FELDENE GEL 0.5%

Active substance: PIROXICAM

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Ref: 0040/040714/1/F

Feldene ® Gel 0.5%
(piroxicam)
Patient Information Leaflet
Read all of this leaflet carefully before you start
using this medicine because it contains
important information for you.
• 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 only.
Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.

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.

Your medicine is called Feldene Gel 0.5% but will be
referred to as Feldene Gel throughout the leaflet.

If you develop a rash or these skin symptoms, seek
immediate advice from a doctor and tell them that
you are taking this medicine.

What is in this leaflet
1 What Feldene Gel is and what it is used for
2 What you need to know before you use
Feldene Gel
3 How to use Feldene Gel
4 Possible side effects
5 How to store Feldene Gel
6 Contents of the pack and other information
1 What Feldene Gel is and what it is used

for
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).

2 What you need to know before you use

Feldene Gel
Do not use Feldene Gel
• If you are allergic to piroxicam or any of the other
ingredients of this medicine (listed in section 6),
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 breathing.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Feldene Gel. 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 targetlike
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).

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.

NSAIDs, including Feldene Gel, may cause kidney
damage or kidney failure.
Children and adolescents
Feldene Gel is not recommended for use in children
under 12 years of age.
Other medicines and Feldene Gel
Feldene Gel is not known to interact with any other
medicines. Tell your doctor or pharmacist if you are
taking, have recently taken or might take any other
medicines.
Pregnancy, breast-feeding and fertility
If you are trying to become pregnant or being
investigated for infertility, withdrawal of Feldene Gel
should be considered. Feldene
Gel may increase the risk of miscarriage in early
pregnancy.
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking
this medicine.
Driving and using machines
Feldene Gel is not expected to affect your ability to
drive or use machines.
Feldene Gel contains propylene glycol
Feldene Gel contains propylene glycol which may
cause skin irritation.

3 How to use Feldene Gel
Always use this medicine exactly as your doctor or
pharmacist has told you. 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 (1 ¼” 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.
SCALE:

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 take
this medicine, 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 using
Feldene Gel if you experience any of the following
symptoms after applying this medicine. Although
they are very rare, these symptoms can be serious:
• 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)

If the gel becomes discoloured or shows any other
signs of deterioration, consult your pharmacist
(chemist) who will tell you what to do.
Storing your medicine
• KEEP THIS MEDICINE OUT OF THE SIGHT
AND REACH OF CHILDREN.
• 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
environment.

6

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
pack
This tube contains 60g of transparent pale yellow
gel.
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
Inc.

POM

PL 15184/0040

Leaflet revision date: 04/07/14

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

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
Uncommon side effects are:
• Nausea (feeling sick)
• Indigestion
• Stomach discomfort
These effects should disappear if you stop using
Feldene Gel. If the discomfort continues tell your
doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

5

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.
Ref: 0040/040714/1/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.

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