FELDENE MELT 20MG TABLETS

Active substance: PIROXICAM

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Patient Information Leaflet







UNITED KINGDOM

Feldene Melt
20 mg piroxicam


Read all of this leaflet carefully before you
start taking this medicine.

• Keep this leaflet. You may need to read it again.
I
• f you have any further questions, ask your doctor
or pharmacist.
•  his medicine has been prescribed for you. Do
T
not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
I
• f 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.

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

1.  hat Feldene Melt is and what it is
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used for
Feldene Melt 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 Melt 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 Melt to you when
you have had unsatisfactory relief of symptoms with other
NSAIDs.

2. Before you take Feldene Melt
Do not take Feldene Melt

• f you have previously had or currently have a stomach
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or intestinal ulcer, bleeding or perforation.
• f you have, or have previously had disorders of the
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stomach or intestines such as ulcerative colitis, Crohn’s
disease, gastrointestinal cancers or diverticulitis
(inflamed or infected pouches/pockets in the colon).
• f you are taking other NSAIDs such as ibuprofen,
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celecoxib or acetylsalicylic acid (aspirin), a substance
present in many medicines used to relieve pain and
lower fever.
• f you are taking anticoagulants, such as warfarin, to
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prevent blood clots.
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• f 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.

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:
•  spirin or other non-steroidal anti-inflammatory drugs
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for pain relief
• anticoagulants such as warfarin to prevent blood clots
Tell your doctor before you take Feldene Melt if you are
taking any of the following medicines:
•  orticosteroids, which are medicines given to treat a
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variety of conditions such as allergies and hormone
imbalances
• ow dose aspirin (75mg) to help prevent heart attack or
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stroke
•  ertain medicines used to treat heart conditions known
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as cardiac glycosides, such as digoxin
•  ertain medicines for depression such as lithium or
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selective serotonin re-uptake inhibitors (SSRIs)
• antihypertensives to treat high blood pressure
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•  ethotrexate, which can be given to treat various conditions
such as cancers, psoriasis and rheumatoid arthritis
•  iclosporin or tacrolimus, which are given to help
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prevent rejection of transplanted organs
•  uinolone antibiotics e.g. ciprofloxacin, which are used
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to treat various infections
• mifepristone, a medicine used to terminate pregnancy
•  iuretics such as hydrochlorothiazide to treat high blood
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pressure or kidney problems.

Taking Feldene Melt with food and drink

Feldene Melt 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 Melt. Do not
take Feldene Melt 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
pregnancy.
Ask your doctor or pharmacist for advice before
taking any medicine.

Driving and using machinery

These tablets 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 Melt

Feldene Melt contains a source of phenylalanine.
May be harmful for people with phenylketonuria.

3. How to take Feldene Melt
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 Melt. 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.

Adults:

The maximum daily dose of Feldene Melt is 20 milligrams

taken as one single daily dose.

If any of the above applies to you, you should 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 Melt

Before prescribing Feldene Melt (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 Melt 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 Melt 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
• phenylketonuria (PKU) which is a genetic disorder.
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.
Your doctor may prescribe Feldene Melt 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 attack or stroke.
Feldene Melt 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 Melt.
You should not take this medicine if you are over 80 years
of age.

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.

How to remove the tablets

Your tablets are in a new type of packaging. Do not try
to push the tablets through the foil as this will break the
tablet. Instead follow the instructions.
•  old the packet of tablets with the flat, printed side
H
facing you.
•  eel back the loose flap at the edge of the packet to
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reveal a tablet.
• Tip the tablet into the palm of your hand.
• Place the tablet on your tongue and close your mouth.
The tablet will dissolve within a few seconds. If you prefer,
you can swallow the tablet with some water.

If you take more Feldene Melt than you should

If you accidentally take too much Feldene Melt 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 Melt left or not.

If you forget to take Feldene Melt

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 the use of this product,
ask your doctor or pharmacist.

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
Melt if you experience any of the following symptoms after
taking this medicine:
•  ny sign of bleeding in the stomach or intestines, such
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as passing black or bloodstained bowel movements or
vomiting blood
•  udden wheeziness, difficulty in breathing, fever,
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swelling of eyelids, face or lips, rash or itching
(especially affecting the whole body)
•  rash, blistering or peeling of the skin, mouth, eyes or
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genitals
•  ellowing of the skin and the whites of your eyes
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(jaundice) which may be a sign of hepatitis or other liver
problems
Common: may affect up to 1 in 10 people
•  hanges in the red blood cells which may result in
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unusual bruising or bleeding
•  hanges in the white blood cells which may result in
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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)
• Indigestion
• Itching
• Skin rash
•  welling of the feet, hands or other parts of the body
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(oedema)
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• 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
•  otentially life-threatening skin rashes including peeling
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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
•  bnormalities in the blood e.g. decreased haemoglobin
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• Fluid retention
•  udden wheeziness, difficulty in breathing, fever,
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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
• Nervousness
• Pins and needles
• Eye irritations
• Swollen eyes
• Hearing impairment
• High blood pressure
• Inflammation of the blood vessels
• Shortness of breath
•  onstriction of the muscles lining the airways of lungs
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(bronchial)
• Nose bleeds
• Inflammation of the stomach lining (gastritis)
•  astrointestinal bleeding including vomiting of blood and
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black, tarry stools
• nflamed pancreas (which may lead to severe pain in the
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upper abdomen or back)
• Stomach (peptic) ulcers
• Upset stomach
• Hair loss
•  llergic reaction involving purple spots on the skin, joint
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pain, abdominal pain and kidney dysfunction (HenochSchoenlein purpura)
•  ashes, blistering, peeling, itching, redness, tenderness,
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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
•  ellowing of the skin and the whites of your eyes
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(jaundice)
• 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 Melt
Keep all medicines out of the reach and sight
of children.
Do not store above 25°C.

Do not use Feldene Melt after the expiry date which is
stamped on the carton and the blister foil. 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 Melt contains

The active substance in Feldene Melt is piroxicam 20 mg.
Other ingredients are aspartame (E951), citric acid
anhydrous, gelatin and mannitol.

What Feldene looks like and contents of the pack

Feldene Melt tablets are white to off-white and are supplied
in a pack containing 30 tablets.

Marketing Authorisation Holder
Pfizer Limited,
Ramsgate Road,
Sandwich,
Kent,
CT13 9NJ,
United Kingdom.

Manufacturer

Haupt Pharma Latina S.r.l.
Latina (LT)
Strada Statale 156 Km 47,600
04100 Borgo San Michele
Italy
This leaflet was last revised 12/2013.
©Pfizer Limited Ref: FE 12_2

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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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