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FELDENE MELT 20MG

Active substance(s): 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.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you.
Do 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.

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. What Feldene Melt is and what it is
used for
Feldene Melt is one of a group of medicines called
non-steroidal 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.

Do not take Feldene Melt
• 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

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.
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
drugs 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:
• corticosteroids, which are medicines given to
treat a variety of conditions such as allergies and
hormone imbalances
• low dose aspirin (75mg) 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 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 breastfeeding 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.
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.
• Hold the packet of tablets with the flat, printed
side facing you.
• Peel back the loose flap at the edge of the packet
to 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.
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2. Before you take Feldene Melt

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skin reactions (regardless of severity) such as
exfoliative dermatitis (intense reddening of skin,
with skin peeling off in scales or layers), StevensJohnson 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, you should
tell your doctor immediately and do not take
Feldene.
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.
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.

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:
• 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
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)
• Indigestion
• Itching
• Skin rash
• Swelling of the feet, hands or other parts of the
body (oedema)
• 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
• Nervousness
• 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 (bronchial)
• 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 (Henoch-Schoenlein 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
(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.
Store below 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 03/2015.
©Pfizer Limited Ref: FE 17_1

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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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