Active substance: PIROXICAM

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Ref: 0040/220713/1/F

Feldene® Gel 0.5%
Patient Information Leaflet
Read all of this leaflet carefully before you start
using 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.
Your medicine is called Feldene Gel 0.5% but will be
referred to as Feldene Gel throughout the leaflet.

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

What Feldene Gel is and what it is used

Feldene Gel 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 when rubbed
into the skin over the affected area.
Feldene Gel is for the treatment of rheumatism,
sprains, strains and mild osteoarthritis of joints
(knees, wrists, ankles etc).


Before you use Feldene Gel

Do not use Feldene Gel
• If you have ever had an allergic reaction to
Feldene Gel, any other form of piroxicam,
aspirin or any other medicines used to treat
painful joints and muscles. This may have been
itching, reddening of the skin or difficulty in
Use Feldene Gel with special care
Medicines are not always suitable for everyone.
Your doctor needs to know before you use Feldene
Gel if you suffer from or have suffered in the past
from any of the following conditions:
• liver disease.
• kidney disease.
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 restarted
on piroxicam at any time.
If you develop a rash or these skin symptoms, seek
immediate advice from a doctor and tell them that
you are taking this medicine.
Feldene Gel is not recommended for use in children
under 12 years of age.
Taking other medicines
Feldene Gel is not known to interact with any other
medicines. However, you should still tell your doctor
about any other medicines you are taking or
applying or have recently taken or applied including
medicines you bought yourself without a
Pregnancy and Breast-feeding
If you are pregnant or breast-feeding tell your doctor
before you use Feldene Gel.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
Feldene Gel is not expected to affect your ability to
drive or use machines.
Important information about some of the
ingredients of Feldene Gel
Feldene Gel contains propylene glycol which may
cause skin irritation.

3 How to use Feldene Gel
Always use Feldene Gel exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
Feldene Gel is for external use on the skin only.
Pierce the tube by reversing the cap and screwing
down to break the seal on the tube.
Apply 3cm (1¼” approximately) of the Gel on the
affected area. Use the scale below as a guide. Rub
the Gel into the skin until the Gel disappears. Do this
three or four times a day.
If there is no improvement in your symptoms, tell
your doctor. If the gel is not rubbed in completely,
mild but temporary staining of the skin and staining
of clothing may occur.

3 cm

Do not use Feldene Gel for more than four weeks
without telling your pharmacist or doctor.
Do not rub your medication into damaged skin, for
example wounds, scratches, infections or dermatitis.
Do not apply near eyes, nose, mouth, genital or anal
(bottom) areas. If the Gel does come into contact
with these areas, rinse away with water.
Do not cover the area where Feldene Gel has been
rubbed in with dressings or bandages.

After using Feldene Gel
1. Always replace the cap
2. Wash your hands
If you use too much or accidentally swallow
Feldene Gel
If you accidentally use too much Feldene Gel this is
unlikely to cause any side effects.
If a large amount of your medication is swallowed
accidentally, tell your doctor immediately, or contact
your nearest hospital casualty department.
If you forget to use Feldene Gel
If you forget to use Feldene Gel, use it as soon as
you remember unless it is time for your next
application. Do not use double the amount to make
up for a missed application.
If you stop using Feldene Gel
Your pain may return if you stop using Feldene Gel.
If you have any further questions on how to use this
product, ask your doctor or pharmacist.


Possible side effects

Like all medicines, Feldene Gel can cause side
effects, although not everybody gets them.
Tell your doctor immediately and stop using
Feldene Gel if you experience any of the following
symptoms after applying this medicine. Although
they are very rare, these symptoms can be
• sudden wheeziness, difficulty in breathing, fever,
swelling of eyelids, face or lips, rash or itching
affecting the whole body
• Potentially life-threatening skin rashes
(Stevens-Johnson syndrome, toxic epidermal
necrolysis) have been reported very rarely (see
section 2).
Other side effects that Feldene Gel may cause are:
• Redness, rash and/or itching of the skin where
Feldene Gel was rubbed in (for example eczema,
contact dermatitis)
• Reaction of the skin to sunlight

Storing your medicine
• Do not store above 30oC.
• 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


Further Information

What Feldene Gel contains
Your medicine contains 5mg of the active ingredient
piroxicam in every gram of gel.
Your medicine also contains the following inactive
ingredients: Benzyl alcohol, carbomer,
di-isopropanolamine, ethyl alcohol, hydroxyethyl
cellulose, propylene glycol and water.
What Feldene Gel looks like and contents of the
This tube contains 60g of transparent pale yellow
Manufacturer and Licence Holder
Feldene Gel is manufactured by Farmasierra
Manufacturing S.L., Ctra. Nacional I, km 26,200 28700 San Sebastian de los Reyes, Madrid, Spain,
and is procured from within the EU and repackaged
by the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.
Feldene is a registered trademark of Pfizer Products

POM PL 15184/0040
Leaflet revision date: 22/07/13

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Uncommon side effects are:
Nausea (feeling sick)
Stomach discomfort

These effects should disappear if you stop using
Feldene Gel. If the discomfort continues tell your
doctor or pharmacist.
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.


How to store Feldene Gel

Expiry Date
Do not use this medicine after the expiry date shown
on the carton label or tube.
If your doctor tells you to stop using this medicine,
return any unused gel to your pharmacist (chemist)
for safe disposal. Only keep this medicine, if your
doctor tells you to.
If the gel becomes discoloured or shows any other
signs of deterioration, consult your pharmacist
(chemist) who will tell you what to do.
Ref: 0040/220713/1/B

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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.