FELDENE 20MG CAPSULES

Active substance: PIROXICAM

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Package Leaflet: Information for the User

Feldene



10mg and 20mg Capsules
piroxicam
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. hat Feldene is and what it is used for
W
2. efore you take Feldene
B
3. ow to take Feldene
H
4. ossible side effects
P
5. ow to store Feldene
H
6. urther information
F

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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
joints.
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
NSAIDs.

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 of 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
eyes).
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
breathing.
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.



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



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Before your take Feldene continued...
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 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
pregnant.
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.

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 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
medicines 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:

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• corticosteroids, which are medicines given to treat a

variety of conditions such as allergies and hormone
imbalances
• low dose aspirin (75 mg) to help prevent heart attack or
stroke
• 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
arthritis
• 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.
Ask your doctor or pharmacist for advice before taking
any medicine.

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.

Adults:

The maximum daily dose of Feldene is 20 milligrams taken
as one single daily dose.

Elderly:

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

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.

4. Possible side effects
Like all medicines, Feldene 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
genitals
• yellowing of the skin and the whites of your eyes
(jaundice) which may be a sign of hepatitis or other liver
problems
The most commonly reported side effects with Feldene are:
• diarrhoea or constipation, wind
• feeling sick (nausea), vomiting, loss of appetite
• sore mouth and/or lips
• stomach ache, indigestion, abdominal pain/discomfort
• stomach (peptic) ulcers.
Other side effects that have been reported include:
Effects on your heart and circulation: fast or pounding
heartbeat, high blood pressure, swollen ankles and/
or feet (oedema). Medicines such as Feldene may be
associated with a small increased risk of heart attack
(myocardial infarction) or stroke.
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Effects on your nervous system: dizziness, vertigo
(a spinning sensation), headache, changes in sleep
patterns, depression, nervousness, hallucinations, mood
alterations, mental confusion, pins and needles.
Effects on your skin: rashes, itching, redness,
tenderness, thickening or scaling of skin, loosening or
splitting of fingernails, hair loss and increased sensitivity
of the skin to sunlight. Potentially life-threatening skin
rashes (Stevens-Johnson syndrome, toxic epidermal
necrolysis) have been reported very rarely (see section
2).
Effects on your kidneys: kidney inflammation, kidney
failure or kidney damage. If you notice any change in
your urine output or appearance, possibly accompanied
by kidney pain, or pain in your abdomen or back contact
your doctor.
Effects on blood and medical tests: abnormalities in
blood and other biochemical tests. These effects may
result in unusual bruising or bleeding or increased risk
of infection. Changes in blood sugar levels may also
occur.
Effects on your eyes and ears: hearing impairment,
ringing in ears, swollen eyes, blurred vision, eye
irritation.
Other effects: fever, nosebleeds, weight increase or
decrease, inflamed pancreas (which may lead to severe
pain in the upper abdomen or back), feeling unwell,
unusual weakness or tiredness without any other
symptoms.
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.

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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

Marketing Authorisation Holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13
9NJ, UK.

Manufacturer
Pfizer PGM Amboise
Zone industrielle – 29 route des Industries
37530- Pocé-sur-Cisse
France
This leaflet was last revised 07/2012
Pfizer Limited
Ref: FE 9_1

©

The active substance in Feldene capsules is piroxicam.
Feldene comes in two strengths; 10mg or 20 mg.
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 10 mg capsules are blue and red.
Feldene 20 mg capsules are white.
The 10mg capsules come in containers of 30 and 20mg
capsules come in containers of 30.

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MOCKUP from 8814710

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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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