PATIENT
INFORMATION LEAFLET (UK)
Please read this leaflet
This
leaflet tells you about Feldene Melt. Please read it
before you start to take your medicine. It will help
you. If you do not understand or you want to know
more, ask your doctor or pharmacist (chemist). Keep
this leaflet, you may want to read it again.
The name
of this medicine is Feldene Melt. The active
ingredient is piroxicam
What is
in your medicine?
Each tablet
contains 20mg piroxicam. Inactive ingredients: aspartame
(E951), citric acid anhydrous, gelatin and mannitol.
Contains a source of phenylalanine.
Your
medicine is supplied in a pack containing 28 tablets.
What
type of medicine is Feldene?
Piroxicam 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 and muscles.
What is
your medicine for?
Feldene is
used to relieve some symptoms caused by rheumatoid
arthritis, osteoarthritis 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.
Feldene is
also used to relieve other kinds of pain and to treat
other painful conditions such as: acute attacks of gout,
muscle sprains and muscle strains and pain following
dental, orthopaedic and minor surgery.
Before
taking your medicine
- Have
you had an allergic reaction to aspirin or other
medications used to treat painful joints and
muscles? This may have been itching, reddening of
the skin or difficulty in breathing.
- Have
you ever had an allergic reaction to Feldene Melt or
any other form of Feldene?
- Are
you under 16 years of age?
- Have
you got or ever had peptic (e.g. stomach) ulcers or
other inflammatory bowel disorders (e.g. Crohn's
Disease)?
- Have
you got severe heart failure?
If the
answer to any of these questions is
YES - DO NOT TAKE Feldene
Melt.
- Are
you pregnant or trying to become pregnant?
- Are
you breast feeding?
- Do
you have kidney disease?
- Do
you have liver disease?
- Do
you have high blood pressure or another heart
condition?
- Do
you have phenylketonuria?
- Do
you suffer from asthma or have you in the past?
- Are
you taking any of the following medicines?
-
anticoagulants such as warfarin to prevent blood
clots
-
antihypertensives to treat high blood pressure
-
methotrexate, which can be given to treat
various conditions such as cancers, psoriasis
and rheumatoid arthritis
-
corticosteroids, which are drugs given to treat
a variety of conditions such as allergies and
hormone imbalances
-
cyclosporin, which is given to help prevent
rejection of transplanted organs
-
quinolone antibiotics, which are used to treat
various infections
-
mifepristone, which is used to medically
terminate pregnancies
-
aspirin or other non-steroidal anti-inflammatory
drugs for pain relief
-
lithium to treat depression
-
diuretics such as hydrochlorothiazide to treat
high blood pressure or kidney problems
If the
answer to any of these
questions is YES - ask
your doctor or pharmacist before
taking Feldene Melt.
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. Do not exceed the recommended dose
or duration of treatment.
If you have
heart problems, previous stroke or think 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.
Remember to
tell your doctor that you are taking Feldene Melt if you
have a blood test or other test or are to have surgery
as it may affect the result.
If you are
over 65 years old your doctor may wish to see you
regularly.
Dosing
instructions
Feldene Melt
tablets should only be taken by mouth.
The usual
doses of this medicine are given below. Check with your
doctor if you are not sure why you have been prescribed
this medicine.
For rheumatoid arthritis,
osteoarthritis and ankylosing spondylitis
One 20mg
tablet each day.
As your
medicine helps to relieve the painful symptoms of
arthritis it is usual for it to be taken for long
periods of time. (Doses above 20mg daily for more
than several days carry an increased risk of effects
on the digestive system).
For acute attacks of gout
Two 20mg
tablets each day for 5 to 7 days.
For muscle sprains and
strains
Two 20mg
tablets each day on the first and second day then
one 20mg tablet each day for the next 5 to 12 days.
For pain following dental
and minor surgery
20mg
each day. Doses of 40mg on each of the first and
second days, then 20mg each day for the duration of
the treatment period may provide a more rapid onset
of action.
For pain following
orthopaedic surgery
40mg on
each of the first and second days, then 20mg each
day for the duration of the treatment period.
These
are the usual doses. Your doctor may prescribe
different doses to these. The label on the pack will
tell you what dose you should take and for how long.
If you are still not sure ask your doctor or
pharmacist.
How to
take Feldene Melt
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.
It is best
to take your tablets at the same time each day and with
food.
What
if you take too many tablets?
Too many
tablets at once may make you unwell. Contact your
doctor or your nearest casualty department at once.
What
if you miss a dose?
Do not
worry. Take the missed dose as soon as you remember.
However, if it is almost time for your next dose,
leave out the missed dose and take your next dose at
the right time.
YOU WILL
FIND MORE ABOUT FELDENE MELT BELOW
Does this medicine cause
undesirable effects?
Feldene Melt
may cause undesirable effects. These generally do not
cause a problem, however, if any of them are severe you
should contact your doctor immediately.
Most common undesirable
effects
Effects
on digestive system including:
-
diarrhoea or constipation, wind.
-
nausea, vomiting, loss of appetite.
-
sore mouth and/or lips.
-
stomach ache, indigestion, abdominal
pain/discomfort.
-
stomach (peptic) ulcers.
Since
there have been reports of gastro-intestinal
bleeding with Feldene it is important that vomiting
of blood, black or bloodstained bowel movements are
reported to your doctor immediately.
Medicines such as Feldene Melt may be associated
with a small increased risk of heart attack
(myocardial infarction) or stroke.
The
above undesirable effects are more likely to occur
if you are taking doses greater than 20mg daily of
Feldene Melt for long periods of time.
Other undesirable effects
are rare and include:
-
swollen ankles and/or feet. These effects may be
associated with other medical conditions. See
your doctor if these effects occur.
-
central nervous system effects: dizziness
(vertigo), headache, changes in sleep patterns,
depression, nervousness, hallucinations, mood
alterations, mental confusion, pins and needles.
-
serious skin effects (Stevens-Johnson syndrome,
toxic epidermal necrolysis (Lyell's Disease))
have rarely been reported with Feldene. See your
doctor if you have blistering, peeling or
burning of the skin.
-
other skin effects are usually mild: skin
rashes; itching, redness, tenderness, thickening
or scaling of skin, loosening or splitting of
fingernails; hairloss; increased sensitivity of
the skin to sunlight; unusual bruising or
bleeding; yellow skin or eyes.
-
changes in kidney function rarely, including
interstitial nephritis, nephrotic syndrome,
renal failure and renal papillary necrosis.
-
effects on the liver, which may include jaundice
(yellowing of the skin and/or eyes).
-
abnormalities in blood and other biochemical
tests. These effects may result in unusual
bruising or bleeding.
-
other rare undesirable effects: fever;
nosebleeds; hearing impairment; ringing in ears;
weight increase or decrease; swollen eyes,
blurred vision; eye irritation; shortness of
breath; fast or pounding heartbeat; feeling
unwell; unusual weakness or tiredness without
any other symptoms.
These
undesirable effects are usually mild but if they
cause you discomfort or are long lasting, check with
your doctor or pharmacist.
Allergic reactions
A few
patients are allergic to medicines. An allergic
reaction may be sudden wheeziness and/or difficulty
in breathing after taking the medicine. Also skin
rash, reddening of the skin, itching all over the
body or fever. If you think you are allergic to
Feldene Melt check with your doctor immediately.
Check
with your doctor or pharmacist if you become unwell
or have any other discomfort you do not understand.
Look
after your medicine
This
treatment is for YOU. Do not give it to others. It may
not suit them.
Do not take
this medicine after the date stamped on the pack.
Where to keep your medicine
-
Store below 25°C.
-
Keep all medicines out of the reach of children.
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