PATIENT
INFORMATION LEAFLET (UK)
Please read this leaflet
This
leaflet tells you about Feldene IM. If you do not
understand or you want to know more, ask your doctor
or nurse. Keep this leaflet, you may want to read it
again.
The name
of this medicine is Feldene IM. The active
ingredient is piroxicam.
What is
in your medicine?
Each ampoule
contains piroxicam 20mg per ml of solution. Inactive
ingredients: benzyl alcohol, ethanol, hydrochloric acid
(E507), nicotinamide, propylene glycol, sodium
dihydrogen phosphate (E339), sodium hydroxide and water.
Your
medicine comes in an ampoule containing 20mg (1ml) of
piroxicam.
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 IM
is used to relieve the flare-up symptoms of rheumatoid
arthritis, osteoarthritis and ankylosing spondylitis
(rheumatism of the spine) such as swelling, stiffness
and joint pain.
Feldene IM
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
you are given 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 IM or
any other form of Feldene?
- Are
you under 16 years of age?
- Have
you got or ever had peptic (eg stomach) ulcers or
other inflammatory bowel disorders (eg Crohn's
Disease)?
- Have
you got severe heart failure?
If the
answer to any of these questions is
YES - TELL YOUR DOCTOR OR
NURSE IMMEDIATELY FELDENE IM IS NOT SUITABLE FOR YOU
- 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 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 - tell
your doctor or nurse before
you are given Feldene IM.
Medicines
such as Feldene IM 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 the doctor that you have been given Feldene IM if
you have a blood test or other test or are to have
surgery as Feldene IM may affect the result.
If you are
over 65 years old your doctor may wish to see you
regularly.
Dosing
instructions
Your
medicine is for intramuscular injection only.
The usual
doses of your medicine are given below. Check with your
doctor if you are not sure why you are being given this
medicine.
For rheumatoid arthritis,
osteoarthritis and ankylosing spondylitis
One 20mg
(1ml) injection each day.
Your
medicine is used for the initial treatment of the
painful symptoms of arthritis. After one to three
days you may be switched to an oral treatment to
help to continue relieving the symptoms of
arthritis.
For acute attacks of gout
One 40mg
(2ml) injection each day. Treatment is usually for 5
to 7 days. You may be switched onto an oral
treatment (after 1 to 2 days) instead of continuing
to have injections.
For muscle sprains and
strains
One 40mg
(2ml) injection each day on the first and second day
then one 20mg (1ml) injection each day for the next
5 to 12 days. After 1-2 days you may be switched to
an oral treatment instead of continuing to have
injections. (Doses above 20mg daily for more than
several days carry an increased risk of effects on
the digestive system).
For pain following dental
and minor surgery
20mg
(1ml) injection each day. Doses of 40mg (2ml)
injection on each of the first and second days, then
20mg (1ml) injection each day for the duration of
the treatment period may provide a more rapid onset
of action
For
pain following orthopaedic surgery
40mg
(2ml) injection on each of the first and second
days, then 20mg (1ml) injection each day for the
duration of the treatment period.
These
are the usual doses. Doctors sometimes prescribe
different doses to these. Ask your doctor or nurse
if you want to know what doses you are being given.
How Feldene IM is given
Your
medicine is given by deep intramuscular injection into
the upper, outer quadrant of the buttock.
YOUR
MEDICINE SHOULD NOT be given intravenously.
YOU WILL FIND
MORE ABOUT FELDENE IM BELOW
Does
this medicine cause undesirable effects?
Feldene IM
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 IM 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 being given doses greater than 20mg daily
of Feldene IM for more than several days duration.
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.
-
short lasting pain may occur following injection
of your medicine and a burning sensation or
abscess at the site of injection may result.
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, this may cause
sudden wheeziness, rash or itching all over the
body. If any of these effects occur when you are
given Feldene IM tell your doctor immediately.
Tell
your doctor or nurse 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.
This
medicine will not be given to you 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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