleeding
• Changes in the white blood cells which may result in
increased risk of infection
• Anorexia
• Increase in blood sugar levels
• Dizziness
• Headache
• Vertigo (a spinning sensation)
• Drowsiness
• Ringing in ears (tinnitus)
• Abdominal pain/discomfort
• Constipation
• Diarrhoea
• Wind
• Feeling sick (nausea)

Being sick (vomiting)
Skin rash
Swelling of the feet, hands or other parts of the body
• Weight increase
Uncommon: may affect up to 1 in 100 people
• Blurred vision
• Fast or pounding heartbeat
• Sore mouth and/or lips
• Decreased/low blood sugar level
Rare: may affect up to 1 in 1,000 people
• Kidney inflammation
• Kidney failure
• Kidney damage
• Change in urine output or appearance
• Kidney pain or pain in abdomen
Very rare: may affect up to 1 in 10,000 people
• Potentially life-threatening skin rashes including peeling
skin, particularly around the mouth, nose, eyes and
genitals (Stevens-Johnson syndrome) or extensive
peeling of the skin (toxic epidermal necrolysis) (see
section 2)
Not known: frequency cannot be estimated from the
available data
• Abnormalities in the blood e.g. decreased haemoglobin
• Fluid retention
• Sudden wheeziness, difficulty in breathing, fever,
swelling of eyelids, face or lips, rash or itching
(especially affecting the whole body)
• Depression
• Dream abnormalities
• Hallucinations
• Changes in sleep patterns

Mental confusion
Mood alterations
Pins and needles
Eye irritations
Swollen eyes
Hearing impairment
High blood pressure
Inflammation of the blood vessels
Shortness of breath
Constriction of the muscles lining the airways of lungs
Nose bleeds
Inflammation of the stomach lining (gastritis)
Gastrointestinal bleeding including vomiting of blood
and black, tarry stools
Inflamed pancreas (which may lead to severe pain in the
upper abdomen or back)
Stomach (peptic) ulcers
Upset stomach
Hair loss
Allergic reaction involving purple spots on the skin, joint
pain, abdominal pain and kidney dysfunction (HenochSchoenlein purpura)
Rashes, blistering, peeling, itching, redness, tenderness,
thickening or scaling of skin
Loosening or splitting of fingernails
Increased sensitivity of the skin to sunlight
Decreased fertility
Feeling unwell, general aches and pains
Weight decrease
Yellowing of the skin and the whites of your eyes
Inflammation of the liver (hepatitis)
Increased risk of heart attack (myocardial infarction)
Increased risk of stroke

If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.

5. How to store Feldene
Keep all medicines out of the reach and sight of children.
Store below 30˚C.
Do not use Feldene after the expiry date which is stamped
on the carton and the bottle label. The expiry date refers to
the last day of that month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. Further information
What Feldene contains

The active substance in Feldene capsules is piroxicam.
Feldene comes in two strengths; 10mg or 20mg.
The other ingredients are: lactose, corn starch, vegetable
magnesium stearate and sodium lauryl sulphate.
The 10mg capsule shells contain gelatin, red iron oxide
(E172), indigotin (E132) and titanium dioxide (E171).
The 20mg capsule shells contain gelatin and titanium
dioxide (E171).

What Feldene looks like and contents of the pack
Feldene 10mg capsules are blue and red.
Feldene 20mg capsules are white.
The 10mg capsules come in containers of 30 and 20mg
capsules come in containers of 30.

Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
CT13 9NJ


Fareva Amboise
Zone Industrielle
29 route des Industries
37530 Pocé-sur-Cisse
This leaflet was last revised in 01/2015.
Pfizer Limited
Ref: FE 18_0

mock-up from 8814712

For supplier use only (glued or folded area)

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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.